Strategies To Prevent Weight Gain Among Adults

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Strategies To Prevent Weight Gain in Adults: Future Research Needs

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Future Research Needs Paper
Number 43

Strategies To Prevent
Weight Gain in Adults:
Future Research Needs
Future Research Needs Paper
Number 43

Strategies To Prevent Weight Gain in Adults:


Future Research Needs

Identification of Future Research Needs From Comparative Effectiveness Review


No. 97

Prepared for:
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
540 Gaither Road
Rockville, MD 20850
www.ahrq.gov

Contract No. 290-2007-10061-I

Prepared by:
Johns Hopkins University Evidence-based Practice Center
Baltimore, MD

Investigators:
Kimberly A. Gudzune, M.D., M.P.H.
Brandyn D. Lau, M.P.H., C.P.H.
Susan Hutfless, Ph.D.
Chad Boult, M.D., M.P.H., M.B.A.
Jodi B. Segal, M.D., M.P.H.

AHRQ Publication No. 13-EHC083-EF


June 2013
Addendum August 2013
Addendum
August 5, 2013

The report Strategies To Prevent Weight Gain in Adults: Future Research Needs was posed
for public comment from June 27, 2013, to July 26, 2013, on the Effective Health Care Program
Web site. We received three sets of comments.

In response to the comments received, the authors add the following discussion point:
• Adults with physical disability may need to be considered as an additional subgroup at
high risk for obesity and targeted for weight gain prevention interventions. If this group is
selected, then investigators should consider including additional outcome measures such
as health-related quality of life and physical function.

All other comments were related to gaps outside the scope of the original systematic review
including endocrine and hormonal causes of weight gain, and the association of geographic
positioning data and weight gain. These comments were considered, and no other changes were
made in this report.

ii
This report is based on research conducted by the Johns Hopkins University Evidence-based
Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality
(AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this
document are those of the author(s), who are responsible for its contents; the findings and
conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this
report should be construed as an official position of AHRQ or of the U.S. Department of Health
and Human Services.

The information in this report is intended to help health care researchers and funders of research
make well-informed decisions in designing and funding research and thereby improve the quality
of health care services. This report is not intended to be a substitute for the application of
scientific judgment. Anyone who makes decisions concerning the provision of clinical care
should consider this report in the same way as any medical research and in conjunction with all
other pertinent information, i.e., in the context of available resources and circumstances.

This document is in the public domain and may be used and reprinted without permission.
Citation of the source is appreciated.

Persons using assistive technology may not be able to fully access information in this report. For
assistance contact [email protected].

None of the investigators have any affiliations or financial involvement that conflicts with the
material presented in this report.

Suggested citation: Gudzune KA, Lau BD, Hutfless S, Boult C, Segal JB. Strategies To Prevent
Weight Gain Among Adults: Future Research Needs. Future Research Needs Paper No. 43.
(Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No.
290-2007-10061-I.) AHRQ Publication No. 13-EHC083-EF. Rockville, MD: Agency for
Healthcare Research and Quality; June 2013. Addendum August 2013.
www.effectivehealthcare.ahrq.gov.

iii
Preface
The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based
Practice Centers (EPCs), sponsors the development of evidence reports and technology
assessments to assist public- and private-sector organizations in their efforts to improve the
quality of health care in the United States. The reports and assessments provide organizations
with comprehensive, science-based information on common, costly medical conditions and new
health care technologies and strategies. The EPCs systematically review the relevant scientific
literature on topics assigned to them by AHRQ and conduct additional analyses when
appropriate prior to developing their reports and assessments.
An important part of evidence reports is to not only synthesize the evidence, but also to
identify the gaps in evidence that limited the ability to answer the systematic review questions.
AHRQ supports EPCs to work with various stakeholders to identify and prioritize the future
research that is needed by decisionmakers. This information is provided for researchers and
funders of research in these Future Research Needs papers. These papers are made available for
public comment and use and may be revised.
AHRQ expects that the EPC evidence reports and technology assessments will inform
individual health plans, providers, and purchasers as well as the health care system as a whole by
providing important information to help improve health care quality. The evidence reports
undergo public comment prior to their release as a final report.
We welcome comments on this Future Research Needs document. They may be sent by mail
to the Task Order Officer named below at: Agency for Healthcare Research and Quality, 540
Gaither Road, Rockville, MD 20850, or by email to [email protected].

Carolyn M. Clancy, M.D. Jean Slutsky, P.A., M.S.P.H.


Director Director, Center for Outcomes and Evidence
Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality

Stephanie Chang, M.D., M.P.H. Christine Chang, M.D., M.P.H.


Director, EPC Program Task Order Officer
Center for Outcomes and Evidence Center for Outcomes and Evidence
Agency for Healthcare Research and Quality Agency for Healthcare Research and Quality

iv
Acknowledgments
The Johns Hopkins University Evidence-based Practice Center thanks the other authors of
the comparative effectiveness review on weight gain prevention in adults and the stakeholders
(each listed below).

Contributors
Caroline Apovian, M.D., FACP, FACN
Boston Medical Center
Boston, MA

Bethany Barone Gibbs, Ph.D.


University of Pittsburgh
Pittsburgh, PA

Kathy McCaskey
Patient Stakeholder
Lancaster, PA

Jeri Miller, Ph.D.


National Institutes of Health
Bethesda, MD

Richard Safeer, M.D.


Johns Hopkins HealthCare
Baltimore, MD

Selen Saydam
Patient Stakeholder
Columbia, MD

Lindsey Wilsnack
Employer Representative
Baltimore, MD

v
Strategies To Prevent Weight Gain in Adults:
Future Research Needs
Structured Abstract
Objective. To identify and prioritize questions for future research in adult weight gain
prevention.

Methods. We identified potential research needs based on gaps identified from a recent
systematic review, and then engaged seven stakeholders to participate in a Delphi process to
prioritize PICOTS (populations, interventions, comparisons, outcomes, timing, settings)
elements. We then used these results to create research questions, which our stakeholders
prioritized.

Results. Based on consensus, seven questions were of highest priority: (1) To prevent weight
gain in all adults, what is the comparative effectiveness of adding physical activity versus not
adding physical activity to a work-based self-management and diet intervention? (2) To prevent
weight gain in all adults, what is the comparative effectiveness of adding physical activity versus
not adding physical activity to a home-based self-management and diet intervention? (3) To
prevent weight gain in all adults, what is the comparative effectiveness of a work-based self-
management and physical activity intervention versus a self-management and diet intervention?
(4) To prevent weight gain in all adults, what is the comparative effectiveness of a home-based
self-management and physical activity intervention versus a self-management and diet
intervention? (5) To prevent weight gain in overweight (body mass index [BMI] ≥27kg/m2)
adults, what is the comparative effectiveness of adding physical activity versus not adding
physical activity to a home-based self-management and diet intervention? (6) To prevent weight
gain in overweight (BMI ≥27kg/m2) adults, what is the comparative effectiveness of a home-
based self-management and physical activity intervention versus a self-management and diet
intervention? (7) To prevent weight gain in young adults (age 18–35), what is the comparative
effectiveness of adding physical activity versus not adding physical activity to a home-based
self-management and diet intervention?

Conclusion. Stakeholders prioritized strategies to prevent weight gain for all/overweight/young


adults in work/home settings, as they may lead to significant benefits from avoiding obesity.
Rigorous studies that evaluate high-quality interventions addressing these topics are needed.

vi
Contents
Executive Summary .................................................................................................................ES-1
Background ....................................................................................................................................1
Context .......................................................................................................................................1
Evidence Gaps ...........................................................................................................................2
Objective ....................................................................................................................................2
Methods ...........................................................................................................................................3
Identification of Evidence Gaps.................................................................................................3
Criteria for Prioritization............................................................................................................4
Delphi Round 1: Prioritization of Populations, Interventions, Outcomes, and Settings......4
Delphi Round 2: Prioritization of Populations, Interventions, and Comparisons................5
Delphi Round 3: Prioritization of Components of Interventions and Research
Questions..............................................................................................................................5
Delphi Round 4: Ranking of Prioritized Research Questions .............................................6
Engagement of Stakeholders, Researchers, and Funders...........................................................6
Identification and Recruitment of Stakeholders ..................................................................6
Orientation of Stakeholders .................................................................................................6
Research Question Development ...............................................................................................7
Research Design Considerations................................................................................................7
Identification of Ongoing Studies ..............................................................................................7
Results .............................................................................................................................................8
Research Needs ..........................................................................................................................8
Research Questions ..................................................................................................................13
Study Design Considerations ...................................................................................................14
Identification of Ongoing Studies ............................................................................................15
Discussion......................................................................................................................................16
Conclusion ....................................................................................................................................18
References .....................................................................................................................................19

Tables
Table A. Key Questions of the comparative effectiveness review ............................................ES-1
Table B. Questions prioritized for future research.....................................................................ES-4
Table 1. Key Questions of the comparative effectiveness review ...................................................1
Table 2. Summary of the strength of evidence from the comparative effectiveness review ...........3
Table 3. Composition of stakeholders group ...................................................................................6
Table 4. Stakeholder priority ratings for population gaps for future research in strategies to
prevent weight gain in adults ...........................................................................................................8
Table 5. Stakeholder rating for the highest and lowest priority strategy gaps for future
research in strategies to prevent weight gain in adults ..................................................................10
Table 6. Stakeholder rating for the highest and lowest priority combination strategy gaps
for future research in strategies to prevent weight gain in adults ..................................................10
Table 7. Highest priority components of dietary interventions .....................................................11
Table 8. Highest priority components of physical activity interventions ......................................11

vii
Table 9. Stakeholder rating for the highest priority comparison strategy gaps for future
research in strategies to prevent weight gain in adults ..................................................................12
Table 10. Stakeholder rating for the highest and lowest priority secondary outcome gaps for
future research in strategies to prevent weight gain in adults ........................................................12
Table 11. Stakeholder rating for the highest and lowest priority setting gaps for future
research in strategies to prevent weight gain in adults ..................................................................13
Table 12. Stakeholder rating for the value in addressing each research question to prevent
weight gain in adults on a 1–5 scale, in which 1 is the lowest value and 5 is the highest
value ...............................................................................................................................................14
Table 13. Methodological question for future research .................................................................14
Table 14. Stakeholder rating for the highest priority methodological needs for future
research in strategies to prevent weight gain in adults ..................................................................15

Figures
Figure A. Framework for future research on strategies for the prevention of adult weight
gain to address high-priority evidence gaps...............................................................................ES-3
Figure 1. Framework for future research on strategies for the prevention of adult weight
gain to address high-priority evidence gaps.....................................................................................9

Appendixes
Appendix A. Ongoing/Recently Completed Studies Related to Adult Weight Maintenance
Search Strategies

viii
Executive Summary
Background
The most recent estimates classify more than 35 percent of U.S. adults as obese. Obesity has
been linked to increased risk of diseases such as hypertension, diabetes mellitus, kidney disease,
and cancer; decreased life expectancy; and increased costs. Healthy People 2020 identified
preventing weight gain and the development of obesity as a priority area, specifically to increase
the prevalence of a healthy weight among adults from 31 percent to 34 percent and reduce the
prevalence of obesity among adults to less than 30 percent. Despite this goal, we know of no
treatment guidelines for the prevention of weight gain or maintenance of weight.
In 2012, the Johns Hopkins University Evidence-based Practice Center completed a
comparative effectiveness review (CER) funded by the Agency for Healthcare Research and
Quality on the comparative effectiveness of strategies to prevent weight gain in adults. Prior
systematic reviews on weight gain prevention were limited by the inclusion of studies that
included a weight loss component or measured only short-term outcomes (less than 12 months).
Understanding what strategies are the most effective to prevent weight gain in adults may help
establish treatment guidelines in order to achieve the Healthy People 2020 goal to increase the
prevalence of a healthy weight among adults to 34 percent. The report, “Strategies To Prevent
Weight Gain Among Adults,” released in 2013
(www.effectivehealthcare.ahrq.gov/reports/final.cfm), focused on the six Key Questions listed in
Table A.

Table A. Key Questions of the comparative effectiveness review


Number Question

KQ1. What is the comparative effectiveness of self-management strategies for the prevention of weight gain
among adults?
KQ2. What is the comparative effectiveness of dietary strategies for the prevention of weight gain among adults?

KQ3. What is the comparative effectiveness of physical activity strategies for the prevention of weight gain
among adults?

KQ4. What is the comparative effectiveness of medications for the prevention of weight gain among adults?

KQ5. What is the comparative effectiveness of a combination of self-management, dietary, physical activity, and
medication strategies for the prevention of weight gain among adults?
KQ6. What is the comparative effectiveness of environment level strategies for the prevention of weight gain
among adults?
Abbreviation: KQ = Key Question

ES-1
In the CER, the authors graded almost all of the evidence as low or insufficient in strength to
address the Key Questions. As a result, all research questions were identified as gaps in the
literature, limiting the report authors’ ability to answer the Key Questions and make conclusions.
The authors also identified broader methodological issues that limited the quality of available
studies and resulted in the downgrading of the evidence.

Methods
We identified potential research needs by abstracting research gaps from the CER and gaps
identified by the authors of the report during in-person discussions. We also searched the
National Institutes of Health’s clinicaltrials.gov Web site to identify any ongoing clinical trials
that may address the Key Questions proposed in the CER. Since all research questions were
identified as gaps in the literature, we used a Delphi process with our stakeholders to prioritize
evidence gaps using PICOTS elements (population, intervention, comparison, outcome, timing,
setting) that need future research.
We recruited a diversity of stakeholders to represent various groups with potential interest in
weight gain prevention, such as patients, physicians, researchers, insurers, employers, and
funding agencies. Stakeholders were recruited via email and completed all rounds of the Delphi
process using Web-based surveys. Stakeholders were directed to read the Executive Summary of
the 2012 draft of the CER and use this document to inform their answers.
We created a list of crucial questions for future research using the PICOTS elements
identified as high-priority research gaps, which our stakeholders prioritized again through a
Delphi process. Based on the identified high-priority research needs, we created a matrix of
potential research questions. Stakeholders were directed to evaluate research questions based on
their potential to positively impact health and public health.

Results
Using the PICOTS framework, stakeholders prioritized all adults, young adults, healthy-
weight adults, and overweight adults according to their prevalence in the U.S. population and the
potential health benefits of preventing the development of obesity in these groups (Figure A).

ES-2
Figure A. Framework for future research on strategies for the prevention of adult weight gain to address high-priority evidence gaps

Note: BMI = body mass index

ES-3
Stakeholders identified combination interventions as the priority for future research. They
stated that multiple factors contribute to weight gain. Therefore, they felt that interventions
would need to address multiple factors, which would likely require multiple components.
Stakeholders selected interventions that combined either self-management, diet, and exercise or
self-management, diet, exercise, and environmental alterations as the two highest priority
combinations of interventions. However, in selecting comparisons of interventions that would be
of greatest priority, stakeholders downgraded interventions that included environmental
approaches (not included in Figure A). The two highest priority comparisons of interest were
self-management and diet versus either self-management and exercise or self-management, diet,
and exercise. Stakeholders prioritized three settings for the interventions to take place: work,
home, and community. These settings were selected because adults spend the majority of their
time in these three locations, and that is where they interact with other people who are likely to
have some influence on their habits and behaviors.
Stakeholders identified the primary outcome of interest for all interventions as weight gain
prevention. Because no standard definition of weight maintenance exists, all stakeholders agreed
that the field of weight gain prevention would benefit from the establishment of a standard
definition. This definition would ensure that future studies of weight gain prevention have an
adequate duration of followup to confirm weight maintenance and also improve comparability of
results across studies. In addition, stakeholders identified two priority secondary outcomes that
should be assessed in future interventions (Figure A). First, they felt that adherence was a critical
intermediate outcome in evaluating the efficacy of the intervention and identifying subgroups
that may be most responsive to a particular intervention. Second, the stakeholders identified
weight-related clinical conditions, including cardiovascular disease and diabetes, as important
secondary outcomes. Their justification was that interventions that not only prevent weight gain
but also prevent or reduce the incidence of weight-related diseases would have a significant
public health impact.
In their response to the matrix of questions, stakeholders identified seven research questions
and one methodologic question as high priorities for future research (Table B). Stakeholders
stated that creating a standard definition of weight maintenance was critical to helping
researchers confirm true weight maintenance over time, as well as to increase comparability of
results across studies.

Table B. Questions prioritized for future research


Research Questions
To prevent weight gain in all adults, what is the comparative effectiveness of adding physical activity
versus not adding physical activity to a work-based self-management and diet intervention?
To prevent weight gain in all adults, what is the comparative effectiveness of adding physical activity
versus not adding physical activity to a home-based self-management and diet intervention?
To prevent weight gain in all adults, what is the effectiveness of a work-based self-management and
physical activity intervention versus a self-management and diet intervention?
To prevent weight gain in all adults, what is the effectiveness of a home-based self-management and
physical activity intervention compared with a self-management and diet intervention?
To prevent weight gain in overweight adults, what is the comparative effectiveness of adding physical
activity versus not adding physical activity to a home-based self-management and diet intervention?
To prevent weight gain in overweight adults, what is the effectiveness of a home-based self-management
and physical activity intervention compared with a self-management and diet intervention?
To prevent weight gain in young adults, what is the comparative effectiveness of adding physical activity
versus not adding physical activity to a home-based self-management and diet intervention?
Methodologic Question
What is a clinically meaningful definition of weight maintenance among adults, expressed as both weight (kg)
2
and body mass index (kg/m ),that can be used as the standard across studies of weight gain prevention?

ES-4
Discussion
Using the draft of the 2013 CER “Strategies To Prevent Weight Gain Among Adults,” we
identified and prioritized future research needs. We identified seven research questions that a
multidisciplinary group of stakeholders considered to have great potential health impact. We also
identified one methodologic question considered to be of critical importance to the advancement
of the weight gain prevention field. This report will help researchers to develop studies
evaluating the questions identified, as well as enable funding agencies to dedicate their resources
to areas most likely to make a health impact.
The populations denoted in our research questions are likely to achieve significant health
benefits with the avoidance of obesity. We would also encourage researchers to consider
recruiting subgroups at high risk of obesity such as adults with cardiovascular disease or diabetes
and low-income adults. We recommend that researchers consider designing head-to-head
comparison interventions that combine self-management and diet intervention with a self-
management and exercise intervention or compare a self-management and diet intervention with
a self-management, diet, and exercise intervention. These combination interventions might use a
multidimensional approach that consists of a specific diet or exercise plan, counseling, and the
use of tailored self-management strategies. Given the findings from this report, these
comparisons of interventions should occur either in the work or home setting. In addition to
measuring the interventions’ effect on weight or body mass index, future studies should measure
and evaluate adherence, as well as the impact of the intervention on the prevention or reduction
of weight-related clinical outcomes.
This project was limited by the large number of evidence gaps, which made it unfeasible to
present all research questions developed from these gaps to our stakeholders. Therefore, we used
a method that relied heavily on input from the CER authors and the stakeholders to identify
priority gaps and key research questions. We feel that the questions developed, if answered, can
impact much of the population and are appropriate first steps in increasing the breadth and
quality of the evidence base in the field of adult weight gain prevention.

Conclusions
Using the draft CER “Strategies To Prevent Weight Gain Among Adults,” we identified and
prioritized future research needs. We identified seven research questions that a multidisciplinary
group of stakeholders considered to be of potential health impact. These questions focus on high-
priority populations, interventions, comparisons, and settings identified by our stakeholders. We
also identified a methodologic research question regarding the creation of a standard definition
of weight maintenance that all of our stakeholders agreed would benefit the overall field of
weight gain prevention. This report may inform and support researchers to develop studies to
evaluate the research questions identified, as well as enable funding agencies to dedicate their
resources to areas most likely to make a health impact.

ES-5
Background
Context
The most recent estimates classify more than 35 percent of U.S. adults as obese.1 Obesity has
been linked to increased risk of diseases such as hypertension, diabetes mellitus, kidney disease,
and cancer;2 decreased life expectancy;3 and increased costs.4 Healthy People 2020 identified
preventing weight gain and the development of obesity as a priority area, specifically to increase
the prevalence of a healthy weight among adults from 31 percent to 34 percent and reduce the
prevalence of obesity among adults to less than 30 percent.5 Despite this goal, we know of no
treatment guidelines for the prevention of weight gain or maintenance of weight.
Prior systematic reviews have focused on weight loss or weight maintenance after weight
loss,6,7 and the few systematic reviews on weight gain prevention included studies that targeted
weight loss or reported outcomes at less than 12 months, which we would not consider true
weight maintenance.8,9 Therefore, a synthesis of the literature on long-term weight gain
prevention was needed. The Johns Hopkins University Evidence-based Practice Center carried
out a comparative effectiveness review (CER), funded by the Agency for Healthcare Research
and Quality (AHRQ), on the comparative effectiveness of strategies to prevent weight gain
among adults.10 The draft review, completed in 2012, was used for the study of future research
needs; the CER was posted in 2013. The report focused on six Key Questions, listed in Table 1.

Table 1. Key Questions of the comparative effectiveness review


Number Question
KQ1 What is the comparative effectiveness of self-management strategies for the prevention of weight gain
among adults?
KQ2 What is the comparative effectiveness of dietary strategies for the prevention of weight gain among adults?
KQ3 What is the comparative effectiveness of physical activity strategies for the prevention of weight gain amon
adults?
KQ4 What is the comparative effectiveness of medications for the prevention of weight gain among adults?
KQ5 What is the comparative effectiveness of a combination of self-management, dietary, physical activity, and
medication strategies for the prevention of weight gain among adults?
KQ6 What is the comparative effectiveness of environment level strategies for the prevention of weight gain
among adults?
Abbreviation: KQ = Key Question

The report authors identified 58 publications describing 51 studies. No tested interventions or


described approaches in observational studies achieved a high strength of evidence to prevent
weight gain in adults. From this body of literature, the authors made the following conclusions:
(1) work-based interventions that combine self management, diet, physical activity, and/or
environmental strategies prevent weight gain as compared to control, and (2) home-based
aerobic and resistance exercise prevent weight gain among women with cancer, as these
interventions were rated as having moderate strength of evidence. These studies compared their
interventions with control or usual care. The report authors graded almost all evidence as low or
insufficient in strength to address the Key Questions.
Overall, the report had limited ability to answer the Key Questions or draw conclusions,
given the lack of high-quality evidence in this field. Much of the existing evidence was
downgraded to low strength of evidence due to study designs and methods that were considered
to be either at high risk for bias for reasons such as lack of blinding of outcome assessors or
imprecise due to a lack of reporting of variance measures. Additionally, weight gain prevention

1
was not the stated goal for many studies included in the review. Other comparisons were graded
as insufficient, as no studies were identified that addressed those specific questions, such as
examining any intervention among adults with low socioeconomic status.

Evidence Gaps
The CER suggests that future research separately examine interventions to prevent weight
gain among healthy-weight, overweight, and obese individuals. The report also places a priority
on designing interventions for adults with severe mental illness taking antipsychotics and for
diabetics taking certain oral medications or insulin, given their high risk of weight gain,
attributed in part to side effects from these medications.
The CER also notes several methodological and reporting limitations that should be
considered during the design of future studies. The authors state that studies designed to measure
weight over time are more likely to collect high-quality weight measurements and have adequate
power to study weight gain prevention; therefore, observational cohorts should make measuring
weight a stated goal in their protocols. In addition, intervention trials should be of sufficient
duration (longer than 12 months) to assess the efficacy of weight gain prevention intervention.
The authors conclude that longer followup will help to identify true effectiveness (weight gain of
only 0.5 kg per year, which was the definition of weight maintenance used in the report).

Objective
In this report, we aimed to establish key areas for future adult weight gain prevention
research by developing a prioritized list of research needs with considerations for potential
research designs for researchers and funders to use for developing research proposals or
solicitations.

2
Methods
We identified potential research needs based on research gaps identified while writing the
report and prioritized with input from stakeholders. The protocol for developing the evidence
gaps into a prioritized list of research needs and feasible researchable questions involved the
following steps: (1) identification of evidence gaps, (2) engagement of stakeholders,
(3) prioritization of PICOTS (population, intervention, comparison, outcome, timing, setting)
research gaps through the Delphi process, (4) creation and prioritization of research questions
through the Delphi process, and (5) identification of ongoing studies through external literature
search.

Identification of Evidence Gaps


To identify evidence gaps, our research team abstracted evidence gaps from the draft CER
“Strategies To Prevent Weight Gain Among Adults.”10 The report authors identified evidence
gaps based on the strength of evidence, applicability, and limitations of the review. We also
identified additional evidence gaps and limitations of the review during in-person discussions
with the original report authors. We created an intervention matrix of comparisons for each Key
Question.
We considered all findings with low or insufficient strength of evidence as evidence gaps.
Given that the report authors graded almost all evidence as low or insufficient to address the Key
Questions (Table 2), all research questions were identified as gaps in the literature. This
extensive deficiency made the use of the typical analytic framework for identifying future
research needs difficult.11 A prior report also noted this challenge in a similar situation,12 and we
modeled our approach based on its methods. We opted to have our stakeholders prioritize
different PICOTS gaps (populations, interventions or comparisons of interventions to each other,
outcomes, timing of interventions, settings) for future research needs. We then used this
prioritization to create a list of questions for future research.

Table 2. Summary of the strength of evidence from comparative effectiveness review


Population BMI Weight Change Waist Circumference Adherence
General population Low with Low with Low with Low
physical activity dietary change dietary and lifestyle Adherence was poor
favored favored changes favored
Obese Insufficient Low Low Low
No difference No difference Adherence was poor
between walking or between walking or
bicycling to work bicycling to work
Work based Low with Moderate with Low with Low
combination of combination of no difference Adherence was poor
individual and individual and
environmental environmental
strategies favored strategies favored
College based Low with Low with Low with Low
combination strategy combination strategy no difference Adherence was poor
favored favored
With or at risk for Low with Low with Low with Insufficient
cardiovascular physical activity no difference no difference
disease or diabetes favored
mellitus

3
Table 2. Summary of the strength of evidence from comparative effectiveness review (continued)
Population BMI Weight Change Waist Circumference Adherence
Cancer Low with Moderate with Insufficient Low
decreased television physical activity Adherence was good
viewing favored favored in dietary trials and
poor in physical
activity and
combination trials
Mental illness Low with Low with Insufficient Insufficient
no difference no difference

Criteria for Prioritization


We used the Delphi method to prioritize and develop consensus about future research
needs.13 After reading the Executive Summary of the draft CER, each stakeholder was asked to
select the highest and lowest priority populations, interventions/strategies, comparisons,
outcomes, and settings. Stakeholders were asked to respond based on their reading of the
executive summary and the potential health impact of each element. We defined consensus as a
majority of respondents identifying an element as being among the highest priority.

Delphi Round 1: Prioritization of Populations, Interventions,


Outcomes, and Settings
Populations. Stakeholders identified four populations that they felt were the highest priority
from a list of all populations in the CER and populations not represented in the report such as
age, sex, race/ethnicity, or socioeconomic status. The list of possible populations included: all
adults, adults with cardiovascular disease/diabetes, adults with severe mental illness, adults with
cancer, young adults (age 18–35), middle-aged adults (age 36–64), older adults (age >64),
women, men, low income, racial/ethnic minorities, normal weight, overweight, obese, or other.

Interventions/strategies. Stakeholders selected two interventions/strategies that they felt were


the highest priority from a list of all possible interventions proposed in the Key Questions of the
CER: self-management, diet, physical activity, medication, environmental/policy, a combination
of these interventions, or other. The stakeholders also chose the lowest priority
intervention/strategy from this same list.

Outcomes. Given the widespread usage of weight and body mass index to study weight gain
prevention, we opted to ask stakeholders to prioritize the top two secondary outcomes in this
field of research. We created a list of secondary outcomes based on elements of the analytic
framework from the CER and other outcomes noted by the report authors to be commonly
assessed throughout the literature. These secondary outcomes included waist circumference,
body fat percentage, skinfold thickness, adherence, adverse effects, weight-related clinical
conditions, mortality, or other. Stakeholders selected the one lowest priority secondary outcome
from this same list.

Settings. Stakeholders identified the two highest priority settings for future research from a list
of settings identified from the CER. The list included college, clinic, work, community, home, or
other. Stakeholders also selected the lowest priority setting from this same list.

4
Delphi Round 2: Prioritization of Populations, Interventions, and
Comparisons
Populations. In round 1, several population subgroups received few or no votes from the
stakeholders; however, the report authors had identified these populations as potential important
subgroups for future research given their high risk of obesity. These subgroups included adults with
cardiovascular disease/diabetes, adults with severe mental illness, adults with cancer, racial/ethnic
minorities, and obese adults. Therefore, we asked the stakeholders to rank these subgroups for future
research in adult weight gain prevention from highest to lowest on a scale of 1–5.

Interventions/strategies. In round 1, stakeholders overwhelmingly identified combination


interventions as the highest priority and medications as the lowest priority. To clarify which
combination of interventions they would recommend, we asked them to select the two highest
priority combination strategies from a list. We created this list based on the possible combinations of
self-management plus diet, physical activity, and/or environment. We defined self-management as
goal setting, self-monitoring, problem solving, relapse prevention, and stimulus control. We included
self-management in all combinations, as our study team felt these targeted behaviors to be an
essential part of any behavior change intervention. The stakeholders also selected the lowest priority
combination strategy from this same list.

Comparisons. In the CER, few head-to-head comparative studies were described, since virtually all
studies compared intervention to control. Based on comments from the report authors and
stakeholders in round 1, we asked stakeholders to select the five highest priority comparisons of
combination interventions. We selected comparisons identified by more than 50 percent of
stakeholders as high-priority comparisons.

Delphi Round 3: Prioritization of Components of Interventions and


Research Questions
Interventions/strategies. In round 2, the majority of stakeholders identified the comparison of
(1) self-management + diet versus self-management + physical activity and (2) self-management
+ diet versus self-management + diet + physical activity. Concerning these priority combination
interventions, the report authors commented on the heterogeneity of elements included within
diet and physical activity interventions. Therefore, we asked stakeholders to select the two
highest priority combinations of elements of diet and physical activity interventions.
Stakeholders could choose to include a diet/exercise plan and/or intervention and/or targeted
behavior. For dietary interventions, dietary plans included changes in dietary composition,
caloric restriction, both, or none and targeted behaviors included meal planning, calorie tracking,
both, or none. For exercise interventions, exercise plans included all combinations of aerobic
exercise, resistance training, and/or stretching and targeted behaviors included exercise tracking,
pedometer, both, or none. Stakeholders could select from group counseling, individual
counseling, telephone/Web-based counseling, education session, or printed materials for the
intervention aspect for both diet and exercise. We created a list of elements based on components
identified in the CER.
Concurrent with ranking components of dietary and exercise interventions, Delphi round 3
also asked stakeholders to prioritize the top five questions for future research based on results
from Delphi rounds 1 and 2. (See research question development section below.)

5
Delphi Round 4: Ranking of Prioritized Research Questions
Delphi round 4 asked stakeholders to rate the value of the prioritized research questions
based on potential value and impact of results. (See research question development section
below.)

Engagement of Stakeholders, Researchers, and Funders


The stakeholders’ role was to participate in the prioritization of PICOTS elements and
subsequent questions for future research.

Identification and Recruitment of Stakeholders


We wanted to identify and recruit stakeholders that represented a variety of interests. Our
team first generated a list of stakeholder groups that would potentially have an interest in the
prevention of weight gain in adults, which included patients, physicians, exercise and nutrition
researchers, funding agencies, and health insurers. We then identified possible stakeholders
within each of these groups who could represent their interests. All possible stakeholders were
contacted via email. We invited previous stakeholders and reviewers for the CER, of whom two
prior Key Informants agreed to participate. We also invited new participants. Table 3 lists our
stakeholders. All participating stakeholders provided curriculum vitae and disclosure statements
to ensure that all potential conflicts of interest were disclosed. The list of stakeholders and their
disclosure statements were approved by AHRQ.

Table 3. Composition of stakeholders group


Area of Expertise Number of Stakeholders*
Patients 2
Physicians 2
Researchers 2
Nutrition providers/educators 2
Exercise 1
College students 1
Funding agencies 1
Health insurers 1
Employers 1
Total 7
*Several stakeholders represented multiple interests; a total of 7 stakeholders participated.

Orientation of Stakeholders
All stakeholders received a copy of the executive summary from the draft 2012 CER on
strategies to prevent adult weight gain10 and a Web link to the complete draft report. We
requested that stakeholders read the Executive Summary in order to meaningfully contribute to
the Delphi process identifying future research needs. We informed stakeholders that we
anticipated four rounds of surveys, which would be administered using a Web-based survey tool
(Survey Monkey www.surveymonkey.com). The surveys included both multiple-choice and
drop-down menus, as well as comment boxes where stakeholders could add free-text responses
to ensure that their input was heard and provide clarification and reasoning for their selections.

6
Research Question Development
Based upon results from the first rounds of the Delphi process, we created a matrix of
possible research questions based on PICOTS elements that stakeholders identified as highest
priority through consensus. We continued to use the Delphi process with our same stakeholders
to prioritize questions for future research. In Delphi round 3, we presented each stakeholder with
the list of research questions created from our matrix. The stakeholders selected the top five
research questions based on their potential health impact. Based on the rankings from round 3,
we presented the final seven priority research questions to the stakeholders in round 4. We asked
each stakeholder to assign a score from 1 to 5 to each question, where 5 indicates that the
question is very likely to provide valuable and impactful results and 1 that it is less likely to
provide valuable and impactful results. We opted not to integrate the prioritized components of
dietary and exercise interventions into our research questions.

Research Design Considerations


With the report authors, we reviewed the research questions that were prioritized by our
stakeholders. We asked the report authors to weigh in on the potential research designs that
would be most appropriate to answer these research questions, including their rationale and the
factors that influenced their decision for choosing such designs over others.
With our stakeholders, we assessed methodologic gaps, which we defined as limitations in
study design and reporting elements found within the literature base. We identified these
methodologic gaps based upon study design limitations cited in the CER and through in-person
discussions with the report authors. During round 1 of the Delphi process, stakeholders were
given a list of methodologic issues and indicated which issues were important to incorporate into
the design of future research. We created the list of study design and reporting elements from
limitations abstracted from the CER and from in-person discussion with the report authors.
Stakeholders were asked to base their responses upon the Executive Summary and to take into
account factors such as feasibility, time, costs, and validity of incorporating these study design
and reporting elements into future research. In addition, we had stakeholders consider whether a
standard definition of weight maintenance in adults would benefit the field. Based upon their
responses to this question, we created a methodologic question for future research.

Identification of Ongoing Studies


We identified ongoing clinical trials that may address the Key Questions in the Comparative
Effectiveness Review by searching the National Institutes of Health’s registry, clinicaltrials.gov
(www.clinicaltrials.gov), for trials registered from January 1, 2008, through October 1, 2012. A
single reviewer examined each title for entry. A single reviewer then examined the full
information from clinicaltrials.gov on these potential trials to determine whether they met the
same inclusion/exclusion criteria used in the CER. If any ongoing studies met our inclusion
criteria, then a single reviewer abstracted the trial identification number, date of registry,
expected date of completion, study name, status, method compared, and any published results,
and identified the Key Question that the study is likely to address.

7
Results
We had six stakeholders participate in the first round, six stakeholders participate in the
second round, six stakeholders participate in the third round, and five stakeholders participate in
the fourth round.

Research Needs
We describe below how our stakeholders prioritized future research needs within the
PICOTS framework by each element. We have created a conceptual framework for studies to
address future research needs in the field of adult weight gain prevention (Figure 1).

Populations. In round 1, our stakeholders reached majority consensus that the following four
populations were of highest priority: all adults, young adults, normal-weight adults, and
overweight adults (Table 4). Stakeholders gave the most votes to the young adult population.
They commented that they made this decision given the potential for the continuation of healthy
habits established in youth throughout the life course. Stakeholders commented that they selected
all adults because they wanted to include the broadest possible audience for weight gain
prevention in order to have the greatest impact on the obesity epidemic. Normal-weight and
overweight adults were selected given that weight gain prevention would prevent the
development of obesity and its associated comorbid conditions. In addition to identifying these
broad populations, stakeholders also prioritized several subgroups at high risk for obesity by
assigning them scores in Delphi round 2. We considered subgroups that received the lowest
average rankings as highest priority. Stakeholders ranked racial/ethnic minorities (1.8) and adults
with cardiovascular disease or diabetes (1.8) as these high-priority subgroups for future research.
Obese adults (2.7), adults with cancer (3.8), and adults with severe mental illness (4.8) received
the highest average scores, which indicated that stakeholders felt they were of lower priority.

Table 4. Stakeholder priority ratings for population gaps for future research in strategies to
prevent weight gain in adults
Population Groups Round 1 Votes Round 2
for High-Priority Scores
Populations (N=6)
(N=6)
Young adults (18–35) 5* ‡
All adults 4* ‡
Overweight 3* ‡
Normal weight 3* ‡
Middle aged (36-64) 2 ‡
Low income 2 ‡
Other 2 ‡
Older (65+) 1 ‡
Racial/ethnic minorities 1 1.8*
Obese 1 2.7
Cardiovascular disease or diabetes 0 1.8*
Severe mental illness 0 4.8
Cancer 0 3.8
Women 0 ‡
Men 0 ‡
Notes: * Indicates prioritized research need from round 1.
‡Indicates option not included for prioritization in round 2.
N = number of stakeholders who participated.

8
Figure 1. Framework for future research on strategies for the prevention of adult weight gain to address high-priority evidence gaps

Note: BMI = body mass index

9
Interventions/strategies. In round 1, our stakeholders reached majority consensus that a
combination of interventions is the highest priority for future research (Table 5). They felt that
no single strategy alone was likely to be effective, and therefore, only a combination of
approaches should be employed in the future. The majority of stakeholders identified
medications as the lowest priority strategies for weight gain prevention research (Table 6).
Stakeholders commented that they ranked medications lower due to concerns about the long-
term viability of such an approach and the potential for side effects.

Table 5. Stakeholder rating for the highest and lowest priority strategy gaps for future research in
strategies to prevent weight gain in adults
Strategies Round 1 Round 1
Votes for High- Priority Strategy Votes for Low- Priority Strategy
(N=6) (N=6)
Combination of interventions 4* 1
Other 2 N/A
Policy 2 1
Self-management 2 0
Diet 1 0
Physical activity 1 0
Medications 0 4
Notes: * Indicates prioritized research need.
N = number of stakeholders who participated.

Stakeholders reached majority consensus that combination interventions should combine the
following elements: (1) self-management + diet + physical activity, or (2) self-management +
diet + physical activity + environment (Table 6). No consensus majority was reached about the
lowest priority combination of interventions (Table 6).

Table 6. Stakeholder rating for the highest and lowest priority combination strategy gaps for
future research in strategies to prevent weight gain in adults
Combination Round 2 Votes Round 2 Votes
for High-Priority for Low-Priority
Combination Combination
Strategy Strategy
(N=6) (N=6)
Self-management AND diet AND physical activity 4* 0
Self-management AND diet AND physical activity AND environmental 3 1
change
Self-management AND environmental change 2 1
Self-management AND diet 1 2
Self-management AND diet AND environmental change 1 0
Self-management AND physical activity AND environmental change 1 1
Self-management AND physical activity 0 1
Notes: * Indicates prioritized research need.
N = number of stakeholders who participated.

In Delphi round 3, stakeholders also identified what components should comprise diet and
physical activity interventions. Stakeholders felt that diet interventions should combine
counseling with specific dietary recommendations regarding calorie intake or dietary
composition and a diet-related self-management strategy such as meal planning or calorie
tracking (Table 7). Stakeholders did not reach consensus on the type of counseling, dietary
recommendation, or self-management strategy of greatest priority. Similarly, stakeholders felt
that physical activity interventions should combine counseling with an exercise plan that
combines aerobic exercise, resistance training, and stretching and an exercise-related self-

10
management strategy such as exercise tracking (Table 8). Stakeholders did not reach consensus
on the type of counseling, exercise plan, or self-management strategy of greatest priority. All
stakeholders felt that printed materials were unlikely to change behavior, and therefore, should
not be a prioritized strategy in future research.

Table 7. Highest priority components of dietary interventions


Dietary Plan Round 3 Modality of Intervention Round 3 Targeted Behavior Round 3
Votes Delivery Votes Votes
(N=6) (N=6) (N=6)
Dietary composition 4 Group 5 Meal planning 5
Calorie restriction 3 Individual 4 Calorie tracking 2
Both 5 Telephone/Web 3 Both 5
None 0 Education session 0 None 0
Printed materials 0
Abbreviation: N = number of stakeholders who participated.

Table 8. Highest priority components of physical activity interventions


Exercise Plan Round 3 Modality of Intervention Round 3 Targeted Behavior Round 3
Votes Delivery Votes Votes
(N=6) (N=6) (N=6)
Aerobic exercise 3 Group 4 Pedometer 2
Resistance training 0 Individual 6 Exercise tracking 8
Stretching 0 Telephone/Web 2 Both 2
Aerobic + resistance 3 Education session 0 None 0
Aerobic + stretching 2 Printed materials 0
Resistance + 0
stretching
Aerobic + resistance 4
+ stretching
Abbreviation: N = number of stakeholders who participated.

Comparisons. Our stakeholders reached majority consensus that several head-to-head


comparisons of interventions would be a high priority for future research. These high priority
comparisons include: (1) self-management + diet VERSUS self-management + physical activity,
or (2) self-management + diet VERSUS self-management + diet + physical activity (Table 9).

11
Table 9. Stakeholder rating for the highest priority comparison strategy gaps for future research in
strategies to prevent weight gain in adults
Arm 1 Arm 2 Round 2
Votes
(N=6)
Self-management AND diet Self-management AND diet 4*
AND physical activity Self-management AND diet AND environmental change 3
Self-management AND physical activity 2
Self-management AND diet AND physical activity AND 2
environmental change
Self-management AND environmental change 2
Self-management AND physical activity AND environmental 1
change
Self-management AND diet Self-management AND physical activity 5*
Self-management AND diet AND environmental change 3
Self-management AND environmental change 2
Self-management AND diet AND physical activity AND 1
environmental change
Self-management AND Self-management AND physical activity AND environmental 3
physical activity change
Self-management AND environmental change 1
Self-management AND Self-management AND diet AND physical activity AND 1
physical activity AND environmental change
environmental change
Notes: *Indicates prioritized research need.
N = number of stakeholders who participated.

Outcomes. We felt that weight and body mass index were logical and well-established outcomes
for the weight gain prevention field. Our stakeholders instead evaluated secondary outcomes.
Our stakeholders reached majority consensus that two secondary outcomes should be assessed in
future trials: weight-related clinical outcomes and adherence to the intervention (Table 10).
Weight-related clinical outcomes may include conditions such as hypertension, diabetes mellitus,
and dyslipidemia. Stakeholders felt that assessing adherence would help determine the efficacy
and effectiveness of the intervention, and that understanding whether preventing weight gain
improves clinical outcomes would justify investment in implementing such programs on a large
scale. The majority of stakeholders identified skinfold thickness as the lowest priority secondary
outcome (Table 10). Skinfold thickness was rated lower due to lack of association with health
outcomes and the existence of other metrics that are easier to measure or provide better estimates
of adiposity.

Table 10. Stakeholder rating for the highest and lowest priority secondary outcome gaps for future
research in strategies to prevent weight gain in adults
Secondary Outcomes Round 1 Votes for High- Round 1 Votes for Low-
Priority Secondary Priority Secondary
Outcomes (N=6) Outcomes (N=6)
Weight-related clinical outcomes 4* 0
Adherence 3* 0
Mortality 2 2
Waist circumference 1 0
Body fat % 1 0
Other 1 0
Skinfold thickness 0 4
Adverse effects 0 0
Notes: * Indicates prioritized research need.
N = number of stakeholders who participated.

12
Settings. In round 1, our stakeholders reached majority consensus regarding three high-priority
settings, which included the workplace, the community, and the home (Table 11). Stakeholders
were motivated to select these settings, because they felt that work, home, and community-based
interventions would likely have the greatest impact on preventing weight gain and obesity. They
noted that adults spend the majority of their time in one of these settings, and that other people in
these settings are likely to have a strong influence on their behavior. The majority of
stakeholders identified clinic-based weight gain prevention programs as the lowest priority for
future research (Table 11). They rated clinic-based interventions low due to concerns of whether
physicians and health care providers have time and adequate training to perform such tasks.

Table 11. Stakeholder ratings for the highest and lowest priority setting gaps for future research in
strategies to prevent weight gain in adults
Settings Round 1 Round 1
Votes for High-Priority Settings Votes for Low-
(N=6) Priority Settings
(N=6)
Home 4* 1
Work 4* 0
Community 4* 0
Clinic 0 4
College 0 1
Other 0 N/A
Notes: * Indicates prioritized research need.
N = number of stakeholders who participated.

Research Questions
Based upon the results of the research needs, we created a matrix of possible research
questions (N=16). In Delphi round 3, our stakeholders reached majority consensus regarding
seven research questions as the highest priorities for future research from the matrix of possible
questions. These seven questions are listed in Table 12. In round 4, stakeholders assigned a score
of 1 to 5 to each question, where 5 means that the question is very likely to provide valuable and
impactful results and 1 that it is less likely to provide valuable and impactful results. The mean
score for each question is presented in Table 12.

13
Table 12. Stakeholder rating for the value in addressing each research question to prevent weight
gain in adults on a 1-5 scale, in which 1 is the lowest value and 5 is the highest value
Research Questions Prioritized in Round 3 Round 4 Mean
Impact Scores
(N=5)
To prevent weight gain in ALL adults, what is the comparative effectiveness of adding
PHYSICAL ACTIVITY versus NOT adding physical activity to a WORK-based self- 4.0
management and diet intervention?
To prevent weight gain in ALL adults, what is the comparative effectiveness of adding
PHYSICAL ACTIVITY versus NOT adding physical activity to a HOME-based self- 3.8
management and diet intervention?
To prevent weight gain in ALL adults, what is the effectiveness of a WORK-based self-
management and PHYSICAL ACTIVITY intervention versus a self-management and DIET 3.8
intervention?
To prevent weight gain in ALL adults, what is the effectiveness of a HOME-based self-
management and PHYSICAL ACTIVITY intervention compared with a self-management 3.8
and DIET intervention?
To prevent weight gain in OVERWEIGHT adults, what is the comparative effectiveness of
adding PHYSICAL ACTIVITY versus NOTadding physical activity to a HOME-based self- 3.4
management and diet intervention?
To prevent weight gain in OVERWEIGHT adults, what is the effectiveness of a HOME-
based self-management and PHYSICAL ACTIVITY intervention compared with a self- 3.4
management and DIET intervention?
To prevent weight gain in YOUNG adults, what is the comparative effectiveness of adding
PHYSICAL ACTIVITY versus NOT adding physical activity to a HOME-based self- 3.4
management and diet intervention?
Abbreviation: N = number of stakeholders who participated.

All stakeholders agreed that the field of weight gain prevention research would benefit from
a standardized definition of weight maintenance (Table 13). The stakeholders felt that the
definition should include standards for maintenance of both weight and BMI. One stakeholder
commented that this standard should be clinically meaningful.

Table 13. Methodological question for future research


What is a clinically meaningful definition of weight maintenance among adults, expressed as both weight (kg)
2
and body mass index (kg/m ),that can be used as the standard across studies of weight gain prevention?

Study Design Considerations


After the report’s authors reviewed the research questions prioritized by our stakeholders,
they suggested that randomized controlled trials (RCTs) may be the most appropriate study
design to answer these questions. They felt that the advantage of the RCT is the lack of
confounding and selection bias; however, they stipulated that a well-conducted RCT should
assess outcomes by individuals blinded to treatment assignment, assess adherence to the
intervention, and maintain adequate followup of enrolled patients. The report authors recognized
that such RCTs would be costly.
Stakeholders also identified improvements in study design, methods, and reporting that they
would recommend be employed by future studies. In Table 14, we present the study design,
methods, and reporting elements that at least 50 percent of our stakeholders agreed should be
used in future studies.

14
Table 14. Stakeholder rating for the highest priority methodological needs for future research in
strategies to prevent weight gain in adults
Methods Round 1 Votes
(N=6)
Describe randomization process 6
Recruit adequate sample size to power 6
Adjust for confounding in observational studies 5
Report non-statistically significant results 5
Report measures of variance 4
Mask outcome assessors to study group assignment 3
Minimize or account for losses to followup 3
Other 0
Abbreviation: N = number of stakeholders who participated.

Identification of Ongoing Studies


We identified 3,027 titles in clinicaltrials.gov, of which 727 were identified as potentially
eligible during title review. During full review, we identified 51 studies currently recruiting or
ongoing that may address at least one of the Key Questions from the original report. We also
identified 35 recently completed studies that may address at least one of the Key Questions;
however, results were not yet available from these studies. These 86 ongoing or recently
completed studies are listed in Appendix Table 2.

15
Discussion
Using the 2012 version of the CER “Strategies To Prevent Weight Gain Among Adults,”10
we identified and prioritized future research needs. We identified seven research questions
considered to be of potential health impact by a multidisciplinary group of stakeholders. We
believe that this report will help researchers to develop studies evaluating the Key Questions
identified, as well as enable funding agencies to dedicate their resources to areas most likely to
make a health impact.
The populations within our research questions purposely target broad audiences (all adults,
young adults, and overweight adults) who are likely to achieve significant health benefit from
preventing the development of obesity. Our stakeholders preferred a broad population, given the
lack of evidence in this field. However, our stakeholders did consider adults with cardiovascular
disease or diabetes and low-income adults to be high-priority subgroups, given their high risk of
obesity.14,15 We would encourage researchers to specifically recruit representatives from these
subgroups in future research studies with an a priori plan for subgroup analyses.
Our stakeholders selected head-to-head comparisons of specific combinations of
interventions as priority comparisons in our research questions. We feel that the lack of these
head-to-head comparisons is a significant evidence gap, as most studies identified in the CER
compared intervention to usual care/control. These head-to-head comparisons would likely
provide critical insight into the creation of guidelines to prevent weight gain, as these types of
comparisons represent real clinical conundrums that patients and health care providers face daily.
The first pairing compares a self-management and diet intervention to a self-management and
exercise intervention to answer the question of whether diet or exercise is superior to prevent
weight gain. The second pairing compares a self-management and diet intervention to a self-
management, diet, and exercise intervention to answer whether the addition of exercise to diet is
superior to diet alone in preventing weight gain. We recommend that future diet and/or exercise
interventions have a multidimensional approach in order to successfully result in behavior
change. These approaches should combine a specific diet or exercise plan with either individual
or group counseling and the use of tailored self-management strategies. Printed educational
materials were not selected as a priority intervention strategy, and prior evidence has shown that
such methods are unlikely to result in behavior change.16
Our research questions also target only work or home settings, as adults spend the majority of
their time there. Family, friends, and colleagues in these places are also likely to influence
behavior through mechanisms such as social influence, norms, and modeling.17 We would
discourage future studies from relying on clinic-based interventions, as health care providers
typically have limited time and training to perform the multicomponent interventions described
above.
With respect to outcomes, we identified weight or body mass index as the prevailing
measures of choice. However, no standard definition of weight maintenance exists. In the CER,
the authors defined weight maintenance as 0.5 kg over 12 months, which was based upon the
predicted average weight gain of an adult.18 We recommend that future research in this field
should first address this major methodologic gap by creating a standard definition of weight
maintenance. Our stakeholders felt that this definition should include standards for change in
both weight and body mass index over a prespecified time period, given the common use of both
these measures. In addition, we feel that the definition should be clinically relevant and be
associated with the prevention or reduction of weight-related comorbidities such as hypertension

16
and diabetes mellitus as well as mortality. The establishment of this definition would help future
researchers ensure that their trials are designed to actually evaluate weight gain prevention and
would facilitate the comparability of weight gain prevention across studies.
In addition to the primary outcome of weight gain prevention, certain secondary outcomes
need to be evaluated in future studies that address our priority research questions. First, all
interventional studies should assess adherence to the intervention. Adherence is essential in
understanding whether and in whom certain interventions work best. This knowledge is critical
in translating an approach to a different population or scaling up a successful program. Second,
studies should also evaluate the effect of the intervention or approach on weight-related clinical
outcomes. In the CER, the authors included cardiovascular disease, diabetes mellitus, infertility,
degenerative joint disease, and liver disease as outcomes of interest. Our stakeholders also
agreed that these weight-related clinical outcomes would be of interest in future studies.
Interventions that prevent weight gain, as well as prevent or reduce these conditions linked with
high morbidity and costs to both the health care system and society, will have significant public
health impact.
There are some limitations of this project. The large number of evidence gaps made it
unfeasible to create and present all research questions from these gaps to our stakeholders, which
would be a more standard approach to identifying future research needs. We modified the
approach piloted in a prior future research needs report12 for this purpose. This method relied
heavily on input from the authors of the CER and the stakeholders, who all have their own
priorities and biases that influence their perceptions of the topic and reflections on the CER
process. We feel that the questions developed would influence a broad audience and are
appropriate first steps in increasing the breadth and quality of the evidence base in the field of
adult weight gain prevention.
There are several strengths to this report. Our research team included several members of the
original report’s research team, which provided ready access to their insight on the process of the
CER and challenges experienced by that original team. We also recruited stakeholders to
represent a variety of interests. The prevention of adult weight gain is not only important to
patients, health care providers, and researchers, but is also of particular interest to health insurers
and employers, given that obesity has been associated with increased morbidity,2,19 health care
costs,4 and decreased workplace productivity.20 We also had high levels of participation from our
stakeholders at each step. We feel that our diverse array of engaged stakeholders helps to ensure
that the priority questions we developed will be of significant public health impact. Finally, we
encouraged stakeholders to provide comments in addition to performing rankings. This
qualitative component gave important insight on the thought process behind many of the
stakeholders’ choices and added an additional element of richness to the data we collected.

17
Conclusion
Using the CER “Strategies To Prevent Weight Gain Among Adults,” we identified and
prioritized future research needs. We identified seven research questions considered to be of
potential health impact by a multidisciplinary group of stakeholders. These questions focus on
high-priority populations, interventions, comparisons, and settings identified by our stakeholders.
We also identified a methodologic research question regarding the creation of a standard
definition of weight maintenance that all of our stakeholders agreed would benefit the overall
field of weight gain prevention. This report may inform and support researchers to develop
studies to evaluate the priority questions identified, as well as enable funding agencies to
dedicate their resources to areas most likely to make a health impact.

18
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Appendix A. Ongoing/Recently Completed Studies
Related to Adult Weight Maintenance Search
Strategies
Appendix Table 1. Search strategies for ongoing studies
Resource Search Parameters Search Terms/Strategy
URL
ClinicalTrials.gov Advanced search, Conditions Prevent adult weight gain OR
http://clinicaltrials.gov/ field used adult weight maintenance

EU Clinical Trials Register Not applicable Prevent adult weight gain OR


https://www.clinicaltrialsregister.eu/ adult weight maintenance

NIH Reporter Projects field searched Prevent adult weight gain OR


http://projectreporter.nih.gov/reporter.cfm adult weight maintenance

Canadian Institute for Health Research Funding Decisions Data field Prevent adult weight gain OR
http://www.cihr-irsc.gc.ca/ searched adult weight maintenance

World Health Organization International Searched Condition field, Prevent adult weight gain OR
Clinical Trials Registry Platform Search Recruitment status = ALL adult weight maintenance
Portal
http://apps.who.int/trialsearch/

A-1
Appendix Table 2. Index of ongoing/recently completed studies potentially applicable to Key
Questions from Comparative Effectiveness Review “Strategies To Prevent Weight Gain Among
Adults”
Study Title URL Status
Move and Moderate in Balance http://ClinicalTrials.gov/show/NCT00715130 Recently
Completed
Diet and Physical Activity Interactions in Obesity http://ClinicalTrials.gov/show/NCT00067964 Recently
Completed
Prevention of Weight Gain http://ClinicalTrials.gov/show/NCT00011102 Recently
Completed
Walking For Wellness Program Evaluation http://ClinicalTrials.gov/show/NCT00156351 Recently
Completed
Long-Term Exercise Maintenance Via Internet http://ClinicalTrials.gov/show/NCT00260117 Recently
Support Completed
Strength Training for Obesity Prevention http://ClinicalTrials.gov/show/NCT00030160 Recently
Completed
Effect of Exercise on Prevention of Weight Gain http://ClinicalTrials.gov/show/NCT00177502 Recently
Completed
Veterans Enhanced Fitness Study http://ClinicalTrials.gov/show/NCT00594399 Recently
Completed
Study of Impact of Behavioral Intervention- http://ClinicalTrials.gov/show/NCT00132132 Recently
Exercise; Nutrition; Education- on Body Mass Completed
Index (BMI)
A Physical Activity and Diet Program to Prevent http://ClinicalTrials.gov/show/NCT00122213 Recently
Accumulation of Abdominal Fat Mass in Recently Completed
Retired Men and Women
LIFT: Lifestyle Interventions For Two http://ClinicalTrials.gov/show/NCT01616147 Ongoing
Promoting Activity and Changes in Eating (PACE) http://ClinicalTrials.gov/show/NCT00119782 Ongoing
to Reduce Obesity
Make Better Choices http://ClinicalTrials.gov/show/NCT01249989 Ongoing
Maintenance After Initiation of Nutrition Training http://ClinicalTrials.gov/show/NCT01357551 Ongoing
An Intergenerational Community Based http://ClinicalTrials.gov/show/NCT01373307 Ongoing
Participatory Research (CBPR) Intervention to
Reduce Appalachian Health Disparities
Study of Ongoing Approaches for Prevention http://ClinicalTrials.gov/show/NCT01183689 Ongoing
Helping People to Exercise Regularly http://ClinicalTrials.gov/show/NCT01335880 Ongoing
Whole Grain Polyphenol Bioavailability and http://ClinicalTrials.gov/show/NCT01293175 Ongoing
Effects on Health
Planned CORR: Planned Care for Obesity and http://ClinicalTrials.gov/show/NCT01134029 Ongoing
Risk Reduction
African American Church-based Cohort http://ClinicalTrials.gov/show/NCT00823394 Ongoing
Tu Salud Si Cuenta Media Campaign http://ClinicalTrials.gov/show/NCT00788879 Ongoing
Efficacy of Lifestyle Changes in Modifying http://ClinicalTrials.gov/show/NCT00395837 Ongoing
Practical Markers of Wellness and Aging
Calorie Restriction and Changes in Body http://ClinicalTrials.gov/show/NCT00955903 Ongoing
Composition; Disease; Function; and Quality of
Life in Older Adults
A Randomized Clinical Trial of Home-based http://ClinicalTrials.gov/show/NCT01206413 Recently
Exercise Combined With a Slight Caloric Completed
Restriction on Obesity Prevention Among Women
The Women's Healthy Lifestyle Study http://ClinicalTrials.gov/show/NCT00583726 Recently
Completed
Lifestyle Intervention for Pakistani Women in Oslo http://ClinicalTrials.gov/show/NCT00425269 Recently
Completed
Healthy Mothers on the Move http://ClinicalTrials.gov/show/NCT01584063 Recently
Completed

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Appendix Table 2. Index of ongoing/recently completed studies potentially applicable to Key
Questions from Comparative Effectiveness Review “Strategies To Prevent Weight Gain Among
Adults” (continued)
Study Title URL Status
Childhood Obesity Prevention http://ClinicalTrials.gov/show/NCT00630617 Recently
Completed
Nutrition Intervention and Play Group Exercise for http://ClinicalTrials.gov/show/NCT00454948 Ongoing
Low-Income Latinas
Community Based Obesity Prevention Among http://ClinicalTrials.gov/show/NCT00938535 Ongoing
Black Women
Fit Over 45 - a Health Promotion Project for http://ClinicalTrials.gov/show/NCT01033110 Ongoing
Inactive Female Hospital Staff Age 45+ From the
University Hospital of Zürich
The Mediterranean Diet and Lactation Study: A http://ClinicalTrials.gov/show/NCT01459991 Ongoing
Diet Study in Lactating Women
eMOMS of Rochester: Electronically-Mediated http://ClinicalTrials.gov/show/NCT01331564 Ongoing
Weight Interventions for Pregnant and Postpartum
Women
Healthy Homes/Healthy Families http://ClinicalTrials.gov/show/NCT01326897 Ongoing
Family Program for Weight Gain Prevention http://ClinicalTrials.gov/show/NCT00989170 Ongoing
Study of a Smart Growth Community's Effect on http://ClinicalTrials.gov/show/NCT00986011 Ongoing
Prevention of Obesity in Middle-; Moderately Low-
and Low-Income Families
Health Promotion of People With Disabilities http://ClinicalTrials.gov/show/NCT00164489 Recently
Completed
Weight Management and Coping Skills Training http://ClinicalTrials.gov/show/NCT00305890 Recently
For Patients With Knee Osteoarthritis Completed
Longitudinal Study of Weight Change Following http://ClinicalTrials.gov/show/NCT00932399 Ongoing
Lower Limb Amputation
A Study on Induced Weight Gain During Atypical http://ClinicalTrials.gov/show/NCT00191828 Recently
Antipsychotic Treatment and Its Management Completed
With Psychoeducational Programme
The Effect of a Weight Management Program http://ClinicalTrials.gov/show/NCT00169702 Recently
During Treatment With Olanzapine Completed
Effect of Dietary and Life Style Modification on http://ClinicalTrials.gov/show/NCT00878592 Ongoing
Post Liver Transplant Obesity
CCRC: Understanding the Effects of Omega-3 http://ClinicalTrials.gov/show/NCT00935922 Recently
Fatty Acids Versus Lignans in Flaxseed on Completed
Metabolic and Inflammatory Markers Leading to
Diabetes and Cardiovascular Disease
Reduced Cardiac Rehabilitation Program http://ClinicalTrials.gov/show/NCT01483235 Recently
Completed
Shared Decision-Making: Effects on Cardiac Risk http://ClinicalTrials.gov/show/NCT00714935 Recently
Factor Modification Behavior Completed
PBWST (Partial Body-Weight Supported http://ClinicalTrials.gov/show/NCT00108030 Recently
Treadmill Training) and Muscle Power Training Completed
After Sub-Acute Stroke
The Effects of Health Education in Cardiovascular http://ClinicalTrials.gov/show/NCT01426282 Recently
Diseases Prevention and Treatment Completed
Cardiovascular Risk Reduction Program Aimed at http://ClinicalTrials.gov/show/NCT00860444 Recently
African American Women (The HHER Lifestyle Completed
Program)
A Randomized Controlled Trial of a Community- http://ClinicalTrials.gov/show/NCT00236210 Recently
based Primary and Secondary Cardiovascular Completed
Prevention Program
Walking Away: Structured Education Versus http://ClinicalTrials.gov/show/NCT00941954 Ongoing
Written Information for Individuals With High Risk
of Developing Type 2 Diabetes

A-3
Appendix Table 2. Index of ongoing/recently completed studies potentially applicable to Key
Questions from Comparative Effectiveness Review “Strategies To Prevent Weight Gain Among
Adults” (continued)
Study Title URL Status
Japan Diabetes Optimal Integrated Treatment http://ClinicalTrials.gov/show/NCT00300976 Ongoing
Study for 3 Major Risk Factors of Cardiovascular
Diseases
Use of Information Technology in the Prevention http://ClinicalTrials.gov/show/NCT00819455 Ongoing
of Diabetes
A Culturally Tailored Lifestyle Intervention to http://ClinicalTrials.gov/show/NCT01084928 Ongoing
Prevent Diabetes in South Asians
Impact of Lifestyle Intervention Programs on http://ClinicalTrials.gov/show/NCT01420198 Ongoing
Glucose Metabolism and Biomarkers for Type 2
Diabetes: Ethnical Aspects
Peer-led and Telehealth Comparative http://ClinicalTrials.gov/show/NCT01307137 Ongoing
Effectiveness Research (CER) Adoption for
Diabetes Prevention and Management
Jordan Diabetes Microclinic Project http://ClinicalTrials.gov/show/NCT01596244 Ongoing
The Diabetes TeleCare Study http://ClinicalTrials.gov/show/NCT00288132 Ongoing
A Randomized Trial of an Intensive Education http://ClinicalTrials.gov/show/NCT01485913 Ongoing
Intervention Using a Network of Involved Diabetic
Patients (Peer Educators) to Improve Glycemic
Control of Type 2 Diabetic Patients
Can a Modified Fat Diet With Low Glycaemic http://ClinicalTrials.gov/show/NCT00163904 Ongoing
Load Improve Insulin Sensitivity and Inflammatory
Mediators in Overweight People With Chronic
Heart Failure?
Risk Reduction in Coronary Heart Disease - a http://ClinicalTrials.gov/show/NCT00679237 Ongoing
Prospective Randomized Study
Step Monitoring to Improve ARTERial Health http://ClinicalTrials.gov/show/NCT01475201 Ongoing
Effect of Balanced Hypocaloric Diet Associated http://ClinicalTrials.gov/show/NCT01622309 Ongoing
with Supplementation of Eggplant Meal in the
Remission of Cardiovascular Risk Factors
Study of Macronutrients and Heart Disease Risk http://ClinicalTrials.gov/show/NCT00609271 Ongoing
Workplace-Sponsored Program to Reduce http://ClinicalTrials.gov/show/NCT00123513 Recently
Obesity Completed
Worksite Program to Prevent Weight Gain Among http://ClinicalTrials.gov/show/NCT00122993 Recently
Bus Drivers Completed
A Cafeteria Based Study of Weight Gain http://ClinicalTrials.gov/show/NCT00573482 Recently
Prevention Completed
Preventing Obesity in the Worksite: A Multi- http://ClinicalTrials.gov/show/NCT01585480 Recently
Message; Multi-\Step\' Approach' Completed
Work; Weight; and Wellness Program: The 3W http://ClinicalTrials.gov/show/NCT00123019 Recently
Program Completed
Workplace Intervention: Activity Monitoring as a http://ClinicalTrials.gov/show/NCT01461382 Recently
Tool for Corporate Wellness and Weight Loss Completed
Peer Education; Exercising and Eating Right - http://ClinicalTrials.gov/show/NCT01043614 Recently
Obesity Prevention in Freshmen Women Completed
School Intervention With Daily Physical Activity http://ClinicalTrials.gov/show/NCT01291238 Recently
and Healthy Food for Students With an Completed
Intellectual Disability
Diabetes Prevention and Control in the http://ClinicalTrials.gov/show/NCT00739336 Ongoing
Workplace: A Pilot Study
Efficacy of \Tailored Physical Activity\' in Health http://ClinicalTrials.gov/show/NCT01543984 Ongoing
Care Workers'
A Web-Based Cardiovascular Intervention for the http://ClinicalTrials.gov/show/NCT00763308 Ongoing
Workplace
Wellness Program for Elementary School http://ClinicalTrials.gov/show/NCT00123500 Ongoing
Personnel

A-4
Appendix Table 2. Index of ongoing/recently completed studies potentially applicable to Key
Questions from Comparative Effectiveness Review “Strategies To Prevent Weight Gain Among
Adults” (continued)
Study Title URL Status
School Worksite Weight Gain Prevention http://ClinicalTrials.gov/show/NCT01467284 Ongoing
Intervention Study
Choosing Healthy Options in College http://ClinicalTrials.gov/show/NCT01134783 Ongoing
Environments and Settings
Prevention of Obesity at Universities: A http://ClinicalTrials.gov/show/NCT00456131 Ongoing
Randomized Trial
DAMES: Daughters And MothErS Against Breast http://ClinicalTrials.gov/show/NCT00630591 Recently
Cancer Completed
Weight Gain Prevention for Breast Cancer http://ClinicalTrials.gov/show/NCT00533338 Ongoing
Survivors
Exercise Program of Breast Cancer Patients http://ClinicalTrials.gov/show/NCT01157767 Ongoing
Undergoing Chemotherapy With or Without
Radiation
Effects of Physical Activity and Dietary Change in http://ClinicalTrials.gov/show/NCT00811824 Ongoing
Minority Breast Cancer Survivors
Weight Control Programs in Women Who Have http://ClinicalTrials.gov/show/NCT00869466 Ongoing
Undergone Surgery for Early Stage Breast
Cancer
Individual Counseling and/or Computer-Based http://ClinicalTrials.gov/show/NCT00217490 Ongoing
Counseling in Helping Healthy Women Adopt a
Cancer Prevention Diet
Energy Balance Interventions for Colorectal http://ClinicalTrials.gov/show/NCT00653484 Ongoing
Cancer Prevention
Isoflavones in Preventing Further Development of http://ClinicalTrials.gov/show/NCT00027950 Ongoing
Cancer in Patients With Stage I or Stage II
Prostate Cancer

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