February 8, 2017 to February 9, 2017
Adult weight loss trials have documented considerable variation in initial weight loss and longer-term weight maintenance in response to behavioral, pharmacological, and surgical treatments. There is a critical need to better understand the sources of this variability and identify models integrating behavioral, psychosocial, environmental, and biological predictors and moderators of treatment responses. Such models could provide the basis for tailoring treatments to optimize initial weight loss and sustain the weight reduced state.
To meet this need, the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) in collaboration with other NIH institutes, centers, and offices convened the Accumulating Data to Optimally Predict obesity Treatment (ADOPT) Core Measures Working Group (WG) to recommend an initial core set of high-priority measures that when consistently used in studies can facilitate the identification of constructs that predict or moderate treatment response. The use of consistent measures across studies, while optional, will enhance opportunities for obesity researchers to pool data across studies in meta-analyses and facilitate identification of replicable predictors and moderators of obesity treatment response. The use of an integrated set of indicators across domains should improve our understanding of how these factors interact, which in turn, should inform the design and delivery of obesity treatment in adults.
The ADOPT Working Group met in May 2016 and in February 2017. Drs. Paul MacLean and Alex Rothman served as co-chairs.
Meeting 1: May 25-26, 2016
The goal of the initial meeting of the ADOPT Working Group was to ensure a common vision of objectives, products, and process involved in this effort that aims to advance obesity therapeutics. The meeting was sponsored by the NHLBI, NCI, and the NIH Office of Disease Prevention (ODP).
The co-chairs opened the meeting by reviewing the objectives of the ADOPT effort. They reviewed some of the putative reasons why obesity therapeutics often fail, and summarized the barriers and challenges to weight loss maintenance identified by a previous WG on Innovative Research for Weight Loss Maintenance (WLM) that met during the Summer of 2014.
The co-chairs then described the process envisioned by the NIH Planning Group to achieve the ADOPT WG goal to develop an initial list of high priority measures integrated across the 4 domains. A critical component of the project is to seek broad engagement with and dissemination to the scientific community. Given this, the NCI’s Grid-Enabled Measures (GEM) database will be used as a repository for ADOPT Core Measures. GEM is a publicly-accessible, easy to use, electronic database developed as a tool for seeking broad input and consensus on common measures.
The Working Group laid out several steps to better engage the obesity research community. It may be critical to start by generating a unified vision within the scientific community regarding the evidence base that is needed to advance obesity treatment. An integral component is to engender an understanding of how the consistent use of high-priority measures can advance the individual goals of a researcher and the collective goals of the field. Several innovative ideas were offered to increase uptake of ADOPT Core Measures, such as using an open science model that offers incentives for transparency including preregistering aims and specifying study measures in a publicly-accessible database (e.g., ClinicalTrials.gov).
The Working Group discussed guiding criteria for developing a high priority list. These included:
- Quality and validity of measures, psychometric properties
- Strengths and limitations
- Clarity of the construct measured
- Cost for measurement and analysis (such as expense, time, and availability of equipment)
- Participant burden
- Value of each proposed measure for modeling
- Predictive capabilities
- Moderators vs predictors of responses
- Value of the measure to the obesity treatment field
- Populations in which the measures are used
Before adjourning the meeting, each domain met by itself in a breakout group. They were charged with discussing how to manage their domain’s measures in GEM. They discussed constructs and measures within their domain. It was clear that while the domains faced many similar challenges, the state of research regarding potential common measures greatly differs across domains and subdomains.
Meeting 2: February 8-9, 2017
At the Working Group’s second in-person meeting, the project’s goals and accomplishments to date were summarized. Members then discussed steps needed to finalize curation of the high priority list of measures and constructs in breakout sessions.
The entire Working Group reconvened and discussed issues surrounding integration of the list, including overlap across domains and logistics of collecting the total battery of recommended measures. The group also discussed how to describe recommendations for future research and development, particularly for intriguing constructs for which there are no existing measures, or the existing measures are not sufficiently reliable or valid or are overly burdensome or expensive.
Further discussions included implementation and dissemination strategies for the ADOPT Core Measures project, and procedures for laying the groundwork for consideration of additional measures as the state of the science advances.
The group plans to produce the following products:
- Core set of high priority list of constructs and measures developed with input from the scientific community
- Publicly-available database of measures and supporting information to facilitate consistency in weight loss research
- Groundwork for future updates of the measures list with advancements in the science
- Publications in peer-reviewed journals describing the rationale, process, and products
Future activities include planning and organizing webinars to publicize the project and holding workshops during professional society meetings to engage investigators.
Proposed metrics to evaluate the impact of the ADOPT Core Measures project, include: 1) initial awareness of ADOPT and engagement e.g., documentation on hits to the GEM Website/workspace, downloads of protocols from GEM workspace, and participation in ADOPT workshops and sessions); 2) use of the ADOPT Core Measures (number of citations for ADOPT publications; increased inclusion of ADOPT Core Measures in publications, grant proposals, and trial registries; and improvements in best practices when using ADOPT Core Measures); and 3) other scientific outputs (advances in knowledge regarding predictors, moderators, and mediators of obesity treatment; advances in knowledge about variability in response to obesity treatment; advances in the development of tailored obesity treatments; advances in measurement for promising constructs; and development of initiatives similar to ADOPT for other populations and/or other health domains).
The Working Group is planning five peer-reviewed publications to document its work, including one main paper to describe the high priority list and four domain-specific papers.
Catherine (Cay) Loria, PhD, MS, MA
Division of Cardiovascular Sciences
Holly Nicastro, PhD, MPH
Division of Cardiovascular Sciences
Paul S. MacLean, PhD, University of Colorado School of Medicine
Alex Rothman, PhD, University of Minnesota
Daniel H. Bessesen, MD; University of Colorado, Anschutz Medical Campus
Kerri Boutelle, PhD; University of California San Diego
Molly Bray, PhD, The University of Texas at Austin
Anita P. Courcoulas, MD, MPH, FACS; University of Pittsburgh Medical Center
Elissa Epel, PhD; University of California San Francisco
Amy Gorin, PhD; University of Connecticut
Mark Hopkins; Leeds Beckett University
John M. Jakicic, PhD; University of Pittsburgh
Leslie A. Lytle, PhD; University of North Carolina, Chapel Hill
Naresh M. Punjabi, MD, PhD; Johns Hopkins University School of Medicine
Susan B. Roberts, PhD; Tufts University
Michael Rosenbaum, MD; Columbia University Medical Center
Donna H. Ryan, MD; Pennington Biomedical Research Center
Brian E. Saelens, PhD; University of Washington
Cary R. Savage, PhD; Banner Alzheimer's Institute
Dana M Small, PhD, Yale Medical School
Angelina R. Sutin, PhD; Florida State University College of Medicine
David M. Williams, PhD; Brown University School of Public Health
Shannon N. Zenk, PhD, MPH, RN; University of Illinois at Chicago
Tanya Agurs-Collins, PhD, RD; NCI
S. Sonia Arteaga, PhD; NHLBI
Rachel Ballard, MD, MPH; ODP
David Berrigan PhD MPH; NCI
Susan M. Czajkowski, PhD; NCI
Mary Evans, PhD; NIDDK
Paige A. Green, PhD, MPH; NCI
Kevin D. Hall, PhD; NIDDK
Christine M. Hunter, PhD, ABPP; NIDDK
Aaron D. Laposky, PhD; NHLBI
Maren R. Laughlin, PhD; NIDDK
Padma Maruvada PhD; NIDDK
Richard P Moser, PhD; NCI
Lis Nielsen, PhD; NIA
Tiffany M. Powell-Wiley MD, MPH, FAHA; NHLBI
Charlotte Pratt, PhD, MS, RD, FAHA; NHLBI
Jill Reedy, PhD, MPH, RD; NCI
Elise L. Rice, PhD; NCI
Katrina J. Serrano, PhD, CHES; ORWH
Luke E. Stoeckel, PhD; NIDDK
Aynur Unalp-Arida, MD, MSc, PhD; NIDDK
Susan Z. Yanovski, MD; NIDDK
Deborah Young-Hyman, PhD; OBSSR