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Abstract
Objective Our objective was to determine the extent to which current evidence from long-term randomised controlled trials (RCTs) of weight management is generalisable and applicable to underserved adult groups with obesity (body mass index (BMI) ≥35 kg/m2).
Methods Descriptive analysis of 131 RCTs, published after 1990–May 2017 with ≥1 year of follow-up, included in a systematic review of long-term weight management interventions for adults with BMI ≥35 kg/m2 (the REBALANCE Project). Studies were identified from MEDLINE, EMBASE, PsychINFO, SCI, CENTRAL and from hand searching. Reporting of trial inclusion and exclusion criteria, trial recruitment strategies, baseline characteristics and outcomes were analysed using a predefined list of characteristics informed by the PROGRESS (Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, Social capital)-Plus framework and the UK Equality Act 2010.
Results Few (6.1%) trials reported adapting recruitment to appeal to underserved groups. 10.0% reported culturally adapting their trial materials. Only 6.1% of trials gave any justification for their exclusion criteria, yet over half excluded participation for age or mental health reasons. Just over half (58%) of the trials reported participants’ race or ethnicity, and one-fifth reported socioeconomic status. Where outcomes were reported for underserved groups, the most common analysis was by sex (47.3%), followed by race or ethnicity (16.8%). 3.1% of trials reported outcomes according to socioeconomic status.
Discussion Although we were limited by poor trial reporting, our results indicate inadequate representation of people most at risk of obesity. Guidance for considering underserved groups may improve the appropriateness of research and inform greater engagement with health and social care services.
Funding National Institute for Health Research Health Technology Assessment Programme (project number: 15/09/04).
PROSPERO registration number CRD42016040190.
- PUBLIC HEALTH
- Clinical trials
- Health policy
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article, uploaded as supplemental information, or are available from the NHIR journals library ((REBALANCE) REview of Behaviour And Lifestyle interventions for severe obesity: AN evidenCE syntheis (nihr.ac.uk))
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
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Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article, uploaded as supplemental information, or are available from the NHIR journals library ((REBALANCE) REview of Behaviour And Lifestyle interventions for severe obesity: AN evidenCE syntheis (nihr.ac.uk))
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Footnotes
Contributors CR, MA-M, MC, MI and AA contributed to conception and design, acquisition of data, or analysis and interpretation of data, and revised data critically for important intellectual content of this manuscript. All authors critically reviewed the manuscript and approved the final version submitted for publication. CR takes responsibility for the integrity of the data and the accuracy of the data analysis. CR is the guarantor and accepts full responsibility for the finished work and/or the conduct of the study, had access to the data, and controlled the decision to publish.
Funding The REBALANCE Study was funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number: 15/09/04).
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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