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.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))
| Original language | English |
|---|---|
| Article number | e054459 |
| Journal | BMJ Open |
| Volume | 12 |
| Issue number | 5 |
| Early online date | 31 May 2022 |
| DOIs | |
| Publication status | E-pub ahead of print - 31 May 2022 |
Bibliographical note
AcknowledgmentsWe thank the members of the REBALANCE Project and Advisory Groups for their contributions to the REBALANCE Project. We thank Shaun Treweek and Heidi Gardner, Health Services Research Unit, University of Aberdeen, for helpful discussions on trial generalisability and inclusion of underserved groups.
Funding National Institute for Health Research Health Technology Assessment Programme (project number: 15/09/04).
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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