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Journal article
Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL)
BMJ open, v 13(2), e064394
28 Feb 2023
PMID: 36854588
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
IntroductionBehavioural weight loss (BWL) treatment is the standard evidence-based treatment for severe obesity (SO; body mass index ≥40.0 kg/m2 or ≥35.0 kg/m2 with obesity-related comorbidity), leading to moderate weight loss which often cannot be maintained in the long term. Because weight loss depends on patients’ use of weight management skills, it is important to support them in daily life. In an ecological momentary intervention design, this clinical trial aims to adapt, refine and evaluate a personalised cognitive-behavioural smartphone application (app) in BWL treatment to foster patients’ weight management skills use in everyday life. It is hypothesised that using the app is feasible and acceptable, improves weight loss and increases skills use and well-being.Methods and analysisIn the pilot phase, the app will be adapted, piloted and optimised for BWL treatment following a participatory patient-oriented approach. In the subsequent single-centre, assessor-blind, exploratory randomised controlled trial, 90 adults with SO will be randomised to BWL treatment over 6 months with versus without adjunctive app. Primary outcome is the amount of weight loss (kg) at post-treatment (6 months), compared with pretreatment, derived from measured body weight. Secondary outcomes encompass feasibility, acceptance, weight management skills use, well-being and anthropometrics assessed at pretreatment, midtreatment (3 months), post-treatment (6 months) and 6-month follow-up (12 months). An intent-to-treat linear model with randomisation arm, pretreatment weight and stratification variables as covariates will serve to compare arms regarding weight at post-treatment. Secondary analyses will include linear mixed models, generalised linear models and regression and mediation analyses. For safety analysis (serious) adverse events will be analysed descriptively.Ethics and disseminationThe study was approved by the Ethics Committee of the University of Leipzig (DE-21-00013674) and notified to the Federal Institute for Drugs and Medical Devices. Study results will be disseminated through peer-reviewed publications.RegistrationThis study was registered at the German Clinical Trials Register (DRKS00026018), www.drks.de.Trial registration numberDRKS00026018
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Details
- Title
- Smartphone-supported behavioural weight loss treatment in adults with severe obesity: study protocol for an exploratory randomised controlled trial (SmartBWL)
- Creators
- Anja Hilbert - Leipzig UniversityAdrienne Juarascio - Drexel UniversityChristiane Prettin - Clinical Trial Centre, University of Leipzig, Leipzig, Saxony, GermanyDavid Petroff - Clinical Trial Centre, University of Leipzig, Leipzig, Saxony, GermanyHaiko Schlögl - University Hospital LeipzigClaudia Hübner - Leipzig University
- Publication Details
- BMJ open, v 13(2), e064394
- Publisher
- British Medical Journal Publishing Group
- Number of pages
- 10
- Grant note
- 01KG2027 / Bundesministerium für Bildung und Forschung (http://dx.doi.org/10.13039/501100002347)
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- College of Arts and Sciences; Center for Weight, Eating and Lifestyle Science (WELL) [Historical]
- Web of Science ID
- WOS:000944467100055
- Scopus ID
- 2-s2.0-85149153631
- Other Identifier
- 991020186998404721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Endocrinology & Metabolism