Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

Dominika Kwasnicka; Aleksandra Luszczynska; Martin S Hagger; Eleanor Quested; Sherry L Pagoto; Peter Verboon; Suzanne Robinson; Anna Januszewicz; Paulina Idziak; Iga Palacz; Felix Naughton

doi:10.1136/bmjopen-2020-040183

Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial

BMJ Open. 2020 Nov 23;10(11):e040183. doi: 10.1136/bmjopen-2020-040183.

Authors

Affiliations

¹ Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland dkwasnicka@swps.edu.pl.
² Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.
³ Psychological Sciences, University of California, Merced, Merced, California, United States.
⁴ Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.
⁵ Physical Activity and Well-being Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.
⁶ Department of Allied Health Sciences, The UConn Center for mHealth and Social Media, University of Connecticut, Connecticut, New England, United States.
⁷ Department of Psychology and Educational Sciences, Open Universiteit Nederland Faculteit Managementwetenschappen, Heerlen, Limburg, The Netherlands.
⁸ School of Public Health, Curtin University, Perth, Western Australia, Australia.
⁹ School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.

Abstract

Introduction: Digital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.

Methods and analysis: The proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.

Ethics and dissemination: Ethics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.

Trial registration details: This trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

Keywords: nutrition & dietetics; preventive medicine; public health.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Electronic Mail*
Humans
Overweight / therapy
Poland
Quality of Life*
Randomized Controlled Trials as Topic
Weight Loss*

Associated data

ClinicalTrials.gov/NCT04291482