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

Journal: BMJ open 2021;10(11):e040183

PMID: 33234638

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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 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 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.

Address: Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland [email protected].; Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.; Psychological Sciences, University of California, Merced, Merced, California, United States.; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.; Physical Activity and Well-being Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.; Department of Allied Health Sciences, The UConn Center for mHealth and Social Media, University of Connecticut, Connecticut, New England, United States.; Department of Psychology and Educational Sciences, Open Universiteit Nederland Faculteit Managementwetenschappen, Heerlen, Limburg, The Netherlands.; School of Public Health, Curtin University, Perth, Western Australia, Australia.; School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.

DOI: 10.1136/bmjopen-2020-040183

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MeSH Terms: Adult, Electronic Mail, Humans, Overweight, Poland, Quality of Life, Randomized Controlled Trials as Topic, Weight Loss