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Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial
journal contributionposted on 2023-02-15, 00:49 authored by D Kwasnicka, A Luszczynska, MS Hagger, E Quested, SL Pagoto, P Verboon, Suzanne RobinsonSuzanne Robinson, A Januszewicz, P Idziak, I Palacz, F Naughton
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.
Article numberARTN e040183
Publication classificationC1.1 Refereed article in a scholarly journal
PublisherBMJ PUBLISHING GROUP
Science & TechnologyLife Sciences & BiomedicineMedicine, General & InternalGeneral & Internal Medicinenutrition & dieteticspreventive medicinepublic healthPHYSICAL-ACTIVITYBEHAVIORAL INTERVENTIONSPRIMARY-CAREN-OF-1OVERWEIGHTDISEASEOBESITYADULTSDIETAdultElectronic MailHumansOverweightPolandQuality of LifeRandomized Controlled Trials as TopicWeight LossClinical ResearchComparative Effectiveness ResearchClinical Trials and Supportive ActivitiesObesityCost Effectiveness ResearchNutritionPrevention3 Prevention of disease and conditions, and promotion of well-being3.1 Primary prevention interventions to modify behaviours or promote wellbeingMetabolic and endocrineStrokeOral and gastrointestinalCardiovascularGeneric health relevance3 Good Health and Well BeingPublic Health and Health Services not elsewhere classifiedMedical and Health Sciences not elsewhere classifiedClinical Sciences not elsewhere classified