1. Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health)
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Suzanne Robinson, Iga Palacz, Aleksandra Luszczynska, Martin S. Hagger, Eleanor Quested, Dominika Kwasnicka, Paulina Idziak, Anna Januszewicz, Peter Verboon, Sherry L. Pagoto, Felix Naughton, Section Methodology & Statistics, RS-Research Line Methodology & statistics (part of IIESB program), and RS-Research Program The Interaction between Implicit and Explicit Strategies for Behaviour (IIESB)
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N of 1 trial ,Comparative Effectiveness Research ,Psychological intervention ,Overweight ,Cardiovascular ,Oral and gastrointestinal ,DISEASE ,law.invention ,BEHAVIORAL INTERVENTIONS ,Randomized controlled trial ,Weight loss ,law ,teleterveydenhuolto ,Randomized Controlled Trials as Topic ,Nutrition and Metabolism ,Electronic Mail ,public health ,PRIMARY-CARE ,General Medicine ,interventiotutkimus ,Stroke ,N-OF-1 ,OBESITY ,Public Health and Health Services ,Medicine ,medicine.symptom ,Adult ,medicine.medical_specialty ,Clinical Trials and Supportive Activities ,Clinical Sciences ,preventive medicine ,painonhallinta ,DIET ,Quality of life (healthcare) ,Clinical Research ,Weight Loss ,medicine ,Humans ,Obesity ,Metabolic and endocrine ,Preventive healthcare ,Nutrition ,nutrition & dietetics ,Other Medical and Health Sciences ,OVERWEIGHT ,business.industry ,Public health ,Prevention ,laihdutus ,ADULTS ,PHYSICAL-ACTIVITY ,Cost Effectiveness Research ,terveyskäyttäytyminen ,Physical therapy ,Quality of Life ,3.1 Primary prevention interventions to modify behaviours or promote wellbeing ,Poland ,Generic health relevance ,business - Abstract
IntroductionDigital 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 analysisThe 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 disseminationEthics 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 detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.
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- 2020
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