The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults
Inês Santos,
Berit Lilienthal Heitmann,
Kirby Sainsbury,
Sarah Ellen Scott,
Cristiana Duarte,
Jorge Encantado,
Elizabeth H Evans,
Marja Harjumaa,
Graham W Horgan,
Sofus C Larsen,
Marta Moreira Marques,
Elina Mattila,
Marcela Matos,
Marie-Louise Mikkelsen,
António L Palmeira,
Beth Pearson,
Lauren Ramsey,
Falko Sniehotta,
Carol Stalker,
PJ Teixeira,
R. James Stubbs
Affiliations
Inês Santos
CIDEFES, Universidade Lusófona, Lisboa, Portugal
Berit Lilienthal Heitmann
1 The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Kirby Sainsbury
4 Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
Sarah Ellen Scott
1 School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, UK
Cristiana Duarte
1 School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, UK
Jorge Encantado
3 Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal
Elizabeth H Evans
4 Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
Marja Harjumaa
5 VTT, VTT Technical Research Centre of Finland, Ltd, Espoo, Finland
Graham W Horgan
8 BioSS, Biomathematics and Statistics Scotland, Aberdeen, UK
Sofus C Larsen
6 Research Unit for Dietary Studies, Bispebjerg and Frederiksberg Hospital, The Parker Institut, Frederiksberg, The Capital Region, Denmark
Marta Moreira Marques
3 Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal
Elina Mattila
5 VTT, VTT Technical Research Centre of Finland, Ltd, Espoo, Finland
Marcela Matos
2 Center for Research in Neuropsychology and Cognitive Behavioral Intervention, University of Coimbra, Coimbra, Portugal
Marie-Louise Mikkelsen
6 Research Unit for Dietary Studies, Bispebjerg and Frederiksberg Hospital, The Parker Institut, Frederiksberg, The Capital Region, Denmark
António L Palmeira
3 Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal
Beth Pearson
1 School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, UK
Lauren Ramsey
Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK
Falko Sniehotta
Population Health Science Institute, Faculty of Medical Sciences, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, UK
Carol Stalker
10 College of Life and Natural Sciences, University of Derby, Derby, UK
PJ Teixeira
3 Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal
R. James Stubbs
1 School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, UK
Introduction Obesity and associated diseases place a severe burden on healthcare systems. Behavioural interventions for weight loss (WL) are successful in the short term but often result in weight regain over time. Self-regulation of eating and activity behaviours may significantly enhance weight loss maintenance (WLM) and may be effectively augmented by contextual behavioural approaches to emotion regulation. The NoHoW trial tests the efficacy of a theoretically informed, evidence-based digital toolkit using a mobile-enabled website, activity trackers and Wi-Fi scales for WLM aiming to target (1) self-regulation and motivation, and (2) emotion regulation in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial body mass index (BMI) ≥25 kg/m2).Methods and analysis The study is an 18-month, 3-centre, 2×2 factorial single-blind, randomised controlled trial, which recruited 1627 participants achieving ≥5% WL between March 2017 and March 2018. Participants are randomly allocated to one of four arms: (1) self-monitoring only (self-weighing and activity tracker), (2) self-regulation and motivation, (3) emotion regulation or (4) combined self-regulation, motivation and emotion regulation. Participants attend four clinical investigation days at 0, 6, 12 and 18 months and are instructed to use the digital toolkit for 18 weeks during the first 6 months and at their discretion for the remaining 12 months. The primary outcome is change in weight (kg) at 12 months from baseline. Secondary outcomes are body composition (eg, bioimpedance analysis), health biomarkers (glycated haemoglobin, lipids, blood pressure, hair cortisol), dietary intake, physical activity, sleep, motivational, self-regulatory, emotion regulatory moderators/mediators of WLM, engagement, user experience, acceptability and cost-effectiveness of the interventions.Ethics and dissemination Ethical approval was granted by Institutional Ethics Committees at the Universities of Leeds (17–0082; 27 February 2017), Lisbon (17/2016; 20 February 2017) and Capital Region of Denmark (H-16030495, 8 March 2017). Results will be published in scientific journals.Trial registration number ISRCTN88405328.
