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The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults

Lookup NU author(s): Dr Elizabeth EvansORCiD, Professor Falko Sniehotta

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.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.


Publication metadata

Author(s): Scott SE, Duarte C, Encantado J, Evans EH, Harjumaa M, Heitmann BL, Horgan GW, Larsen SC, Marques MM, Mattila E, Matos M, Mikkelsen M-L, Palmeira AL, Pearson B, Ramsey L, Sainsbury K, Santos I, Sniehotta F, Stalker C, Teixeira PJ, Stubbs RJ

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2019

Volume: 9

Issue: 9

Acceptance date: 28/08/2019

Date deposited: 14/10/2019

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

URL: https://doi.org/10.1136/bmjopen-2019-029425

DOI: 10.1136/bmjopen-2019-029425

PubMed id: 31575569


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Funding

Funder referenceFunder name
643309
713567

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