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

Abstract

IntroductionObesity 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 analysisThe 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 disseminationEthical 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 numberISRCTN88405328.

Weekly, seasonal and holiday body weight fluctuation patterns among individuals engaged in a European multi-centre behavioural weight loss maintenance intervention

“…It was delivered in three centres located in the United Kingdom (Leeds), Denmark (Copenhagen), and Portugal (Lisbon). A detailed description of the trial can be found elsewhere [33]. In short, eligible participants were randomised into 4 arms upon entry to the trial ((1) active control, (2) self-regulation and motivation, (3) contextual behavioural emotion regulation and (4) self-regulation, motivation and emotion regulation (i.e.…”

“…Participants were instructed to weigh themselves at least twice per week and wear the activity monitor at all times apart from when charging and during activities involving water. No specific dietary or physical activity advice was given, though intervention content (which is provided in more detail elsewhere [33]) provided guidance on self-regulation and planning which may support a healthy lifestyle. Outcome measures were made at 6, 12 and 18 months.…”

“…Such techniques include isolation of body weight variability patterns from linear and non-linear trends which may confound the specific outcomes of interest [11], such as risk of disease [31,32]. A recent pan-European multi-centre weight loss maintenance intervention (the NoHoW trial [33]) has collected body weight data over 18 months from a large sample of individuals provided with smart scales. The aim of the present paper is to improve the understanding of body weight variability by describing weekly, holiday and seasonal patterns according to gender, country, BMI and age groups using improved methods of data collection and data analysis.…”

Estimating physical activity and sedentary behaviour in a free-living environment: A comparative study between Fitbit Charge 2 and Actigraph GT3X

“…This study was part of the baseline examination in the Danish part of the NoHoW study [29], which is a multi-centre randomised controlled trial focusing on weight loss maintenance in adults after a clinically significant weight loss. As part of the trial, all participants received a FB tracker.…”

A novel scaling methodology to reduce the biases associated with missing data from commercial activity monitors

“…The study was conducted in accordance with the Helsinki Declaration and ethical approval has been granted by local institutional ethics committees at the Universities of Leeds (17-0082; 27-Feb-2017), Lisbon (17/2016; 20-Feb-2017) and the Capital Region of Denmark (H-16030495; 8-Mar-2017) and all participants provided informed consent to have their data used for research purposes by this research team. Full details of the trial protocol have been published previously [33]. The NoHoW trial recruited 1,627 participants and some of the observational work reported in this study utilised the entire sample of NoHoW participants and when this is the case, this is specified in the manuscript.…”