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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

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Protocol
The NoHoW protocol: a multicentre 2×2 factorial randomised controlled trial investigating an evidence-based digital toolkit for weight loss maintenance in European adults
  1. Sarah Ellen Scott1,
  2. Cristiana Duarte1,2,
  3. Jorge Encantado3,
  4. Elizabeth H Evans4,
  5. Marja Harjumaa5,
  6. Berit Lilienthal Heitmann6,7,
  7. Graham W Horgan8,
  8. Sofus C Larsen6,
  9. Marta Moreira Marques3,9,
  10. Elina Mattila5,
  11. Marcela Matos2,
  12. Marie-Louise Mikkelsen6,
  13. António L Palmeira3,
  14. Beth Pearson1,
  15. Lauren Ramsey1,
  16. Kirby Sainsbury4,
  17. Inês Santos3,
  18. Falko Sniehotta4,
  19. Carol Stalker10,
  20. PJ Teixeira3,
  21. R. James Stubbs1
  1. 1 School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, UK
  2. 2 Center for Research in Neuropsychology and Cognitive Behavioral Intervention, University of Coimbra, Coimbra, Portugal
  3. 3 Faculty of Human Kinetics, University of Lisbon, Lisbon, Portugal
  4. 4 Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
  5. 5 VTT, VTT Technical Research Centre of Finland, Ltd, Espoo, Finland
  6. 6 Research Unit for Dietary Studies, Bispebjerg and Frederiksberg Hospital, The Parker Institut, Frederiksberg, The Capital Region, Denmark
  7. 7 Department of Public Health, University of Copenhagen, Copenhagen, Denmark
  8. 8 BioSS, Biomathematics and Statistics Scotland, Aberdeen, UK
  9. 9 Trinity Centre for Practice and Healthcare Innovation & ADAPT Centre, University of Dublin Trinity College, Dublin, UK
  10. 10 College of Life and Natural Sciences, University of Derby, Derby, UK
  1. Correspondence to Dr R. James Stubbs; r.j.stubbs{at}leeds.ac.uk

Abstract

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.

  • Weight loss maintenance
  • Digital health
  • Behaviour change
  • Self-regulation
  • Emotion regulation
  • Motivation

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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

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    Footnotes

    • Contributors RJS, BLH, PJT, FFS, ALP and GH conceived the study. RJS is the principle investigator; BLH is the grant coordinator; and SES and CD are the trial managers. SCL, ALP and SES are site coordinators. GH is the trial statistician and leads data management. MH and EM are responsible for the technological development and management of the NoHoW digital toolkit. ALP, MMM, MM and CD developed the content of the arms of the digital toolkit. JE, IS, MLM, CS, BP and LR conducted the trial activities at each respective trial sites. EHE and KS were involved in the development of some of the trial outcome measures. SES, CD and RJS drafted the manuscript and all authors revised and approved the final version. All authors made substantial contributions to the conceptualisation of the study design and conduct of the protocol.

    • Funding This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 643309. The material presented and views expressed here are the responsibility of the author(s) only. The EU Commission takes no responsibility for any use made of the information set out. MMM is funded by the Marie-Sklodowska-Curie (EDGE) Fellowship programme (grant agreement No. 713567).

    • Competing interests RJS consults for Slimming World through the University of Leeds. MMM and GH also conducted consultancy work with Slimming World. Slimming World were a partner of the project to aid recruitment within the UK but will not be involved in the analysis and interpretation of the trial.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.