Article Text

Protocol
Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol
  1. Alexandre Mazéas1,2,3,
  2. Aïna Chalabaev1,
  3. Marine Blond3,
  4. Bruno Pereira4,
  5. Martine Duclos2,5
  1. 1SENS, Univ. Grenoble Alpes, 38000 Grenoble, France
  2. 2Department of Human Nutrition, INRAE Centre Clermont-Auvergne-Rhône-Alpes, Clermont-Ferrand, France
  3. 3Kiplin, Nantes, France
  4. 4Department of Biostatistics Unit (DRCI), University Hospital Centre, Clermont-Ferrand, France
  5. 5Department of Sport Medicine and Functional Exploration, University Hospital Centre, Clermont-Ferrand, France
  1. Correspondence to Mr Alexandre Mazéas; alexandre.mazeas{at}univ-grenoble-alpes.fr

Abstract

Introduction Physical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.

Methods and analysis This trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. A total of 50 patients will be randomised to one of the two interventions and will follow a 3-month programme with a 6-month follow-up postintervention. The primary outcome of the study is the daily step count change between the baseline assessment and the end of the intervention. Accelerometer data, self-reported PA, body composition and physical capacities will also be evaluated. To advance our understanding of complex interventions like gamified and group-based ones, we will explore several psychological mediators relative to motivation, enjoyment, in-group identification or perceived weight stigma. Finally, to assess a potential superior economic efficiency compared with the current treatment, we will conduct a cost–utility analysis between the two conditions. A mixed-model approach will be used to analyse the change in outcomes over time.

Ethics and dissemination The research protocol has been reviewed and approved by the Local Human Protection Committee (CPP Ile de France XI, No 21 004-65219). Results will inform the Kiplin app development, be published in scientific journals and disseminated in international conferences.

Trial registration number NCT04887077.

  • behavior change
  • cost-utility
  • e-health
  • gamification
  • intervention
  • mhealth
  • mobile app
  • obesity
  • physical activity
  • RCT
  • T2DM
  • weight stigma
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Supplementary materials

Footnotes

  • Twitter @AlexMazeas

  • Contributors AM, AC, MB and MD conceptualised the project and obtained the funding. All authors provided input into the study design. AM and BP designed the data analysis plan. The first draft of the manuscript was written by AM and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

  • Funding This project is funded by a grant of the challenge 3 I-SITE Clermont Auvergne Project 20-25. The work of AM is supported by an ANRT grant (Cifre PhD Thesis) and by the company Kiplin. Trial sponsor: University Hospital CHU G. Montpied, Clermont-Ferrand.

  • Disclaimer The funders had no input in the design of the trial and will have no influence on the collection, interpretation or publication of the study results.

  • Competing interests AC, BP and MD declare that they have no competing interests. AM’s PhD grant is funded by the French National Association for Research and Technology (ANRT) and Kiplin. MB is employed by Kiplin.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

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

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.