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Completed

NCT Number: NCT04887077

Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)

Overweight and obesity are today considered among the most important health risks facing humanity with more than one in two adults overweight or obese in western countries. In addition, Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with overweight and obesity and counts for 5% of the French population under 65 years of age and 15% in people over 65 years old. Despite the accumulation of scientific evidence supporting the benefits of physical activity, obese and diabetic people remain insufficiently active and current programs struggle to engage and sustain physical activity of patients over long periods of time. It is therefore urgent to develop interventions that can effectively change individuals' behavior. In this context, "e-health" interventions and gamification appear to be a particularly promising avenue to improve physical activity and reduce attrition rates of current programs.

This clinical trial aim to test the effectiveness of a digital intervention based on gamification and teamwork in comparison to a supervised physical activity program. The investigators hypothesized that the intervention will be efficient by the development of a self-determined motivation through the process of gamification on the one hand. On the other hand, through the in-group collaboration with other people who share the same stigmatized criteria that will help participants to overcome weight stigmas, acting generally as physical activity barriers.

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Key information

About this study

This trial is a randomized, two-arm intervention design that will examine the efficacy of a digital group-based intervention based on gamification and teamwork among obese and T2DM patients. The experimental arm will be compared to an active control group representing the traditional care program (supervised physical activity).

The digital intervention is composed of four components within a smartphone application: a) a gamification of PA, b) a remote adapted physical activity program with telecoaching sessions, c) an interface for exchange and conversation and, d) an activity monitoring tool. Accelerometer data, self-reported PA, body composition, and physical capacities will be assessed before, at the end of the intervention and then at the issue of a 6-month follow up. To advance our understanding of complex interventions like gamified and group-based ones, this study will explore several psychological mediators relative to motivation, enjoyment, in-group identification, or perceived weight stigma. Finally, to assess a potential superior efficiency compared to the current treatment (face-to-face supervised PA), this study will include a cost-utility analysis between the two conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject affected for obesity (BMI ≥30 kg/m² and <45 kg/m²) and/or T2DM.
  • Subject treated at the University Hospital of Clermont-Ferrand.
  • The participants must have an iOS (at least iOS8 version) or Android (at least version 5) smartphone.
  • Subjects must also be able to provide informed consent to participate in the research and be covered by health social security.
  • Subjects must be native to any physical activity intervention.
  • Sufficient proficiency of French will be required to ensure the understanding of the questionnaires.

Exclusion criteria

  • Medical or surgical history judged by the investigator to be incompatible with the study.
  • Subject with an unstable psychiatric condition.
  • Pregnant or breastfeeding women.
  • Heavy alcohol consumption (> 2 to 3 drinks per day depending on gender) or drug addiction.
  • Disability or contraindication to PA.
  • Subject with cardiorespiratory and/or osteoarticular disorders that limit their ability to perform physical tests or moderate PA for 30 minutes.
  • Subject with progressive cardiovascular or neoplastic disease.
  • Subject who has presented a major infection in the 3 months prior to inclusion.
  • Subject with a known neuro-muscular pathology (i.e., myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia).
  • Subject with chronic or acute inflammatory pathology within 3 months prior to inclusion.
  • Subject diagnosed and/or treated for schizophrenia, bipolar disorder, major depression.
  • Subject deprived of their liberty by judicial or administrative decision.
  • Subject refusing to sign the written consent to participate.
  • Subject participating in another study.

Treatment and study plan

Kiplin

Device

The Kiplin intervention will be composed of four components within a smartphone application: a) a gamification of Physical Activity through multiple games called "animations", b) a remote adapted physical activity program with telecoaching sessions, c) an interface for exchange and conversation and, d) an activity monitoring tool.

Face-to-face

Behavioral

three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.

Primary outcomes

  1. Change in daily physical activity from baseline to 3 months

    Time frame: Month 3

    The primary outcome will be the change of daily physical activity measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)

Secondary outcomes

  1. Change in body composition (BMI) from baseline to 9 months

    Time frame: Month 9

    in kg/m2

  2. Change in body composition from baseline to 9 months

    Time frame: Month 9

    evaluated by bioelectrical impedance analysis

  3. Change in daily physical activity from baseline to 9 months

    Time frame: Month 9

    measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)

  4. Change in physical activity level from baseline to 9 months

    Time frame: Month 9

    total physical activity (minutes/day) measured using the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)

  5. Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months

    Time frame: Month 9

    measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).

  6. Change in light physical activity (LPA) from baseline to 9 months

    Time frame: Month 9

    measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).

  7. Change in sedentary time from baseline to 9 months

    Time frame: Month 9

    measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).

  8. Change in self-reported physical activity from baseline to 9 months

    Time frame: Month 9

    measured using the RPAQ

  9. Change in six minute walking distance from baseline to 9 months

    Time frame: Month 9

    measured via the 6-minute walking test

  10. Change in muscular strength of the upper limbs from baseline to 9 months

    Time frame: Month 9

    measured via handgrip measurements

  11. Change in muscular strength of the lower limbs from baseline to 9 months

    Time frame: Month 9

    measured via isokinetic dynamometer

  12. Programme adherence

    Time frame: Month 3

    number of APA sessions attended. Application engagement and utilization for the experimental group only

  13. Change in quality of life from baseline to 9 months

    Time frame: Month 9

    measured via the EQ-5D

  14. Cost-utility analysis

    Time frame: Month 9

    measured using incremental cost-effectiveness ratio between the average difference in cost and the average difference in effectiveness (QALY) observed between the two arms

  15. Perceived enjoyment of physical activity at the end of the intervention

    Time frame: Month 3

    measured using the Physical Activity Enjoyment Scale (PACES)

  16. Social identification at the end of the intervention

    Time frame: Month 3

    measured via the In-group identification questionnaire

  17. Psychological needs satisfaction at the end of the intervention

    Time frame: Month 3

    measured via the Psychological Need Satisfaction in Exercise Scale (PNSES)

  18. Change in motivation toward physical activity from baseline to 9 months

    Time frame: Month 9

    Autonomous and controlled motivation toward physical activity via the EMAPS.

  19. Change in weight stigma concerns from baseline to 9 months

    Time frame: Month 9

    measured using the scale developed by Hunger and Major

  20. Change in perceived daily discrimination from baseline to 9 months

    Time frame: Month 9

    measured via the everyday discrimination scale

  21. Change in weight bias internalisation from baseline to 9 months

    Time frame: Month 9

    measured via the Modified Weight Bias Internalization Scale (WBIS-M)

Other outcomes

  1. Perceived vulnerability toward COVID-19

    Time frame: Month 9

    measured using the perceived vulnerability questionnaire

  2. Perceived digitalization

    Time frame: Month 9

    measured using a single item

  3. Perceived exertion during the APA sessions

    Time frame: Month 3

    measured via the Borg scale

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • I-SITE Clermont Auvergne Project 20-25
  • INRAE, UNH, CRNH Auvergne, Clermont Auvergne University
  • Kiplin
  • SENS laboratory, Univ. Grenoble Alpes

Registry information

Official study title

Digital Intervention Promoting Physical Activity Among Obese People Randomized Controlled Trial: Assessing the Effects of a Digital Intervention to Promote Physical Activity in Patients With Obesity and/or Type 2 Diabetes Mellitus

Acronym: DIPPAO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 14, 2021
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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