Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity, Diabete Type 2

Intervention / Treatment
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* Device: Kiplin
* Behavioral: face-to-face


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled with two parallel arms.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kiplin intervention<br>Kiplin intervention composed of the access to a mobile app and to telecoaching sessions. The number of teleocaching sessions per week will decrease over 3 months. | Device: Kiplin<br>* 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.<br>|
| Active Comparator: face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France)<br>three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. | Behavioral: face-to-face<br>* three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in daily physical activity from baseline to 3 months | 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) | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition (BMI) from baseline to 9 months | in kg/m2 | Month 9 | 
| Change in body composition from baseline to 9 months | evaluated by bioelectrical impedance analysis | Month 9 | 
| Change in daily physical activity from baseline to 9 months | measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA) | Month 9 | 
| Change in physical activity level from baseline to 9 months | total physical activity (minutes/day) measured using the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA) | Month 9 | 
| Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months | measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA). | Month 9 | 
| Change in light physical activity (LPA) from baseline to 9 months | measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA). | Month 9 | 
| Change in sedentary time from baseline to 9 months | measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA). | Month 9 | 
| Change in self-reported physical activity from baseline to 9 months | measured using the RPAQ | Month 9 | 
| Change in six minute walking distance from baseline to 9 months | measured via the 6-minute walking test | Month 9 | 
| Change in muscular strength of the upper limbs from baseline to 9 months | measured via handgrip measurements | Month 9 | 
| Change in muscular strength of the lower limbs from baseline to 9 months | measured via isokinetic dynamometer | Month 9 | 
| Programme adherence | number of APA sessions attended. Application engagement and utilization for the experimental group only | Month 3 | 
| Change in quality of life from baseline to 9 months | measured via the EQ-5D | Month 9 | 
| Cost-utility analysis | measured using incremental cost-effectiveness ratio between the average difference in cost and the average difference in effectiveness (QALY) observed between the two arms | Month 9 | 
| Perceived enjoyment of physical activity at the end of the intervention | measured using the Physical Activity Enjoyment Scale (PACES) | Month 3 | 
| Social identification at the end of the intervention | measured via the In-group identification questionnaire | Month 3 | 
| Psychological needs satisfaction at the end of the intervention | measured via the Psychological Need Satisfaction in Exercise Scale (PNSES) | Month 3 | 
| Change in motivation toward physical activity from baseline to 9 months | Autonomous and controlled motivation toward physical activity via the EMAPS. | Month 9 | 
| Change in weight stigma concerns from baseline to 9 months | measured using the scale developed by Hunger and Major | Month 9 | 
| Change in perceived daily discrimination from baseline to 9 months | measured via the everyday discrimination scale | Month 9 | 
| Change in weight bias internalisation from baseline to 9 months | measured via the Modified Weight Bias Internalization Scale (WBIS-M) | Month 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, Physical activity, Gamification, Mobile app, Behavior change, Cost-utility, Weight stigma