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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03091-38 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| SENS laboratory, Univ. Grenoble Alpes | UNKNOWN |
| INRAE, UNH, CRNH Auvergne, Clermont Auvergne University | UNKNOWN |
| Kiplin | UNKNOWN |
| I-SITE Clermont Auvergne Project 20-25 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kiplin intervention | Experimental | 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. |
|
| face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France) | Active Comparator | three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived vulnerability toward COVID-19 | measured using the perceived vulnerability questionnaire | Month 9 |
| Perceived digitalization | measured using a single item |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Duclos | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35710254 | Derived | Mazeas A, Chalabaev A, Blond M, Pereira B, Duclos M. Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol. BMJ Open. 2022 Jun 16;12(6):e058015. doi: 10.1136/bmjopen-2021-058015. |
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We will share de-identified data associated with the collected samples by depositing these data at the Open Science Framework (OSF) repository. The storage will be in Germany (Frankfurt). Data will include demographic, anthropometric, and physical measurements along with data from questionnaires and intervention adherence. We agree that we will identify where the data will be available and how to access the data in any publications and presentations that we author about these data.
Data will be available via a public OSF project that will be accessible by everyone. We agree to deposit outcome data into the OSF repository as soon as possible but no later than within two years after the completion of the trial or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D009043 | Motor Activity |
| D000079322 | Weight Prejudice |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| UNKNOWN |
Prospective, randomized, controlled with two parallel arms.
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Research assistants collecting data will be blinded to the treatment allocation. Double blinding is nevertheless not possible in such interventions because allocation concealment is impossible for participants.
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| face-to-face | Behavioral | three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. |
|
| 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 |
| Month 9 |
| Perceived exertion during the APA sessions | measured via the Borg scale | Month 3 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D011287 | Prejudice |
| D012919 | Social Behavior |