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Follow-up of patients not completed. Primary endpoint not assessable
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Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months
Regular physical activity (PA) is a key element in the success of bariatric surgery and the prevention of complications associated with frequent co-morbidities. However, the levels of PA observed in patients who will benefit from bariatric surgery are generally low, and many patients do not comply with the recommendations of their course in terms of PA. It is envisaged that coaching interventions and adapted programs can improve the level of PA. The objective of this pilot study is to evaluate the effectiveness and adherence to digital tools on the level of PA in preparation for bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STIMUL group | Active Comparator | The STIMUL Group participants in the Adaptive Physical Activity Focus (APA) program receive access to an online digital Platform, as well as a starter kit consisting of a connected pedometer measuring several physical activity indicators including the number of steps, number of so-called active minutes, sleep time, and distance travelled; a tape measure and a starter guide. They then conduct a remote assessment and motivational interview by videoconference or telephone, followed by 15-20 minute support interviews (month 1, month 3, month 6). Between these interviews, during months 1, 2, and 3, participants exchange weekly written messages with an educator on their platform. A planner of their physical activity objectives is provided. |
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| STANDARD group | No Intervention | The STANDARD group participants dont receive an access to an online digital platform but they receive an adapted advice sheet. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STIMUL group | Device | The STIMUL Group participants in the Adaptive Physical Activity Focus (APA) program receive access to an online digital Platform, as well as a starter kit consisting of a connected pedometer measuring several physical activity indicators including the number of steps, number of so-called active minutes, sleep time, and distance travelled; a tape measure and a starter guide. They then conduct a remote assessment and motivational interview by videoconference or telephone, followed by 15-20 minute support interviews (month 1, month 3, month 6). Between these interviews, during months 1, 2, and 3, participants exchange weekly written messages with an educator on their platform. A planner of their physical activity objectives is provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Ricci-Gagnon score (9-45) | This score describe the physical profile : inactive, active, very active, at month 4 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question. Less than 18=inactive Between 18 and 35=active More than 35=Active | month 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Ricci-Gagnon score (9-45) | This score describe the physical profile : inactive, active, very active, at month 10 et 16 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question. Less than 18=inactive Between 18 and 35=active More than 35=Active | 10 and 16 months |
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Inclusion Criteria:
Exclusion Criteria:
• Contra-indication to the practice of sport
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Intercommunal Créteil | Créteil | 94000 | France |
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Patients will be randomized to the STANDARD group for which management will be standard or to the STIMUL group with digital coaching program
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| International Physical Activity Questionnaire (IPAQ) |
physical activity score
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| 4, 10 and 16 months |
| Body masse Index (BMI) (kg/m²) | Comparison of BMI in the 2 groups at 4, 10, and 16 months BMI < 18.5 kg/m²: underweight 18.5 < BMI < 24.9: normal weight 25 < BMI < 29.9: overweight BMI > 30: obesity | 4, 10 and 16 months |
| Waist circumference (cm) | Comparison of waist circumference in the 2 groups at 4, 10, and 16 months | 4, 10 and 16 months |
| Hip circumference (cm) | Comparison of waist circumference in the 2 groups at 4, 10, and 16 months | 4, 10 and 16 months |
| Lipid balance (g/l) | Evolution of the lipid balance in the 2 groups | 4, 10 and 16 months |
| Blood pressure (mmHg) | Evolution of blood pressure in the 2 groups | 4, 10 and 16 months |
| Quality of Life, Obesity and Dietetics Scale(EQVOD) | Evolution of the quality of life (EQVOD) | 4, 10 and 16 months |