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| Name | Class |
|---|---|
| European Georges Pompidou Hospital | OTHER |
| Hospital Ambroise Paré Paris | OTHER |
| French Environment and Energy Management Agency | UNKNOWN |
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The goal of clinical trial is to evaluate the impact of use of health-connected devices and of an Internet-based Intensive follow-up on physical activity recovery during the 6-month period after bariatric surgery in obese patients.
90 patients with morbid obesity, having recently benefited from an act of bariatric surgery will be recruited for clinical trial if they meet the inclusion and no inclusion criteria. This is a single-center, open, controlled, randomized, 2 parallel-groups:
The "Diet Coaching" group will be the "control group" of "Mobility Coaching" group and vice versa.
Patients in both groups will be equipped with a connected-scale and a wristwatch equipped with a pedometer connected. The online tools available to patients will be used to motivate patients to progress and alert the coaches and the medical team in case of difficulties to achieve the objectives.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobility Coaching | Experimental | 45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months. |
|
| Diet Coaching | Experimental | 45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobility coaching | Behavioral | The intensive follow-up for the patients of "Mobility Coaching " arm will consist on a monthly remote coaching of 20 to 30 minutes led by a "Mobility" coach. The web platform allows self-administration of a questionnaire to establish patient's diagnosis of mobility to enable personalized coaching. The web platform can also track the parameters collected by connected devices (pedometer and connected scale), organize appointments with patients and ensure the traceability of exchanges with patients. A smartphone application tracks different modes of locomotion used. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline mean number of steps per day at 6th month | The primary endpoint is the difference between mean number of steps recorded by the pedometer during the last 15 days of the 6th month (Period Day 164 to Day 179) and the mean number of steps per day recorded in the last 15 days of the first month (Period Day 15 to Day 30). . | Period from Day 164 to Day 179 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline mean daily energy expenditure at 6th month | Estimated by self-administrated questionnaire (RPAQ) | At 6th month |
| Change from baseline mean daily energy expenditure at 3rd month |
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Inclusion Criteria:
Non-inclusion criteria • Patient with major disabilities causing a definitive loss of mobility
Exclusion Criteria:
• None
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| Name | Affiliation | Role |
|---|---|---|
| Karl AUZOU, Msc | My Goodlife SAS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral Surgery - European Georges Pompidou Hospital - | Paris | ÃŽle-de-France Region | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468168 | Background | Blood Pressure Lowering Treatment Trialists' Collaboration; Ying A, Arima H, Czernichow S, Woodward M, Huxley R, Turnbull F, Perkovic V, Neal B. Effects of blood pressure lowering on cardiovascular risk according to baseline body-mass index: a meta-analysis of randomised trials. Lancet. 2015 Mar 7;385(9971):867-74. doi: 10.1016/S0140-6736(14)61171-5. Epub 2014 Nov 4. | |
| 25771441 |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016059 | Range of Motion, Articular |
| D004032 | Diet |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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|
|
| Diet coaching | Behavioral | The intensive follow-up for the patients of "Diet Coaching " arm will consist on a monthly remote coaching of 20 to 30 minutes led by dietitian trained in the care of patients undergoing bariatric surgery. |
|
|
Estimated by self-administrated questionnaire (RPAQ)
| At 3rd month |
| Change from baseline weight at 6th month | At 6th month |
| Change from baseline weight at 3rd month | At 3rd month |
| % of patients having nutritional deficiency in vitamins and / or minerals | Biological measurements | At 6th month |
| Change from baseline Quality of life at 6th month | Estimated by self-administered quality-of-life questionnaire (EQVOD) | At the 6th month |
| Change from baseline Quality of life at 3rd month | Estimated by self-administered quality-of-life questionnaire (EQVOD) | At the 3rd month |
| Change from baseline mean number of steps per day at 3rd month | Period from Day 75 to Day 90 |
| Background |
| Thereaux J, Corigliano N, Poitou C, Oppert JM, Czernichow S, Bouillot JL. Comparison of results after one year between sleeve gastrectomy and gastric bypass in patients with BMI >/= 50 kg/m(2). Surg Obes Relat Dis. 2015 Jul-Aug;11(4):785-90. doi: 10.1016/j.soard.2014.11.022. Epub 2014 Dec 4. |
| 25366293 | Result | Czernichow S, Moszkowicz D, Szwarcensztein K, Emery C, Lafuma A, Gourmelen J, Fagnani F. Impact of bariatric surgery on the medical management and costs of obese patients in France: an analysis of a national representative claims database. Obes Surg. 2015 Jun;25(6):986-96. doi: 10.1007/s11695-014-1488-3. |
| 36976624 | Derived | Lurbe I Puerto K, Bruzzi M, Rives-Lange C, Poghosyan T, Bretault M, Chatellier G, Vilfaillot A, Chevallier JM, Czernichow S, Carette C. MyGood Trip, a Telemedicine Intervention for Physical Activity Recovery After Bariatric Surgery: Randomized Controlled Trial. JMIR Form Res. 2023 Mar 28;7:e26077. doi: 10.2196/26077. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |