Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Mobility Coaching group Diet Coaching group 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.

Official Title
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Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.

Conditions
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Obesity, Morbid, Bariatric Surgery Candidate

Intervention / Treatment
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* Behavioral: Mobility coaching
* Behavioral: Diet coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primo-surgery bariatric surgery a week before their inclusion Absence of surgical side events related to the surgical procedure Adult female or male Weight ≤ 150 kg Knowing read and write French routinely, Possessing an internet connection at home, Possessing and knowing how to use a computer or tablet, Owning a smartphone, Affiliated with a social security scheme Not Trust Having signed the informed consent letter Non-inclusion criteria • Patient with major disabilities causing a definitive loss of mobility Exclusion Criteria: • None

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobility Coaching<br>45 patients undergoing bariatric surgery received a monthly mobility coaching session of 20 to 30 min by phone during 6 months. | Behavioral: Mobility coaching<br>* 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.<br>* Other names: Mobility;|
| Experimental: Diet Coaching<br>45 patients undergoing bariatric surgery received a monthly diet coaching session of 20 to 30 min by phone during 6 months. | Behavioral: Diet coaching<br>* 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.<br>* Other names: Diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutrition, Physical activity, Bariatric surgery, Obesity, Health technology, Health-connected devices