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: * "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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
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.
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.
Department of Visceral Surgery - European Georges Pompidou Hospital -
Paris, Île-de-France Region, France
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). .
Time frame: Period from Day 164 to Day 179
Change from baseline mean daily energy expenditure at 6th month
Estimated by self-administrated questionnaire (RPAQ)
Time frame: At 6th month
Change from baseline mean daily energy expenditure at 3rd month
Estimated by self-administrated questionnaire (RPAQ)
Time frame: At 3rd month
Change from baseline weight at 6th month
Time frame: At 6th month
Change from baseline weight at 3rd month
Time frame: At 3rd month
% of patients having nutritional deficiency in vitamins and / or minerals
Biological measurements
Time frame: At 6th month
Change from baseline Quality of life at 6th month
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Time frame: At the 6th month
Change from baseline Quality of life at 3rd month
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Time frame: At the 3rd month
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Change from baseline mean number of steps per day at 3rd month
Time frame: Period from Day 75 to Day 90