Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity, Morbid
- Sponsor
- My Goodlife SAS
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change from baseline mean number of steps per day at 6th month
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline mean number of steps per day at 6th month
Time Frame: Period from Day 164 to Day 179
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). .
Secondary Outcomes
- % of patients having nutritional deficiency in vitamins and / or minerals(At 6th month)
- Change from baseline Quality of life at 6th month(At the 6th month)
- Change from baseline Quality of life at 3rd month(At the 3rd month)
- Change from baseline mean number of steps per day at 3rd month(Period from Day 75 to Day 90)
- Change from baseline weight at 6th month(At 6th month)
- Change from baseline weight at 3rd month(At 3rd month)
- Change from baseline mean daily energy expenditure at 3rd month(At 3rd month)
- Change from baseline mean daily energy expenditure at 6th month(At 6th month)