Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients
- Conditions
- Obesity, MorbidBariatric Surgery Candidate
- Interventions
- Behavioral: Mobility coachingBehavioral: Diet coaching
- Registration Number
- NCT02716480
- Lead Sponsor
- My Goodlife SAS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
• None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobility Coaching Mobility coaching 45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months. Diet Coaching Diet coaching 45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.
- Primary Outcome Measures
Name Time Method Change from baseline mean number of steps per day at 6th month 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 Outcome Measures
Name Time Method % of patients having nutritional deficiency in vitamins and / or minerals At 6th month Biological measurements
Change from baseline Quality of life at 6th month At the 6th month Estimated by self-administered quality-of-life questionnaire (EQVOD)
Change from baseline Quality of life at 3rd month At the 3rd month Estimated by self-administered quality-of-life questionnaire (EQVOD)
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 Estimated by self-administrated questionnaire (RPAQ)
Change from baseline mean daily energy expenditure at 6th month At 6th month Estimated by self-administrated questionnaire (RPAQ)
Trial Locations
- Locations (1)
Department of Visceral Surgery - European Georges Pompidou Hospital -
🇫🇷Paris, Ile-de-France, France