NCT02716480

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: My Goodlife SAS · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Morbid
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
BEHAVIORAL	Mobility coaching	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.
BEHAVIORAL	Diet coaching	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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-02-01
• Completion: 2018-08-01
• First posted: 2016-03-23
• Last updated: 2019-03-06

Locations

1 site across 1 country: France