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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Obesity, Morbid Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mobility Coaching

45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months.

Group Type EXPERIMENTAL

Mobility coaching

Intervention Type BEHAVIORAL

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.

Diet Coaching

45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.

Group Type EXPERIMENTAL

Diet coaching

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mobility Diet

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