Clinical trial NCT02716480: Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients
Official title: Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Bariatric Surgery Candidate
Keywords: Nutrition
Physical activity
Bariatric surgery
Obesity
Health technology
Health-connected devices
Lead sponsor: My Goodlife SAS
Sponsor class: INDUSTRY
Collaborators: name: European Georges Pompidou Hospital
name: Hospital Ambroise Paré Paris
name: French Environment and Energy Management Agency
First posted: 2016-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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
* Having signed the informed consent letter

Non-inclusion criteria • Patient with major disabilities causing a definitive loss of mobility

Exclusion Criteria:

• None

Primary outcomes:
measure: Change from baseline mean number of steps per day at 6th month
timeFrame: Period from Day 164 to Day 179
Secondary outcomes:
measure: Change from baseline mean daily energy expenditure at 6th month
timeFrame: At 6th month
measure: Change from baseline mean daily energy expenditure at 3rd month
timeFrame: At 3rd month
measure: Change from baseline weight at 6th month
timeFrame: At 6th month
measure: Change from baseline weight at 3rd month
timeFrame: At 3rd month
measure: % of patients having nutritional deficiency in vitamins and / or minerals
timeFrame: At 6th month
measure: Change from baseline Quality of life at 6th month
timeFrame: At the 6th month
measure: Change from baseline Quality of life at 3rd month
timeFrame: At the 3rd month
measure: Change from baseline mean number of steps per day at 3rd month
timeFrame: Period from Day 75 to Day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Department of Visceral Surgery - European Georges Pompidou Hospital -
state: Ile-de-France
Study officials:
affiliation: My Goodlife SAS
name: Karl AUZOU, Msc
role: STUDY_DIRECTOR
References:
citation: Blood Pressure Lowering Treatment Trialists' Collaboration; Ying A, Arima H, Czernichow S, Woodward M, Huxley R, Turnbull F, Perkovic V, Neal B. Effects of blood pressure lowering on cardiovascular risk according to baseline body-mass index: a meta-analysis of randomised trials. Lancet. 2015 Mar 7;385(9971):867-74. doi: 10.1016/S0140-6736(14)61171-5. Epub 2014 Nov 4.
citation: Thereaux J, Corigliano N, Poitou C, Oppert JM, Czernichow S, Bouillot JL. Comparison of results after one year between sleeve gastrectomy and gastric bypass in patients with BMI >/= 50 kg/m(2). Surg Obes Relat Dis. 2015 Jul-Aug;11(4):785-90. doi: 10.1016/j.soard.2014.11.022. Epub 2014 Dec 4.
citation: Czernichow S, Moszkowicz D, Szwarcensztein K, Emery C, Lafuma A, Gourmelen J, Fagnani F. Impact of bariatric surgery on the medical management and costs of obese patients in France: an analysis of a national representative claims database. Obes Surg. 2015 Jun;25(6):986-96. doi: 10.1007/s11695-014-1488-3.