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

Bariatric Surgery Candidate Clinical Trial

— MYGOODTRIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716480
• Other study ID #: MY GOODLIFE
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: August 2018

Study information

• Verified date: March 2019
• Source: My Goodlife SAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Department of Visceral Surgery - European Georges Pompidou Hospital -	Paris	Ile-de-France

Sponsors (4)

Lead Sponsor	Collaborator
My Goodlife SAS	European Georges Pompidou Hospital, French Environment and Energy Management Agency, Hospital Ambroise Paré Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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 — View 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/m². Surg Obes Relat Dis. 2015 Jul-Aug;11(4):785-90. doi: 10.1016/j.soard.2014.11.022. Epub 2014 Dec 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline mean number of steps per day at 6th month	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).	Period from Day 164 to Day 179
Secondary	Change from baseline mean daily energy expenditure at 6th month	Estimated by self-administrated questionnaire (RPAQ)	At 6th month
Secondary	Change from baseline mean daily energy expenditure at 3rd month	Estimated by self-administrated questionnaire (RPAQ)	At 3rd month
Secondary	Change from baseline weight at 6th month		At 6th month
Secondary	Change from baseline weight at 3rd month		At 3rd month
Secondary	% of patients having nutritional deficiency in vitamins and / or minerals	Biological measurements	At 6th month
Secondary	Change from baseline Quality of life at 6th month	Estimated by self-administered quality-of-life questionnaire (EQVOD)	At the 6th month
Secondary	Change from baseline Quality of life at 3rd month	Estimated by self-administered quality-of-life questionnaire (EQVOD)	At the 3rd month
Secondary	Change from baseline mean number of steps per day at 3rd month		Period from Day 75 to Day 90