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

Primary Purpose

Obesity, Morbid, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mobility coaching
Diet coaching
Sponsored by
My Goodlife SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity, Morbid focused on measuring Nutrition, Physical activity, Bariatric surgery, Obesity, Health technology, Health-connected devices

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Visceral Surgery - European Georges Pompidou Hospital -

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mobility Coaching

Diet Coaching

Arm Description

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

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

Outcomes

Primary Outcome Measures

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). .

Secondary Outcome Measures

Change from baseline mean daily energy expenditure at 6th month
Estimated by self-administrated questionnaire (RPAQ)
Change from baseline mean daily energy expenditure at 3rd month
Estimated by self-administrated questionnaire (RPAQ)
Change from baseline weight at 6th month
Change from baseline weight at 3rd month
% of patients having nutritional deficiency in vitamins and / or minerals
Biological measurements
Change from baseline Quality of life at 6th month
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Change from baseline Quality of life at 3rd month
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Change from baseline mean number of steps per day at 3rd month

Full Information

First Posted
March 17, 2016
Last Updated
March 5, 2019
Sponsor
My Goodlife SAS
Collaborators
European Georges Pompidou Hospital, Hospital Ambroise Paré Paris, French Environment and Energy Management Agency
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1. Study Identification

Unique Protocol Identification Number
NCT02716480
Brief Title
Health-connected Devices and Physical Activity Recovery in Bariatric Surgery Patients
Acronym
MYGOODTRIP
Official Title
Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
My Goodlife SAS
Collaborators
European Georges Pompidou Hospital, Hospital Ambroise Paré Paris, French Environment and Energy Management Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Bariatric Surgery Candidate
Keywords
Nutrition, Physical activity, Bariatric surgery, Obesity, Health technology, Health-connected devices

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobility Coaching
Arm Type
Experimental
Arm Description
45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months.
Arm Title
Diet Coaching
Arm Type
Experimental
Arm Description
45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Mobility coaching
Other Intervention Name(s)
Mobility
Intervention Description
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
Intervention Name(s)
Diet coaching
Other Intervention Name(s)
Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline mean number of steps per day at 6th month
Description
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). .
Time Frame
Period from Day 164 to Day 179
Secondary Outcome Measure Information:
Title
Change from baseline mean daily energy expenditure at 6th month
Description
Estimated by self-administrated questionnaire (RPAQ)
Time Frame
At 6th month
Title
Change from baseline mean daily energy expenditure at 3rd month
Description
Estimated by self-administrated questionnaire (RPAQ)
Time Frame
At 3rd month
Title
Change from baseline weight at 6th month
Time Frame
At 6th month
Title
Change from baseline weight at 3rd month
Time Frame
At 3rd month
Title
% of patients having nutritional deficiency in vitamins and / or minerals
Description
Biological measurements
Time Frame
At 6th month
Title
Change from baseline Quality of life at 6th month
Description
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Time Frame
At the 6th month
Title
Change from baseline Quality of life at 3rd month
Description
Estimated by self-administered quality-of-life questionnaire (EQVOD)
Time Frame
At the 3rd month
Title
Change from baseline mean number of steps per day at 3rd month
Time Frame
Period from Day 75 to Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl AUZOU, Msc
Organizational Affiliation
My Goodlife SAS
Official's Role
Study Director
Facility Information:
Facility Name
Department of Visceral Surgery - European Georges Pompidou Hospital -
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25468168
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.
Results Reference
background
PubMed Identifier
25771441
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.
Results Reference
background
PubMed Identifier
25366293
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.
Results Reference
result

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

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