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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716480
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
European Georges Pompidou Hospital
Hospital Ambroise Paré Paris
French Environment and Energy Management Agency
Information provided by (Responsible Party):
My Goodlife SAS

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Bariatric Surgery Candidate Behavioral: Mobility coaching Behavioral: Diet coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of the Use of Health-connected Devices on Recovery of Physical Activity in Obese Patients After Bariatric Surgery.
Study Start Date : June 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mobility Coaching
45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months.
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.
Other Name: Mobility

Experimental: Diet Coaching
45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.
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.
Other Name: Diet




Primary Outcome Measures :
  1. Change from baseline mean number of steps per day at 6th month [ Time Frame: Period from Day 164 to Day 179 ]

    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 :
  1. Change from baseline mean daily energy expenditure at 6th month [ Time Frame: At 6th month ]
    Estimated by self-administrated questionnaire (RPAQ)

  2. Change from baseline mean daily energy expenditure at 3rd month [ Time Frame: At 3rd month ]
    Estimated by self-administrated questionnaire (RPAQ)

  3. Change from baseline weight at 6th month [ Time Frame: At 6th month ]
  4. Change from baseline weight at 3rd month [ Time Frame: At 3rd month ]
  5. % of patients having nutritional deficiency in vitamins and / or minerals [ Time Frame: At 6th month ]
    Biological measurements

  6. Change from baseline Quality of life at 6th month [ Time Frame: At the 6th month ]
    Estimated by self-administered quality-of-life questionnaire (EQVOD)

  7. Change from baseline Quality of life at 3rd month [ Time Frame: At the 3rd month ]
    Estimated by self-administered quality-of-life questionnaire (EQVOD)

  8. Change from baseline mean number of steps per day at 3rd month [ Time Frame: Period from Day 75 to Day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716480


Locations
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France
Department of Visceral Surgery - European Georges Pompidou Hospital -
Paris, Ile-de-France, France, 75015
Sponsors and Collaborators
My Goodlife SAS
European Georges Pompidou Hospital
Hospital Ambroise Paré Paris
French Environment and Energy Management Agency
Investigators
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Study Director: Karl AUZOU, Msc My Goodlife SAS
Publications of Results:
Other Publications:
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Responsible Party: My Goodlife SAS
ClinicalTrials.gov Identifier: NCT02716480    
Other Study ID Numbers: MY GOODLIFE
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by My Goodlife SAS:
Nutrition
Physical activity
Bariatric surgery
Obesity
Health technology
Health-connected devices
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight