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

March 5, 2019 updated by: My Goodlife SAS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75015
        • Department of Visceral Surgery - European Georges Pompidou Hospital -

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

.
Period from Day 164 to Day 179

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

My Goodlife SAS

Collaborators

European Georges Pompidou Hospital
Hospital Ambroise Paré Paris
French Environment and Energy Management Agency

Investigators

  • Study Director: Karl AUZOU, Msc, My Goodlife SAS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (ESTIMATE)

March 23, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MY GOODLIFE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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