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Completed

NCT Number: NCT02716480

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

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.

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Visceral Surgery - European Georges Pompidou Hospital -

Paris, Île-de-France Region, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobility coaching

Behavioral

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

Diet coaching

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

My Goodlife SAS

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: MYGOODTRIP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 23, 2016
Registry last updated
Mar 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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