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Obesity, MorbidMYGOODTRIPNCT02716480

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

A study testing Mobility coaching and Diet coaching in people with Obesity, Morbid and Bariatric Surgery Candidate, run by My Goodlife SAS at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Morbid, Bariatric Surgery Candidate
What is being tested?
Mobility coaching and Diet coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
Jun 2016to Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
Show all 12Show fewer
  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site

  • Department of Visceral Surgery - European Georges Pompidou Hospital -

    Paris, Île-de-France Region, 75015

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
Mobility coaching, Diet coaching
Keywords
Nutrition, Physical activity, Bariatric surgery, Obesity, Health technology, Health-connected devices
Medical subject headings
Obesity, Morbid, Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobility coachingBehavioural

    Also called Mobility

    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 coachingBehavioural

    Also called Diet

    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.

Study groups in NCT02716480
Study groupRoleWhat they receive
Mobility CoachingExperimental45 patients undergoing bariatric surgery received a monthly "mobility" coaching session of 20 to 30 min by phone during 6 months.
Receives: Behavioral: Mobility coaching
Diet CoachingExperimental45 patients undergoing bariatric surgery received a monthly "diet" coaching session of 20 to 30 min by phone during 6 months.
Receives: Behavioral: Diet coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    .

    Measured: Period from Day 164 to Day 179

Secondary outcomes (8)

  1. Change from baseline mean daily energy expenditure at 6th month

    Estimated by self-administrated questionnaire (RPAQ)

    Measured: At 6th month

  2. Change from baseline mean daily energy expenditure at 3rd month

    Estimated by self-administrated questionnaire (RPAQ)

    Measured: At 3rd month

  3. Change from baseline weight at 6th month

    Measured: At 6th month

  4. Change from baseline weight at 3rd month

    Measured: At 3rd month

  5. % of patients having nutritional deficiency in vitamins and / or minerals

    Biological measurements

    Measured: At 6th month

  6. Change from baseline Quality of life at 6th month

    Estimated by self-administered quality-of-life questionnaire (EQVOD)

    Measured: At the 6th month

  7. Change from baseline Quality of life at 3rd month

    Estimated by self-administered quality-of-life questionnaire (EQVOD)

    Measured: At the 3rd month

  8. Change from baseline mean number of steps per day at 3rd month

    Measured: Period from Day 75 to Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionFeb 2018
  4. Study completionAug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716480
Sponsor's protocol ID
MY GOODLIFE
Acronym
MYGOODTRIP
Status last verified
Mar 2019
First submitted
17 Mar 2016
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25468168

  • 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.

    PubMed 25771441

  • 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.

    PubMed 25366293

  • Lurbe I Puerto K, Bruzzi M, Rives-Lange C, Poghosyan T, Bretault M, Chatellier G, Vilfaillot A, Chevallier JM, Czernichow S, Carette C. MyGood Trip, a Telemedicine Intervention for Physical Activity Recovery After Bariatric Surgery: Randomized Controlled Trial. JMIR Form Res. 2023 Mar 28;7:e26077. doi: 10.2196/26077.

    PubMed 36976624

Questions about this trial

What is this clinical trial studying?

A study testing Mobility coaching and Diet coaching in people with Obesity, Morbid and Bariatric Surgery Candidate, run by My Goodlife SAS at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline mean number of steps per day at 6th month (time frame: Period from Day 164 to Day 179). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716480, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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