NCT02716480

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

March 17, 2016

Last Update Submit

March 5, 2019

Conditions

Obesity, MorbidBariatric Surgery Candidate

Keywords

NutritionPhysical activityBariatric surgeryObesityHealth technologyHealth-connected devices

Outcome Measures

Primary Outcomes (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). .

    Period from Day 164 to Day 179

Secondary Outcomes (8)

  • Change from baseline mean daily energy expenditure at 6th month

    At 6th month

  • Change from baseline mean daily energy expenditure at 3rd month

    At 3rd month

  • Change from baseline weight at 6th month

    At 6th month

  • Change from baseline weight at 3rd month

    At 3rd month

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

    At 6th month

  • +3 more secondary outcomes

Study Arms (2)

Mobility Coaching

EXPERIMENTAL

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

Behavioral: Mobility coaching

Diet Coaching

EXPERIMENTAL

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

Behavioral: Diet coaching

Interventions

Mobility coachingBEHAVIORAL

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.

Also known as: Mobility
Mobility Coaching
Diet coachingBEHAVIORAL

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.

Also known as: Diet
Diet Coaching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Visceral Surgery - European Georges Pompidou Hospital -

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

Location

Related Publications (4)

  • 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.

    PMID: 25468168BACKGROUND

  • 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.

    PMID: 25771441BACKGROUND

  • 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.

    PMID: 25366293RESULT

  • 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.

    PMID: 36976624DERIVED

MeSH Terms

Conditions

Obesity, MorbidMotor ActivityObesity

Interventions

Range of Motion, ArticularDiet

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Karl AUZOU, Msc

    My Goodlife SAS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 23, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

August 1, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)