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Impacts of Remote Digital Support on Physical Activity for Patients in Bariatric Surgery (STIMUL)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03963986
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
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Brief Summary:
Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

Condition or disease Intervention/treatment Phase
Bariatric Surgery Device: STIMUL group Not Applicable

Detailed Description:
Regular physical activity (PA) is a key element in the success of bariatric surgery and the prevention of complications associated with frequent co-morbidities. However, the levels of PA observed in patients who will benefit from bariatric surgery are generally low, and many patients do not comply with the recommendations of their course in terms of PA. It is envisaged that coaching interventions and adapted programs can improve the level of PA. The objective of this pilot study is to evaluate the effectiveness and adherence to digital tools on the level of PA in preparation for bariatric surgery.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to the STANDARD group for which management will be standard or to the STIMUL group with digital coaching program
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impacts of Remote Digital Support on Adapted Physical Activity for Patients in Pre-bariatric Surgery Care Pathways
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: STIMUL group
The STIMUL Group participants in the Adaptive Physical Activity Focus (APA) program receive access to an online digital Platform, as well as a starter kit consisting of a connected pedometer measuring several physical activity indicators including the number of steps, number of so-called active minutes, sleep time, and distance travelled; a tape measure and a starter guide. They then conduct a remote assessment and motivational interview by videoconference or telephone, followed by 15-20 minute support interviews (month 1, month 3, month 6). Between these interviews, during months 1, 2, and 3, participants exchange weekly written messages with an educator on their platform. A planner of their physical activity objectives is provided.
 Device: STIMUL group
The STIMUL Group participants in the Adaptive Physical Activity Focus (APA) program receive access to an online digital Platform, as well as a starter kit consisting of a connected pedometer measuring several physical activity indicators including the number of steps, number of so-called active minutes, sleep time, and distance travelled; a tape measure and a starter guide. They then conduct a remote assessment and motivational interview by videoconference or telephone, followed by 15-20 minute support interviews (month 1, month 3, month 6). Between these interviews, during months 1, 2, and 3, participants exchange weekly written messages with an educator on their platform. A planner of their physical activity objectives is provided.
No Intervention: STANDARD group
The STANDARD group participants dont receive an access to an online digital platform but they receive an adapted advice sheet.


Outcome Measures
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Primary Outcome Measures :
  1. Ricci-Gagnon score (9-45) [ Time Frame: month 4 ]

    This score describe the physical profile : inactive, active, very active, at month 4 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question.

    Less than 18=inactive Between 18 and 35=active More than 35=Active



Secondary Outcome Measures :
  1. Ricci-Gagnon score (9-45) [ Time Frame: 10 and 16 months ]

    This score describe the physical profile : inactive, active, very active, at month 10 et 16 It is calculated by adding the number of points (1 to 5) corresponding to the box checked for each question.

    Less than 18=inactive Between 18 and 35=active More than 35=Active


  2. International Physical Activity Questionnaire (IPAQ) [ Time Frame: 4, 10 and 16 months ]

    physical activity score

    1. - LowNo activity is reported ORAn activity is reported but does not reach levels 2 or 3.
    2. -ModerateCorresponds to one of the following 3 criteria:3 days or more of intense activity for at least 20 min per day OR5 days or more of moderate intensity activity and/or walking for at least 30 min per day OR5 days or more of combined walking, moderate or high intensity activity, reaching at least 600 MET-minutes/week
    3. -HighCorresponds to one of the following 2 criteria:Intense activity at least 3 days per week and at least 1500 MET-minutes/week OR 7 or more days of combined walking, moderate or high intensity activity, reaching at least 3000 MET-minutes/week.

  3. Body masse Index (BMI) (kg/m²) [ Time Frame: 4, 10 and 16 months ]
    Comparison of BMI in the 2 groups at 4, 10, and 16 months BMI < 18.5 kg/m²: underweight 18.5 < BMI < 24.9: normal weight 25 < BMI < 29.9: overweight BMI > 30: obesity

  4. Waist circumference (cm) [ Time Frame: 4, 10 and 16 months ]
    Comparison of waist circumference in the 2 groups at 4, 10, and 16 months

  5. Hip circumference (cm) [ Time Frame: 4, 10 and 16 months ]
    Comparison of waist circumference in the 2 groups at 4, 10, and 16 months

  6. Lipid balance (g/l) [ Time Frame: 4, 10 and 16 months ]
    Evolution of the lipid balance in the 2 groups

  7. Blood pressure (mmHg) [ Time Frame: 4, 10 and 16 months ]
    Evolution of blood pressure in the 2 groups

  8. Quality of Life, Obesity and Dietetics Scale(EQVOD) [ Time Frame: 4, 10 and 16 months ]
    Evolution of the quality of life (EQVOD)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient aged 30 to 50 years.
  • Candidate for bariatric surgery within 4 to 6 months of inclusion: BMI >40 kg/m² or BMI 35-40 kg/m² with obesity-related comorbidity
  • Ability to follow the STIMUL education program focused on adapted physical activity
  • Has and knows how to use a computer connected to the Internet or mobile phone
  • Ability to understand, read and write French

Exclusion Criteria:

  • • Contra-indication to the practice of sport

    • refusal to participate in the study
    • refusal to participate in the study
Contacts and Locations
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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): NCT03963986


Contacts
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Contact: Camille JUNG, MD, PhD +331457022268 camille.jung@chicreteil.fr

Locations
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France
Centre Hospitalier Intercommunal Créteil Recruiting
Créteil, France, 94000
Contact: Andrea LAZZATI, MD    +330145175957    Andrea.Lazzati@chicreteil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
More Information
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT03963986    
Other Study ID Numbers: STIMUL
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
Regular physical activity