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

Impacts of Remote Digital Support on Adapted Physical Activity for Patients in Pre-bariatric Surgery Care Pathways

Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

Study Overview

• Status: Recruiting
• Conditions: Bariatric Surgery
• Intervention / Treatment: Device: STIMUL group

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Camille JUNG, MD, PhD; Phone Number: +331457022268; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94000
    • Recruiting
    • Centre Hospitalier Intercommunal Creteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ricci-Gagnon score (9-45)	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	month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ricci-Gagnon score (9-45)	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	10 and 16 months
International Physical Activity Questionnaire (IPAQ)	physical activity score; - LowNo activity is reported ORAn activity is reported but does not reach levels 2 or 3.; -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; -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.	4, 10 and 16 months
Body masse Index (BMI) (kg/m²)	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, 10 and 16 months
Waist circumference (cm)	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months	4, 10 and 16 months
Hip circumference (cm)	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months	4, 10 and 16 months
Lipid balance (g/l)	Evolution of the lipid balance in the 2 groups	4, 10 and 16 months
Blood pressure (mmHg)	Evolution of blood pressure in the 2 groups	4, 10 and 16 months
Quality of Life, Obesity and Dietetics Scale(EQVOD)	Evolution of the quality of life (EQVOD)	4, 10 and 16 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2018
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 23, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Regular physical activity
• Other Study ID Numbers: STIMUL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No