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

Not Applicable

• Conditions: Bariatric Surgery

• Registration Number: NCT03963986
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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

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 Timeline

• Study Start: 2018-11-28
• Study First Submitted: 2019-05-23
• Study First Submitted QC: 2019-05-23
• Study First Posted: 2019-05-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ricci-Gagnon score (9-45)	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

Name	Time	Method
Ricci-Gagnon score (9-45)	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
International Physical Activity Questionnaire (IPAQ)	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.
Body masse Index (BMI) (kg/m²)	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
Waist circumference (cm)	4, 10 and 16 months	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months
Hip circumference (cm)	4, 10 and 16 months	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months
Lipid balance (g/l)	4, 10 and 16 months	Evolution of the lipid balance in the 2 groups
Blood pressure (mmHg)	4, 10 and 16 months	Evolution of blood pressure in the 2 groups
Quality of Life, Obesity and Dietetics Scale(EQVOD)	4, 10 and 16 months	Evolution of the quality of life (EQVOD)

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal Créteil; 🇫🇷 Créteil, France