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

Bariatric Surgery Clinical Trial

— STIMUL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03963986
• Other study ID #: STIMUL
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Camille JUNG, MD, PhD
• Phone: +331457022268
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Waist circumference (cm)	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months	4, 10 and 16 months
Secondary	Hip circumference (cm)	Comparison of waist circumference in the 2 groups at 4, 10, and 16 months	4, 10 and 16 months
Secondary	Lipid balance (g/l)	Evolution of the lipid balance in the 2 groups	4, 10 and 16 months
Secondary	Blood pressure (mmHg)	Evolution of blood pressure in the 2 groups	4, 10 and 16 months
Secondary	Quality of Life, Obesity and Dietetics Scale(EQVOD)	Evolution of the quality of life (EQVOD)	4, 10 and 16 months