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

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Bariatric Surgery

Treatments: Device: STIMUL group

Study type: Interventional

Funder types: Other

Identifiers

NCT03963986

STIMUL

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

STIMUL group

Active Comparator group

Description:

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.

Treatment:

Device: STIMUL group

STANDARD group

No Intervention group

Description:

The STANDARD group participants dont receive an access to an online digital platform but they receive an adapted advice sheet.