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

NCT03963986 | Unknown

• 1 other identifier: STIMUL
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bariatric Surgery

Keywords

Regular physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Ricci-Gagnon score (9-45)

  10 and 16 months

• International Physical Activity Questionnaire (IPAQ)

  4, 10 and 16 months

• Body masse Index (BMI) (kg/m²)

  4, 10 and 16 months

• Waist circumference (cm)

  4, 10 and 16 months

• Hip circumference (cm)

  4, 10 and 16 months

Study Arms (2)

STIMUL group

ACTIVE COMPARATOR

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

STANDARD group

NO INTERVENTION

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

Interventions

STIMUL group DEVICE

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.

STIMUL group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged 30 to 50 years.
• 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

You may not qualify if:

• Contra-indication to the practice of sport
• refusal to participate in the study
• refusal to participate in the study

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

RECRUITING

Central Study Contacts

Camille JUNG, MD, PhD

CONTACT

+331457022268; camille.jung@chicreteil.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to the STANDARD group for which management will be standard or to the STIMUL group with digital coaching program

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: November 28, 2018
• Primary Completion: April 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)