Clinical trial NCT04478331: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery
Official title: Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery Candidate
Keywords: obesity
physical activity
information and communication technology
engagement
active lifestyle
technology-based program
eHealth
videoconferencing
mobile application
Lead sponsor: Universite Cote d'Azur
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
name: Association Azur Sport Santé, Nice, France
First posted: 2020-07-20
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.

The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.

One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.

This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.


Eligibility criteria: Inclusion Criteria:

* Undergone bariatric surgery at a tertial referral center for bariatric surgery (Nice University Hospital, France) 3 to 6 months ago
* Respect with the national recommendations (e.g., BMI ≥ 40kg/m² or ≥ 35kg/m² with at least one co-morbidity among blood hypertension, type 2 diabetes, invalidating arthritis, and sleep apnea syndrome; and no physical disability to practice PA)
* Having a smartphone compatible with the proposed technologies.

Exclusion Criteria:

* Serious adverse events
* Withdrawal of informed consent or violation of the protocol

Primary outcomes:
measure: Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of distance traveled during a six-minute walk test (6MWT)
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of body mass
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Height
timeFrame: Baseline (T0)
measure: Date of birth
timeFrame: Baseline (T0)
Secondary outcomes:
measure: Change of subjective physical activity level
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of objective physical activity level
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of stage of change for physical activity
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of energetic consumption measured during the 6MWT
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of muscle strength
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of quality of life in 5 dimensions
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of quality of life in visual analog scale
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of body mass index
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of body composition
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
Other outcomes:
measure: Change of technology acceptability
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Program compliance
timeFrame: 3 months (T3)
measure: Change of motivation for physical activity
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of general causality orientations scale for physical activity
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
measure: Change of basic psychological needs
timeFrame: Baseline (T0), 3 months (T3), and 6 months (T6)
Locations:
city: Nice
country: France
facility: Centre Spécialisé Obésité
Study officials:
affiliation: Université Côte d'Azur, Nice, France
name: Fabienne d'Arripe-Longueville, Pr
role: STUDY_DIRECTOR
References:
citation: Hayotte M, Iannelli A, Negre V, Pradier C, Therouanne P, Fuch A, Diagana O, Garbarino JM, Vuillemin A, Colson SS, Chevalier N, d'Arripe-Longueville F. Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial. BMJ Open. 2021 Jul 30;11(7):e046184. doi: 10.1136/bmjopen-2020-046184.