Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery

NCT04478331 | Unknown DMC

• 2 other identifiers: IDRCB: 2020.A00172-37ANR-15-IDEX-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery Candidate

Keywords

obesity; physical activity; information and communication technology; engagement; active lifestyle; technology-based program; eHealth; videoconferencing; mobile application

Outcome Measures

Primary Outcomes (5)

• Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula

  We will aggregate the following primary outcome measures into the Capodaglio (2013) formula: 894.2177 - (2.0700 x age(years)) - (51.4489 x 1) - 5.1663 x BMI (kg/m²) to obtain the theoretical distance, and we will calculate the percentage achievement of this theoretical distance: ((distance traveled(meters) - theoretical distance(meters)) / theoretical distance(meters))x100. Higher percentage of achievement reflecting higher functional capacity.

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of distance traveled during a six-minute walk test (6MWT)

  Distance traveled during a six-minute walk test (6MWT) will be expressed in meters

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of body mass

  Kilograms

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Height

  Meters

  Baseline (T0)

• Date of birth

  The date of birth will be requested once (pre-bariatric surgery) and will be used to calculate the age in years at the different periods needed to calculate the theoretical 6MWT distance

  Baseline (T0)

Secondary Outcomes (9)

• Change of subjective physical activity level

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of objective physical activity level

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of stage of change for physical activity

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of energetic consumption measured during the 6MWT

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Change of muscle strength

  Baseline (T0), 3 months (T3), and 6 months (T6)

Other Outcomes (5)

• Change of technology acceptability

  Baseline (T0), 3 months (T3), and 6 months (T6)

• Program compliance

  3 months (T3)

• Change of motivation for physical activity

  Baseline (T0), 3 months (T3), and 6 months (T6)

Study Arms (3)

CONTROL

NO INTERVENTION

The Control group will receive the usual care. In the physical activity (PA) field, this includes two individual motivational interviews with a PA professional, and a group workshop during the first year after BS. PA recommendations will be explained to each participant, and their achievement will be encouraged and supported during these sessions. No face-to-face PA sessions will be offered as part of the usual care.

ACTI-VISIO

EXPERIMENTAL

The two PA sessions per week will be delivered via videoconferencing (developed by Mooven™). The PA program consists in tailored adapted PA sessions led by a professional specialized in adapted PA. These sessions were specifically designed to be appropriate for the population and were developed in collaboration with the authors to ensure standardization of the recommended volume of PA. The PA sessions will be given live, individually at the beginning and then in groups of four women. During sessions, the professional and the participants will interact simultaneously, and the execution of the exercises will be monitored and adapted live by the professional. To ensure the safety of the PA, a rating of perceived exertion will be requested after each session on a 10-point scale. If the RPE exceed 7, the professional specialized in adapted PA will adjust the training load. In addition to the exercises, the sessions will also include advice and tips for reaching the recommended PA level.

Behavioral: Technology-based physical activity interventions

ACTI-MOBIL

EXPERIMENTAL

The PA sessions will be delivered by an eHealth platform (developed by BePatient™) associated with an activity bracelet. The researchers enrich PA content on the platform and ensure standardization of the recommended volume of PA. The platform consists of tips for reaching the PA level, PA questionnaires, PA feedback measured by the activity bracelet, and a video demonstration of PA sessions performed by a peer. The PA sessions are automatically broadcasted twice a week for 12 weeks. To ensure the safety of the PA, the sessions were designed to be appropriate for this population and the RPE will be measured after each session on a 10-point scale. If the RPE exceeds 7 for 3 consecutive sessions, the training load will be adjusted. The platform will also include a variety of content, including dietary tips, obesity-related facts, information about surgery, and frequently asked questions.

Behavioral: Technology-based physical activity interventions

Interventions

Technology-based physical activity interventions BEHAVIORAL

The technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations.

ACTI-MOBIL; ACTI-VISIO

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Pr Fabienne d'Arripe-Longueville: lead
• Centre Hospitalier Universitaire de Nice: collaborator
• Association Azur Sport Santé, Nice, France: collaborator

Study Sites (1)

Centre Spécialisé Obésité

Nice, 06200, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 34330855 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Fabienne d'Arripe-Longueville, Pr

  Université Côte d'Azur, Nice, France

  STUDY DIRECTOR

Central Study Contacts

Fabienne d'Arripe-Longueville, Pr

CONTACT

762485953; fabienne.d-arripe-longueville@univ-cotedazur.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Professor CEX1 - Director of the Human Motricity Expertise Sport Health Laboratory (LAMHESS, UPR 6312) and co-director of the "Fédération de Recherche Interventions en Santé" (FRIS).

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 20, 2020
• Study Start: October 26, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)