Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery: a Three-arm Randomized Control Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of distance traveled during a six-minute walk test (6MWT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Serious adverse events
- •Withdrawal of informed consent or violation of the protocol
研究组 & 干预措施
CONTROL
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
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.
干预措施: Technology-based physical activity interventions (Behavioral)
ACTI-MOBIL
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.
干预措施: Technology-based physical activity interventions (Behavioral)
结局指标
主要结局
Change of distance traveled during a six-minute walk test (6MWT)
时间窗: Baseline (T0), 3 months (T3), and 6 months (T6)
Distance traveled during a six-minute walk test (6MWT) will be expressed in meters
Height
时间窗: Baseline (T0)
Meters
Date of birth
时间窗: Baseline (T0)
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
Change of functional capacity calculated by the percentage achievement of the theoretical distance calculated by the Capodaglio's (2013) formula
时间窗: Baseline (T0), 3 months (T3), and 6 months (T6)
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.
Change of body mass
时间窗: Baseline (T0), 3 months (T3), and 6 months (T6)
Kilograms
次要结局
- Change of quality of life in 5 dimensions(Baseline (T0), 3 months (T3), and 6 months (T6))
- Change of quality of life in visual analog scale(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 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))
- Change of stage of change for physical activity(Baseline (T0), 3 months (T3), and 6 months (T6))
- Change of body mass index(Baseline (T0), 3 months (T3), and 6 months (T6))
- Change of subjective physical activity level(Baseline (T0), 3 months (T3), and 6 months (T6))
- Change of body composition(Baseline (T0), 3 months (T3), and 6 months (T6))
研究者
Pr Fabienne d'Arripe-Longueville
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).
Universite Cote d'Azur