Effects of technology-based physical activity interventions for women after bariatric surgery: study protocol for a three-arm randomised controlled trial.

INTRODUCTION: 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 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 objectives of this study are to determine the effects of two technology-based (mobile technology and videoconferencing) physical activity programmes after bariatric surgery compared with standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on physical activity, physiological measures and health indicators. METHODS AND ANALYSIS: One hundred and twenty young women who have undergone bariatric surgery in the last 3-6 months will be included. The volunteers will be randomly assigned to one of three arms: CONTROL (standard care), ACTI-MOBIL (mobile technology) or ACTI-VISIO (videoconferencing). The primary outcome is the distance travelled during a 6 min walk test relativised according to Capadaglio's theoretical distance. Secondary outcomes are behavioural measures of physical activity, physiological measures, health indicators, technology acceptability and motivational concepts. Data will be collected at baseline (T0), 3 months (T3) and 6 months (T6). The technology groups will receive a physical activity programme for 12 weeks (between T0 and T3). A mixed model approach will be used to analyse the change in outcomes over time for each group. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the French East 1 Protection of Persons Ethics Committee (number: 2020.A00172-37) and the French National Commission for Information Technology and Civil Liberties (number: UCA-R20-034). The results will be disseminated through conference presentations and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT04478331.

"As du Coeur" study: a randomized controlled trial on quality of life impact and cost effectiveness of a physical activity program in patients with cardiovascular disease.

BACKGROUND: Physical activity programs (PAP) in patients with cardiovascular disease require evidence of cost-utility. To assess improvement in health-related quality of life (QoL) and reduction of health care consumption of patients following PAP, a randomized trial was used. METHODS: Patients from a health insurance company who had experienced coronary artery disease or moderate heart failure were invited to participate (N = 1891). Positive responders (N = 50) were randomly assigned to a progressively autonomous physical activity (PAPA) program or to a standard supervised physical activity (SPA) program. The SPA group had two supervised sessions per week over 5 months. PAPA group had one session per week and support to aid habit formation (written tips, exercise program, phone call). To measure health-related quality of life EQ-5D utility score were used, before intervention, 6 months (T6) and 1 year later. Health care costs were provided from reimbursement databases. RESULTS: Mobility, usual activities and discomfort improved significantly in both group (T6). One year later, EQ-5D utility score was improved in the PAPA group only. Total health care consumption in the intervention group decreased, from a mean of 4097 euros per year before intervention to 2877 euros per year after (p = 0.05), compared to a health care consumption of 4087 euros and 4180 euros per year, in the total population of patients (N = 1891) from the health insurance company. The incremental cost effectiveness ratio was 10,928 euros per QALYs. CONCLUSION: A physical activity program is cost-effective in providing a better quality of life and reducing health care consumption in cardiovascular patients. TRIAL REGISTRATION: ISRCTN77313697 , retrospectively registered on 20 November 2015.