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App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.

ABSTRACT: BACKGROUND:To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended. OBJECTIVE:The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery. METHODS:The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer. RESULTS:A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021. CONCLUSIONS:Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients. TRIAL REGISTRATION:ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/19624.

SUBMITTER: Bonn SE

PROVIDER: S-EPMC7455871 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.

Bonn Stephanie Erika SE Hult Mari M Spetz Kristina K Löf Marie M Andersson Ellen E Wiren Mikael M Trolle Lagerros Ylva Y

JMIR research protocols 20200814 8

<h4>Background</h4>To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended.<h4>Objective</h4>The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other life ...[more]

PMID: 32795990

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Project description:IntroductionA 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 analysisOne 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 disseminationThis 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 numberNCT04478331.

Project description:Although Iran is a high-risk region for esophageal squamous cell carcinoma (ESCC), dietary factors that may contribute to this high incidence have not been thoroughly studied. The aim of this study was to evaluate the effect of macronutrients, vitamins and minerals on the risk of ESCC.In this hospital-based case-control study, 47 cases with incident ESCC and 96 controls were interviewed and usual dietary intakes were collected using a validated food frequency questionnaire. Data were modeled through unconditional multiple logistic regression to estimate odds ratios (OR) and 95% confidence intervals (CI), controlling for age, sex, gastrointestinal reflux, body mass index, smoking history (status, intensity and duration), physical activity, and education.ESCC cases consumed significantly more hot foods and beverages and fried and barbecued meals, compared to the controls (p < 0.05). After adjusting for potential confounders, the risk of ESCC increased significantly in the highest tertiles of saturated fat [OR:2.88,95%CI:1.15-3.08], cholesterol [OR:1.53, 95%CI: 1.41-4.13], discretionary calorie [OR:1.51, 95%CI: 1.06-3.84], sodium [OR:1.49,95%CI:1.12-2.89] and total fat intakes [OR:1.48, 95%CI:1.09-3.04]. In contrast, being in the highest tertile of carbohydrate, dietary fiber and (n-3) fatty acid intake reduced the ESCC risk by 78%, 71% and 68%, respectively. The most cancer-protective effect was observed for the combination of high folate and vitamin E intakes (OR: 0.02, 95%CI: 0.00-0.87; p < 0.001). Controls consumed 623.5 times higher selenium, 5.48 times as much β-carotene and 1.98 times as much α-tocopherol as the amount ESCC cases consumed.This study suggests that high intake of nutrients primarily found in plant-based foods is associated with a reduced esophageal cancer risk. Some nutrients such as folate, vitamin E and selenium might play major roles in the etiology of ESCC and their status may eventually be used as an epidemiological marker for esophageal cancer in Iran, and perhaps other high-risk regions.

Dataset Information

App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.

Publications

App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.

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