Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 25, 2020
Date Accepted: Jun 25, 2020
App technology to support physical activity and intake of vitamins and minerals after bariatric surgery – Protocol for the PromMera-study: 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-application (app) intervention on promotion of physical activity (primary outcome), adherence to post-surgery 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 post-surgery 1:1 to either intervention group, i.e. use of the PromMera-app during 12 weeks, or control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and post-surgery after 18-weeks (post-intervention assessment), 6-months, and 1- and 2-years. Assessments include body composition (Tanita/BodPod), muscle function (handgrip), biomarkers in blood and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the Actigraph GT3X.
Results:
The last study participant was recruited in May 2019. Data collection will be complete in May 2021. A total of 154 participants have been enrolled to the study.
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 behavioural patterns in this rapidly growing group of patients. Clinical Trial: ClinicalTrials.gov Identifier: NCT03480464. Retrospectively registered on March 29, 2018, first submitted June, 2017. Last Updated: April 10, 2019. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT03480464.
Citation
Request queued. Please wait while the file is being generated. It may take some time.