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

Stephanie Erika Bonn, Mari Hult, Kristina Spetz, Marie Löf, Ellen Andersson, Mikael Wiren, Ylva Trolle Lagerros, Stephanie Erika Bonn, Mari Hult, Kristina Spetz, Marie Löf, Ellen Andersson, Mikael Wiren, Ylva Trolle Lagerros

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://ichgcp.net/clinical-trials-registry/NCT03480464.

International registered report identifier (irrid): DERR1-10.2196/19624.

Keywords: adults; body composition; exercise; metabolic health; mobile phone; obesity; randomized controlled trial; smartphones; vitamin intake.

Conflict of interest statement

Conflicts of Interest: None declared.

©Stephanie Erika Bonn, Mari Hult, Kristina Spetz, Marie Löf, Ellen Andersson, Mikael Wiren, Ylva Trolle Lagerros. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.08.2020.

Figures

Figure 1
Figure 1
Flowchart of the PromMera study design.

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