A smartphone application to improve adherence to vitamin and mineral supplementation after bariatric surgery.

OBJECTIVE: This trial evaluated a smartphone application's effectiveness in improving adherence to vitamin and mineral supplementation postoperatively. METHODS: This study was a randomized controlled trial comprising 140 patients undergoing bariatric surgery (gastric bypass or sleeve gastrectomy). Participants were randomized 1:1 to the 12-week intervention, using the smartphone application PromMera, or to standard care. The primary end point was adherence to vitamin and mineral supplementation. RESULTS: Initiation rate and overall adherence to supplementation were high in both groups. Change in objectively measured adherence rate from before the intervention to 1 year post surgery, measured with pharmacy refill data, did not differ between groups for vitamin B12 (-9.6% [SD = 27%] vs. -9.3% [SD = 30%]; p = 0.48) or calcium/vitamin D (-12.3% [SD = 29%] vs. -11.5% [SD = 32%]; p = 0.44). A modest effect on the secondary end point (subjectively measured adherence, using the Medication Adherence Report Scale-5) was seen immediately after the intervention (intervention group 0.00 [SD = 1.3] vs. control group -1.2 [SD = 3.5]; p = 0.021), but this effect did not persist 1 year post surgery. No differences were detected in the prevalence of biochemical deficiencies. CONCLUSIONS: The use of the smartphone application PromMera did not obtain a lasting improvement in adherence to vitamin and mineral supplementation 1 year post bariatric surgery.

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.

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.