App-technology to increase physical activity among patients with diabetes type 2 - the DiaCert-study, a randomized controlled trial

BACKGROUND: Physical activity can decrease the risk of complications related to diabetes type 2. Feasible and scalable strategies to implement support for a healthy lifestyle for patients in primary care are needed. The aim of the DiaCert-study is to evaluate a digital healthcare platform and the effect of a 12-week long smartphone-app physical activity intervention aiming at increasing physical activity (primary outcome) and improve levels of HbA1c (glycated hemoglobin), blood lipids, blood pressure, body composition, as well as other lifestyle factors and overall health in patients with diabetes type 2. METHODS/DESIGN: The DiaCert-study is a two-arm, randomized controlled trial that will include 250 patients with diabetes type 2. At baseline, participants are randomized 1:1 to intervention, i.e. use of the smartphone-app, during 12 weeks, or to a control group receiving only standard care. Physical activity and sedentary behavior, is objectively measured using the Actigraph GT3X. Biomarkers including HbA1c and blood lipids are measured in fasting blood samples. Anthropometrics include height, weight, waist circumference and body composition, and a number of lifestyle factors including sleep, diet, self-efficacy, and quality of life, are assessed through an extensive questionnaire. Measurements are made at baseline and at follow-up after 3, 6 and 12 months. DISCUSSION: Using new technology, is one way to bridge the gap between what patients need and what health care can offer. This study evaluates a new digital health care platform and will show if use of a smartphone-app to promote daily steps is an effective and feasible method to increase physical activity and improve clinical markers in patients with diabetes type 2. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03053336; 7 Feb, 2017.