Protocol of a cluster randomized trial to investigate the impact of a type 2 diabetes risk prediction model on change in physical activity in primary care

BACKGROUND: Little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient’s behavior, perceived risk of persons, shared-decision making and particularly on patient’s health. The aim of this study is to investigate the impact of a non-invasive type 2 diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity. METHODS: Parallel group cluster randomized controlled trial including 30 primary care physicians (PCPs) and 300 participants in the region of Düsseldorf and surrounding urban and rural municipalities, West Germany. On cluster level, PCPs will be randomized into intervention or control group using a biased coin minimization technique. Participants in the control group are going to have a routine health check “Check-up 35” which is recommended biannually for all people ≥35 years of age in Germany. In the intervention group, the routine health check is expanded by usage of a non-invasive diabetes risk prediction model (German Diabetes Risk Score). Primary outcome is change in physical activity after 1 year. Secondary outcomes include aspects of targeted counseling, motivation of participant’s to change lifestyle, perceived and objectively measured diabetes risk, acceptance of diabetes risk scores, quality of life, depression and anxiety. Patients will be followed over 12 months. Hierarchical or mixed models will be conducted, including a random intercept to adjust for cluster, the respective baseline value, and covariates to compare the groups. DISCUSSION: This pragmatic cluster randomized controlled trial will enhance our knowledge on the clinical impact of diabetes risk scores for the first time in the real-life primary health care setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03234322, registered on July 28, 2017.