Key result
This is a study protocol for a cluster randomized trial investigating whether applying a non-invasive type 2 diabetes risk prediction model during routine health checks improves physical activity at 12 months.
Why the study?
Does the addition of a diabetes risk prediction model to routine primary care health checks improve physical activity in overweight adults without known diabetes?
RCT (n=300)
Single-blind (participants and analysts blinded)
Cluster randomized (minimization technique)
Yes
Does the addition of a diabetes risk prediction model to routine primary care health checks improve physical activity in overweight adults without known diabetes?
This study protocol outlines a cluster randomized trial to evaluate whether integrating a diabetes risk prediction model into routine primary care health checks improves physical activity in at-risk adults.
Protocol for cluster RCT testing diabetes risk model integration in primary care; leaves open whether it improves physical activity until results emerge.
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.
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Jacobs et al. (2018) conducted an RCT in High risk for type 2 diabetes (n=300). German Diabetes Risk Score (GDRS) application during routine health check vs. Routine health check alone (Check-up 35) was evaluated on Change in physical activity at 12 months after the routine health check (measured by IPAQ-SF). This is a study protocol for a cluster randomized trial investigating whether applying a non-invasive type 2 diabetes risk prediction model during routine health checks improves physical activity at 12 months.
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