German Diabetes Center, Institute for Biometrics and Epidemiology
Düsseldorf, North Rhine-Westphalia, 40225, Germany
NCT Number: NCT03234322
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 diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
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Notify Me35 year and older
All sexes
Interventional
Not applicable
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Diabetes risk scores are predictive models to estimate the probability for an individual to develop diabetes within a defined time period. In the last years, many diabetes risk prediction models were developed worldwide. It has been proposed that using diabetes risk scores as first step of diabetes screening is more practical than blood glucose tests as the latter are time consuming and costly. Given the rapid development of diabetes risk scores and a simultaneous reluctance of primary care physicians (PCPs) to implement diabetes risk scores in everyday practice, there is an urgent need to expand our knowledge of the impact of diabetes risk scores in the primary health care setting. Thus, the aim of the study is to investigate the impact of a non-invasive risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for participation of medical practitioners:
Exclusion criteria
for participation of medical practitioners:
Inclusion criteria
for participation of participants
Exclusion criteria
for participation of participants
The risk prediction model will be integrated into a routine health check. The diabetes risk prediction model contains modifiable non-invasive risk factors and consists of eleven questions on age, height, waist circumference, hypertension, physical activity, smoking status, intake of whole-grain bread, intake of red meat, coffee consumption, and family history of diabetes (parents and siblings) to predict the five-year diabetes risk. The filled diabetes risk score will be used in the counseling interview with the PCP at the end of the health check as a practical guide to discuss individual tailored preventive strategies.
Other names: The German Diabetes Risk Score
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcome, international validated questionnaire Physical Activity Questionnaire Short Last 7 Days Format (IPAQ-SF), which has been shown to be a reliable and valid tool to obtain comparable estimates of physical activity.
Time frame: at baseline and up to one year after the PCP entered the study
Self-reported outcome, analyzed as difference in proportion of counseling regarding preventive strategies on balanced nutrition, body weight reduction, physical activity, and smoking secession between the groups. Questions are derived from a previous study.
Time frame: at 6 months follow-up
Self-reported outcome, analyzed as difference in proportion of counseling regarding preventive strategies on balanced nutrition, body weight reduction, physical activity, and smoking secession between the groups. Questions are derived from a previous study.
Time frame: at baseline
Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.
Time frame: at baseline
Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups.
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcome, questions are based on the stage of change model to assess the stage of motivation according to weight reduction, physical activity, healthy diet, smoking cessation and were derived from previous studies. We will assess the difference of motivation change between the groups.
Time frame: at baseline, 6 and 12 months follow-up
At baseline, weight and height is objectively measured by the PCP, in the follow-up weight will be self-reported. We will analyse group differences in change of BMI at 6 and 12 months follow-up.
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcome, question has been derived from previous studies. We will assess the change of quality of life between the groups.
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcomes, depression and anxiety will be assessed with a validated questionnaire, the Hospital Anxiety and Depression Scale (HADS-D). We will assess the change of depression and anxiety between the groups.
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcome by participants, questions derived from previous studies. We will assess the change in perceived risk between the groups.
Time frame: at baseline, and up to one year after the PCP entered the study
Self-reported outcome, differences between the groups will be analyzed. Questions are derived from previous studies.
Time frame: at 6 months follow-up
Self-reported outcome, questions derived from previous studies.
Time frame: at baseline, 6 and 12 months follow-up
Self-reported outcome. Individual diabetes risk will be derived from the diabetes risk score in the intervention group at baseline, which is a validated questionnaire. In the follow-up questionnaires at 6 and 12 months, the questions of the diabetes risk score are included in the questionnaire of both groups.
German Diabetes Center
Other
A Cluster Randomized Trial to Investigate the Impact of a Type 2 Diabetes Risk Prediction Model on Change in Physical Activity Within Routine Health Checks in Primary Care.
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