Primary Prevention, Type 2 Diabetes Mellitus
Conditions
Keywords
prevention, risk score, behaviour, physical activity
Brief summary
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.
Detailed description
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.
Interventions
OTHERexternal validated risk prediction model
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.
Sponsors
Association of Statutory Health Insurance Physicians North Rhine
German Institute of Human Nutrition
German Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A pragmatic blinded parallel group superiority cluster randomized controlled trial. Clusters are PCPs (general practitioners, medical practitioners and internists working as general practitioners).
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for participation of medical practitioners: * general practitioners, medical practitioners and internists working as general practitioners with and without further training in diabetology according to German Diabetes Association standards * provide the routine health check
Exclusion criteria
for participation of medical practitioners: * treat exclusively patients with private insurance * treat exclusively diabetes patients in a specialized medical practice Inclusion criteria for participation of participants * appointment for the routine health check * insured in statutory health insurance * age \> 35 years * Body Mass Index (BMI) of ≥ 27 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of participant's physical activity at twelve months after the routine health check between the groups. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the counseling process assessed by PCPs. | 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. |
| Improvement in the counseling process assessed by participants. | 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. |
| Improvement of shared decision making, assessed by participants. | at baseline | Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups. |
| Improvement of shared decision making, assessed by PCPs. | at baseline | Self-reported outcome, modified questionnaire to assess the difference in proportion of shared decision making for diabetes prevention opportunities between the groups. |
| Improved motivation to change lifestyle, assessed by participants. | 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. |
| Change in participant's quality of life. | 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. |
| Change in participant's level of depression and anxiety. | 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. |
| Change of participant's perceived risk of developing diabetes. | 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. |
| Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice. | 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. |
| Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice. | at 6 months follow-up | Self-reported outcome, questions derived from previous studies. |
| Change in Body-Mass-Index (BMI) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change on participant's individual diabetes risk. | 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. |
Countries
Germany
Outcome results
None listed