Skip to main content
OpenTrials
Completed

NCT Number: NCT03234322

The Impact of a Diabetes Risk Prediction Model in Primary Care.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Center, Institute for Biometrics and Epidemiology

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

for participation of participants

  • type 1 or type 2 diabetes diagnosis or already abnormal blood glucose level (fasting glucose ≥ 126 mg/dl or 2 hours oral glucose tolerance test (oGTT) ≥ 200mg/dl or glycated hemoglobin (HbA1c) ≥6,5%) before the routine health check
  • no sufficient German language skills to fill in the questionnaires
  • presence of an incurable disease with a prognosis of less than one year
  • severe mental illness or dementia
  • severe underlying disease, which largely impairs physical activity
  • pregnancy
  • participation in another clinical study 30 days before study inclusion

Treatment and study plan

external validated risk prediction model

Other

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

Primary outcomes

  1. Difference of participant's physical activity at twelve months after the routine health check between the groups.

    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.

Secondary outcomes

  1. Improvement in the counseling process assessed by PCPs.

    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.

  2. Improvement in the counseling process assessed by participants.

    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.

  3. Improvement of shared decision making, assessed by participants.

    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.

  4. Improvement of shared decision making, assessed by PCPs.

    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.

  5. Improved motivation to change lifestyle, assessed by participants.

    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.

  6. Change in Body-Mass-Index (BMI)

    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.

  7. Change in participant's quality of life.

    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.

  8. Change in participant's level of depression and anxiety.

    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.

  9. Change of participant's perceived risk of developing diabetes.

    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.

  10. Acceptance of PCPs according to the application of a diabetes risk score for routine use in clinical practice.

    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.

  11. Acceptance of participants according to the application of a diabetes risk score for routine use in clinical practice.

    Time frame: at 6 months follow-up

    Self-reported outcome, questions derived from previous studies.

Other outcomes

  1. Change on participant's individual diabetes risk.

    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.

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Collaborators

  • Association of Statutory Health Insurance Physicians North Rhine
  • German Institute of Human Nutrition

Registry information

Official study title

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.

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jul 31, 2017
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.