NCT Number: NCT03835923
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The aim of this program is to reduce cardiovascular risk factors by promoting individual health literacy and a healthy lifestyle, thereby improving metabolism and reducing the progress of the disease as well as mortality.
Patients will receive individual exercise prescriptions and nutritional recommendations. This lifestyle intervention is accompanied by step counters, heart rate sensors, blood glucose meters and smartphones to allow regional implementation in different areas in Germany. In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial.
The project examines whether the intervention positively affects metabolic health and lifestyle behaviors, increases health literacy, and reduces cardiovascular events of these high risk patients. Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University Hospital: Rheinisch-Westfälische Technische Hochschule Aachen, Aachen, Germany
Chronic ischemic heart disease and diabetes mellitus type II have one of the highest morbidity and mortality rates. Especially in the presence of both diseases, these risks increase exponentially. The combined endpoint of death and myocardial infarction reaches up to 30% within four years. A lifestyle intervention with exercise training and dietary change can reduce the mortality by 20-30% and is a class-I indication in the current guidelines of the European Association of Preventive Cardiology (EAPC). Nevertheless, the implementation of lifestyle interventions in the population is insufficient.
This prospective randomized controlled trial examines whether a structured, individual and telemedicine-supported lifestyle intervention improves health literacy and reduces cardiovascular risk factors compared to a guideline-based recommendation (usual care). Furthermore, the effectiveness of the intervention will be compared between urban and rural areas.
In total, 1500 patients with diabetes mellitus type II and chronic ischemic heart disease will participate in the trial. After randomization (1:1), the 750 patients of the intervention group will receive individual exercise prescriptions and nutritional recommendations based on a maximum exercise stress test and a multi-day nutrition protocol. The intervention is accompanied by pedometers, heart rate sensors, blood glucose meters and smartphones as well as regular oral and written feedback.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback.
intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback.
Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise)
Time frame: 6 months
measured in percent (%)
Time frame: 12 months
measured in percent (%)
Time frame: 6 and 12 months
European Health Literacy Survey Questionnaire (HLS-EU-Q16)
Time frame: 6 and 12 months
International Physical Activity Questionnaire (IPAQ)
Time frame: 6 and 12 months
7-day average of steps/day measured by pedometers
Time frame: 6 and 12 months
Fragebogen zum Essverhalten (FEV; German questionnaire on eating behavior)
Time frame: 6 and 12 months
Short form health survey (SF-36)
Time frame: 6 and 12 months
routine data of health insurance company
Time frame: 6 and 12 months
measured in kilograms (kg)
Time frame: 6 and 12 months
measured in centimeters (cm)
Time frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
measured in milligram/deciliter (mg/dL)
Time frame: 6 and 12 months
measured in millimeters of mercury (mmHG)
Time frame: 6 and 12 months
measured in millimeters of mercury (mmHG)
Time frame: 6 and 12 months
cardiovascular deaths, non-fatal stroke, non-fatal myocardial infarction, hospitalization due to angina pectoris
Techniker Krankenkasse
Other
Acronym: LeIKD
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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.
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