Lifestyle Intervention in Chronic Ischemic Heart Disease and Diabetes

Summary

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.

Conditions

• Ischemic Heart Disease Chronic
• Diabetes Mellitus, Type 2

Interventions

BEHAVIORAL

lifestyle intervention

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.

BEHAVIORAL

usual care

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)

Sponsors & Collaborators

• Technical University of Munich

  collaborator OTHER

• privates Institut für angewandte Versorgungsforschung GmbH

  collaborator UNKNOWN

• IDS Diagnostic Systems AG

  collaborator UNKNOWN

• Federal Joint Committee

  collaborator OTHER_GOV

• Techniker Krankenkasse

  lead OTHER

Principal Investigators

• Martin Halle, Prof. Dr. med. · Klinikum rechts der Isar Technische Universität München

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-12

Primary Completion

2020-12-16

Completion

2021-04-16

Countries

• Germany

Study Locations