Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial

Universität Duisburg-Essen

Status: Completed

Conditions: Hypertension; Metabolic Syndrome

Treatments: Behavioral: Standard Lifestyle Modification / modified DASH; Behavioral: Comprehensive Lifestyle Modification

Study type: Interventional

Funder types: Other

Identifiers

NCT02099968

CORONA

Details and patient eligibility

About

Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on meditation or mindfulness-based interventions have shown positive effects in patients with hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a combination of diet, exercise, and stress management, have improved coronary atherosclerosis. However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification in patients with metabolic syndrome and/or in combination with fasting therapy.

This study is supported by a grant from the Corona-Foundation, Germany.

Enrollment: 145 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypertension or antihypertensive medication or subclinical atherosclerosis
• Metabolic syndrome
• Basic mobility

Exclusion criteria

• Diabetes type 1
• Insulin bolus therapy
• Coronary artery disease
• Myocardial infarct, pulmonary embolism, or stroke within the past 3 months
• Heart failure
• Peripheral vascular disease
• Chronic kidney disease
• Eating disorder
• Dementia
• Other severe internal disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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145 participants in 2 patient groups

Comprehensive Lifestyle Modification

Experimental group

Treatment:

Behavioral: Comprehensive Lifestyle Modification

Standard Lifestyle Modification / modified DASH

Active Comparator group

Treatment:

Behavioral: Standard Lifestyle Modification / modified DASH