PREMIER: Lifestyle Interventions for Blood Pressure Control

Study Overview
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Brief Summary
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To compare the effectiveness of advice versus two multicomponent lifestyle interventions to control blood pressure in participants with Stage 1 hypertension or higher than optimal blood pressure.

Detailed Description
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BACKGROUND: A large body of data has been collected over the years documenting that on the one hand, reduced sodium intake, increased physical activity, weight loss, and moderate alcohol ingestion (Comprehensive Intervention) have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and Stage 1 hypertension. On the other hand, the Dietary Approaches to Stop Hypertension (DASH) study has shown that a diet rich in fruits, vegetables, low-fat dairy products, and decreased saturated fat, total fat, and cholesterol (DASH intervention) reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups. DESIGN NARRATIVE: A multicenter study to determine the BP-lowering effects of two multi-component lifestyle intervention programs compared with advice only. Eight hundred and ten men and women were randomly assigned to one of three treatment arms: (A) advice only; (B) comprehensive lifestyle intervention, in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for BP control (reduced salt intake, increased physical activity, reduced alcohol intake, and weight control or weight loss if needed); and (C) comprehensive lifestyle intervention plus the DASH diet, in which participants received a behavioral intervention program to promote the DASH dietary pattern in addition to the same lifestyle recommendations for BP control. Participants were followed for 18 months. The primary outcome variable was systolic blood pressure measured at six and 18 months after randomization. Other variables included diastolic blood pressure, dietary adherence, physical activity, and onset of hypertension over the 18 months of follow-up. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
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Heart Diseases, Hypertension

Intervention / Treatment
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* Behavioral: diet, sodium-restricted
* Behavioral: diet, fat-restricted
* Behavioral: exercise
* Behavioral: diet, reducing
* Behavioral: alcohol drinking


Participation Criteria
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Eligibility Criteria
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Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, sodium-restricted|nan|
|Behavioral: diet, fat-restricted|nan|
|Behavioral: exercise|nan|
|Behavioral: diet, reducing|nan|
|Behavioral: alcohol drinking|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |