Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

High Blood Pressure Clinical Trial

Official title:

Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00583310
• Other study ID #: AAAC0714
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: November 18, 2013
• Start date: January 2007
• Est. completion date: July 2012

Study information

• Verified date: November 2013
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Individuals with prehypertension are at risk for developing cardiovascular disease and sustained hypertension. Modifying lifestyle behaviors (diet, weight loss, sodium intake, physical activity, alcohol intake) has been shown to reduce blood pressure in hypertensives. Participants in this study will be enrolled in one of two groups. Participants in the first group will receive usual care, and participants in the second group will receive a 4 session telephone-based lifestyle intervention. The goal of the study is to determine whether this intervention is effective in promoting behavior change and reducing blood pressure among prehypertensives.

Description:

Individuals with prehypertension are at increased cardiovascular risk compared with normotension, as well as increased risk of progression to sustained hypertension. The recommended treatment for prehypertension is lifestyle modification, including weight loss, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, reduction of dietary sodium, physical activity, and moderation of alcohol intake. The proposed pilot study will test the effect of a 4 session telephone-based lifestyle intervention on blood pressure change in 125 prehypertensive participants. The intervention includes education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure among hypertensives.

Following baseline assessment, participants will be randomized to the intervention or usual care, and will complete follow-up assessments at 6 weeks and 3 months post-randomization. The primary aim of the study is to examine the effect of the intervention on blood pressure at 3 months. Secondary aims include examining intervention effects on lifestyle behavior changes at 6 weeks and 3 months. This study will provide pilot and feasibility data for a future application to study effects of the intervention on risk factor modification, blood pressure reduction, and cardiovascular morbidity and mortality. If successful, this brief, cost-effective intervention could easily be incorporated into routine care, and could have a significant impact on the management of prehypertension.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: July 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Screening BP in prehypertensive range (SBP of 120-139 mmHg or DBP of 80-89 mmHg). If SBP or DBP is below these ranges, the patient is eligible. However, if either SBP or DBP is above the upper cutoffs (i.e., patient meets criteria for HTN), the patient will not be eligible.

2. Able to read and communicate in English or Spanish.

3. Must have access to a telephone at home or at work.

4. Age 18 years or older

Exclusion Criteria:

1. Patients who are currently taking anti-hypertensive medication will be excluded.

2. Patients with diabetes or kidney disease will be excluded, because pharmacologic treatment may be initiated to achieve the JNC 7 recommended BP goal of 130/80 mmHg in patients with these compelling indications.

3. Patients who are currently participating in another HTN-related clinical trial will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Blood Pressure
• Hypertension

Intervention

Behavioral:
• Telephone-based lifestyle counseling
Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	UNITE HERE Health Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	American Heart Association, UNITE HERE Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory blood pressure change		3 months	No
Secondary	Weight change		3 months	No
Secondary	Change in dietary habits		6 weeks and 3 months	No
Secondary	Change in physical activity level		6 weeks and 3 months	No