Clinical trial NCT00583310: Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients
Official title: Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: High Blood Pressure
Keywords: Prehypertension
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: UNITE HERE Health Center
First posted: 2007-12-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ambulatory blood pressure change
timeFrame: 3 months
Secondary outcomes:
measure: Weight change
timeFrame: 3 months
measure: Change in dietary habits
timeFrame: 6 weeks and 3 months
measure: Change in physical activity level
timeFrame: 6 weeks and 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: UNITE HERE Health Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Tanya M Goyal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Matthew M Burg
role: PRINCIPAL_INVESTIGATOR
References: