Clinical Trials Directory

Trials / Completed

CompletedNCT00580528

Reducing Blood Pressure in Prehypertensive Older Rural Women Also Known as Wellness for Women: DASHing Toward Health

Modifying Lifestyle in Prehypertensive Older Rural Women

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
289 (actual)
Sponsor
University of Nebraska · Academic / Other
Sex
Female
Age
40 Years – 69 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to evaluate the effectiveness of a theory-based intervention tailored to constructs in the Health Promotion Model and delivered by two distance modes to achieve improvement in healthy eating and physical activity for the control of blood pressure (BP) among an underserved and vulnerable population of prehypertensive rural women aged 50 to 69.

Detailed description

Hypertension (HTN), a major health problem in the US, is the most prevalent modifiable risk factor for cardio-vascular disease (CVD), the leading killer of women. The incidence of HTN in women increases markedly after menopause, equaling or exceeding that in men. The prehypertension category of blood pressure (BP) -- systolic BP of 120-139 mm Hg or diastolic BP of 80-89 mm Hg -- designates individuals at high risk of developing HTN. Prehypertensive women are not candidates for drug therapy, but for lifestyle modifications to prevent progression to HTN and CVD. Recommended lifestyle modifications include adoption of the Dietary Approaches to Stop Hypertension (DASH) diet that is high in fruits, vegetables and low fat dairy products; dietary sodium reduction; regular endurance physical activity supplemented by resistance exercise; and weight reduction by those who are overweight or obese. A few studies of face-to-face individual and/or group interventions have demonstrated that these lifestyle modifications could lower BP over 6 months in pre-hypertensive individuals. There remains a need to develop distance delivery methods to target rural women with similar behavioral interventions to lower BP. This competitive renewal application will build upon our current work in which we demonstrated that computer-generated print (mailed) newsletters tailored to constructs in the Health Promotion Model (HPM) resulted in significant and clinically important changes in behavioral and biomarkers of healthy eating and physical activity in a general population of rural midlife/older women. The proposed randomized controlled trial will evaluate Internet versus mailed print delivery methods for delivering theory-based tailored newsletters to encourage lifestyle change for BP reduction. A sample of 275 prehypertensive rural women aged 50-69 will be randomly assigned 2:2:1 to receive a) tailored messages delivered via the Internet and brief telephone counseling, b) tailored print newsletters delivered via mail and brief telephone counseling, or c) initial standard advice only. Results of this study may lead to expanded access to lifestyle guidance via the Internet by other populations.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTailored Internet NewslettersTailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
BEHAVIORALTailored print newsletters delivered via mailTailored Newsletters with content to improve eating and activity to reduce blood pressure

Timeline

Start date
2006-08-01
Primary completion
2010-05-01
Completion
2011-05-01
First posted
2007-12-24
Last updated
2023-09-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00580528. Inclusion in this directory is not an endorsement.