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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

289 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-01

Study Completion Date

2011-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00583310

High Blood Pressure

TERMINATED PHASE2

Mindfulness Attitude to Deliver Dietary Approach to Stop Hypertension

NCT02830529

Prehypertension

COMPLETED NA

Home-Based Program to Treat High Blood Pressure in African Americans

NCT00139490

Cardiovascular Diseases Heart Diseases Hypertension

COMPLETED NA

Lowering Blood Pressure by Changing Lifestyle

NCT04505150

High Blood Pressure

UNKNOWN NA

The Effect of Interventions for Health Behaviors in Hypertensive Patients

NCT06640751

Hypertension Health Behavior Public Health

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 Tailored internet newsletters

Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure.

Group Type EXPERIMENTAL

Tailored Internet Newsletters

Intervention Type BEHAVIORAL

Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure

2 Tailored print newsletters

Tailored print newsletters delivered via the mail with content for improving eating and activity to reduce blood pressure.

Group Type EXPERIMENTAL

Tailored print newsletters delivered via mail

Intervention Type BEHAVIORAL

Tailored Newsletters with content to improve eating and activity to reduce blood pressure

3 No newsletters

Participants receive no newsletters

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tailored Internet Newsletters

Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure

Intervention Type BEHAVIORAL

Tailored print newsletters delivered via mail

Tailored Newsletters with content to improve eating and activity to reduce blood pressure

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* women aged 50-69
* BP in prehypertensive range (SBP 120-139 or DBP 80-89 mm Hg)
* speak and read English (including ESL)
* able to communicate over the telephone
* able to use a computer with minimal assistance
* have access to the Internet
* have access to a VCR or DVD player
* able to walk without an assistive device
* answer 'no' to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) or obtain clearance from their physician

Exclusion Criteria

* in the maintenance stage of readiness for change in both components of physical activity and all three components of healthy eating behaviors
* more than 14 alcoholic drinks per week
* taking anti-hypertensive medication, including diuretics
* taking cortisone
* currently enrolled in a formal program of cardiac rehabilitation or undergoing physical rehabilitation
* unable to walk one mile continuously without stopping to rest
* current cancer treatment
* other physical or medical restrictions that would preclude following the JNC7 recommendations for moderate physical activity and healthy eating.

Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes