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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol H. Pullen, BSN MSN EdD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00580528
First received: December 17, 2007
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Pre-Hypertension
Behavioral: Tailored Internet Newsletters
Behavioral: Tailored print newsletters delivered via mail

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modifying Lifestyle in Prehypertensive Older Rural Women

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Blood pressure with the criterion of normotensive status is the health outcome of interest in the proposed study. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Engaging regularly, preferably daily, in sustained or intermittent (10 minute bouts) moderate physical activity for at least 30 minutes per day and performing physical activities that enhance and maintain muscular strength at least twice a week [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Meeting the DASH diet's average daily goals of no more than 27% of calories from fat, less than 7% of calories from saturated fat 4-5 servings of fruits, 4-5 servings of vegetables, 2-3 servings of low fat dairy products and no more than 2400 mg. sodium [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: August 2006
Study Completion Date: May 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: Tailored Internet Newsletters
Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
Experimental: 2 Behavioral: Tailored print newsletters delivered via mail
Tailored Newsletters with content to improve eating and activity to reduce blood pressure
No Intervention: 3

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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580528

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Carol H Pullen, EdD University of Nebraska
  More Information

No publications provided by University of Nebraska

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol H. Pullen, BSN MSN EdD, Faculty, University of Nebraska
ClinicalTrials.gov Identifier: NCT00580528     History of Changes
Other Study ID Numbers: 352-05-FB, NIH 5 RO1 NR004861-06
Study First Received: December 17, 2007
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014