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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00580528
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : May 22, 2013
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Carol H. Pullen, BSN MSN EdD, University of Nebraska

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-Hypertension Behavioral: Tailored Internet Newsletters Behavioral: Tailored print newsletters delivered via mail Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modifying Lifestyle in Prehypertensive Older Rural Women
Study Start Date : August 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Blood pressure with the criterion of normotensive status is the health outcome of interest in the proposed study. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00580528

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
National Institute of Nursing Research (NINR)
Principal Investigator: Carol H Pullen, EdD University of Nebraska