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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Modifying Lifestyle in Prehypertensive Older Rural Women

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.

Detailed Summary: 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 newslet
Sponsor: University of Nebraska

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • 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 ]


Original Secondary Outcome: Same as current

Information By: University of Nebraska

Dates:
Date Received: December 17, 2007
Date Started: August 2006
Date Completion:
Last Updated: May 20, 2013
Last Verified: May 2013