Reducing Blood Pressure in Prehypertensive Older Rural Women Also Known as Wellness for Women: DASHing Toward Health
Primary Purpose
Pre-Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Internet Newsletters
Tailored print newsletters delivered via mail
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Hypertension
Eligibility 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.
Sites / Locations
- University of Nebraska Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
1 Tailored internet newsletters
2 Tailored print newsletters
3 No newsletters
Arm Description
Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure.
Tailored print newsletters delivered via the mail with content for improving eating and activity to reduce blood pressure.
Participants receive no newsletters
Outcomes
Primary Outcome Measures
Blood pressure
Blood pressure with the criterion of normotensive status
Secondary Outcome Measures
Daily moderate physical activity and strength enhancing/maintenance activities
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.
DASH diet goals
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.
Full Information
NCT ID
NCT00580528
First Posted
December 17, 2007
Last Updated
August 29, 2023
Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT00580528
Brief Title
Reducing Blood Pressure in Prehypertensive Older Rural Women Also Known as Wellness for Women: DASHing Toward Health
Official Title
Modifying Lifestyle in Prehypertensive Older Rural Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2006 (Actual)
Primary Completion Date
May 1, 2010 (Actual)
Study Completion Date
May 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
289 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Tailored internet newsletters
Arm Type
Experimental
Arm Description
Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure.
Arm Title
2 Tailored print newsletters
Arm Type
Experimental
Arm Description
Tailored print newsletters delivered via the mail with content for improving eating and activity to reduce blood pressure.
Arm Title
3 No newsletters
Arm Type
No Intervention
Arm Description
Participants receive no newsletters
Intervention Type
Behavioral
Intervention Name(s)
Tailored Internet Newsletters
Intervention Description
Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
Intervention Type
Behavioral
Intervention Name(s)
Tailored print newsletters delivered via mail
Intervention Description
Tailored Newsletters with content to improve eating and activity to reduce blood pressure
Primary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure with the criterion of normotensive status
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Daily moderate physical activity and strength enhancing/maintenance activities
Description
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
Title
DASH diet goals
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol H Pullen, EdD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25480461
Citation
Hageman PA, Pullen CH, Hertzog M, Boeckner LS. Effectiveness of tailored lifestyle interventions, using web-based and print-mail, for reducing blood pressure among rural women with prehypertension: main results of the Wellness for Women: DASHing towards Health clinical trial. Int J Behav Nutr Phys Act. 2014 Dec 6;11:148. doi: 10.1186/s12966-014-0148-2.
Results Reference
derived
PubMed Identifier
23227315
Citation
Hageman PA, Pullen CH, Hertzog M, Boeckner LS, Walker SN. Associations of cardiorespiratory fitness and fatness with metabolic syndrome in rural women with prehypertension. J Obes. 2012;2012:618728. doi: 10.1155/2012/618728. Epub 2012 Nov 25. Erratum In: J Obes. 2014;2014:412430.
Results Reference
derived
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Reducing Blood Pressure in Prehypertensive Older Rural Women Also Known as Wellness for Women: DASHing Toward Health
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