Pre-HypertensionNCT00580528
Reducing Blood Pressure in Prehypertensive Older Rural Women Also Known as Wellness for Women: DASHing Toward Health
A study testing Tailored Internet Newsletters and Tailored print newsletters delivered via mail in people with Pre-Hypertension, run by University of Nebraska at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Hypertension
- What is being tested?
- Tailored Internet Newsletters and Tailored print newsletters delivered via mail
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2006to 1 May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Modifying Lifestyle in Prehypertensive Older Rural Women
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.
Read the 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.
- Conditions
- Pre-Hypertension
- Being tested
- Tailored Internet Newsletters, Tailored print newsletters delivered via mail
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Internet NewslettersBehavioural
Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure
Tailored print newsletters delivered via mailBehavioural
Tailored Newsletters with content to improve eating and activity to reduce blood pressure
| Study group | Role | What they receive |
|---|---|---|
| 1 Tailored internet newsletters | Experimental | Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure. Receives: Behavioral: Tailored Internet Newsletters |
| 2 Tailored print newsletters | Experimental | Tailored print newsletters delivered via the mail with content for improving eating and activity to reduce blood pressure. Receives: Behavioral: Tailored print newsletters delivered via mail |
| 3 No newsletters | No intervention | Participants receive no newsletters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Blood pressure with the criterion of normotensive status
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study start1 Aug 2006
- Primary completion1 May 2010
- Study completion1 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-HypertensionStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Carol H Pullen, EdD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580528
- Sponsor's protocol ID
- 0352-05-FB
- Other IDs
- 5R01NR004861-06, 31-4334-0124
- Status last verified
- Aug 2023
- First submitted
- 17 Dec 2007
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25480461Hageman 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.
PubMed 23227315
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Lifestyle in Prehypertensive Older Rural Women
- ClinicalTrials.gov ID
- NCT00580528
- Acronym / sponsor ID
- 0352-05-FB
- Conditions
- Pre-Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Aug 2006 (actual)
- Primary completion
- 1 May 2010 (actual)
- Study completion
- 1 May 2011 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Tailored internet newsletters | Experimental | Behavioral: Tailored Internet NewslettersTailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure. |
| 2 Tailored print newsletters | Experimental | Behavioral: Tailored print newsletters delivered via mailTailored print newsletters delivered via the mail with content for improving eating and activity to reduce blood pressure. |
| 3 No newsletters | No intervention | –Participants receive no newsletters |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Internet NewslettersTailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure | Behavioural | 1 Tailored internet newsletters |
| Tailored print newsletters delivered via mailTailored Newsletters with content to improve eating and activity to reduce blood pressure | Behavioural | 2 Tailored print newsletters |
Primary outcome
Blood pressure
Time frame: 24 months
Blood pressure with the criterion of normotensive status
2 secondary outcomes
Daily moderate physical activity and strength enhancing/maintenance activities
Time frame: 24 months
DASH diet goals
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 25480461Hageman 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.
- Derived from this study: PubMed 23227315Hageman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol H Pullen, EdD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Internet Newsletters and Tailored print newsletters delivered via mail in people with Pre-Hypertension, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580528, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.