NCT00580528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 24, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

September 1, 2023

Status Verified

August 1, 2023

Enrollment Period

3.8 years

First QC Date

December 17, 2007

Last Update Submit

August 29, 2023

Conditions

Pre-Hypertension

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Blood pressure with the criterion of normotensive status

    24 months

Secondary Outcomes (2)

  • Daily moderate physical activity and strength enhancing/maintenance activities

    24 months

  • DASH diet goals

    24 months

Study Arms (3)

1 Tailored internet newsletters

EXPERIMENTAL

Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure.

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.

Behavioral: Tailored print newsletters delivered via mail

3 No newsletters

NO INTERVENTION

Participants receive no newsletters

Interventions

Tailored Internet NewslettersBEHAVIORAL

Tailored newsletters delivered via the Internet with content for improving eating and activity to reduce blood pressure

1 Tailored internet newsletters
Tailored print newsletters delivered via mailBEHAVIORAL

Tailored Newsletters with content to improve eating and activity to reduce blood pressure

2 Tailored print newsletters

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (2)

  • 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.

    PMID: 25480461DERIVED

  • 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.

    PMID: 23227315DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Carol H Pullen, EdD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2007

First Posted

December 24, 2007

Study Start

August 1, 2006

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

September 1, 2023

Record last verified: 2023-08

Locations

US(1)