NC Enhanced WISEWOMAN Project

This study has been completed.
Sponsor:
Collaborators:
North Carolina Department of Health and Human Services
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00288327
First received: February 6, 2006
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.


Condition Intervention
Cardiovascular Disease
Behavioral: Lifestyle behavior change program
Behavioral: Pamphlets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • physical activity
  • fruit intake
  • vegetable intake
  • fat intake

Secondary Outcome Measures:
  • Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
  • CVD risk factors (total and HDL cholesterol, blood pressure);
  • Psychosocial variables

Enrollment: 258
Study Start Date: March 2003
Study Completion Date: January 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Enhanced New Leaf Intervention
Behavioral: Lifestyle behavior change program
Intervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls.
2
Minimum Intervention
Behavioral: Pamphlets
Nutritional and physical activity pamphlets from American Heart Association

Detailed Description:

We conducted a 2 year study to test the feasibility and effectiveness of a CVD risk reduction intervention program for older, under or uninsured women. We used an existing nutrition and physical activity (PA) intervention tool (New Leaf…Choices for Healthy Living) designed specifically for this demographic group as part of the WISEWOMAN program (A CDC-funded CVD risk factor screening and intervention program for older, low-income women). We enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (LHAs); and 3) a community resource linkage component delivered primarily by LHAs. We tested the enhanced intervention in a randomized controlled trial in a community health center setting.

A total of 240 women aged 40-64 were randomized to the enhanced New Leaf intervention or minimum intervention groups. Women in the enhanced New Leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the CHC, postcard mailings, 3 group sessions, and lay health advisor (LHA) guided linkages to community resources for diet and PA. This was followed by a 6 month maintenance period led by the LHA and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. Primary outcome measures at 6 and 12 months included 1) PA measured by CSA accelerometer and 2) fruit, vegetable, and fat intake. Secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), CVD risk factors (total and HDL cholesterol, blood pressure), and psychosocial variables.

  Eligibility

Ages Eligible for Study:   40 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 40-64 years old
  • Patient at participating site who is considered an appropriate candidate by the primary care clinician
  • Ability and willingness to provide informed consent
  • Availability for follow-up--plan to reside within 50 miles of study site for 1 year
  • Home phone or easy access to phone

Exclusion Criteria:

  • Medical condition for which intervention may not be appropriate
  • Pregnancy/lactation
  • Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288327

Locations
United States, North Carolina
New Hanover Community Health Center
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Department of Health and Human Services
Investigators
Principal Investigator: Alice S Ammerman, DrPH, RD University of North Carolina, Chapel Hill
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Ammerman, DrPH, RD/Director, Center for Health Promotion and Disease Prevention
ClinicalTrials.gov Identifier: NCT00288327     History of Changes
Other Study ID Numbers: U48/CCU409660
Study First Received: February 6, 2006
Last Updated: March 12, 2009
Health Authority: United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
diet
physical activity
smoking cessation

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014