NC Enhanced WISEWOMAN Project

NCT ID: NCT00288327

Last Updated: 2009-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 258 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2005-01-31

Brief Summary

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.

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Enhanced New Leaf Intervention

Group Type: EXPERIMENTAL

Lifestyle behavior change program

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Pamphlets

Intervention Type: BEHAVIORAL

Nutritional and physical activity pamphlets from American Heart Association

Interventions

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.

Intervention Type: BEHAVIORAL

Pamphlets

Nutritional and physical activity pamphlets from American Heart Association

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

North Carolina Department of Health and Human Services

OTHER_GOV

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Center for Health Promotion and Disease Prevention

Principal Investigators

Alice S Ammerman, DrPH, RD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

New Hanover Community Health Center

Wilmington, North Carolina, United States

Countries

United States

References

Rosamond WD, Ammerman AS, Holliday JL, Tawney KW, Hunt KJ, Keyserling TC, Will JC, Mokdad AH. Cardiovascular disease risk factor intervention in low-income women: the North Carolina WISEWOMAN project. Prev Med. 2000 Oct;31(4):370-9. doi: 10.1006/pmed.2000.0726.

Reference Type: BACKGROUND

PMID: 11006062 (View on PubMed)

Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.

Reference Type: DERIVED

PMID: 18394692 (View on PubMed)

Other Identifiers

U48/CCU409660

Identifier Type: -

Identifier Source: org_study_id