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Completed

NCT Number: NCT00288327

NC Enhanced WISEWOMAN Project

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.

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Key information

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New Hanover Community Health Center

Wilmington, North Carolina, 28401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle behavior change program

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.

Pamphlets

Behavioral

Nutritional and physical activity pamphlets from American Heart Association

Primary outcomes

  1. physical activity

  2. fruit intake

  3. vegetable intake

  4. fat intake

Secondary outcomes

  1. Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);

  2. CVD risk factors (total and HDL cholesterol, blood pressure);

  3. Psychosocial variables

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Centers for Disease Control and Prevention
  • North Carolina Department of Health and Human Services

Registry information

Official study title

Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Feb 7, 2006
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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