Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

NC Enhanced WISEWOMAN Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00288327
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : March 13, 2009
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services
Information provided by:
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: Lifestyle behavior change program Behavioral: Pamphlets Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project
Study Start Date : March 2003
Actual Primary Completion Date : December 2004
Actual Study Completion Date : January 2005

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. physical activity
  2. fruit intake
  3. vegetable intake
  4. fat intake

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288327


Locations
Layout table for location information
United States, North Carolina
New Hanover Community Health Center
Wilmington, North Carolina, United States, 28401
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centers for Disease Control and Prevention
North Carolina Department of Health and Human Services
Investigators
Layout table for investigator information
Principal Investigator: Alice S Ammerman, DrPH, RD University of North Carolina, Chapel Hill
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Alice Ammerman, DrPH, RD/Director, Center for Health Promotion and Disease Prevention
ClinicalTrials.gov Identifier: NCT00288327    
Other Study ID Numbers: U48/CCU409660
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009
Keywords provided by University of North Carolina, Chapel Hill:
diet
physical activity
smoking cessation
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases