Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00288327
Status:
COMPLETED
Last Update Posted:
2009-03-13
First Post:
2006-02-06
Brief Title:
NC Enhanced WISEWOMAN Project
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Testing Lifestyle Interventions for CVD Risk Reduction in Older Underserved Women Enhanced WISEWOMAN Project
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 LeafChoices for Healthy Living which was designed specifically for this demographic group as part of the CDCs 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 LeafChoices 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None