Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04313751
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2020-03-16
Brief Title:
Reducing Cardiovascular Disease Risk in Perimenopausal Latinas
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Reducing Cardiovascular Disease Risk in Perimenopausal Latinas Pilot Study of a Multi-Component Intervention
Status:
COMPLETED
Status Verified Date:
2024-04
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 goal of this study is to pilot test a 12-week behavioral intervention among perimenopausal Latinas age 40-55 years that integrates evidence-based education with physical activity stress management and coping skills training to 1 reduce cardiovascular disease CVD risk factors and arterial stiffness 2 improve nutrition physical activity and sleep behaviors and 3 improve stress management coping strategies and self-efficacy This study will recruit participants from two community groups one group will be randomly assigned to complete the intervention the other will be a wait-list control
Detailed Description:
While CVD mortality is the leading cause of death in the United States large racialethnic disparities in cardiovascular health exist between Latinas and non-Hispanic populations Risk of CVD increases significantly for women following menopause There are substantial increases in CVD risk factors during perimenopause specifically perimenopausal women exhibit greater visceral adipose tissue fasting glucose total cholesterol and systolic blood pressure compared to premenopausal women Although behavioral intervention research targeting CVD risk during perimenopause emerged over the past decade no studies were designed to decrease biological CVD risk among perimenopausal Latinas This study will recruit perimenopausal Latinas age 40-55 years from two community groups one group will be randomly assigned to complete the intervention the other will be a wait-list control This intervention has 3 phases 12 weekly sessions Phase I education physical activity stress management coping skills training followed by 3 monthly sessions of continued support Phase II and finally 6 months of skill maintenance on their own Phase III Data will be collected at Time 1 0 months baseline Time 2 6 months completion of the intervention and Time 3 12 months after 6 months of maintenance on own Data collected will include biological CVD risk factors and arterial stiffness primary outcomes blood pressure lipid profile blood glucose carotid-femoral pulse wave velocity Secondary outcomes will include health behaviors and self-efficacy Food Behavior Checklist 7 day Accelerometer Sleep Quality Scale Eating Self-Efficacy Scale Exercise Self-Efficacy Scale and other biological factors related to CVD risk waist circumference weight body mass index BMI C-reactive protein hair cortisol The investigators will also evaluate the feasibility of the intervention eg enrollment and retention rates barriers and facilitators to enrollment intervention fidelity suitability of study procedures and outcome measures and participant satisfaction with the intervention and study protocol The knowledge to be gained from this pilot study may provide a foundation for extending this intervention to a larger efficacy trial This research holds potential to accelerate greatly the acquisition of knowledge related to CVD risk among perimenopausal Latinas and the impact of behavioral interventions to reduce CVD risk in this underserved population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MD014767 | NIH | None | httpsreporternihgovquickSearchK23MD014767 |