Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061386
Status:
COMPLETED
Last Update Posted:
2005-09-13
First Post:
2003-05-27
Brief Title:
Improving Health in Low Income Women Following the Birth of a Child
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Reducing Disease Risk in Low Income Postpartum Women
Status:
COMPLETED
Status Verified Date:
2005-09
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:
This study will evaluate a community-based program to improve diet and physical activity in women during the first 12 months following the birth of a child The program is designed to complement existing federal programs for low-income families and is directed toward low-income postpartum multi-ethnic women
Detailed Description:
The postpartum period is a window of opportunity to promote behaviors that reduce the risk of chronic disease and benefit reproductive health The Expanded Food and Nutrition Education Program EFNEP is an educational program delivered by community-based paraprofessionals that aims to improve dietary and activity patterns among low income multi-ethnic women during the postpartum period This study will evaluate the efficacy of the EFNEP to impact the diet and activity patterns of women
Women were recruited through the Special Supplemental Food Program for Women Infants and Children WIC and randomized to either the EFNEP group or a usual care group Women in both groups will receive standard WIC care consisting of nutrition-risk and breastfeeding educational messages at postpartum and follow-up visits Women in the EFNEP group participated in an additional two component intervention that included five home visits and motivational telephone calls from project staff
Primary study outcomes were assessed at Months 1 and 12 Primary outcomes included fruit and vegetable intake saturated fat intake and physical activity Secondary outcomes will include Body Mass Index and indicators of fat mass and distribution The study will also analyze mediating and modifying factors including social support and norms perceived health status smoking television viewing food insecurity food and activity access and utilization of federal programs and health care
Women were recruited through the Special Supplemental Food Program for Women Infants and Children WIC and randomized to either the EFNEP group or a usual care group Women in both groups will receive standard WIC care consisting of nutrition-risk and breastfeeding educational messages at postpartum and follow-up visits Women in the EFNEP group participated in an additional two component intervention that included five home visits and motivational telephone calls from project staff
Primary study outcomes were assessed at Months 1 and 12 Primary outcomes included fruit and vegetable intake saturated fat intake and physical activity Secondary outcomes will include Body Mass Index and indicators of fat mass and distribution The study will also analyze mediating and modifying factors including social support and norms perceived health status smoking television viewing food insecurity food and activity access and utilization of federal programs and health care
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