Improving Health in Low Income Women Following the Birth of a Child

Not Applicable

Completed

• Conditions: Health Promotion

• Registration Number: NCT00061386
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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 paraprofessional's 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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2003-05-27
• Study First Submitted QC: 2003-05-27
• Study First Posted: 2003-05-28
• Study Completion: 2004-03
• Status Verified: 2005-09
• Last Update Submitted: 2005-09-09
• Last Update Posted: 2005-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 680

Inclusion Criteria

• Less than 20 weeks postpartum
• Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)

Exclusion Criteria

• Less than 18 years of age upon recruitment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
fruit and vegetable intake
physical activity
saturated fat intake

Secondary Outcome Measures

Name	Time	Method
body mass index
indicators of fat mass and distribution.

Trial Locations

Locations (1)

Harvard School of Public Health, SHDH Department; 🇺🇸 Boston, Massachusetts, United States