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

Health Promotion Clinical Trial

Official title:

Reducing Disease Risk in Low Income Postpartum Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061386
• Other study ID #: 5R01HD37368-4
• Status: Completed
• Phase: N/A
• First received: May 27, 2003
• Last updated: September 9, 2005
• Start date: March 2001
• Est. completion date: March 2004

Study information

• Verified date: September 2005
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Health Promotion

Intervention

Behavioral:
• Nutrition and physical activity program

Locations

Country	Name	City	State
United States	Harvard School of Public Health, SHDH Department	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Peterson KE, Sorensen G, Pearson M, Hebert JR, Gottlieb BR, McCormick MC. Design of an intervention addressing multiple levels of influence on dietary and activity patterns of low-income, postpartum women. Health Educ Res. 2002 Oct;17(5):531-40. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fruit and vegetable intake
Primary	saturated fat intake
Primary	physical activity
Secondary	body mass index
Secondary	indicators of fat mass and distribution.