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

Reducing Disease Risk in Low Income Postpartum Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00061386
Enrollment
680
Registered
2003-05-28
Start date
2001-03-31
Completion date
2004-03-31
Last updated
2005-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Promotion

Keywords

Postpartum, Low income, Diet, Physical activity

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.

Interventions

BEHAVIORALNutrition and physical activity program

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
fruit and vegetable intake
saturated fat intake
physical activity

Secondary

MeasureTime frame
body mass index
indicators of fat mass and distribution.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026