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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) (NIH)
Overall Status
Completed
CT.gov ID
NCT00061386
Collaborator
(none)
680
Enrollment
1
Location
36
Duration (Months)
18.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Nutrition and physical activity program
 N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single
Primary Purpose:
Prevention
Official Title:
Reducing Disease Risk in Low Income Postpartum Women
Study Start Date :
Mar 1, 2001
Study Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

  1. fruit and vegetable intake []

  2. saturated fat intake []

  3. physical activity []

Secondary Outcome Measures

  1. body mass index []

  2. indicators of fat mass and distribution. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harvard School of Public Health, SHDH Department Boston Massachusetts United States 021115

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Karen E. Peterson, ScD, RD, Harvard School of Public Health (HSPH)

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00061386
Other Study ID Numbers:
  • 5R01HD37368-4
First Posted:
May 28, 2003
Last Update Posted:
Sep 13, 2005
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Postpartum
Low income
Diet
Physical activity

Study Results

No Results Posted as of Sep 13, 2005