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

NCT ID: NCT00061386

Last Updated: 2005-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 680 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-03-31
• Study Completion Date: 2004-03-31

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.

Conditions

Health Promotion

Keywords

Postpartum; Low income; Diet; Physical activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Interventions

Nutrition and physical activity program

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Principal Investigators

Karen E. Peterson, ScD, RD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Harvard School of Public Health, SHDH Department

Boston, Massachusetts, United States

Countries

United States

References

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. doi: 10.1093/her/17.5.531.

Reference Type: BACKGROUND

PMID: 12408198 (View on PubMed)

Other Identifiers

5R01HD037368

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HD37368-4

Identifier Type: -

Identifier Source: org_study_id