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

Tracking Information

First Received Date ^ICMJE

May 27, 2003

Last Updated Date

September 9, 2005

Start Date ^ICMJE

March 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

fruit and vegetable intake
saturated fat intake
physical activity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00061386 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

body mass index
indicators of fat mass and distribution.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Reducing Disease Risk in Low Income Postpartum Women

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Health Promotion

Intervention ^ICMJE

Behavioral: Nutrition and physical activity program

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

680

Completion Date

March 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00061386

Responsible Party

Study ID Numbers ^ICMJE

5R01HD37368-4

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Karen E. Peterson, ScD, RD

Harvard School of Public Health

Information Provided By

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

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP