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Home > "I" Clinical Trials Conditions > Improving Health in Low Income Women Following the Birth of a Child  Improving Health in Low Income Women Following the Birth of a Child
Improving Health in Low Income Women Following the Birth of a Child
For Condition: Health Promotion,Health Education
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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 paraprofessionals 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 will be 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 will participate in an additional three component intervention that include four home visits and four group cooking and activity classes delivered by EFNEP paraprofessionals, as well as monthly motivational telephone calls from project staff. During a 6 month maintenance period, staff will make calls bimonthly. Primary study outcomes will be assessed at Months 1, 6, 12, and 18. Primary outcomes will include 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/44 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Less than 20 weeks postpartum - Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)
Total Enrollment: 680
Location and Contact Information:
Overall Study Official:
KarenPeterson, Principal Investigator, Harvard School of Public Health
Additional Information:
Study ID Numbers: 5R01HD37368-4;
Study Start Date: March 2001
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061386
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Improving Health in Low Income Women Following the Birth of a Child
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