Health Promotion Clinical Trial
Official title:
Reducing Disease Risk in Low Income Postpartum Women
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention
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