Improving Health in Low Income Women Following the Birth of a Child
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|ClinicalTrials.gov Identifier: NCT00061386|
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : September 13, 2005
|Condition or disease||Intervention/treatment||Phase|
|Health Promotion||Behavioral: Nutrition and physical activity program||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||680 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Reducing Disease Risk in Low Income Postpartum Women|
|Study Start Date :||March 2001|
|Study Completion Date :||March 2004|
- fruit and vegetable intake
- saturated fat intake
- physical activity
- body mass index
- indicators of fat mass and distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061386
|United States, Massachusetts|
|Harvard School of Public Health, SHDH Department|
|Boston, Massachusetts, United States, 021115|
|Principal Investigator:||Karen E. Peterson, ScD, RD||Harvard School of Public Health|