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Trial record 13 of 165 for:    "health promotion" AND (woman OR women OR female)

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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Health Promotion Behavioral: Nutrition and physical activity program

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Reducing Disease Risk in Low Income Postpartum Women
Study Start Date : March 2001
Estimated Study Completion Date : March 2004
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. fruit and vegetable intake
  2. saturated fat intake
  3. physical activity

Secondary Outcome Measures :
  1. body mass index
  2. indicators of fat mass and distribution.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Karen E. Peterson, ScD, RD Harvard School of Public Health
More Information

ClinicalTrials.gov Identifier: NCT00061386     History of Changes
Other Study ID Numbers: 5R01HD37368-4
First Posted: May 28, 2003    Key Record Dates
Last Update Posted: September 13, 2005
Last Verified: September 2005

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Low income
Physical activity