NCT00061386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
680

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2001

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

September 13, 2005

Status Verified

September 1, 2005

First QC Date

May 27, 2003

Last Update Submit

September 9, 2005

Conditions

Health Promotion

Keywords

PostpartumLow incomeDietPhysical activity

Outcome Measures

Primary Outcomes (3)

  • fruit and vegetable intake

  • saturated fat intake

  • physical activity

Secondary Outcomes (2)

  • body mass index

  • indicators of fat mass and distribution.

Interventions

Nutrition and physical activity programBEHAVIORAL

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Less than 20 weeks postpartum
  • Receive services of USDA's Special Supplemental Food Program for Women, Infants, and Children (WIC)

You may not qualify if:

  • Less than 18 years of age upon recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Public Health, SHDH Department

Boston, Massachusetts, 021115, United States

Location

Related Publications (1)

  • 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. doi: 10.1093/her/17.5.531.

    PMID: 12408198BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Karen E. Peterson, ScD, RD

    Harvard School of Public Health (HSPH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

May 27, 2003

First Posted

May 28, 2003

Study Start

March 1, 2001

Study Completion

March 1, 2004

Last Updated

September 13, 2005

Record last verified: 2005-09

Locations

US(1)