Status:
COMPLETED
Preventing Childhood Obesity Through Early Guidance
Lead Sponsor:
Arizona State University
Conditions:
Childhood Obesity
Eligibility:
All Genders
1-40 years
Phase:
NA
Brief Summary
The goal of this study is to compare the effectiveness of structured CHW- provided home visits, using an intervention created through community-based participatory research, to standard care received ...
Detailed Description
Along with birth weight and parental body size, infant feeding is recognized as one of the most influential biological and environmental factors that affect weight gain during infancy. Parental feedin...
Eligibility Criteria
Inclusion
- MATERNAL - Self-described as Mexican American, pre-pregnant BMI of 25 or greater, speaks English or Spanish, is between the ages of 18 and 40, lives in a home where she can receive home visitors, has no diagnosed chronic diseases that can affect the growth of a fetus (cardiac, respiratory, etc.), have a telephone contact, and is not intending to move from the area. Gestational diabetes will be noted but is not an exclusion criterion; however, Type 1 diabetics will be excluded. Exposure to tobacco smoke (either maternal or household smoking) will be noted as it is associated with infant obesity, but will not be an inclusion or exclusion criteria.
- INFANT - We will enroll the full-term singleton infants of enrolled mothers. The infants will be enrolled if they are \> 38 weeks gestation, have a birth weight \> 2500 gm, and are without endocrine/chromosomal/genetic abnormality that could interfere with growth.
Exclusion
- MATERNAL - Not enrolled in WIC clinic or does not plan to continue with WIC clinic after delivery, high-risk pregnancy, hospitalized after discharge of infant, separated from infant, or experiencing significant postpartum complications. If these criteria develop in an enrolled mother, she will remain in the study per CONSORT guidelines, but her infant will not be followed for study outcomes. We have sufficient power with our sample size to allow for these events.
- INFANT - Not discharged home with the mother or who are otherwise separated from their mothers or who has a severe illness that can affect growth. CONSORT guidelines will apply in these cases as well as in maternal cases.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT01905072
Start Date
October 1 2012
End Date
June 30 2017
Last Update
January 18 2020
Active Locations (1)
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1
St. Austin Center - Arizona State University Group
Houston, Texas, United States, 77023