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NCT number NCT03141346
Study type Interventional
Source University of Southern California
Contact Michael I Goran
Phone 323-442-3027
Email goran@usc.edu
Status Recruiting
Phase N/A
Start date September 21, 2017
Completion date November 2020

Clinical Trial Summary

This study will determine whether a home visitation program incorporating sugar sweetened beverage and juice (SSB/J) reduction and home water delivery affects maternal and infant risk for obesity. The postpartum period is a time of both opportunity and vulnerability for mothers and their infants to diminish risk for obesity and related health problems. This is particularly relevant in the context of Hispanic families. Hispanic mothers are at high-risk for excess gestational weight gain and postpartum weight retention, and their infants are at high-risk for rapid weight gain associated with early onset obesity. A contributing factor may be their intake of SSB/J. There is a high prevalence of reported SSB/J consumption in low-income Hispanic households, and Hispanic mothers are more likely to incorporate sweet foods during weaning. Because evidence suggests that obese Hispanic children are responsive to SSB/J reduction and substitution with non-caloric beverages, this may be a potential strategy for Hispanic mothers that may also be beneficial for their infants.

This study will be conducted in collaboration with Antelope Valley Partners for Health, who will deliver a home visitation program intervention once a week for 24 months. Two-hundred-and-forty overweight/obese Hispanic mothers and their infants will be recruited. They will be randomly assigned to: group 1, a standard home visitation program only; group 2, a standard home visitation program that incorporates sugar reduction; and group 3, a standard home visitation program that incorporates sugar reduction with home water delivery. The main outcomes are maternal BMI and infant weight-for-length growth. We will also assess maternal and infant diet using 24-hour recalls, and maternal feeding style and infant eating behaviors using questionnaires. Linear mixed effects models will be used to compare changes between the intervention groups in maternal BMI and infant weight-for-length.


Clinical Trial Description

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Study Design


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