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Clinical Trials/NCT02893319
NCT02893319
Completed
Not Applicable

Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)

Leann Birch0 sites115 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal Behavior
Sponsor
Leann Birch
Enrollment
115
Primary Endpoint
Change in Infant Weight-for-Age Z-score over time by group
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Rapid growth early in infancy is a risk factor for obesity and cardiovascular disease later in the lifespan. Evidence is limited, but both pre- and postnatal factors are associated with early rapid growth, and include high maternal BMI prior to pregnancy and excessive gestational weight gain. This research focuses on aspects of early feeding as potentially modifiable factor affecting early infant weight gain. Formula feeding mothers are randomized to receive either 5 oz of 8 oz bottles to use in feeding their infants from 2- to 16 weeks postpartum. In addition, a reference group of exclusively breastfeeding mother-infant dyads are also included. The hypothesis is that differences in feeding practices will be associated with differences in growth and that infants randomized to be fed from smaller bottles will grow more slowly that those randomized to larger bottles. Growth patterns of formula fed infants will also be compared to those of exclusively breastfed infants.

Detailed Description

Mothers complete feeding logs, questionnaires on health history, demographics, feeding attitudes and practices. Infant growth and body composition are measured via PEA POD, and maternal anthropometrics and body composition are measured in BOD POD the laboratory at 2, 8, and 16 weeks postpartum. Primary outcome is change in weight-for-age z-scores.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
July 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Leann Birch
Responsible Party
Sponsor Investigator
Principal Investigator

Leann Birch

William P. Flatt Professor

University of Georgia

Eligibility Criteria

Inclusion Criteria

  • pregnant or newborn aged 28 days or younger

Exclusion Criteria

  • gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

Outcomes

Primary Outcomes

Change in Infant Weight-for-Age Z-score over time by group

Time Frame: 2, 8 and 16 weeks of age

Infant weight (kg) (PEA POD scale) will be measured at each of three time points (2, 8, 16 weeks of age). Weight-for-Age Z-score (WAZ) will be calculated based on World Health Organization Global Database on Child Growth, means will be calculated and compared.

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