Overview

This trial is active, not recruiting.

Conditions maternal behavior, body weight, infant behavior
Treatment feeding and growth differences, 5oz vs 8oz bottle
Sponsor Leann Birch
Start date June 2014
End date July 2016
Trial size 115 participants
Trial identifier NCT02893319, 2013102510

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(No Intervention)
control group
(Active Comparator)
Subject will feed infant with 5oz medela bottle
feeding and growth differences, 5oz vs 8oz bottle
Group A: 5oz bottle Group B: 8oz bottle
(Active Comparator)
Subject will feed infant with 8oz medela bottle
feeding and growth differences, 5oz vs 8oz bottle
Group A: 5oz bottle Group B: 8oz bottle

Primary Outcomes

Measure
Infant Weight-for-Age Z-score over time by group
time frame: 2, 8 and 16 weeks of age

Eligibility Criteria

Female participants from 18 years up to 45 years old.

Inclusion Criteria: - pregnant or newborn aged 28 days or younger Exclusion Criteria: - gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

Additional Information

Official title Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)
Principal investigator Leann L Birch, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Georgia.