Maternal and Infant Growth Study

NCT02893319 | Completed

• 1 other identifier: 2013102510
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Maternal Behavior; Body Weight; Infant Behavior

Keywords

Infant Feeding; Infant Growth

Outcome Measures

Primary Outcomes (1)

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

  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.

  2, 8 and 16 weeks of age

Study Arms (3)

Breastfeeding

NO INTERVENTION

control group

5 oz bottle

ACTIVE COMPARATOR

Subject will feed infant with 5oz medela bottle

Behavioral: Feeding and growth differences, 5oz vs 8oz bottle

8 oz bottle

ACTIVE COMPARATOR

Subject will feed infant with 8oz medela bottle

Behavioral: Feeding and growth differences, 5oz vs 8oz bottle

Interventions

Feeding and growth differences, 5oz vs 8oz bottle BEHAVIORAL

Group A: 5oz bottle Group B: 8oz bottle

5 oz bottle; 8 oz bottle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant or newborn aged 28 days or younger

You may not qualify if:

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

Sponsors & Collaborators

• Leann Birch: lead

MeSH Terms

Conditions

Body Weight; Infant Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Child Behavior; Behavior

Study Officials

• Leann L Birch, PhD

  The University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: William P. Flatt Professor

Study Record Dates

• First Submitted: August 24, 2016
• First Posted: September 8, 2016
• Study Start: June 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share