Maternal and Infant Growth Study

Body Weight Clinical Trial

— RIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893319
• Other study ID #: 2013102510
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: July 2018

Study information

• Verified date: October 2018
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant or newborn aged 28 days or younger

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Body Weight
• Infant Behavior
• Maternal Behavior

Intervention

Behavioral:
• Feeding and growth differences, 5oz vs 8oz bottle
Group A: 5oz bottle Group B: 8oz bottle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leann Birch

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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