Maternal and Infant Growth Study

NCT ID: NCT02893319

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-07-31

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.

Conditions

Maternal Behavior; Body Weight; Infant Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Breastfeeding

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

5 oz bottle

Subject will feed infant with 5oz medela bottle

Group Type: ACTIVE_COMPARATOR

Feeding and growth differences, 5oz vs 8oz bottle

Intervention Type: BEHAVIORAL

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

8 oz bottle

Subject will feed infant with 8oz medela bottle

Group Type: ACTIVE_COMPARATOR

Feeding and growth differences, 5oz vs 8oz bottle

Intervention Type: BEHAVIORAL

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

Interventions

Feeding and growth differences, 5oz vs 8oz bottle

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Leann Birch

OTHER

Sponsor Role: lead

Responsible Party

Leann Birch

William P. Flatt Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Leann L Birch, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Georgia

Other Identifiers

2013102510

Identifier Type: -

Identifier Source: org_study_id