Maternal and Infant Growth Study (RIF)

Leann Birch

Status: Completed

Conditions: Maternal Behavior; Infant Behavior; Body Weight

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02893319

2013102510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pregnant or newborn aged 28 days or younger

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 3 patient groups

Breastfeeding

No Intervention group

Description:

control group

5 oz bottle

Active Comparator group

Description:

Subject will feed infant with 5oz medela bottle

Treatment:

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

8 oz bottle

Active Comparator group

Description:

Subject will feed infant with 8oz medela bottle

Treatment:

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