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Maternal and Infant Growth Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02893319
Acronym
RIF
Enrollment
115
Registered
2016-09-08
Start date
2014-06-30
Completion date
2018-07-31
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Infant Behavior, Maternal Behavior

Keywords

Infant Feeding, Infant Growth

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.

Interventions

BEHAVIORALFeeding and growth differences, 5oz vs 8oz bottle

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

Sponsors

Leann Birch
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* pregnant or newborn aged 28 days or younger

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Infant Weight-for-Age Z-score over time by group2, 8 and 16 weeks of ageInfant 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026