Maternal and Infant Growth Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Behavior, Body Weight, Infant Behavior

Intervention / Treatment
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* Behavioral: Feeding and growth differences, 5oz vs 8oz bottle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant or newborn aged 28 days or younger Exclusion Criteria: gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breastfeeding<br>control group | |
| Active Comparator: 5 oz bottle<br>Subject will feed infant with 5oz medela bottle | Behavioral: Feeding and growth differences, 5oz vs 8oz bottle<br>* Group A: 5oz bottle Group B: 8oz bottle<br>|
| Active Comparator: 8 oz bottle<br>Subject will feed infant with 8oz medela bottle | Behavioral: Feeding and growth differences, 5oz vs 8oz bottle<br>* Group A: 5oz bottle Group B: 8oz bottle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant Feeding, Infant Growth