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Completed

NCT Number: NCT02893319

Maternal and Infant Growth Study

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.

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Key information

Conditions

Maternal Behavior Behavior Body Weight Child Behavior Infant Behavior Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant or newborn aged 28 days or younger

Exclusion criteria

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

Treatment and study plan

Feeding and growth differences, 5oz vs 8oz bottle

Behavioral

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

Primary outcomes

  1. Change in Infant Weight-for-Age Z-score over time by group

    Time frame: 2, 8 and 16 weeks of age

    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.

Sponsors and collaborators

Lead sponsor

Leann Birch

Other

Registry information

Official study title

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

Acronym: RIF

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Sep 8, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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