Maternal and Infant Growth Study (RIF)

October 9, 2018 updated by: Leann Birch

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant or newborn aged 28 days or younger

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2, 8 and 16 weeks of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leann Birch

Investigators

  • Principal Investigator: Leann L Birch, PhD, The University of Georgia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013102510

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data is de-identified.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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