Maternal and Infant Growth Study (RIF)
Primary Purpose
Maternal Behavior, Body Weight, Infant Behavior
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Feeding and growth differences, 5oz vs 8oz bottle
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Behavior focused on measuring Infant Feeding, Infant Growth
Eligibility Criteria
Inclusion Criteria:
- pregnant or newborn aged 28 days or younger
Exclusion Criteria:
- gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Breastfeeding
5 oz bottle
8 oz bottle
Arm Description
control group
Subject will feed infant with 5oz medela bottle
Subject will feed infant with 8oz medela bottle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02893319
Brief Title
Maternal and Infant Growth Study
Acronym
RIF
Official Title
Role of Infant Feeding, Childhood Food Habits and Early Childhood Adiposity (RIF)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leann Birch
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Behavior, Body Weight, Infant Behavior
Keywords
Infant Feeding, Infant Growth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breastfeeding
Arm Type
No Intervention
Arm Description
control group
Arm Title
5 oz bottle
Arm Type
Active Comparator
Arm Description
Subject will feed infant with 5oz medela bottle
Arm Title
8 oz bottle
Arm Type
Active Comparator
Arm Description
Subject will feed infant with 8oz medela bottle
Intervention Type
Behavioral
Intervention Name(s)
Feeding and growth differences, 5oz vs 8oz bottle
Intervention Description
Group A: 5oz bottle Group B: 8oz bottle
Primary Outcome Measure Information:
Title
Change in Infant Weight-for-Age Z-score over time by group
Description
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.
Time Frame
2, 8 and 16 weeks of age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pregnant or newborn aged 28 days or younger
Exclusion Criteria:
gestational diabetes, hypertension, pregnancy/delivery complications, premature birth, low birth weight
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leann L Birch, PhD
Organizational Affiliation
The University of Georgia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data is de-identified.
Learn more about this trial
Maternal and Infant Growth Study
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