search
Back to results

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
Leann Birch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Behavior focused on measuring Infant Feeding, Infant Growth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    August 24, 2016
    Last Updated
    October 9, 2018
    Sponsor
    Leann Birch
    search

    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

    We'll reach out to this number within 24 hrs