Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
1 other identifier
interventional
7
1 country
1
Brief Summary
The purpose of this study is to compare female, preschool-aged children breastfed during infancy to female, preschool-aged children bottle-fed during infancy in their ability to adjust calorie intake in response to internal signals of hunger and fullness. Children and a parent will come to two sessions, with the children given drinks that are either high or low in energy, and then consume a lunch following the drink. The parent will be present during the lunch. Greater ability to self-regulate intake is demonstrated when less energy is consumed at lunch following the high energy drink as compared to the lunch following the low energy drink. Lunches will be videotaped so that parental feeding styles (i.e., how the parent interacted with the child during lunch) can be examined. The primary hypotheses are: 1.) the exclusively breastfed children will have higher self-regulation ability than the exclusively bottle-fed children, and 2.) the mothers of the exclusively breastfed children will demonstrate a parental feeding style characterized by less control and restriction than the mothers (or parent primarily responsible for child feeding) of the exclusively bottle-fed children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 5, 2018
April 1, 2018
Same day
October 12, 2009
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compensation for high energy density and low energy density preloads
2 days
Secondary Outcomes (1)
Parental feeding style
2 days
Study Arms (2)
Breastfed child
EXPERIMENTALFemale, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
Bottle Fed Child
ACTIVE COMPARATORFemale, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
Interventions
Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is high in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles
Each child with a parent will attend a lunch session. In these sessions children will drink a liquid preload that is low in energy density and then they will consume an ad libitum lunch. The ad libitum lunch will be videotaped, and the videotapes will be coded for parental feeding styles.
Eligibility Criteria
You may qualify if:
- Children will be eligible for study participation if they meet the following criteria:
- female
- BMI between the 5th and the 85th percentile
- were of normal birth weight (\>2500 g)
- full-term
- have no chronic disease conditions effecting growth and intake
- have not been in foster care for longer than one month (if at all)
- are between 3 and 5 years of age
- are willing to consume and are not allergic to the preloads and meals used in the study
- are not lactose-intolerant
- have a parent who is able to recall mode of feeding in infancy and was either exclusively breast-fed from birth to 3 months of age (defined as being fed from a bottle on average \< 1 time per week from birth to 3 months of age, with all other feedings from the breast) or was exclusively bottle-fed from birth to 3 months of age (defined as being completely bottle-fed, with feedings comprised of formula and/or breastmilk)
- have a parent willing to transport child to the University of Tennessee lab at two different times during their participation in the project
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee
Knoxville, Tennessee, 37996, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hollie A Raynor, PhD
University of Tennessee
- STUDY CHAIR
Katie Kavanagh, PhD
Univerisity of Tennessee
- STUDY CHAIR
Hiliary Fouts, PhD
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 12, 2009
First Posted
October 14, 2009
Study Start
June 1, 2010
Primary Completion
June 1, 2010
Study Completion
July 1, 2010
Last Updated
April 5, 2018
Record last verified: 2018-04