NCT00994487

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

Same day

First QC Date

October 12, 2009

Last Update Submit

April 3, 2018

Conditions

Keywords

Childhood ObesityBreastfeedingBottle FeedingDietary IntakePreloadCompensationParental Feeding Style

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

EXPERIMENTAL

Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age

Other: High Energy Density PreloadOther: Low Energy Density Preload

Bottle Fed Child

ACTIVE COMPARATOR

Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age

Other: High Energy Density PreloadOther: Low Energy Density Preload

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

Bottle Fed ChildBreastfed child

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.

Bottle Fed ChildBreastfed child

Eligibility Criteria

Age3 Years - 5 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

Related Links

MeSH Terms

Conditions

Pediatric ObesityBreast FeedingBottle Feeding

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFeeding BehaviorBehavior

Study Officials

  • Hollie A Raynor, PhD

    University of Tennessee

    PRINCIPAL INVESTIGATOR
  • Katie Kavanagh, PhD

    Univerisity of Tennessee

    STUDY CHAIR
  • Hiliary Fouts, PhD

    University of Tennessee

    STUDY CHAIR

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

Locations