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Breastfeeding in Infancy and Food Intake in Preschool-Aged Children

Primary Purpose

Childhood Obesity, Breastfeeding

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Energy Density Preload
Low Energy Density Preload
Sponsored by
The University of Tennessee, Knoxville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Childhood Obesity focused on measuring Childhood Obesity, Breastfeeding, Bottle Feeding, Dietary Intake, Preload, Compensation, Parental Feeding Style

Eligibility Criteria

3 Years - 5 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

  • University of Tennessee

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Breastfed child

Bottle Fed Child

Arm Description

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

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

Outcomes

Primary Outcome Measures

Compensation for high energy density and low energy density preloads

Secondary Outcome Measures

Parental feeding style

Full Information

First Posted
October 12, 2009
Last Updated
April 3, 2018
Sponsor
The University of Tennessee, Knoxville
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1. Study Identification

Unique Protocol Identification Number
NCT00994487
Brief Title
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
Official Title
Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Research reports that children who were breastfed as infants have a decreased risk of becoming obese. However, it is not clear how breastfeeding may prevent the development of obesity. Breastfeeding may support the maintenance of sensitivity to internal hunger/fullness cues, which helps with self-regulating energy intake. Additionally, breastfeeding may facilitate the development of a parental feeding style low in control or restriction. This type of feeding style is also associated with greater ability to self-regulate energy intake. Bottle-feeding shifts feeding control to parents, and may lead to a parental feeding style high in control or restriction, impairing children's self-regulation abilities. The aims of this study are to determine in females aged 3-5 years if: 1.) breastfed children have greater energy self- regulation capabilities; 2.) parents of breastfed children demonstrate a parental feeding style characterized by less control or restriction; and 3.) children with the greatest energy self-regulation capabilities were breastfed and have parents with feeding styles lowest in control or restriction. It is hypothesized that female, preschool-aged children breastfed and/or parented with a feeding style low in control or restriction self-regulate intake better than females not breastfed and/or parented with a feeding style high in control or restriction. A within-subjects, counterbalanced design, using a standard preloading paradigm, will measure children's ability to self-regulate intake to preloads of differing energy densities. Children and a parent will participate in two trials, with children consuming preloads high and low in energy followed by a lunch in which energy intake is measured. Lunch will be videotaped so parental feeding style during the child's lunch can be coded for restriction and control. Results will provide information about potential mechanisms by which breastfeeding reduces the risk of obesity and obesity related diseases in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Breastfeeding
Keywords
Childhood Obesity, Breastfeeding, Bottle Feeding, Dietary Intake, Preload, Compensation, Parental Feeding Style

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breastfed child
Arm Type
Experimental
Arm Description
Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
Arm Title
Bottle Fed Child
Arm Type
Active Comparator
Arm Description
Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
Intervention Type
Other
Intervention Name(s)
High Energy Density Preload
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Low Energy Density Preload
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compensation for high energy density and low energy density preloads
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Parental feeding style
Time Frame
2 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hollie A Raynor, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katie Kavanagh, PhD
Organizational Affiliation
Univerisity of Tennessee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hiliary Fouts, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Study Chair
Facility Information:
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States

12. IPD Sharing Statement

Links:
URL
http://heal.utk.edu
Description
Website for the Healthy Eating and Activity Laboratory (HEAL) where the study is conducted

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Breastfeeding in Infancy and Food Intake in Preschool-Aged Children

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