Trial record 5 of 222 for:    (childhood OR child) AND (female OR girl) AND obesity NOT (male OR men)

Breastfeeding in Infancy and Food Intake in Preschool-Aged Children

This study has suspended participant recruitment.
(Study was suspended due to difficulty recruiting eligible subjects.)
Sponsor:
Information provided by:
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00994487
First received: October 12, 2009
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Childhood Obesity
Breastfeeding
Other: High Energy Density Preload
Other: Low Energy Density Preload

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Compensation for high energy density and low energy density preloads [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parental feeding style [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: June 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Breastfed child
Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
Other: High Energy Density Preload
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
Other: Low Energy Density Preload
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.
Active Comparator: Bottle Fed Child
Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
Other: High Energy Density Preload
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
Other: Low Energy Density Preload
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994487

Locations
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37996
Sponsors and Collaborators
University of Tennessee
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Hollie Raynor, PhD, RD, University of Tennessee
ClinicalTrials.gov Identifier: NCT00994487     History of Changes
Other Study ID Numbers: 7828B
Study First Received: October 12, 2009
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Tennessee:
Childhood Obesity
Breastfeeding
Bottle Feeding
Dietary Intake
Preload
Compensation
Parental Feeding Style

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014