Breastfeeding in Infancy and Food Intake in Preschool-Aged Children - NCT00994487-37996 (Clinical Trial 369048)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy369048.aspx
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| City: |
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Knoxville |
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State:
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TN |
| Zip Code: |
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37996 |
| Conditions: |
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Childhood Obesity - Breastfeeding |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of Tennessee
Knoxville, TN 37996
United States
Primary Contact:
Hollie A Raynor, PhD
Email: hraynor@utk.edu
Phone: 865-974-6259
Secondary Contact:
Hollie A Raynor, PhD
Email: hraynor@utk.edu
Phone: 865-974-6259 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 17, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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