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| Sponsor: | University of Tennessee |
|---|---|
| Information provided by: | University of Tennessee |
| ClinicalTrials.gov Identifier: | NCT00994487 |
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: | Basic Science, Non-Randomized, Single Blind (Subject), Active Control, Crossover Assignment |
| Official Title: | Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children |
| Estimated Enrollment: | 52 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 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.
|
|
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 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.
|
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 |
Inclusion Criteria:
Children will be eligible for study participation if they meet the following criteria:
Contacts and Locations| Contact: Hollie A Raynor, PhD | 865-974-6259 | hraynor@utk.edu |
| Contact: Elizabeth T Anderson, MS | 865-974-0752 | eander24@utk.edu |
| United States, Tennessee | |
| University of Tennessee | Recruiting |
| Knoxville, Tennessee, United States, 37996 | |
| Contact: Hollie A Raynor, PhD 865-974-6259 hraynor@utk.edu | |
| 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
| Responsible Party: | University of Tennessee ( Hollie Raynor, PhD, RD ) |
| Study ID Numbers: | 7828B |
| Study First Received: | October 12, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00994487 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Childhood Obesity Breastfeeding Bottle Feeding Dietary Intake |
Preload Compensation Parental Feeding Style |
|
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
