- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00994487
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Tennessee
-
Knoxville, Tennessee, Förenta staterna, 37996
- University of Tennessee
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Breastfed child
Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
|
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
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.
|
Aktiv komparator: Bottle Fed Child
Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
|
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
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Compensation for high energy density and low energy density preloads
Tidsram: 2 days
|
2 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Parental feeding style
Tidsram: 2 days
|
2 days
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Hollie A Raynor, PhD, University of Tennessee
- Studiestol: Katie Kavanagh, PhD, Univerisity of Tennessee
- Studiestol: Hiliary Fouts, PhD, University of Tennessee
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 7828B
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