- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00994487
Breastfeeding in Infancy and Food Intake in Preschool-Aged Children
Breastfeeding, Parental Feeding Style, and Self-regulation Capabilities in Female Preschool-age Children
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37996
- University of Tennessee
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Breastfed child
Female, normal weight, 3 to 5 year old children, exclusively breastfed from birth to 3 months of age
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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.
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Comparatore attivo: Bottle Fed Child
Female, normal weight, 3 to 5 year old children, exclusively bottle fed from birth to 3 months of age
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Compensation for high energy density and low energy density preloads
Lasso di tempo: 2 days
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2 days
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Parental feeding style
Lasso di tempo: 2 days
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2 days
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Hollie A Raynor, PhD, University of Tennessee
- Cattedra di studio: Katie Kavanagh, PhD, Univerisity of Tennessee
- Cattedra di studio: Hiliary Fouts, PhD, University of Tennessee
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
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Maggiori informazioni
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Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 7828B
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