- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01041820
Critical Periods of Exercise
Early childhood (~3-7 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence obesity risk. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure.
The interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity vs. sedentary behavior) may 'environmentally induce' alterations in body composition and predispose individuals to obesity throughout life.
Aim 1. To examine the associations between body composition via DXA and objectively-measured physical activity/inactivity.
- Hypothesis 1.1: There is a positive association between physical activity and bone mass.
Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.
Aim2. To examine the associations between adipose tissue distribution via MRI and objectively-measured physical activity/inactivity.
- Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
- Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.
Studienübersicht
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, Vereinigte Staaten, 35210
- Family Care Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- children aged 3 to 7 years
- healthy, not under the care of a doctor
- not taking medications known to alter body composition or metabolism
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Exercise group
Children will participate in a 10-week moderate to vigorous exercise program
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Children will be exposed to a 10-week exercise intervention
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Kein Eingriff: non-exercising
Participants will receive no intervention
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Association between exercise and bone marrow adipose tissue in children 3-7 years
Zeitfenster: 10 weeks of exercise
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10 weeks of exercise
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Übung
- Knochenmineraldichte
- Knochenmark -Fettgewebe
- Children in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeks
- Control treatment will be provided no intervention
- All participants will be instructed not to change their current dietary habits during the study period.
Andere Studien-ID-Nummern
- F090904001
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