- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00746083
Challenge!, a Health Promotion/ Obesity Prevention Program for Teens
Randomized Controlled Trial for Health Promotion/ Obesity Prevention Targeting Low-income, Urban, African-American Adolescents
Studienübersicht
Detaillierte Beschreibung
Pediatric overweight is a major public health problem in the US, with the prevalence of overweight among children of all ages increasing dramatically over the past several decades. Interventions aimed at reducing the increased weight gain during adolescence have produced mixed results.
Challenge! is a randomized controlled trial for health promotion/ obesity prevention targeting low-income, urban, African American adolescents. Healthy adolescents were recruited from an urban medical center and from local middle schools. Weight status was not part of the inclusion criteria.
The intervention was home- and community-based and delivered one-on-one to each adolescent by a college-age "personal trainer". The intervention focused on goal-setting, consuming a healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and convenience foods), and increasing physical activity. We hypothesized that the teens enrolled in the intervention would have a healthier BMI-for-age z-score and a healthier body composition (body fat %) compared to those that did not receive the intervention over time. Additionally, we hypothesized that those enrolled in the intervention would consume healthier diets and have higher levels of physical activity compared to those that did not receive the intervention over time.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- University of Maryland School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Ages 11-16, willing to participate in a randomized controlled trial for health promotion
Exclusion Criteria:
- Outside of age range
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Kein Eingriff: Kontrollgruppe
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Experimental: Interventionsgruppe
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Each adolescent in the intervention group received 12 lessons administered in adolescent's home or community by a "personal trainer" (a college-aged mentor).
The lessons focused on behavior change relating to diet and physical activity and was based on social cognitive theory.
At the end of each lesson the adolescent set a behavior change goal for themselves.
The adolescents were taught how to track their goals and they discussed thir ability/inability to meet their goals at each meeting with their personal trainer.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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BMI-for-age z-score and percentiles (measured weight and height, self-reported gender and date of birth)and Body composition (Dual Energy X-ray Absorptiometry, and Bioelectrical Impedance Analysis)
Zeitfenster: 2 years
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2 years
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Physical Activity (accelerometry and self-report) Diet (Food frequency questionnaire)
Zeitfenster: 2 years
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2 years
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Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Maureen M Black, PhD, University of Maryland School of Medicine, Department of Pediatrics, United States
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Snitker S, Le KY, Hager E, Caballero B, Black MM. Association of physical activity and body composition with insulin sensitivity in a community sample of adolescents. Arch Pediatr Adolesc Med. 2007 Jul;161(7):677-83. doi: 10.1001/archpedi.161.7.677.
- Mitola AL, Papas MA, Le K, Fusillo L, Black MM. Agreement with satisfaction in adolescent body size between female caregivers and teens from a low-income African-American community. J Pediatr Psychol. 2007 Jan-Feb;32(1):42-51. doi: 10.1093/jpepsy/jsl004. Epub 2006 Jun 8.
- Devonshire AL, Hager ER, Black MM, Diener-West M, Tilton N, Snitker S. Elevated blood pressure in adolescent girls: correlation to body size and composition. BMC Public Health. 2016 Jan 26;16:78. doi: 10.1186/s12889-016-2717-6.
- Black MM, Hager ER, Le K, Anliker J, Arteaga SS, Diclemente C, Gittelsohn J, Magder L, Papas M, Snitker S, Treuth MS, Wang Y. Challenge! Health promotion/obesity prevention mentorship model among urban, black adolescents. Pediatrics. 2010 Aug;126(2):280-8. doi: 10.1542/peds.2009-1832. Epub 2010 Jul 26.
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
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H-21033
- R40MC00241, M01 RR16500
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