- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00186173
Sports to Prevent Obesity: Feasibility and Pilot RCT
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
After school sports programs may be generalizable, motivating and cost-efficient interventions for long-term weight control among at-risk and overweight children. The infrastructure needed to provide such programs already exists in most communities. In contrast, more traditional, medically- and behaviorally-oriented treatment programs are expensive, generally not very effective, often inconvenient, and not available in most communities. While children involved in team sports tend to be more physically fit than their uninvolved peers, team sports has not yet been tested as a method to increase involvement of at-risk and overweight children in regular physical activity. As an added bonus, these sports programs can displace typical after school television viewing and snacking. Team sports is a potentially innovative and high impact approach for intervening with at-risk and overweight children, as it may provide an opportunity to reduce weight gain while increasing social interaction and self-esteem. If our proposed research finds that team sports are an efficacious intervention for reducing weight gain among low-income at-risk and overweight children, it is an intervention approach that could be rapidly diffused and tested for effectiveness. The policy implications of these findings would be great, encouraging expanded access to team sports programs to a population that has not been previously targeted or included.
We propose a two-phase project in East Palo Alto, California, a low-income, primarily Latino, African-American and Pacific Islander community. The first phase will be a 3-month feasibility trial of an after school team sports program for overweight children to examine several theory-driven approaches to program design and implementation, including assessments of liking and participation and barriers and facilitators of participation. The second phase will be a 6-month randomized controlled pilot trial (RCT) comparing weight changes among overweight children randomized to participate in the after school team sports program versus a traditional weight control/health education program.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
- Phase 1
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- In 4th or 5th grade of a participating school at time of enrollment
- BMI greater than or equal to the 85th percentile on the 2000 CDC growth charts
- Medical clearance obtained from primary care provider
Exclusion Criteria:
Our goal is to be inclusive as possible, however, children will not be eligible to participate if they:
- have a condition that limits their participation in physical activity enough that they are not able to participate in Physical Education at school (e.g. significant structural heart disease)
- are pregnant
- have been diagnosed with a chronic illness that affects their growth and/or weight (e.g., type 1 diabetes, hypothyroidism, inflammatory bowel disease)
- have taken systemic steroids (oral, intravenous, or intramuscular) for a period of more than 21 days in the past year
- are taking other medications potentially affecting their growth and/or weight (e.g. methylphenidate HCL)
- are unable to complete the informed consent process
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: After school sports
After school team sports intervention designed specifically for overweight and obese children
|
After school team sports intervention designed specifically for overweight and obese children
|
Aktiver Komparator: After school health education
After school heath and nutrition education program
|
After school health and nutrition education program
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Body mass index
Zeitfenster: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Waist circumference
Zeitfenster: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Triceps skinfold thickness
Zeitfenster: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Resting heart rate
Zeitfenster: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Physical activity monitoring
Zeitfenster: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Sedentary behaviors
Zeitfenster: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Psychosocial measures
Zeitfenster: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Thomas N Robinson, MD, MPH, Stanford University
- Studienleiter: Dana L Weintraub, MD, Stanford University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
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
- MM-0851-05/05
- SPO#31174
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur After school sports program
-
The University of QueenslandRestorative Outcomes Australia; Department of Education, Queensland; Queensland... und andere MitarbeiterUnbekanntUnsoziales Verhalten | Schulbesuch | SozialhilfeabhängigkeitAustralien
-
Human Development Research Foundation, PakistanNational Institute of Mental Health (NIMH); University of Washington; World Health... und andere MitarbeiterAbgeschlossenVerhaltenssymptome | Emotionale Störung | ADHS | Verhaltensstörung | Emotionaler Stress | Depressionen, Angst | Emotionales Problem | Verhaltensproblem | Emotionales TraumaPakistan