- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00186173
Sports to Prevent Obesity: Feasibility and Pilot RCT
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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
|
Aktiv komparator: After school health education
After school heath and nutrition education program
|
After school health and nutrition education program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Body mass index
Tidsramme: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Waist circumference
Tidsramme: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Triceps skinfold thickness
Tidsramme: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Resting heart rate
Tidsramme: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Physical activity monitoring
Tidsramme: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Sedentary behaviors
Tidsramme: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Psychosocial measures
Tidsramme: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Thomas N Robinson, MD, MPH, Stanford University
- Studieleder: Dana L Weintraub, MD, Stanford University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MM-0851-05/05
- SPO#31174
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