- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00186173
Sports to Prevent Obesity: Feasibility and Pilot RCT
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- La phase 1
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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
|
Comparateur actif: After school health education
After school heath and nutrition education program
|
After school health and nutrition education program
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Body mass index
Délai: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Waist circumference
Délai: Baseline, 3 and 6 months
|
Baseline, 3 and 6 months
|
Triceps skinfold thickness
Délai: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Resting heart rate
Délai: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Physical activity monitoring
Délai: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Sedentary behaviors
Délai: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Psychosocial measures
Délai: baseline, 3 and 6 months
|
baseline, 3 and 6 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Thomas N Robinson, MD, MPH, Stanford University
- Directeur d'études: Dana L Weintraub, MD, Stanford University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MM-0851-05/05
- SPO#31174
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