- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03215485
WAVE~Ripples for Change: Obesity Prevention in Active Youth
The WAVE~Ripples for Change: Obesity Prevention in Active Youth in Afterschool Programs Using Virtual- and Real-World Experiential Learning
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Active youth are just as likely to develop poor dietary habits that can contribute to obesity later in life, after high school sports has ended. However, youth in sports may provide a key "window of opportunity" to teach them about eating health foods if that information is tied to sport performance. This project will test to see if that is true.
The virtual world is an idea medium for learning for this project. The project will test whether it indeed can result in behavior change more effectively than just more traditional face to face learning.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- youth ages 14 - 19 at baseline
- enrolled in a high school soccer program
- living with a parent/caregiver in Oregon
- without medical condition that hinders them from consuming normal healthy diets
- has assess to the internet during the 2-year study
- proficient in English
Exclusion Criteria:
- non-English speakers (youth)
- prisoners
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention Group
All intervention youth participants will receive three components:
|
Face-to-face interactive group lessons delivered in the classroom.
Every participant has their own unique avatar in the virtual world learning environment named Rippleville.
They can choose to complete quests, watch archived nutrition video lessons, explore, and socialize with other avatars.
They receive rewards (Rippleville dollar and badges) for their efforts.
Autres noms:
All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
|
|
Comparateur actif: Comparison
All comparison youth participants will only receive one component: 1) Newsletters |
All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Nutrition: Meet specific good groups dietary recommendation/guideline for fruit, vegetables, fat, and sugar intakes.
Délai: Change from baseline at 12 and 24 months later
|
Intakes of fat, sugar, fruits and vegetables are measured by self-reported screener using the Block Food Frequency Questionnaires (FFQ).
Change in intake frequencies are compared baseline, 12 and 24 months later.
|
Change from baseline at 12 and 24 months later
|
|
Physical activity: Meet moderate to vigorous physical activity (MVPA) recommendation.
Délai: Change from baseline at 12 and 24 months later
|
MVPA is measured by total steps and minutes per day with the use of a wearable lifestyle tracker such as the Fitbit.
Average steps during soccer season and outside soccer season are compared.
|
Change from baseline at 12 and 24 months later
|
|
Sleep about 8 hours/day.
Délai: Change from baseline at 12 and 24 months later
|
Together with MVPA, sleep is measured by average number of sleep hours per day as self-reported by participants via written and/or electronic surveys .
|
Change from baseline at 12 and 24 months later
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Growth-adjusted Body Mass Index (kg/m2)
Délai: Change from baseline at 12 and 24 months later
|
Height and body weight are measured using a stadiometer (SECA 217, SECA Corp., Singapore) and a Tanita scale (TM-300A, Tanita Corp., Itabashi-Ku, Tokyo, Japan).
|
Change from baseline at 12 and 24 months later
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Siew Sun Wong, PhD, OSU
- Chercheur principal: Melinda M Manore, PhD, RD, OSU
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
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
- 6317
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
- RSE
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Prévention de l'obésité infantile
-
Wafaa Uthman AhmedAin Shams Maternity HospitalInconnueCARBETOCINE POUR LA PREVENTION DE LA RETENUE PLACENTAIREEgypte
-
Bambino Gesù Hospital and Research InstituteComplétéObésité pédiatrique sévère (IMC > 97° pc -Selon les Centers for Disease Control and Prevention BMI Charts-) | Tests de la fonction hépatique altérée | Intolérance glycémiqueItalie
Essais cliniques sur Nutrition lessons
-
Università Politecnica delle MarcheInconnueNourrisson de très faible poids à la naissanceItalie