- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03022474
Kindergarten-based Intervention for Childhood Obesity in Guangzhou(KICOG) (KICOG)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The intervention protocol was developed by an expert group from the National Children Obesity Intervention Team, comprising pediatricians, children healthcare doctors, preschool teachers, and nutritionists, and included three integrated components:
Component 1 - training of kindergarten staff: Before the start of the program, two members of the intervention team (a dietitian and a physician) delivered eight 40-min sessions (twice a week for a month) on dietary management in children and daily food purchasing for school doctors and kitchen staff. During the trial, two health education doctors gave lectures every two months on general knowledge in nutrition to all preschool staff, focusing on the promotion of healthy food and restriction of unhealthy food. To assess the effectiveness of these lectures, we administered a questionnaire on the material covered. We also trained the kitchen staff to use the dietary software to plan menu with balanced nutrition for preschool children.
Component 2 - a curriculum promoting healthy diet and lifestyle: We designed a health education curriculum and associated picture books for the children. Children in the intervention group received a 20-minute health education lesson every week, where they had learning activities and games covering healthy food choice, appropriate portion sizes and eating pace, and reduction of sedentary behaviours. Learning aids such as colourful picture books or cards, food models, nursery rhymes and stories were used. Two elements were introduce to increase children's activity such as lunchtime activity and daily dance at less than 10 minutes during break.
Component 3 - collaboration between families and kindergartens: We organized lectures designed for parents every two months during the intervention period. Topics covered included the cause and harms of childhood obesity, advice on healthy diet (increasing consumption of vegetables and fruits, reducing consumption of meat, snacks, fast foods, and eating out, and avoiding sugary drinks), body mass index (BMI) reference for preschool-age children, and how to use growth curves. We produced a handbook for communication between families and schools, to be handed out to every family weekly, in which children's health behaviours were documented and reviewed by teachers and parents. Finally, parents were notified of their children's anthropometric measurements every three months, so that they could plot and interpret their children's growth curves.
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:
(i) run by the government (public kindergarten); (ii) located in the central area of the district; (iii) had no less than 100 students; (iv)had no less than two school doctors.
Exclusion Criteria:
- None
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 |
---|---|
Aucune intervention: Groupe de contrôle
|
|
Expérimental: Groupe d'intervention
|
The program included three major components.
The first component consists of live lectures to kindergarten staff about basic nutrition and food concepts that attempted to correct false beliefs.
The second component was a health curriculum for children that focused on promoting healthy nutrition habits and a healthy living style.
Preschools were required to ensure that children received a health education lesson every two weeks.
The third component was aimed at educating parents and consisted of lectures every two months, preschool-home communication every week and child growth monitoring every three months.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Body mass index (BMI) change
Délai: BMI was measured at baseline and one year after intervention
|
BMI was measured at baseline and one year after intervention
|
BMI Z-score change
Délai: BMI Z-score was measured and calculated at baseline and one year after intervention
|
BMI Z-score was measured and calculated at baseline and one year after intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Feasibility and acceptability of the intervention
Délai: During intervention
|
Qualitatively describe
|
During intervention
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Xiu Qiu, Doctor, Guangzhou Women and Children's Medical Center, China
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- 20121A011070
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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 Healthy Lifestyles Intervention
-
Karolinska InstitutetSwedish Council for Working Life and Social Research; The Kamprad Family Foundation...ComplétéActivité physique | Relations parents-enfants | Habitudes alimentaires | Surpoids et obésité | La préventionSuède
-
University of Texas at AustinUniversity of Maryland; The University of Texas Health Science Center at San... et autres collaborateursActif, ne recrute pasObésité | Activité physique | Perte de poids | Pauvre nutritionÉtats-Unis
-
Baylor College of MedicineComplété
-
The University of Texas at ArlingtonUniversity of South Florida; Center for Transportation, Equity, Decisions...ComplétéManque de ressources | Manque de mobilitéÉtats-Unis
-
Oklahoma State University Center for Health SciencesUniversity of Oklahoma; Osage NationActif, ne recrute pasPression artérielle | Insécurité alimentaire | Surpoids ou obésité | Régime alimentaire, santé | État de santéÉtats-Unis
-
University of Wisconsin, MadisonRecrutement
-
Washington University School of MedicineOperation Food Search Inc.RecrutementNaissance prématurée | Poids à la naissance | Dépression postpartum | Complications fœtales | Utilisation des soins de santé | Privation alimentaire | Problèmes de logement | Carence nutritionnelle due à une alimentation insuffisanteÉtats-Unis
-
Tufts UniversityComplétéQualité de vie | Obésité | En surpoidsÉtats-Unis
-
University of Kansas Medical CenterNational Institute of Nursing Research (NINR)ComplétéPerte de poidsÉtats-Unis
-
University of Wisconsin, MadisonComplétéLa détresse psychologique | Solitude | Dépression, AnxiétéÉtats-Unis