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Preschool Based Obesity Prevention Effectiveness Trial

4 mai 2016 mis à jour par: National Heart, Lung, and Blood Institute (NHLBI)
The purpose of this study is to compare changes in body mass index (BMI) among 3- to 5-year-old minority children randomized to a weight control intervention (WCI) or a general health control intervention.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

BACKGROUND:

Obesity is epidemic in the U.S. and is associated with increased risk for numerous medical problems. Many obesity-related risk factors are strikingly apparent in minority populations. Ethnic differences in obesity related risk factors begin as early as six to nine years of age. Thus, the need for overweight prevention efforts as early as the preschool years is critical.

This study builds upon the findings of the "Hip-Hop to Health" program. The primary aim of Hip-Hop was to compare changes in body mass index (BMI [kg/m2]) in two groups of 3- to 5-year-old minority children randomized to a Weight Control Intervention (WCI) or a General Health Control Intervention (GHI). Results for the children at the Year 1 and 2 follow-ups showed that children in the WCI had significantly smaller relative changes in BMI compared to children in the GHI control group. The success was among the schools that served predominantly Black children. Hip-Hop to Health was an efficacy trial delivered by trained specialists in early childhood education, and the first efficacy trial to document change in BMI in preschool children.

DESIGN NARRATIVE:

This study will test a 14-week teacher-delivered weight control intervention (TD-WCI) to a 14-week teacher delivered general health control intervention (TD-GHI) in a randomized community trial occurring in 16 preschools in the Chicago School District. The study has the following aims: 1) to compare children in these two conditions on changes in BMI post intervention and at Year 1 follow-up; 2) to compare children in these two conditions on changes in television viewing, physical activity, and fat, fiber, fruit and vegetable intake at post-intervention and Year 1 follow-up; and 3) to compare classroom teachers in these two conditions on nutrition and exercise knowledge, nutrition attitudes, and support for healthy eating post-intervention and Year 1 follow-up.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Type d'étude

Interventionnel

Inscription (Anticipé)

648

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

3 ans à 5 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Have received an annual physical
  • Parent or guardian willing to give informed consent
  • Parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child

Exclusion Criteria:

  • Requires a specialized diet outside of that served by the Chicago Public Schools
  • Has a chronic physical or behavioral disorder that requires participant to be under close medical psychological supervision and routinely absent from the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 1
Teacher-Delivered Weight Control Intervention
Comportemental: Teacher-Delivered Weight Control Intervention
The teacher-delivered weight control intervention (TD-WCI) is implemented over 14 weeks with three lessons per week. Many lessons include the use of colorful, friendly, hand-made puppets that represent the seven food groups of the food pyramid (Miss Grain, Miss Fruit, Mr. Vegetable, Mr. Protein, Miss Dairy, Mr. Fat and Miss Sugar). Please see Appendix IX for complete curriculum and pictures of puppets. There are three 40-minute lessons per week that consist of a 15-20 minutes interactive healthy eating and exercise didactic session and then 20 minutes of ongoing physical activity (5 minutes warm-up, 15 minutes aerobic activity composed of a number of games and dances with music, 5 minutes cool-down). In addition to the child-based curriculum the WCI has parent newsletters. These newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum
Autre: 2
Teacher-Delivered General Health Intervention
Comportemental: Teacher-Delivered General Health Intervention
The teacher-delivered general health intervention (TD-GHI) serves as the control group in the proposed study. TD-GHI is a general health intervention that is similar in structure and length to TD-WCI. Topics include those related to general health and safety, such as car safety, being a good friend, poison safety, disease prevention, etc. An example of an activity is the 911 emergency call. The children learn what 911 is and what would be an appropriate call. They then practice calling 911 on play telephones and relating the important information: nature of the emergency, their name, their address, etc. They learn also to stay on the phone with the 911 dispatcher until someone comes to help them. In addition to the child-based curriculum the GHI has parent newsletters. Like TD-WCI these newsletters are distributed on a weekly basis and provide information that parallels the children's curriculum

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Body height and weight
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Healthy Start Knowledge Quiz
Délai: Sept 2006- May 2009
Sept 2006- May 2009
24-hour diet observation and recall
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Physical activity
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit)
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit)
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Nutrition and exercise knowledge
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Self-efficacy for eating and exercise behaviors
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Score on Nutrition Attitudes Scale
Délai: Sept 2006- May 2009
Sept 2006- May 2009
Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit)
Délai: Sept 2006- May 2009
Sept 2006- May 2009

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Heart, Lung, and Blood Institute (NHLBI)

Les enquêteurs

  • Chercheur principal: Marian Fitzgibbon, University of Illinois at Chicago

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2006

Achèvement primaire (Réel)

1 mai 2009

Achèvement de l'étude (Réel)

1 mai 2010

Dates d'inscription aux études

Première soumission

17 octobre 2005

Première soumission répondant aux critères de contrôle qualité

17 octobre 2005

Première publication (Estimation)

19 octobre 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

5 mai 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2016

Dernière vérification

1 décembre 2007

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 334
  • R01HL081645 (Subvention/contrat des NIH des États-Unis)

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 .

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Conditions

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