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- Essai clinique NCT01146314
A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children (FBI)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type 2 diabetes (DM2), and obesity is increasing dramatically in the United States and worldwide among children. Even before children are diagnosed with DM2, they often show signs such as being overweight, having high blood pressure, abnormal lipid metabolism, and impaired glucose tolerance that put them at risk for other diseases, such as heart disease. In addition, children who are at risk for DM2 also face elevated risks of other major medical complications along with psychological and social consequences (e.g., depression, teasing, discrimination, school problems), which can often be just as damaging as the medical problems. Since obesity plays an important role in the progression to DM2, the need to prevent children from progressing to a diagnosis of DM2 is critical.
The proposed study was a randomized controlled trial comparing an education group for families of children at high risk for progression to metabolic syndrome and type 2 diabetes with a family-focused multi-component lifestyle intervention. The study addressed these specific aims:
- Evaluated the effects of a family-focused lifestyle intervention on the health status of children at risk of metabolic syndrome (BMI, blood pressure, cholesterol, impaired glucose tolerance, waist circumference).
- Evaluated the effects of a family focused psychosocial treatment on the health behaviors of children at risk for developing metabolic syndrome (eating behaviors, physical activity).
- Evaluated the effects of a family focused psychosocial treatment on psychological outcomes of children at risk of developing metabolic syndrome (overall behavioral functioning, perception, self esteem, depression, quality of life).
- Analyzed variables that are predictive of maintenance or termination of engagement in the family-focused lifestyle intervention.
It was hypothesized that this intervention approach will result in: a) improved health status and a reduction of risk for developing metabolic syndrome (BMI, waist circumference, blood pressure, cholesterol, and glucose levels), b) improved health behaviors (physical activity, diet), and c) generalize to more optimal psychosocial functioning (depression, self-perception, quality of life, school attendance) at short and long-term follow-up of the children in the intervention group compared with children in the education group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Florida
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Jacksonville, Florida, États-Unis, 32207
- Nemours Children's Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- BMI 85th percentile and above, otherwise healthy
- Age between 8-11 years old
Exclusion Criteria:
- Diagnosis of metabolic syndrome
- Diagnosis of type 2 diabetes
- Diagnosis of Mental Retardation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Lifestyle intervention
A 6-month 14 session lifestyle intervention led by a psychologist and a dietitian for 90 minutes group sessions.
Intervention sessions were help weekly, biweekly, and monthly over the course of 6 months.
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The lifestyle intervention is a 6-month intervention study lasting 6 months.
The intervention is 14 sessions and conducted by a dietician and psychologist in a group setting with each intervention session lasting 90 minutes.
The sessions are conducted weekly, biweekly, and monthly over the course of 6 months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Improvement of health status of overweight children
Délai: Measured at 6 and 12 months
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Evaluated the effects of the intervention on improving BMI, blood pressure, waist circumference, and reducing the risk of the development of type 2 diabetes and metabolic syndrome.
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Measured at 6 and 12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Improvement of health behaviors and psychosocial adjustment
Délai: Measured at 6 and 12 months
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Evaluated the effects of the intervention on changing health behaviors, such as eating patterns, diet, and eating behavior, and evaluate the effects of maintaining of improving adjustment to psychological stressors associated with being overweight (self esteem, depression, behavior).
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Measured at 6 and 12 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Amanda S Lochrie, PhD, Nemours Children's Clinic
Publications et liens utiles
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 18-06038-001
- 1-06-JF-33 (Autre subvention/numéro de financement: American Diabetes Association)
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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