- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01674920
CHOICES: Family Physicians Treat Overweight Children (CHOICES)
Descripción general del estudio
Descripción detallada
The specific aim of this pilot study was to use the group office visit model to provide an obesity treatment intervention for children 8-11 years of age in gender-specific groups and their parents in a clinic setting. The targeted lifestyle components of the intervention are less TV viewing, less sweetened beverages, smaller food portions, less fast food/better choices away from home and more general physical activity. The psychosocial component was based in Resiliency; the Choices model focused on a non-judgmental approach to empowerment in relation to personal goals and knowledge of the basics of nutrition and physical activity.
Our aim was to recruit 35-40 children (approximately equal boys and girls) ages 8-11 and their parents for a 12 weekly sessions group office visit program. Participants were randomized into 2 groups; one group starting in March 2006 and the lagged intervention control group starting in September 2006. Physical measurements and data collection were at baseline, 4, 8, 12, 16 months from randomization.
We evaluated the acceptability and feasibility of the group office visit model and effect size (body mass index (BMI) and weight-for-age Z-scores). Feasibility and acceptability included ability to recruit within clinics, attendance, completion, follow-up rates, focus groups data and interviews of those who drop out. Evaluation of effect size included the patterns of growth over 15 months from baseline in relation to expected growth patterns and intervention exposure.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Arizona
-
Tucson, Arizona, Estados Unidos, 85724
- University of Arizona
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children in the 3rd to 5th grades and above the 85th percentile of BMI for age.
Exclusion Criteria:
- Conditions that would preclude dietary change or physical activity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Choices
The 3-month twelve-session intervention, "Choices", included topics on nutrition, physical activity, and resiliency.
Parents, boys and girls met separately.
The sessions were developed for delivery by a family physician, two family medicine residents, and a nutritionist, who received training in positive psychology and resilience skills.
All children were measured on the same dates, but children were randomly assigned to two cohorts, beginning 6 months apart, to facilitate statistical analysis by having one group experience "normal growth" on study prior to intervention.
|
The 12-week intervention included 1.5 hour classes each week.
Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
body mass index age-and-gender specific Z-score
Periodo de tiempo: 9 months post intervention baseline
|
body mass index is weight over height squared; z-score described the position of that BMI in relation to the reference population in terms of standard deviation units.
It is used to control for growth effects in children.
|
9 months post intervention baseline
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
weight for age-and-gender specific Z-score
Periodo de tiempo: 9 months post-intervention baseline
|
9 months post-intervention baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cheryl K Ritenbaugh, PhD, MPH, University of Arizona
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R21HD050962 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .