- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01039116
Taking Action Together- A Diabetes Prevention Program (TAT)
Taking Action Together: Development, Implementation and Evaluation of Community-Based Programs That Aims to Reduce Risk of Type 2 Diabetes in High BMI African American Children.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Oakland, California, Estados Unidos, 94612
- YMCA of the East Bay, Oakland, CA 94612
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Child age of 9-10 yr old at baseline
- Child BMI at least 85th percentile when matched for age and gender
- Able and willing to participate in normal daily activities
- Living in inner-city regions of Oakland CA
Exclusion Criteria:
- Fasting blood glucose of 120 mg/dl or higher
- Diagnosis of diabetes or other central metabolic disease
- Taking medications that interfere with or treat main study outcomes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Level of intervention intensity
High Intensity: Behavioral Experimental:Participating children were invited to attend a 2 week summer day camp at the beginning of each intervention year, and to attend a weekly, 2 hr interactive session for children. Activities provided hand-on experiences preparing and tasting healthy food alternatives, engaging in a range of physical activities and self-esteem boosting via activities that promoted communication and positive behavioral development. Active Comparator: Low-intensity Participants were provided with educational materials 4 times yearly. |
High-intensity intervention, Experimental.
Participating children were invited to attend a 2 week summer day camp at the beginning of each intervention year, and to attend a weekly, 2 hr interactive session for children.
Activities provided hand-on experiences preparing and tasting healthy food alternatives, engaging in a range of physical activities and self-esteem boosting via activities that promoted communication and positive behavioral development.
Low-intensity intervention, Active comparator.
Participants were provided with educational materials 4 times yearly.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1 Year change in insulin resistance via HOMA-IR
Periodo de tiempo: Change during first year
|
Baseline HOMA-IR minus Year 1 HOMA-IR
|
Change during first year
|
|
2 year change in insulin resistance via HOMA-IR
Periodo de tiempo: Change during 2 years
|
Baseline HOMA-IR minus Year 2 HOMA-IR
|
Change during 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in dietary intakes of energy, fat, carbohydrate and selected essential nutrients. Change in minutes/day spend in moderate- and high-intensity physical activity. Improvement or stabilization of self-esteem.
Periodo de tiempo: 3years
|
3years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharon E Fleming, PhD, University of California, Berkeley
Publicaciones y enlaces útiles
Publicaciones Generales
- Raman A, Fitch MD, Hudes ML, Lustig RH, Murray CB, Ikeda JP, Fleming SE. Baseline correlates of insulin resistance in inner city high-BMI African-American children. Obesity (Silver Spring). 2008 Sep;16(9):2039-45. doi: 10.1038/oby.2008.329.
- Raman A, Lustig RH, Fitch M, Fleming SE. Accuracy of self-assessed Tanner staging against hormonal assessment of sexual maturation in overweight African-American children. J Pediatr Endocrinol Metab. 2009 Jul;22(7):609-22. doi: 10.1515/jpem.2009.22.7.609.
- Sharma S, Roberts LS, Hudes ML, Lustig RH, Fleming SE. Macronutrient intakes and cardio metabolic risk factors in high BMI African American children. Nutr Metab (Lond). 2009 Oct 13;6:41. doi: 10.1186/1743-7075-6-41.
- Raman A, Sharma S, Fitch MD, Fleming SE. Anthropometric correlates of lipoprotein profile and blood pressure in high BMI African American children. Acta Paediatr. 2010 Jun;99(6):912-9. doi: 10.1111/j.1651-2227.2009.01639.x. Epub 2010 Jan 7.
- Susan Stone,Aarthi Raman, Sharon Fleming.Behavioral characteristics among obese/overweight inner-city African American Children: A secondary analysis of participants in a community-based Type 2 diabetes risk reduction program. Children and Youth Services Review 32 (2010)833-839. doi:10.1016/j.childyouth.2010.02.002
- Sharma S, Roberts LS, Lustig RH, Fleming SE. Carbohydrate intake and cardiometabolic risk factors in high BMI African American children. Nutr Metab (Lond). 2010 Feb 9;7(1):10. doi: 10.1186/1743-7075-7-10.
- Raman A, Ritchie LD, Lustig RH, Fitch MD, Hudes ML, Fleming SE. Insulin resistance is improved in overweight African American boys but not in girls following a one-year multidisciplinary community intervention program. J Pediatr Endocrinol Metab. 2010 Jan-Feb;23(1-2):109-20. doi: 10.1515/jpem.2010.23.1-2.109.
- Ritchie LD, Sharma S, Ikeda JP, Mitchell RA, Raman A, Green BS, Hudes ML, Fleming SE. Taking Action Together: a YMCA-based protocol to prevent type-2 diabetes in high-BMI inner-city African American children. Trials. 2010 May 21;11:60. doi: 10.1186/1745-6215-11-60.
- Sharma S, Lustig RH, Fleming SE. Identifying metabolic syndrome in African American children using fasting HOMA-IR in place of glucose. Prev Chronic Dis. 2011 May;8(3):A64. Epub 2011 Apr 15.
- Fyfe M, Raman A, Sharma S, Hudes ML, Fleming SE. Insulin resistance and self-perceived scholastic competence in inner-city, overweight and obese, African American children. Physiol Behav. 2011 Jan 10;102(1):36-41. doi: 10.1016/j.physbeh.2010.09.015. Epub 2010 Sep 29.
- Sharma S, Fleming SE. One-year change in energy and macronutrient intakes of overweight and obese inner-city African American children: effect of community-based Taking Action Together type 2 diabetes prevention program. Eat Behav. 2012 Aug;13(3):271-4. doi: 10.1016/j.eatbeh.2012.03.003. Epub 2012 Mar 29.
Enlaces Útiles
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
- USDA 2004-35215-14250
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