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Family Partners for Health (WEIGHT)

12 de julio de 2012 actualizado por: University of North Carolina, Chapel Hill

Children and Parents Partnering Together to Manage Their Weight

Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise. Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity. The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group. Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds). Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

718

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599-7460
        • The University of North Carolina at Chapel Hill

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

7 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: Inclusion criteria for children include:

  • ability to speak, write, and read in English
  • a BMI > 85th percentile for age and gender
  • at least one parent or guardian with a BMI >25
  • assent and their parent or guardian's consent to their participation

Inclusion criteria for parents or guardians include:

  • ability to speak, write, and read in English
  • a BMI >25
  • a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
  • reside with the child; and consent to join the study

Exclusion Criteria: Parents and children will be excluded if either has a:

  • history of a heart murmur
  • congenital heart disease
  • family history of sudden death
  • history of psychological problems such as claustrophobia that would prevent participation in group classes
  • participation in another clinical trial or intervention
  • Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention
A 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in body mass index in adults and body mass index percentile in children.
Periodo de tiempo: Baseline to 18 months.
Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.
Baseline to 18 months.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Periodo de tiempo: Baseline to 18 months.
Waist circumference and triceps and subscapular skinfold measures.
Baseline to 18 months.
Change in health behaviors as measured by nutrition and exercise in adults and children.
Periodo de tiempo: Baseline to 18 months.
nutrition and exercise behaviors in adults and children based on questionnaire scores.
Baseline to 18 months.
Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
Periodo de tiempo: Baseline to 18 months.
eating and exercise self-efficacy in adults and children based on questionnaire scores.
Baseline to 18 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Diane C Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de abril de 2007

Finalización primaria (Actual)

1 de octubre de 2011

Finalización del estudio (Actual)

1 de octubre de 2011

Fechas de registro del estudio

Enviado por primera vez

2 de junio de 2011

Primero enviado que cumplió con los criterios de control de calidad

20 de junio de 2011

Publicado por primera vez (Estimar)

22 de junio de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

13 de julio de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

12 de julio de 2012

Última verificación

1 de julio de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 07-0436
  • R0100254-05 (Otro número de subvención/financiamiento: NINR)
  • 5-34696 (Otro identificador: The University of North Carolina at Chapel)

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. .

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