PACE CALL: Weight Loss Study for Childhood Leukemia Survivors
PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos, 92093
- UC San Diego
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 7 - 18 years old
- survived childhood acute lymphoblastic leukemia (defined as being off treatment for at least 2 years)
- greater than or equal to 85th percentile BMI-for-age and gender)
- read and speak English
- have a parent that reads and speaks English or Spanish
- willingness to attend assessments
- access to the Internet
Exclusion Criteria:
- any comorbidities of obesity that require immediate sub-specialist referral including pseudotumor cerebri, sleep apnea, and obesity hypoventilation syndrome
- any subject with a known disease of the liver, pancreas or small intestine that would adversely effect digestion or absorption of nutrients
- any pulmonary, cardiovascular, orthopedic, or musculoskeletal problem that would limit ability to adhere to moderate-level physical activity recommendations
- have a history of substance abuse or other psychiatric disorder that would impair compliance with the study protocol
- are using any medications which alter body weight
- are currently enrolled in another weight loss program
- in foster care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: PACE CALL/Fit4Life
Fit4Life intervention activities: Website: Provides weekly nutrition, physical activity, and weight loss information. Counseling Calls: Participants and their parents will get phone calls from their Health Coach to assess progress & problems. Health Coach Question & Answer: Participants will be assigned a Health Coach that they can contact at any time to ask questions or express any concerns. Text & Picture Messages: Participants will receive daily text messages to help remind them of being healthy. Messages will relate to the weekly topics and general checking in questions. Parent Materials: Parents will receive a packet of printed materials that relate to parenting skills regarding being a healthy role model for their child and healthy eating and exercise tips. |
The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving. The Fit4Life intervention includes: Web-based weight loss program Text and Picture messages Counseling Calls Health Coach |
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Sin intervención: Control
The Control group will receive monthly mailings on basic nutrition and physical activity information.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
BMI
Periodo de tiempo: Baseline, 4 months
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To determine the impact of a weight loss intervention on BMI compared to a control group
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Baseline, 4 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight Loss Behaviors
Periodo de tiempo: Baseline, 4 months
|
To determine the impact of a weight loss intervention vs. a control group on self-reported behavioral measures of diet and physical activity.
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Baseline, 4 months
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Metabolic Blood Measures
Periodo de tiempo: Baseline, 4 months
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To determine the impact of a weight loss intervention vs. control on fasting serum insulin, fasting blood glucose, and blood lipid levels.
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Baseline, 4 months
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Psychosocial Mediators of Weight Loss Behaviors
Periodo de tiempo: Baseline, 4 months
|
To determine the impact of a weight loss intervention vs. control on psychosocial mediators of diet and physical activity behavior changes
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Baseline, 4 months
|
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Quality of Life
Periodo de tiempo: Baseline, 4 months
|
To determine the impace of a weight loss intervention vs. control on quality of life and depression.
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Baseline, 4 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y 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
- 070731
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