A Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
A Randomized Controlled Trial To Study The Effects Of Group Versus Individual Dietary Counseling In Pediatric Obesity
Aim 1 - The primary aim of the study is to assess whether group counseling is a non-inferior intervention compared to the usual care of individual counseling in the management of childhood obesity. In order to achieve this aim, the investigators will compare the mean change in BMI after 6 months of intervention in the two study arms.
Aim 2 - The secondary aim of the study is to determine if the change in BMI is associated with changes in the dietary composition, physical activity and metabolic profile.
Descripción general del estudio
Descripción detallada
This is a non-inferiority study to determine the sample size needed for a larger study to explore an intervention strategy focused on nutrition counseling to maximize weight loss and minimize cardiovascular risk factors in obese children and adolescents. This is a prospective parallel arm, randomized trial, to study the impact of nutritional counseling in an individual vs. group setting. There will be a total of four groups. Obese pre-adolescents (ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions: individual nutrition counseling or group nutrition counseling. Subjects will receive the same information in both interventions. All content will be developed prior to starting the intervention. Each group session will have a maximum of 7 children with 1 parent/caregiver per child and a minimum of 5 children with a caregiver. Group sessions will be one time a month for 60 minutes (30 minutes for dietetic session and 30 minutes for discussion/questions) and individual sessions will be one time a month for 30 minutes. There will be 6 sessions for each group.
All groups will receive standard of care for physical fitness counseling which includes recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours a day. All groups will be evaluated for depression and appropriately referred if found to be depressed. Behavioral strategies, like mindful eating, will be included in the nutrition education.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Bronx, New York, Estados Unidos, 10467
- Albert Einstein College of Medicine West Campus CRC
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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:
- Subjects 9-17 years of age with a BMI percentile for age of ≥95
- Subjects must be able to attend monthly sessions with a parent and/or guardian.
Exclusion Criteria:
- Subjects with diabetes at baseline, mental or psychological disease that would interfere with understanding, disease or medication causing obesity or weight loss, and participants in an alternative weight management program will not be included in the study.
- Subjects with impaired glucose tolerance will not be excluded from participation.
- Non-English speaking subjects will not be excluded.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group nutritional counseling
In this arm, the Nutritionist will conduct the nutritional counseling with numerous patient families as a group
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Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes.
Classes will meet one time a month.
Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
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Comparador activo: Individual nutritional counseling
In this arm the nutritionist conducts the nutritional counseling with one patient family at a time
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Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes.
Classes will meet one time a month.
Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change I Mean Body Mass Index
Periodo de tiempo: Baseline, month 6
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The primary aim of the study is to assess whether group counseling is a non-inferior intervention compared to the usual care of individual counseling in the management of childhood obesity.
In order to achieve this aim, investigators will compare the mean change in BMI after 6 months of intervention in the two study arms.
As per previous studies, it is expected the group intervention arm to achieve a mean BMI reduction of 0.8 +/- 1.4 greater than the control arm.
The study also posits that a difference in mean BMI change as low as 0.1 would be clinically equivalent.
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Baseline, month 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in BMI with diet
Periodo de tiempo: Baseline, month 6
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The secondary aim of the study is to determine if the change in BMI is associated with changes in the dietary composition.
All the secondary outcomes will be measured by Pearson correlation coefficients or multi-variable linear regression models as appropriate to calculate this.
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Baseline, month 6
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Change in BMI with physical activity
Periodo de tiempo: Baseline, month 6
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The study will assess if there is a change in BMI with increased physical activity
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Baseline, month 6
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Change in BMI with metabolic profile
Periodo de tiempo: Baseline, month 6
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Study will assess if the change in BMI affects Metabolic profile of the subject.
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Baseline, month 6
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lisa Underland, MD, Albert Einstein College of Medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- 2012-214
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