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Brain Activation and Satiety in Children: Functional Magnetic Resonance Imaging (BASIC-FMRI)

5 de septiembre de 2018 actualizado por: Christian Roth, Seattle Children's Hospital

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

BASIC fMRI is a prospective single center intervention trial using fMRI imaging in 9-11 year old obese male and females pre and post family-based behavioral treatment of 24 weeks duration to determine the relationship between impulsivity and central satiety responses.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

The high prevalence of childhood obesity in the U.S. demands a better understanding of factors that drive weight gain and influence the outcome of pediatric obesity interventions. This project investigates the hypothesis that, as in adults, a subset of obese children experience a diminished satiety response to food consumption, and that these children are more resistant to gold standard family-based behavioral treatment (FBT) for obesity. FBT is targeted almost exclusively toward parents; however, there is evidence that obesity development and response to intervention may depend on additional factors such as individual internal satiety perception and variability in the function of brain centers associated with impulsivity and reward. The proposed research uses functional magnetic resonance imaging (fMRI) to characterize brain function related to satiety and examines fMRI along with behavioral, cognitive, and hormonal testing to fully examine potential mediators of children's experience of satiety and response to FBT. The approach is based on evidence that failure to attenuate the reward value of palatable foods after eating can be a manifestation of a blunted central satiety response that is reliably detected using fMRI. Key objectives will be to determine if differences in the central satiety response exist between obese and non-obese children, and, among obese children, if the strength of the central satiety response is associated with impulsivity and/or the success of obesity treatment. The central hypothesis is that, in obese children, a blunted central nervous system satiety response impairs the success of obesity interventions. To achieve study objectives, brain activation by high-calorie visual food cues before and after food consumption will be measured by fMRI. Participants will be obese and non-obese children aged 9-11 years. The 49 obese children will be evaluated before and after they participate in a 6-month evidence-based FBT intervention. Their pre-intervention fMRI will be compared to those of 20 non-obese controls to test for a blunted central satiety response (Aim 1). The relationship of impulsivity to satiety responses and food intake will be determined in obese children (Aim 2). The longitudinal component tests whether central satiety responses prior to treatment predict treatment outcomes (Aim 3A) and whether changes in central satiety responses during treatment predict maintenance of reduced weight 6 and 12 months after treatment cessation (Aim 3B). Behavioral, cognitive, and hormonal measures will be examined as potential mediating or confounding factors contributing to fMRI responses. The proposed research is guided by an integrated, transdisciplinary team with expertise in pediatric and adult neuroimaging, appetite regulation, and family-based childhood obesity treatment. This research will provide new insights into the neurobiological basis of child obesity and the relevance of neurobiological factors to treatment success. The long-term objective is to translate these findings to improve obesity interventions cost-effectively and sustain better long-term results.

During years 1-3, obese children will be enrolled into intervention groups of 9-11 families with staggered start dates by 3-6 months. Years 1-4 includes enrollment, intervention, longitudinal follow-up, and data collection for obese children. Control children will primarily be recruited during years 2-3 to facilitate matching. FMRI scans are processed on a rolling basis as studies are completed. In years 3 and 4 hormonal assays will be performed. Final data analyses will be completed in year 4.

Tipo de estudio

Intervencionista

Inscripción (Actual)

81

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

    • Washington
      • Seattle, Washington, Estados Unidos, 89105
        • Seattle Childrens Hospital

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

9 años a 11 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • 9-11 years of age
  • Male or female
  • Ability and willingness to participate in study visits including fMRI scans and blood draws;
  • ability to provide informed written consent and assent;
  • BMI z-score for lean control children 15th to 84.9th perc. for age and sex,
  • BMI z-score for obese children BMI z-score >90th perc. for age and sex;
  • Additional inclusion criteria for obese children: One overweight parent (BMI >25 kg/m2); willingness of 1 parent (does not have to be the obese parent) to engage in family-based weight control treatment.

Exclusion Criteria:

  • History of acute or chronic serious medical conditions;
  • known diabetes mellitus or recent (6 mo.) history of anemia;
  • presence of any implanted metal or metal devices, including ferro-metallic surgical clips or braces;
  • claustrophobia;
  • documented cognitive disorder, disruptive behavior, inability to participate in group sessions;
  • current use of medications known to alter appetite, body weight, or brain response (e.g. anti-seizure medications, glucocorticoids, medications for attention deficit disorder);
  • food intolerance or vegetarianism.

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: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Family Based Behavioral Treatment
Central satiety brain and hormonal responses will be compared pre-and post-Family Based Behavioral Treatment, as well, as to a non-obese sample.
Obese children accompanied by at least one parent or caregiver will attend 24 weekly in-person sessions. Sessions will include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 9-11 children/families will be initiated every 3-6 mos. in study yrs. 1-3.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Blunted central satiety response measured by functional magnetic resonance imaging
Periodo de tiempo: Baseline
Baseline

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change of brain response to visual food cues or eating behavior measured by functional magnetic resonance imaging
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by functional magnetic resonance imaging.
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Relative Reinforcing Value of Food (RRV).
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Developmental NEuroPSYchological Assessment (NEPSY).
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Relationship between impulsivity and satiety in obese children as measured by the Delayed Choice Questionnaire (DCQ).
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)

Otras medidas de resultado

Medida de resultado
Periodo de tiempo
Predictors of treatment outcomes measured by functional magnetic resonance imaging.
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by behavioral skills use questionnaires.
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)
Predictors of treatment outcomes measured by hormonal measures.
Periodo de tiempo: Change from pre- to post-treatment (end of 6 month intervention)
Change from pre- to post-treatment (end of 6 month intervention)

Colaboradores e Investigadores

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

Colaboradores

Investigadores

  • Investigador principal: Christian Roth, MD, Seattle Children's

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 septiembre de 2014

Finalización primaria (Actual)

1 de julio de 2018

Finalización del estudio (Actual)

1 de agosto de 2018

Fechas de registro del estudio

Enviado por primera vez

20 de noviembre de 2014

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2015

Publicado por primera vez (Estimar)

30 de junio de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de septiembre de 2018

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

5 de septiembre de 2018

Última verificación

1 de septiembre de 2018

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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