- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01913743
The Effects of Mindsets on the Brain's Response to Food Cues (MINDSETS)
Previous studies have shown that obese individuals exhibit greater reward-related brain activity in response to food cues than lean individuals and our group has shown that successful weight loss maintainers who were previously obese and now maintain a healthy weight have increased control-related activity when viewing food cues. These findings suggest key roles for both reward-related brain areas and inhibitory control regions in eating behavior. However, no studies to date have examined (a) whether the response to food cues (i.e., cue-reactivity) can be changed in obese individuals, (b) which strategies are most effective at altering brain response to food cues, or (c) the neural mechanisms that support such change.
Given the omnipresent environmental cues to eat and the association between heightened reward-responsivity and obesity, it is critical to investigate ways to potentially alter food cue-reactivity in the obese. The most widely employed approach for behavioral weight loss treatment is Cognitive Behavioral Therapy (CBT), which incorporates strategies to control and change cognitions (e.g., avoid desire to eat tempting foods by focusing on something else). This approach is sometimes described as "change- focused" because modifying negative thoughts is assumed to thereby change associated maladaptive emotions and behaviors. Alternatively, emerging evidence suggests Acceptance and Commitment Therapy (ACT), which teaches participants to recognize and accept their cravings as feelings that need not be acted upon, may also be effective in treating obesity. A third strategy often employed in smoking cessation and substance abuse treatment is to focus on the long-term consequences of behaviors, however this form of treatment is not typically used in behavioral weight loss therapy. Thus although each approach is potentially effective, these treatment approaches differ greatly in the cognitive strategies they employ.
The primary aim of the proposed research is to compare a cognitive strategy used in CBT ('CHANGE'), a cognitive strategy emphasized in ACT ('ACCEPT'), and a cognitive strategy used in smoking cessation ('LATER') relative to a control condition ('NOW'), in their effectiveness in altering reward and inhibitory control responses to food cues among obese individuals.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Reclutamiento
- Weight Control & Diabetes Research Center
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Contacto:
- Kathryn E Demos, PhD
- Número de teléfono: 401-793-8939
- Correo electrónico: kathryn_demos@brown.edu
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Investigador principal:
- Kathryn E Demos, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- MRI compatibility
- 25-55 yrs old
- 25-40 BMI
- weight stable
- right handed
Exclusion Criteria:
- MRI incompatibility
- left handed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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MINDSETS
overweight/obese
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Blood oxygen level dependent (BOLD) signal differences between 4 different mindset conditions in response to food cues
Periodo de tiempo: 1 day (single time point)
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brain response to food cues measured via functional magnetic resonance imaging (fMRI) BOLD signal change will be assessed across all participants while using the 4 different mindsets potential differences in the BOLD response to food cues will be assessed between the 4 mindsets
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1 day (single time point)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
behavioral measures of physical activity and eating behavior assessed via questionnaires
Periodo de tiempo: 1 day (single time point)
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behavioral measures of physical activity and eating behavior will be assessed via questionnaires in order to describe the sample
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1 day (single time point)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathryn E Demos, PhD, Brown University Medical School
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- MINDSETS - TOS
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