Efectos del ejercicio sobre la neurobiología subyacente a las conductas alimentarias relacionadas con el estrés en los veteranos
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The purpose of this study is to learn more about how common lifestyle interventions, such as exercise, affect how our brains respond to performing thinking tasks and to viewing pictures of foods and various other objects. The investigators are also interested in how changes in hormones that might be different in men and women could affect how lifestyle interventions change these brain responses. This will help us to better understand how different lifestyle interventions affect the brain and how this might relate to various behaviors. Eligible participants will be asked to complete 2 study days before and again after a 12-week intervention period, during which they will either continue with usual activities or be asked to complete exercise sessions four times per week. They will be randomly assigned to one of these conditions (exercise or not) and will not be able to choose their group assignment.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Kristina T Legget, PhD
- Número de teléfono: (720) 724-5809
- Correo electrónico: kristina.legget@va.gov
Ubicaciones de estudio
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Colorado
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Aurora, Colorado, Estados Unidos, 80045-7211
- Reclutamiento
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contacto:
- Kristina T Legget, PhD
- Número de teléfono: (720) 724-5809
- Correo electrónico: kristina.legget@va.gov
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Investigador principal:
- Kristina T. Legget, PhD
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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:
- Veteran
- Body mass index (BMI) of 25 or greater
- Physically inactive
- Able to attend study visits in person in Aurora, CO
Exclusion Criteria:
- Currently pregnant
- History of bariatric surgery
- Current eating disorder
- Current treatment with appetite-altering medications (e.g., glucagon-like peptide-1 (GLP-1) agonists)
- Contraindication to MRI (weight > 500 pounds (lbs); claustrophobia; metal or electronic devices in the body)
- Cardiovascular disease, chronic kidney disease, pulmonary disease, or diabetes
- Unable to exercise due to cardiac, pulmonary, neurologic, or orthopedic reasons
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Exercise
Participants will complete 4 aerobic exercise training sessions per week for 12 weeks. The exercise program will begin at 15 minutes per session and duration will be gradually increased by 5 minutes each week until participants reach 30 minutes per session (with 5 min warm-up and cool-down). Exercise will be performed at a "moderate" intensity, which will be about 60-70% of your predicted maximal level. Participants will meet with study personnel once per week. |
12 weeks of aerobic exercise, with 4 sessions per week. |
|
Sin intervención: Usual activity
Participants will keep doing what they usually do for the 12-week intervention period. They will be asked not to change their usual physical activity levels during this period. They will meet with study personnel once per week |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percent change in blood oxygen level dependent (BOLD) response to visual food cues as measured by functional magnetic resonance imaging (fMRI)
Periodo de tiempo: Baseline, 12 weeks
|
Percent change in blood oxygen level dependent (BOLD) response from baseline to after the 12-week intervention period while viewing visual food cues. The primary contrast of interest is the comparison of high-calorie food images to nonfood object images. |
Baseline, 12 weeks
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Change in serum cortisol response to counting task
Periodo de tiempo: Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in serum cortisol levels (micrograms per deciliter (mcg/dL)) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in heart rate response to counting task
Periodo de tiempo: Baseline, 12 weeks
|
Change from baseline to after the 12-week intervention period in heart rate (measured by photoplethysmograph; aggregated in 1 min intervals) throughout a counting task involving mental math (measured as area under the curve). |
Baseline, 12 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in percent body fat
Periodo de tiempo: Baseline, 12 weeks
|
Change in percent body fat, as measured by dual-energy x-ray absorptiometry, from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
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Percent change in body weight
Periodo de tiempo: Baseline, 12 weeks
|
Percent change in body weight (kilograms) from baseline to after the 12-week intervention period. |
Baseline, 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kristina T. Legget, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Trastornos Nutricionales
- Sobrenutrición
- Peso corporal
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Ejercicio
Otros números de identificación del estudio
- ENDA-009-24S
- I01CX002752 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
As some journals now require authors to provide access to data, de-identified, anonymized data sets will be created after study results are published, and made available upon request for general research purposes, based on availability of resources. No proprietary data will be made publicly available. Sufficient data and descriptors will be made available to confirm conclusions in resulting publications and duplicate statistical analyses.
Marco de tiempo para compartir IPD
Data will become available after publication of study results and be available at least 3 years beyond the completion of the study.
Criterios de acceso compartido de IPD
Data will be made available upon request for general research purposes, based on availability of resources.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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