- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00548652
Role of Apathy in the Effectiveness of Weight Loss Interventions
Role of Apathy in the Effectiveness of Weight Loss Interventions in Obese Patients
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Title: The role of Apathy in the effectiveness of weight loss interventions in obese patients
Objective: Obesity is a major public health problem. Apathy is a common behavioral problem characterized by loss of initiative, poor motivation and persistence. Presence of apathy impairs the self-care behavior in obese patients. Lack of novelty might impair a patient's ability to seek new interactions, life styles and new treatment options for obesity. Lack of motivation might impair a patient's ability to initiate exercise regimen or diet whereas lack of persistence impairs the compliance with these regimens. Thus, apathy influences all stages of self-care. We hypothesize that the treatment of apathy will result in better adherence to weight loss interventions in obese veterans enrolled in the MOVE program.
Research Design: A prospective open label randomized study. Group 1 will have patients with obesity as defined as BMI>30, and apathy defined as AES score of > 40. This group will be treated with standard nutrition counseling. Group 2 will have patients with obesity and apathy as defined above and will receive the MOVE enhancement program alone (The MOVE program is a national VA weight loss program). Group 3 will be treated with methylphenidate along with the MOVE enhancement program. Group 4 will be treated with medical crisis counseling along with the MOVE enhancement program. Group 5 will be treated with methylphenidate, and the medical crisis counseling along with the MOVE enhancement program.
Methodology: 30 patients meeting the criteria will be enrolled in each of the five arms. All patients will be in the study for duration of six months. All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks. Patients will be assessed on regular intervals using the Apathy Evaluation Scale, Hamilton Depression Scale and the Patient activation measure. MOVE sessions will be held once weekly from the 2nd visit to the end of the study. Medical Crisis Counseling visits will be every week for nine sessions and then every other week till the end of the study
Clinical Relationships/Significance: The prevalence of obesity in the general population is over 30%. However the prevalence of obesity in the VA health system is almost 70%. Since obesity predisposes to several co-morbid conditions such as hypertension, diabetes and cardiovascular disease, it is important to develop interventions that are effective in inducing weight loss. Since apathy plays a large role in the self care behaviours that lead to obesity, treating apathy may improve adherence to weight loss programs
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68105-1873
- VA Medical Center, Omaha
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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:
- BMI >30
- Apathy score >40
Exclusion Criteria:
- History of cancer, except basal cell
- Cardiovascular event in last 6 months
- Renal failure
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 |
|---|---|
|
Sin intervención: 1
standard nutrition counselling
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|
|
Experimental: 2
MOVE -weight loss intervention
|
is a VA based multidesciplinary weight loss intervention
|
|
Experimental: 3
MOVE plus medical crisis counselling
|
is a VA based multidesciplinary weight loss intervention
group counselling sessions
|
|
Experimental: 4
MOVE plus methylphenidate
|
is a VA based multidesciplinary weight loss intervention
methyphenidate will be used to treat apathy dose 10mg bid
|
|
Experimental: 5
MOVE plus methyphenidate plus medical crisis counselling
|
is a VA based multidesciplinary weight loss intervention
group counselling sessions
methyphenidate will be used to treat apathy dose 10mg bid
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Apathy Evaluation Scale
Periodo de tiempo: 6 months
|
Apathy Evaluation Scale (AES) measures apathy over the previous four weeks Scale range: 18 (minimum score)- 72 (Maximum score) Higher scores indicate higher apathy Better outcome would be reduction in the score
|
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Weight
Periodo de tiempo: 6 months
|
value at 6 months minus value at baseline
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cyrus DeSouza, MD, VA Medical Center, Omaha
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 (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
- 00469
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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