- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00017810
The Healthy Life Choices Project in HIV-Positive Patients
Symptom Management of HIV-related Diarrhea by Using Normal Foods: A Randomized Controlled Clinical Trial.
This randomized clinical trial is designed to determine the efficacy of a dietary intervention to reduce the frequency of bowel movements and improve stool consistency as compared with subjects assigned to a control group. The study enrolled HIV patients with a history of three or more episodes of diarrhea for 3 weeks or more.
The purpose of this study was to compare the efficacy of a combined behavioral dietary intervention using normal foods (Condition 1: treatment) with HIV self-care (Condition 2: control) to reduce the frequency and improve the consistency of bowel movements after 3 weeks and 24 weeks of study intervention.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Thirty to fifty percent of individuals with HIV can be expected to have diarrhea at some point during their illness. Diarrhea can be a chronic condition in HIV disease wherein three or more daily episodes of loose, watery stools are experienced for 4 weeks or more. Chronic diarrhea has been associated with significant morbidity, weight loss, and severe malnutrition. Researchers have reported that patients with chronic diarrhea experience a marked decrease in quality of life in comparison with HIV patients without diarrhea.
The goal of nutrition management for patients with chronic diarrhea is to ensure that adequate caloric consumption meets the metabolic needs of such individuals and to provide symptomatic relief. HIV infection, regardless of stage, causes an increase in resting energy expenditure because of the response of the body to the viral infection. Proper nutrition management can therefore assist in preventing further nutritional imbalances.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10032
- Columbia Univ School of Nursing / Center for AIDS Research
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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:
- 18 years of age or older
- diagnosed with HIV or AIDS based on the Centers for Disease Control and Prevention criteria
- experienced a minimum of three episodes of loose, watery, or liquid stools in a 24-hour period for at least 3 weeks
- provide verification from their primary care provider of HIV status, chronic diarrhea history, documentation of medical evaluations completed
- laboratory confirmation that stool samples were negative for pathogens
- patients who were taking antidiarrheal agents were required to be on a stable regimen (same drug, dosage, and frequency) for at least 7 days before entry into the study and still meet diarrhea frequency and consistency criteria
- antiretroviral agents taken to manage HIV required a stable regimen (same drugs, dosage, and frequency) for at least 8 weeks before study entry
- patients were required to complete a mini-mental state examination, obtaining a score of 24 or higher
Exclusion Criteria:
- not meeting any of the above criteria
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Condition 1: Dietary Intervention
Patients will receive behavioral dietary intervention using normal foods.
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The dietary intervention focused on diarrhea management using skill-building techniques that provided subjects with knowledge and a sense of confidence about making food choices. Behavioral dietary intervention (Condition 1: treatment) - a low-fat, lactose-free, low insoluble fiber, high soluble fiber, and caffeine-free diet based on normal foods |
Comparador activo: Condition 2 (Control): HIV Self-Care
Patients will receive HIV self-care information, and be given the dietary intervention at the completion of the last study session (post study).
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Standard information regarding self-care and healthy living with HIV - focused on healthy living with HIV and did not include dietary restrictions or dietary information that could affect bowel movements.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Joyce Anastasi, PhD, Helen F. Pettit Endowed Professor of Nursing
Publicaciones y enlaces útiles
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
- 6510
- R29NR004169 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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