- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01227473
We Can Prevent Diabetes: A Behavioral Intervention to Reduce Diabetes Risk in African Americans
A Mindfulness-based Intervention to Reduce Diabetes Risk in Pre-diabetic African Americans
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Pre-diabetes, characterized by glucose levels that are above normal but below the diagnostic criteria for diabetes, is an increasingly common condition affecting approximately 54 million U.S. adults. African Americans are disproportionately affected by pre-diabetes and experience high rates of diabetes-associated morbidity and mortality including damage to the circulatory system, kidneys, and nervous system. Patients with pre-diabetes who increase their physical activity and improve their diets have reduced risk of developing diabetes. Psychological distress negatively influences the course of the disease by increasing deleterious health behaviors; preventing scheduling and maintenance of positive behavior change; and stimulating HPA-axis activation and dysregulation, which may have a direct impact on insulin resistance and glucose metabolism. African Americans may have increased exposure to stress and increased vulnerability to adverse stress-related health outcomes like diabetes, because of their unique history, sociocultural experiences, and societal position in the U.S. Helping individuals to reduce stress and to increase healthy coping strategies may enhance conventional diabetes prevention efforts, especially among African Americans.
Mindfulness-based stress reduction (MBSR), a mind-body practice with a wide range of health benefits, has been shown to result in statistically significant reductions in psychological stress and anxiety in randomized, controlled studies. Mindfulness training is cost-effective in comparison with other small-group or individualized programs, and can be taught safely and effectively by well-trained instructors. There is little research, and no randomized, controlled trials of MBSR as a treatment for individuals with pre-diabetes. There is also little research on the acceptability of MBSR program to a prediabetic subgroup of African Americans, or on the acceptability of an MBSR program for a general population of African Americans.
Overall goals of this exploratory pilot study are to study the potential efficacy of a diabetes prevention education program that includes training in mindfulness-based stress reduction for pre-diabetic African Americans. Specific Aims are 1) to determine the feasibility of developing a clinical trial to compare the effectiveness of a mindfulness-based diabetes prevention program (treatment group) with a conventional diabetes prevention program (control group) in improving glucose metabolism in pre-diabetic African American adults; 2) to identify relevant physiological and psychological secondary outcomes associated with a mindfulness-based, educational self-care program in African-Americans with pre-diabetes; 3) to assess the acceptability and cultural relevance of MBSR for pre-diabetic African Americans via a post-intervention qualitative study, to include interviews of participants, dropouts, and instructors; and 4) to identify, and find solutions for, problems in conducting a well-powered clinical trial to assess the efficacy of a mindfulness-based diabetes prevention program in improving glucose metabolism in pre-diabetic African-Americans.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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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:
- African-American
- 25-65 years of age
- meeting the ADA criteria for pre-diabetes (either by fasting plasma glucose (FPG) of 100-125 mg/dl or glucose of 140-199 mg/dl at 2 hours in an oral glucose tolerance test (OGTT))or a HbA1c of 5.7-6.4%
- experiencing some degree of stress
- willing to attend 1 1/2 hour group meetings once weekly for 8 weeks, followed by monthly booster sessions for six months, and to complete assessment instruments.
Exclusion Criteria:
- diabetes diagnosed by a physician
- past or current use of hypoglycemic medication (except gestational diabetes)
- disease associated with disordered glucose metabolism
- use of medications associated with impaired glucose metabolism
- active treatment for or history of a major medical illness
- previous training in meditation or mindful yoga, tai chi, qigong
- pregnant or planning a pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: mindfulness prediabetes education group
The mindfulness-based diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the mindfulness-based diabetes prevention group, the instruction will be enhanced with instruction in mindfulness.
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The mindfulness-based diabetes prevention group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, this group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the mindfulness-based diabetes prevention group, the instruction will be enhanced with a modified mindfulness meditation training designed to support the behavioral-change programming.
Otros nombres:
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Comparador activo: conventional prediabetes education group
The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
|
The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months.
During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program).
In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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insulin resistance, as measured by the homeostatic model assessment-insulin resistance (HOMA-IR)
Periodo de tiempo: Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.
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The homeostatic model assessment-insulin resistance (HOMA-IR) is a calculated measure based on the FPG and fasting insulin levels.
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Fasting samples will be collected 3 weeks, on average, before the intervention and at 3 months post intervention.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Salivary cortisol
Periodo de tiempo: Salivary cortisol will be measured before the intervention and at 2 weeks, 3 months, and 6 months post intervention
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Salivary cortisol will be measured before the intervention and at 2 weeks, 3 months, and 6 months post intervention
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Insulin resistance as measured by the HOMA-IR
Periodo de tiempo: 2 weeks and 6 months post-intervention
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The HOMA-IR is calculated from the fasting insulin and fasting glucose.
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2 weeks and 6 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Susan Gaylord, PhD, University Of North Carolina, Chapel Hill
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 (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
- 09-0563
- 1R21AT004276-01A (Otro identificador: NIH NCCAM)
- 1R21AT004276-01 (Subvención/contrato del NIH de EE. UU.)
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