Finding the Patient's Voice Diabetes Prevention Programs
Finding the Patient's Voice: Development of Practical Approaches for Adolescent and Family Focused Diabetes Prevention Programs
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. To address this need, the investigators designed the ENCOURAGE Healthy Families curriculum; a program based on the scientifically proven U.S. Diabetes Prevention Program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including:
- helping youth/families understand the importance of prevention,
- on-going interest and participation, and
- differing personal beliefs.
Patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. The investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Indiana
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Carmel, Indiana, Estados Unidos, 46032
- Riley Children's Specialties
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Estados Unidos, 46202
- Riley Children's Hospital
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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:
- Overweight (BMI >85th percentile for age and sex, weight for height >85th percentile, or weight >120% of ideal [50th percentile] for height)
At least two of the following risk factors:
- Have been diagnosed with prediabetes;
- Have a family history of T2DM in first- and second-degree relatives;
- Belong to a minority race/ethnic group (Native Americans, African-Americans, Hispanic Americans, Asians/South Pacific Islanders);
- Have conditions associated with insulin resistance; and/or
- Have had gestational diabetes or were exposed to gestational diabetes in utero.
- A family support person who is also willing to participate in the study. This person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with T2D).
Exclusion Criteria:
1. Type 2 diagnosis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
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Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study.
It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Subject's BMI calculation Charted on CDC Stature for Age and Weight for Age Percentiles chart
Periodo de tiempo: 12 months
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hemoglobin A1C
Periodo de tiempo: 12 months
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12 months
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Physical activity
Periodo de tiempo: 12 months
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self-report
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12 months
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Quality of life
Periodo de tiempo: 12 months
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Pediatric Quality of Life Inventory
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12 months
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Intervention group session attendance
Periodo de tiempo: 12 months
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12 months
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Dietary records
Periodo de tiempo: 12 months
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Semi-quantitative food frequency questionniare
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12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Tamara Hannon, MD, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 1510313617
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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