- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02458131
Community-based Adolescent Diabetes Prevention Program
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
Descripción general del estudio
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for pre-diabetes screening:
- Adolescents ages 13-19 years of age
- English speaking
Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:
- attending a school in East Harlem
- attending an after school or recreational activity in East Harlem
- receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
- At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
- No plans to relocate from New York City in the next year
Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test
Exclusion Criteria for pre-diabetes screening:
- <13 or >19 years of age
- Previous diagnosis of diabetes
- BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
- Currently pregnant
- Speaking a language other than English
- On medications that may raise or lower blood sugar
- Plans to relocate from New York City within one year of enrollment-
Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites.
The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
|
Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
|
Sin intervención: Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in body mass index (BMI)
Periodo de tiempo: Baseline and 3 months
|
Change in BMI at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in BMI
Periodo de tiempo: Baseline and 1 year
|
Change in BMI at 1 year as compared to baseline
|
Baseline and 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in fasting blood glucose levels
Periodo de tiempo: Baseline and 3 months
|
Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in fasting blood glucose levels
Periodo de tiempo: Baseline and 1 year
|
Change in fasting blood glucose levels at 1 year as compared to baseline
|
Baseline and 1 year
|
Change in post prandial blood glucose level
Periodo de tiempo: Baseline and 3 months
|
Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in post prandial blood glucose level
Periodo de tiempo: Baseline and 1 year
|
Change in post prandial blood glucose level at 1 year as compared to baseline
|
Baseline and 1 year
|
Change in blood pressure
Periodo de tiempo: Baseline and 3 months
|
Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in blood pressure
Periodo de tiempo: Baseline and 1 year
|
Change in blood pressure at 1 year as compared to baseline
|
Baseline and 1 year
|
Change in percent body fat
Periodo de tiempo: Baseline and 3 months
|
Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in percent body fat
Periodo de tiempo: Baseline and 1 year
|
Change in percent body fat at 1 year as compared to baseline
|
Baseline and 1 year
|
Change in waist circumference
Periodo de tiempo: Baseline and 3 months
|
Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in waist circumference
Periodo de tiempo: Baseline and 1 year
|
Change in waist circumference at 1 year as compared to baseline
|
Baseline and 1 year
|
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Periodo de tiempo: Baseline and 3 months
|
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
|
Baseline and 3 months
|
Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
Periodo de tiempo: Baseline and 1 year
|
Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
|
Baseline and 1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nita Vangeepuram, MD, MPH, Icahn School of Medicine at Mount Sinai
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
- GCO 13-0901
- 5K23DK101692-02 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Prediabetes
-
Thomas Jefferson UniversityTerminado
-
University of WashingtonTerminado
-
Skidmore CollegeAmerican Heart AssociationAún no reclutandoHipertensión | Pre hipertensiónEstados Unidos
-
Gemelli Molise HospitalOpera CRO, a TIGERMED Group CompanyAún no reclutandoMujeres Pre-Peri y Postmenopáusicas
-
Fundación para la Investigación del Hospital Clínico...Terminado
-
University of ReadingTerminadoPre hipertensiónReino Unido
-
University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)Activo, no reclutandoSaludable | Pre hipertensiónEstados Unidos
-
University of VermontDesconocido
-
NYU Langone HealthNational Institute on Aging (NIA)Reclutamiento
-
Riphah International UniversityTerminadoPre hipertensiónPakistán
Ensayos clínicos sobre TEEN HEED
-
Eunice Kennedy Shriver National Institute of Child...Centers for Disease Control and PreventionTerminadoComportamiento de salud | Accidentes, Tráfico
-
Pro-Change Behavior SystemsTerminadoViolencia | Intimidación
-
Icahn School of Medicine at Mount SinaiAlbert Einstein College of Medicine; North General Hospital, New York; Union Settlement...Terminado
-
University of Massachusetts, WorcesterTerminadoFumar cigarrillosEstados Unidos
-
citiesRISEAfrican Population and Health Research Center; Schizophrenia Research Foundation...Inscripción por invitaciónSalud mental juvenilIndia, Kenia
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenTerminadoTrasplante de corazón pediátrico | Receptores de trasplantes de corazón pediátricos | Trasplante cardíaco pediátricoEstados Unidos