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Community-based Adolescent Diabetes Prevention Program

20 de noviembre de 2019 actualizado por: Icahn School of Medicine at Mount Sinai

TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

Tipo de estudio

Intervencionista

Inscripción (Actual)

90

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • New York, New York, Estados Unidos, 10029
        • Icahn School of Medicine at Mount Sinai

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

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:

    1. attending a school in East Harlem
    2. attending an after school or recreational activity in East Harlem
    3. 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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nita Vangeepuram, MD, MPH, Icahn School of Medicine at Mount Sinai

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de noviembre de 2016

Finalización primaria (Actual)

24 de agosto de 2019

Finalización del estudio (Actual)

24 de agosto de 2019

Fechas de registro del estudio

Enviado por primera vez

22 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

27 de mayo de 2015

Publicado por primera vez (Estimar)

29 de mayo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

21 de noviembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

20 de noviembre de 2019

Última verificación

1 de noviembre de 2019

Más información

Términos relacionados con este estudio

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

Ensayos clínicos sobre TEEN HEED

3
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