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Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury (GLB Scale-Up)

15 de junio de 2026 actualizado por: Baylor Research Institute
The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI Evidence Based Intervention (EBI) in a real world setting at a CDC-recognized site

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Despite strong efficacy data, CDC recognition of our modified curricula, and online training modules, efforts to ensure the systematic adoption of our GLB-TBI evidence based intervention (EBI) in real-world settings (i.e., CDC-recognized sites) remain limited, yet are critically needed. The proposed scale-up evaluation trial is an important and logical next step in this systematic line of research to increase the impact and scope of our GLB-TBI EBI. The Investigators have proposed targeted efforts to address the feasibility, effectiveness, fidelity, and evaluation of the GLB-TBI EBI in a real world setting at a CDC-recognized site. Results will provide a scalable EBI that can be implemented at CDC-recognized sites nationally) to improve obesity and cardiometabolic health of people with TBI.

Tipo de estudio

De observación

Inscripción (Estimado)

70

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Texas
      • Dallas, Texas, Estados Unidos, 75204
        • Baylor Scott & White Research Institute

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adults (18-80 years of age) who are at least 6 months post moderate to severe traumatic brain injury (TBI) and willing to participate in a 12-month, 22-session healthy lifestyle intervention.

Descripción

Inclusion Criteria:

  • 18-80 years of age

    -≥6 months post-TBI

  • Moderate to severe TBI at time of injury
  • BMI ≥25 kg/m2
  • Able to communicate in English

Exclusion Criteria:

  • Contraindications to physical activity
  • Low cognitive function
  • Residing in hospital, acute rehab, SNF
  • Self-Reported Pregnancy
  • Pre-existing diagnosis of an eating disorder
  • Former DPP-GLB Participants (less than 6months since participation ended)

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Cohort 1

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 2

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 3

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 4

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 5

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 6

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 7

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 8

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury
Cohort 9

The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions.

Cohorts consist of 8-10 people.
Conductual: Group Lifestyle Balance for People with TBI (GLB-TBI)
The GLB-TBI is a one-year program with 22 sessions. It begins with 12 weekly sessions called the Core Program, followed by a Transition phase consisting of 2 bi-weekly and 2 monthly sessions, and a Support Phase consisting of 6 monthly sessions. The GLB-TBI is a modification of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) with modifications specifically for people with a Traumatic Brain Injury

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Body Weight
Periodo de tiempo: Baseline and 12 months
Body weight will be measured at each session using an accessible scale.
Baseline and 12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Pressure
Periodo de tiempo: Baseline and 12 months
Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Hemoglobin A1c
Periodo de tiempo: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Fasting Blood Glucose
Periodo de tiempo: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Lipid Panel
Periodo de tiempo: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Self-Efficacy
Periodo de tiempo: Baseline and 12 months
Self reported measure using the Self-Rated Abilities for Health Practice scale. Measure includes 28 items that assess health practices among people with disabilities and yields a total Health Practices Score plus 4 subscale scores regarding Exercise, Nutrition, Health Practices, and Psychological Well Being. Items are rated on a 5-point scale from 0 'not at all' to 4 'completely.' Scores range from 0-28 with higher scores indicating higher exercise self-efficacy.
Baseline and 12 months
Exit Survey
Periodo de tiempo: 12 months
Participants will be asked to complete Exit Survey at the 12-month assessment. This survey will ask about participant experience in, and satisfaction with, the GLB-TBI program and suggestions for improvement.
12 months

Colaboradores e Investigadores

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

Patrocinador

Baylor Research Institute

Colaboradores

National Institute on Disability, Independent Living, and Rehabilitation Research

Investigadores

  • Investigador principal: Evan McShan, PhD, Baylor Scott & White Research Institute

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 (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

30 de agosto de 2028

Finalización del estudio (Estimado)

30 de agosto de 2028

Fechas de registro del estudio

Enviado por primera vez

10 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

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

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 026-349
  • 90IFRE0110 (Otro número de subvención/financiamiento: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR))

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Please contact the PI

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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