Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

15 czerwca 2026 zaktualizowane przez: 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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

70

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75204
        • Baylor Scott & White Research Institute

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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.
Behawioralne: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Body Weight
Ramy czasowe: Baseline and 12 months
Body weight will be measured at each session using an accessible scale.
Baseline and 12 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Blood Pressure
Ramy czasowe: 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
Ramy czasowe: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Fasting Blood Glucose
Ramy czasowe: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Lipid Panel
Ramy czasowe: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Self-Efficacy
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Baylor Research Institute

Współpracownicy

National Institute on Disability, Independent Living, and Rehabilitation Research

Śledczy

  • Główny śledczy: Evan McShan, PhD, Baylor Scott & White Research Institute

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 sierpnia 2026

Zakończenie podstawowe (Szacowany)

30 sierpnia 2028

Ukończenie studiów (Szacowany)

30 sierpnia 2028

Daty rejestracji na studia

Pierwszy przesłany

10 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

15 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 026-349
  • 90IFRE0110 (Inny numer grantu/finansowania: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

Please contact the PI

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Congo

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj