Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

15. Juni 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

70

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Texas
      • Dallas, Texas, Vereinigte Staaten, 75204
        • Baylor Scott & White Research Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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.
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body Weight
Zeitfenster: Baseline and 12 months
Body weight will be measured at each session using an accessible scale.
Baseline and 12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Blood Pressure
Zeitfenster: 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
Zeitfenster: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Fasting Blood Glucose
Zeitfenster: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Lipid Panel
Zeitfenster: Baseline and 12 months
Blood sample will be obtained either in person or via Quest Diagnostics.
Baseline and 12 months
Self-Efficacy
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Baylor Research Institute

Mitarbeiter

National Institute on Disability, Independent Living, and Rehabilitation Research

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. August 2026

Primärer Abschluss (Geschätzt)

30. August 2028

Studienabschluss (Geschätzt)

30. August 2028

Studienanmeldedaten

Zuerst eingereicht

10. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

15. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 026-349
  • 90IFRE0110 (Andere Zuschuss-/Finanzierungsnummer: National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

Please contact the PI

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Hirnverletzungen, traumatisch

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Kyrgyzstan

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren