Group Lifestyle Balance™ for Individuals With Traumatic Brain Injury (GLB-TBI)

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Study completion pushed from Dec 30, 2026 to Dec 30, 2027 Show 4 more changesShow less
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 22 of 28 entries
    • Site details revised
    • Publications: details revised at 9 of 9 entries
  2. Study completion date: Dec 30, 2025 to Dec 30, 2026v15
  3. Study completion date: Dec 30, 2024 to Dec 30, 2025v14
  4. Study completion date: Dec 30, 2023 to Dec 30, 2024v13
  5. Study completion date: Dec 30, 2022 to Dec 30, 2023v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Dec 30, 2021 to Dec 30, 2022
    • Study completion date: Sep 30, 2022 to Dec 30, 2022
    v11
  2. Publications: 2 to 9v10
  3. Secondary endpoints: 25 to 28v9
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  5. Enrollment target: 28 to 57v7
  6. Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 24 to 25
    v6
  7. Secondary endpoints: 23 to 24
    • Site contact updated
    • Eligibility criteria expanded, about 4 words
    v5
  8. Secondary endpoints revised (23)
    • Study description expanded, about 217 words
    • Eligibility criteria expanded, about 2 words
    v4
  9. Enrollment target: 66 to 28
    • Start date changed from estimate of Jan 1, 2019 to Jan 8, 2019
    • Secondary endpoints: 18 to 23
    v3
  10. Secondary endpoints revised (18)v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.
Trial Details
NCT Number NCT03594734
Lead Sponsor Baylor Research Institute
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research, University of Texas Southwestern Medical Center
Conditions
(from sponsor)		 Traumatic Brain Injury
Related terms Brain Injuries, Traumatic, Weight Loss
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov