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NCT Number: NCT07648901

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

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

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Key information

Conditions

Traumatic Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury, Chronic Central Nervous System Diseases Chronic Disease Craniocerebral Trauma Disease Attributes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group Lifestyle Balance for People with TBI (GLB-TBI)

Behavioral

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

Primary outcomes

  1. Body Weight

    Time frame: Baseline and 12 months

    Body weight will be measured at each session using an accessible scale.

Secondary outcomes

  1. Blood Pressure

    Time frame: Baseline and 12 months

    Using an automatic cuff diastolic and systolic scores will be obtained either in person or via Quest Diagnostics.

  2. Hemoglobin A1c

    Time frame: Baseline and 12 months

    Blood sample will be obtained either in person or via Quest Diagnostics.

  3. Fasting Blood Glucose

    Time frame: Baseline and 12 months

    Blood sample will be obtained either in person or via Quest Diagnostics.

  4. Lipid Panel

    Time frame: Baseline and 12 months

    Blood sample will be obtained either in person or via Quest Diagnostics.

  5. Self-Efficacy

    Time frame: 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.

  6. Exit Survey

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandria Suhalka, MPH

CONTACT

[email protected]

214-865-2496

Shahad Alrawi, MS

CONTACT

[email protected]

214-820-9324

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

Registry information

Acronym: GLB Scale-Up

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 15, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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