Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI

NCT05699772 | Active Not Recruiting

• 1 other identifier: BSW IRB #022-356
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to extend the accessibility of the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) modified for people with TBI (GLB-TBI) to reduce health inequities and reach a broad and diverse sample. To increase the accessibility and reach of the GLB-TBI we will conduct a randomized control trial (RCT) to assess intervention efficacy of telehealth delivery of the GLB-TBI (tGLB-TBI). Results will provide a scalable telehealth weight-loss program that clinicians and community workers across the country can use to help people with TBI lose weight and improve health.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Change in Weight

  Weight will be obtained at a lab local to the participant based on their preference. Weight for participants randomized to the GLB-TBI will also be captured via self-weighing using provided BodyTrace Smart Scale, which include cellular connectivity so weight will be sent directly to the research team. The scales have demonstrated good concordance rates with in-person weighing in previous weight management research.Scales will be setup by our team before being mailed to participants with instructions for use.

  Baseline, 3, 6, and 12 months

Secondary Outcomes (14)

• Change in Hemoglobin A1c (HbA1c)

  Baseline, 3, 6, and 12 months

• Change in Lipid Panel

  Baseline, 3, 6, and 12 months

• Change in Arm Circumference

  Baseline, 3, 6, and 12 months

• Change in Waist Circumference

  Baseline, 3, 6, and 12 months

• Change in Blood Pressure

  Baseline, 3, 6, and 12 months

Study Arms (2)

Telehealth GLB-TBI (tGLB-TBI)

EXPERIMENTAL

The goal of the tGLB-TBI program is to help the participant achieve and maintain a 5-7% weight-loss using a two-pronged approach: 1. Physical activity: This is based upon recommendations by the American Heart Association and the American College of Sports Medicine (ACSM) to achieve 150 minutes of moderate intensity activity each week. Walking is the primary activity recommended. 2. Healthy eating: Based on United States Department of Agriculture guidelines, the GLB emphasizes healthy eating patterns and tracking dietary intake. The tGLB-TBI was modified from the DPP-GLB and 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. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).

Behavioral: Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI)

Brain Health Group (BHG)

ACTIVE COMPARATOR

The Brain Health Group (BHG) meets at the same frequency as the GLB-TBI (i.e., 22 group-based sessions, 12 weekly, 4 bi-monthly, and 6 monthly).The focus of the BHG is on brain health education, self-management, and problem-solving and the BHG did not receive any education on weight-loss strategies. Sessions will be delivered in a group setting via telehealth (Microsoft Teams).

Behavioral: Brain Health Group (BHG)

Interventions

Telehealth-delivered Group Lifestyle Balance for people with TBI (tGLB-TBI) BEHAVIORAL

The GLB-TBI was modified from the Diabetes Prevention Program Group Lifestyle Balance (DPP-GLB) by a group of stakeholders using a community based participatory research approach. The GLB-TBI is modified for people with Traumatic Brain Injury and addresses their unique weight loss and healthy lifestyle needs.

Telehealth GLB-TBI (tGLB-TBI)

Brain Health Group (BHG) BEHAVIORAL

The BHG was developed by researchers and clinicians at Baylor Scott \& White Institute for Rehabilitation.

Brain Health Group (BHG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Greater than or equal to 6 months post traumatic brain injury (TBI)
• Moderate to severe TBI at time of injury
• Body Mass Index greater than or equal to 25
• Able to participate in physical activity
• Willing to use a tablet/computer/smartphone (either personal device or one provided by the research team)

You may not qualify if:

• Contraindications to physical activity (e.g., uncontrolled hypertension, unstable angina, severe joint disease, uncontrolled vertigo/dizziness)
• Not fluent in the English language
• Low cognitive function
• Residing in a hospital, acute rehabilitation facility, or skilled nursing facility
• Diagnosed with or taking medications for Type 2 diabetes
• Self-reported pregnancy
• Pre-existing diagnosis of an eating disorder

Sponsors & Collaborators

• Baylor Research Institute: lead
• North Texas Traumatic Brain Injury Model System (NTX-TBIMS): collaborator
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Simon Driver, PhD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 26, 2023
• Study Start: May 25, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

US (1)