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

NCT ID: NCT05699772

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2027-08-31

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.

Detailed Description

Diabetes Prevention Program Group Lifestyle Balance Program (DPP-GLB): The DPP-GLB is a 12-month, evidence-based, CDC-accredited weight-loss intervention designed for delivery in group-based, community settings, and has resulted in weight loss in a variety of settings such as community centers, churches, worksites, and healthcare settings. Alternate modes of delivery (e.g., DVD, telehealth, telephone call) have also proven efficacious. The primary goal of the DPP-GLB intervention is to help the participant achieve and maintain a 5-7% weight loss by following federal guidelines for physical activity participation (safe and progressive increase to achieve 150 minutes of moderate intensity activity each week) and dietary recommendations.

DPP-GLB for individuals with TBI: In 2015 we modified the DPP-GLB with a group of stakeholders to meet the unique needs of individuals with TBI (GLB-TBI). We pilot tested the GLB-TBI in a group of 18 individuals with TBI who lost -10.2±13lbs (-5% weight-loss) over 12 months. These results warranted rigorous testing.

Efficacy of the GLB-TBI using an RCT: We then completed an in-person randomized controlled trial (RCT) to assess the efficacy of the GLB-TBI compared to an attention control (NCT03594734) for Dallas residents after TBI. Individuals in the GLB-TBI group (n=27) lost -17.8±41.4lbs (-7.9%) over the 12-month program and the attention control group (n=28) lost 0±55.4lbs (0%). The GLB-TBI group also had significant improvements in diastolic blood pressure, waist circumference, triglycerides, and HDL cholesterol. As a result of this strong evidence, our GLB-TBI curriculum was recognized by the CDC as an evidence-based approach to in-person weight-loss.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telehealth GLB-TBI (tGLB-TBI)

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Brain Health Group (BHG)

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).

Group Type: ACTIVE_COMPARATOR

Brain Health Group (BHG)

Intervention Type: BEHAVIORAL

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

Interventions

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

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.

Intervention Type: BEHAVIORAL

Brain Health Group (BHG)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18-80 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

North Texas Traumatic Brain Injury Model System (NTX-TBIMS)

UNKNOWN

Sponsor Role: collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Evan Elizabeth Rainey

Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Driver, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute

Locations

Baylor Scott & White Research Institute

Dallas, Texas, United States

Countries

United States

Other Identifiers

BSW IRB #022-356

Identifier Type: -

Identifier Source: org_study_id