Clinical trial NCT05699772: Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
Official title: Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: North Texas Traumatic Brain Injury Model System (NTX-TBIMS)
name: National Institute on Disability, Independent Living, and Rehabilitation Research
First posted: 2023-01-26
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Change in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Lipid Panel
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Arm Circumference
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Waist Circumference
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Blood Pressure
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in 8-Year Diabetes Risk
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Metabolic Syndrome Severity Score
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Dietary Change
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Neighborhood Environment Walkability Scale (NEWS)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Healthy Eating and Physical Activity
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Self-Rated Abilities for Health Practice (SRAHP)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Quality of Life After Brain Injury - Overall Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Telehealth Usability Questionnaire (TUQ)
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Exit Survey
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Simon Driver, PhD
role: PRINCIPAL_INVESTIGATOR
References: