Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05699772
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2023-01-13
Brief Title:
Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
Sponsor:
Baylor Research Institute
Organization:
Baylor Research Institute
Study Overview
Official Title:
Expanding Delivery of an Evidence-based Weight-loss Intervention to Enhance Access and Reach Underserved Groups After TBI
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
tGLB-TBI
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
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 eg 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 -10213lbs -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 n27 lost -178414lbs -79 over the 12-month program and the attention control group n28 lost 0554lbs 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
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 -10213lbs -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 n27 lost -178414lbs -79 over the 12-month program and the attention control group n28 lost 0554lbs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None