Health TrialsbyHealthPanel

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

ConditionsTraumatic Brain InjuryBrain Injuries, TraumaticBrain Injury, Chronic
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorBaylor Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-80 years of age

Moderate to severe TBI at time of injury

BMI ≥25 kg/m2

Able to communicate in English

Disqualifiers

Contraindications to physical activity

Low cognitive function

Residing in hospital, acute rehab, SNF

Self-Reported Pregnancy

Trial population

Adults (18-80 years of age) who are at least 6 months post moderate to severe traumatic brain injury (TBI) and willing to participate in a 12-month, 22-session healthy lifestyle intervention.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Cohort 11 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Group D: Cohort 41 intervention
Group E: Cohort 51 intervention
Group F: Cohort 61 intervention
Group G: Cohort 71 intervention
Group H: Cohort 81 intervention
Group I: Cohort 91 intervention

Trial outcomes

Primary outcomes

1

Body Weight

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

Time frame
Baseline and 12 months

Secondary outcomes

1

Blood Pressure

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

Time frame
Baseline and 12 months
2

Hemoglobin A1c

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

Time frame
Baseline and 12 months
3

Fasting Blood Glucose

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

Time frame
Baseline and 12 months
4

Lipid Panel

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

Time frame
Baseline and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor Research Institute

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: