Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07648901

Opening soonNot applicableObservational

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionTraumatic Brain Injury, Brain Injuries, Traumatic, Brain Injury, Chronic

Full registry criteria

Inclusion Criteria: * 18-80 years of age -≥6 months post-TBI * Moderate to severe TBI at time of injury * BMI ≥25 kg/m2 * Able to communicate in English Exclusion Criteria: * Contraindications to physical activity * Low cognitive function * Residing in hospital, acute rehab, SNF * Self-Reported Pregnancy * Pre-existing diagnosis of an eating disorder * Former DPP-GLB Participants (less than 6months since participation ended)

Treatments and study arms

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

Primary outcomes

Body WeightBaseline and 12 months

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Baylor Scott & White Research Institute🇺🇸 Dallas, Texas, United States

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