Status:
COMPLETED
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lif...
Eligibility Criteria
Inclusion
- age 19 years or older
- English speaking
- sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
- overweight or obese as defined by a BMI score of ≥ 25 kg/m2
- 1-year or greater post-injury
- not currently enrolled in a weight loss program or receiving weight loss medication
- regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
- if person with TBI who meets criteria 1-7 but does not cook, shop, and/or prepare meals independently, he or she must have a non-paid, study partner willing to participate in the study.
Exclusion
- 1
- pregnant or planning to become pregnant in the next 7 months
- concurrent medical condition for which changes in exercise or diet would be contraindicated
- severe hearing or visual impairment
- significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
- unable to communicate
- significant cognitive impairment and without a study partner, and/or
- person with TBI who does not cook, shop, and/or prepare meals independently who does not have a non-paid, study partner willing to participate in the study
- currently enrolled in an organized weight loss program
- has lost \> 10% of body weight over the past 6 months
- history of an eating disorder
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT02223728
Start Date
August 1 2014
End Date
November 1 2018
Last Update
November 29 2018
Active Locations (1)
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1
University of Alabama at Birmingham/Spain Rehabilitation Center
Birmingham, Alabama, United States, 35294