Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury
NCT ID: NCT02223728
Last Updated: 2018-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
79 participants
INTERVENTIONAL
2014-08-31
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Condition
Telehealth Lifestyle Program
Lifestyle
Attention Control Condition
Health Education Program
Health Education
Interventions
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Lifestyle
Health Education
Eligibility Criteria
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Inclusion Criteria
2. English speaking
3. sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
4. overweight or obese as defined by a BMI score of ≥ 25 kg/m2
5. 1-year or greater post-injury
6. not currently enrolled in a weight loss program or receiving weight loss medication
7. regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
8. 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 Criteria
2. concurrent medical condition for which changes in exercise or diet would be contraindicated
3. severe hearing or visual impairment
4. significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
5. unable to communicate
6. significant cognitive impairment and without a study partner, and/or
7. 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
8. currently enrolled in an organized weight loss program
9. has lost \> 10% of body weight over the past 6 months
10. history of an eating disorder
19 Years
ALL
No
Sponsors
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U.S. Department of Education
FED
University of Alabama at Birmingham
OTHER
Responsible Party
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Laura E. Dreer, PhD
Assistant Professor
Principal Investigators
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Laura Dreer, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham/Spain Rehabilitation Center
Birmingham, Alabama, United States
Countries
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Other Identifiers
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H133A120096
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H133A120096
Identifier Type: -
Identifier Source: org_study_id
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