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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02223728
Other study ID # H133A120096
Secondary ID H133A120096
Status Completed
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date November 2018

Study information

Verified date November 2018
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date November 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. age 19 years or older

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:1

1. pregnant or planning to become pregnant in the next 7 months

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

Study Design


Intervention

Behavioral:
Lifestyle

Health Education


Locations

Country Name City State
United States University of Alabama at Birmingham/Spain Rehabilitation Center Birmingham Alabama

Sponsors (2)

Lead Sponsor Collaborator
University of Alabama at Birmingham U.S. Department of Education

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Mass Index (BMI) scores Changes in baseline and post-program BMI scores at 7-months
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