Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury

Traumatic Brain Injury Clinical Trial

— ProjectLIFT  

Official title:

Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223728
• Other study ID #: H133A120096
• Secondary ID: H133A120096
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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