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

Not Applicable

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT02223728
• Lead Sponsor: University of Alabama at Birmingham

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-21
• Study First Posted: 2014-08-22
• Primary Completion: 2018-10
• Status Verified: 2018-11
• Study Completion: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) scores	Changes in baseline and post-program BMI scores at 7-months

Trial Locations

Locations (1)

University of Alabama at Birmingham/Spain Rehabilitation Center; 🇺🇸 Birmingham, Alabama, United States