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CompletedNCT02223728ProjectLIFTUpdated Nov 29, 2018

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

An interventional study of Lifestyle and Health Education in Traumatic Brain Injury, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2018-11-29.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 79 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
79 participants (actual)

Study arms

  • Experimental
    Treatment Condition

    Telehealth Lifestyle Program

    Behavioral: Lifestyle

  • Sham comparator
    Attention Control Condition

    Health Education Program

    Behavioral: Health Education

Interventions

  • BehavioralLifestyle
  • BehavioralHealth Education
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What researchers measure

Primary outcomes

  1. Body Mass Index (BMI) scores

    Time frame: Changes in baseline and post-program BMI scores at 7-months

07

Study locations

1 site
  • University of Alabama at Birmingham/Spain Rehabilitation Center
    Birmingham, Alabama 35294, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02223728
Lead sponsor
University of Alabama at Birmingham
Collaborators
U.S. Department of Education
Responsible party
Laura E. Dreer, PhD (Assistant Professor, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 22, 2014
Start date
Aug 2014
Primary completion
Oct 2018
Completion
Nov 2018
Last update
Nov 29, 2018

Study contacts

Laura Dreer, Ph.D.
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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