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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02223728
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Laura E. Dreer, PhD, 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Lifestyle Behavioral: Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
Study Start Date : August 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Condition
Telehealth Lifestyle Program
Behavioral: Lifestyle
Sham Comparator: Attention Control Condition
Health Education Program
Behavioral: Health Education



Primary Outcome Measures :
  1. Body Mass Index (BMI) scores [ Time Frame: Changes in baseline and post-program BMI scores at 7-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223728


Locations
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United States, Alabama
University of Alabama at Birmingham/Spain Rehabilitation Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
U.S. Department of Education
Investigators
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Principal Investigator: Laura Dreer, Ph.D. University of Alabama at Birmingham

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Responsible Party: Laura E. Dreer, PhD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02223728     History of Changes
Other Study ID Numbers: H133A120096
H133A120096 ( Other Grant/Funding Number: H133A120096 )
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System