Traumatic Brain InjuryProjectLIFTNCT02223728
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury
A study testing Lifestyle and Health Education in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Lifestyle and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 19 years or older
- English speaking
- sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
- overweight or obese as defined by a BMI score of ≥ 25 kg/m2
- 1-year or greater post-injury
- not currently enrolled in a weight loss program or receiving weight loss medication
- regular access to a computer/laptop with internet capability which allows internet and telephone access simultaneously
- 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.
Who cannot join
- pregnant or planning to become pregnant in the next 7 months
- concurrent medical condition for which changes in exercise or diet would be contraindicated
- severe hearing or visual impairment
- significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
- unable to communicate
- significant cognitive impairment and without a study partner, and/or
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- 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
- currently enrolled in an organized weight loss program
- has lost > 10% of body weight over the past 6 months
- history of an eating disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham/Spain Rehabilitation Center
Birmingham, Alabama, 35294
About this study
Official title: Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Lifestyle, Health Education
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment Condition | Experimental | Telehealth Lifestyle Program Receives: Behavioral: Lifestyle |
| Attention Control Condition | Sham comparator | Health Education Program Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI) scores
Measured: Changes in baseline and post-program BMI scores at 7-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Laura E. Dreer, PhD, University of Alabama at Birmingham
- Investigators
- Laura Dreer, Ph.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223728
- Sponsor's protocol ID
- H133A120096
- Other IDs
- H133A120096
- Acronym
- ProjectLIFT
- Status last verified
- Nov 2018
- First submitted
- 19 Aug 2014
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
- ClinicalTrials.gov ID
- NCT02223728
- Acronym / sponsor ID
- ProjectLIFT / H133A120096
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Aug 2014
- Primary completion
- Oct 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Condition | Experimental | Behavioral: LifestyleTelehealth Lifestyle Program |
| Attention Control Condition | Sham comparator | Behavioral: Health EducationHealth Education Program |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 19 years or older
- English speaking
- sustained a moderate or severe TBI (as defined by a period of confusion after the injury of more than 24 hours)
- overweight or obese as defined by a BMI score of ≥ 25 kg/m2
- 1-year or greater post-injury
Key exclusion criteria (10 listed)
- pregnant or planning to become pregnant in the next 7 months
- concurrent medical condition for which changes in exercise or diet would be contraindicated
- severe hearing or visual impairment
- significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)
- unable to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle | Behavioural | Treatment Condition |
| Health Education | Behavioural | Attention Control Condition |
Primary outcome
Body Mass Index (BMI) scores
Time frame: Changes in baseline and post-program BMI scores at 7-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Dreer, Ph.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle and Health Education in people with Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) scores (time frame: Changes in baseline and post-program BMI scores at 7-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.