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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02223728

Acronym

ProjectLIFT

Enrollment

Registered

2014-08-22

Start date

2014-08-31

Completion date

2018-11-30

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

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.

Interventions

BEHAVIORALLifestyle

BEHAVIORALHealth Education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026