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OpenTrials
Completed

NCT Number: NCT02223728

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham/Spain Rehabilitation Center

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

1

  • 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
  • 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

Treatment and study plan

Lifestyle

Behavioral

Health Education

Behavioral

Primary outcomes

  1. Body Mass Index (BMI) scores

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • U.S. Department of Education

Registry information

Official study title

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

Acronym: ProjectLIFT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2014
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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