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

November 28, 2018 updated by: Laura E. Dreer, PhD, University of Alabama at Birmingham

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

U.S. Department of Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

August 19, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (Estimate)

August 22, 2014

Study Record Updates

Last Update Posted (Actual)

November 29, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H133A120096 (Other Grant/Funding Number: H133A120096)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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