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

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle
Health Education
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham/Spain Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Condition

Attention Control Condition

Arm Description

Telehealth Lifestyle Program

Health Education Program

Outcomes

Primary Outcome Measures

Body Mass Index (BMI) scores

Secondary Outcome Measures

Full Information

First Posted
August 19, 2014
Last Updated
November 28, 2018
Sponsor
University of Alabama at Birmingham
Collaborators
U.S. Department of Education
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1. Study Identification

Unique Protocol Identification Number
NCT02223728
Brief Title
Evaluation of a Telehealth Lifestyle Management Program to Improve Healthy Behaviors Post Head Injury
Acronym
ProjectLIFT
Official Title
Evaluation of Telehealth Lifestyle Program for Persons With Traumatic Brain Injury: Objective 2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
U.S. Department of Education

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Condition
Arm Type
Experimental
Arm Description
Telehealth Lifestyle Program
Arm Title
Attention Control Condition
Arm Type
Sham Comparator
Arm Description
Health Education Program
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
Body Mass Index (BMI) scores
Time Frame
Changes in baseline and post-program BMI scores at 7-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Dreer, Ph.D.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham/Spain Rehabilitation Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

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

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