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

NCT ID: NCT02223728

Last Updated: 2018-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment Condition

Telehealth Lifestyle Program

Group Type EXPERIMENTAL

Lifestyle

Intervention Type BEHAVIORAL

Attention Control Condition

Health Education Program

Group Type SHAM_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Interventions

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Lifestyle

Intervention Type BEHAVIORAL

Health Education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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. 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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U.S. Department of Education

FED

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Laura E. Dreer, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Dreer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham/Spain Rehabilitation Center

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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H133A120096

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H133A120096

Identifier Type: -

Identifier Source: org_study_id

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