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

NCT02223728 | Completed DMC

• 1 other identifier: H133A120096
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Body Mass Index (BMI) scores

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

Study Arms (2)

Treatment Condition

EXPERIMENTAL

Telehealth Lifestyle Program

Behavioral: Lifestyle

Attention Control Condition

SHAM COMPARATOR

Health Education Program

Behavioral: Health Education

Interventions

Lifestyle BEHAVIORAL

Treatment Condition

Health Education BEHAVIORAL

Attention Control Condition

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• U.S. Department of Education: collaborator

Study Sites (1)

University of Alabama at Birmingham/Spain Rehabilitation Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Laura Dreer, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

US (1)