A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury

NCT ID: NCT04288258

Last Updated: 2023-10-31

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-10-01

Brief Summary

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To evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program on promoting healthy lifestyle behaviors and improving health outcomes.

Detailed Description

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The purpose of this study is to evaluate the efficacy of an adapted telehealth-based, health and wellness lifestyle program (POWERS-TBI) on promoting healthy lifestyle behaviors and improving self-efficacy for healthy activities such as amount of physical activity, dietary/food intake, mental stimulation and activity, substance use, mindfulness/spirituality, social relationships, and/or leisure activities among persons with TBI and their caregivers. The treatment program will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse. The goals are to evaluate the impact of the treatment program on improving health outcomes for people with TBI. The investigators plan to accomplish this by evaluating the impact of the program using a case-control crossover design.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

case-control crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Health and Wellness Program

Group Type EXPERIMENTAL

Telehealth-Based Health and Wellness Program (POWERS-TBI)

Intervention Type BEHAVIORAL

The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.

Interventions

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Telehealth-Based Health and Wellness Program (POWERS-TBI)

The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 19 years or older
* sustained a TBI
* at least 6-months or greater out from injury
* willing to work on one or more health goals among any of the following areas of focus (e.g., health knowledge, physical activity/exercise, dietary intake/nutrition, stress management, mental activity/stimulation, social ' relationships, leisure, sleep, mindfulness/spirituality, substance use)
* able to potentially participate in physical activity or alter dietary intake, if that is a potential health goal (e.g., no medical contraindication given by their doctor)
* not currently enrolled in a health and wellness program or research study involving a health/wellness program or intervention
* indicates a potential health goal to lose weight and does not independently prepare their own meals, cook, grocery shop, but has a caregiver defined by providing some type of ongoing support (emotional or instrumental) who is willing to participate as a study partner during the intervention condition
* has access to a telephone
* has regular access to the internet from a computer or laptop
* not pregnant (due to the effect on engaging in certain health promoting behaviors such as weight loss)
* does not have a significant psychiatric disorder, such as schizophrenia or bipolar disorder (those with depression or anxiety will not be excluded)

Exclusion Criteria

* non-English speaking
* difficulty hearing
* significant problems with communication
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Laura E. Dreer, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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90DPTB0015

Identifier Type: -

Identifier Source: org_study_id

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