Clinical trial NCT04288258: A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury
Official title: A Health and Wellness Lifestyle Program to Support Community-Dwelling Persons With Traumatic Brain Injury (TBI) and Their Caregivers: In-House Research Project, Objective 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 62
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: case-control crossover
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Promoting Lifestyle Profile II
timeFrame: Up to 13 months
Secondary outcomes:
measure: Barriers to Physical Activity and Disability Survey
timeFrame: Up to 13 months
measure: Social Support and Exercise Support for Eating and Physical Activity Habits
timeFrame: Up to 13 months
measure: Stages of Change Readiness and Treatment Engagement Scale
timeFrame: Up to 13 months
measure: Patient Health Questionnaire-9 Item
timeFrame: Up to 13 months
measure: Fatigue Severity Scale
timeFrame: Up to 13 months
measure: Bodily Pain Index
timeFrame: Up to 13 months
measure: Craig Handicap Assessment Reporting Technique short form
timeFrame: Up to 13 months
measure: Perceived Wellness Survey
timeFrame: Up to 13 months
measure: Barriers to Health Activities among Disabled Persons scale
timeFrame: Up to 13 months
measure: Zarit Burden Scale
timeFrame: Up to 13 months
measure: Sociodemographic Characteristics
timeFrame: Up to 13 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: