NCT04288258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

3.5 years

First QC Date

February 21, 2020

Last Update Submit

October 30, 2023

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Health Promoting Lifestyle Profile II

    HPLP-II; Total scores and subscale scores are summed and divided by number of items on each scale respectively for an average, with higher scores indicating greater lifestyle behaviors

    Up to 13 months

Secondary Outcomes (11)

  • Barriers to Physical Activity and Disability Survey

    Up to 13 months

  • Social Support and Exercise Support for Eating and Physical Activity Habits

    Up to 13 months

  • Stages of Change Readiness and Treatment Engagement Scale

    Up to 13 months

  • Patient Health Questionnaire-9 Item

    Up to 13 months

  • Fatigue Severity Scale

    Up to 13 months

  • +6 more secondary outcomes

Study Arms (1)

Treatment

EXPERIMENTAL

Health and Wellness Program

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

Interventions

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

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • non-English speaking
  • difficulty hearing
  • significant problems with communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: case-control crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 28, 2020

Study Start

April 1, 2020

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

October 31, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Will need IRB approval

Locations

US(1)