Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT04288258
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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04288258
Study Brief:
Protocol Section:
NCT04288258