Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury. (MENTOR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03207737|
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : September 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: MENTOR + Telehealth Behavioral: Telehealth Only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: MENTOR + Telehealth
This group will complete baseline testing, the MENTOR (Mindfulness, Exercise, and Nutrition To Optimize Resilience) program, and 5-days post baseline testing before beginning a one-year telehealth program.
Behavioral: MENTOR + Telehealth
Participants will live on campus for one week and complete the MENTOR program, which is a course about resilience and how nutrition, exercise and mindfulness help with resilience for individuals with a spinal cord injury. Different experts will cover the three main topics with lectures and application of knowledge through related activities. Participants will then begin a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.
Active Comparator: Telehealth Only
This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.
Behavioral: Telehealth Only
Participants will complete a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.
- Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience [ Time Frame: Change from baseline to 7 days post baseline to 1 year post baseline. ]This scale measures resilience-A person's ability to understand, cope, adapt and strive for a positive balance between gains and losses in health and function across their lifespan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207737
|Contact: Alex Yates, MAfirstname.lastname@example.org|
|United States, Alabama|
|Birmingham, Alabama, United States, 35209|
|Contact: Dustin Dew, MA 205-403-5503 email@example.com|
|Principal Investigator:||James Rimmer, PhD||University of Alabama at Birmingham|