Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury. (MENTOR)
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|ClinicalTrials.gov Identifier: NCT03207737|
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : September 13, 2017
|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 7-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 7-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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03207737
|Contact: Alex Yates, MAemail@example.com|
|United States, Alabama|
|Birmingham, Alabama, United States, 35209|
|Contact: Dustin Dew, MA 205-403-5503 firstname.lastname@example.org|
|Principal Investigator:||James Rimmer, PhD||University of Alabama at Birmingham|