Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.

Study Overview
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Brief Summary
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The purpose of this study is to examine the effects of onsite and telehealth programs for individuals with spinal cord injury. The primary aim of this study is to compare the effectiveness of a blended 5-day onsite health promotion program followed by a 12-month telehealth package composed of exercise, nutrition, and mindfulness, to a 12-month telehealth-only package in individuals with spinal cord injury. The investigators hypothesize that the blended onsite and telehealth program will achieve better gains in fitness, dietary control, body composition, and pain management scores across a one-year period in comparison to the telehealth-only group. The secondary objective of this study is to examine changes in psychosocial mediators between the two groups to determine if key social cognitive theory constructs were significantly different between the two groups. The investigators hypothesize that the blended onsite and telehealth program will achieve better improvements in these outcomes compared to the telehealth only group.

Official Title
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A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: MENTOR + Telehealth
* Behavioral: Telehealth Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SCI ≥ 1 year post injury Able to use arms for exercise 18-60 years old Reliable access to the internet Ability to prepare own food, or have input into person responsible for food preparation Can provide own self-care. Exclusion Criteria: Cognitive impairment Depression Poorly controlled blood pressure (SBP ˃ 159 or DBP ˃ 95 mm HG) Cardiovascular disease event within the past six months Severe pulmonary disease Renal failure Current use of insulin or sulfonylurea agents Current use of medications for psychosis or bipolar disorder Active pressure ulcers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MENTOR + Telehealth<br>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<br>* 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.<br>|
| Active Comparator: Telehealth Only<br>This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program. | Behavioral: Telehealth Only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience | 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. | Change from baseline to 7 days post baseline to 1 year post baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCI, Spinal Cord Injuries, Telehealth, Mindfulness, Nutrition, Exercise