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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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

June 28, 2017
July 5, 2017
September 13, 2017
September 1, 2017
April 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03207737 on ClinicalTrials.gov Archive Site
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Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
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 7-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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Spinal Cord Injuries
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: MENTOR + Telehealth
  • Active Comparator: Telehealth Only
    This group will complete baseline and 7-days post baseline testing before beginning a one-year telehealth program.
    Intervention: Behavioral: Telehealth Only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2019
April 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • SCI ≥ 1 year post injury
  • Manual wheelchair user
  • Able to use arms for exercise
  • 18-50 years old
  • Reliable access to the internet
  • Ability to prepare own food, or have input into person responsible for food preparation
  • Willing to come to Lakeshore Foundation three times over a year
  • Willing to stay on Lakeshore's campus for one week if selected for the residential arm
  • 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 smoker or recently quit less than 6 months prior
  • Current use of insulin or sulfonylurea agents
  • Current use of medications for psychosis or bipolar disorder
  • Active pressure ulcers
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Alex Yates, MA 2054035525 alexy@lakeshore.org
United States
 
 
NCT03207737
IRB-170123001
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
James Rimmer, University of Alabama at Birmingham
University of Alabama at Birmingham
  • Lakeshore Foundation
  • The Craig H. Neilsen Foundation
Principal Investigator: James Rimmer, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP