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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 19, 2018
Sponsor:
Collaborators:
Lakeshore Foundation
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
James Rimmer, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE June 28, 2017
First Posted Date  ICMJE July 5, 2017
Last Update Posted Date September 19, 2018
Actual Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03207737 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
Official Title  ICMJE A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: MENTOR + Telehealth
  • Active Comparator: Telehealth Only
    This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.
    Intervention: Behavioral: Telehealth Only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alex Yates, MA 2054035525 alexy@lakeshore.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03207737
Other Study ID Numbers  ICMJE IRB-170123001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party James Rimmer, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE
  • Lakeshore Foundation
  • The Craig H. Neilsen Foundation
Investigators  ICMJE
Principal Investigator: James Rimmer, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date September 2018

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