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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

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.

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
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Alex Yates, MA 2054035525 alexy@lakeshore.org

Locations
United States, Alabama
Lakeshore Foundation Recruiting
Birmingham, Alabama, United States, 35209
Contact: Dustin Dew, MA    205-403-5503    dustind@lakeshore.org   
Sponsors and Collaborators
University of Alabama at Birmingham
Lakeshore Foundation
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: James Rimmer, PhD University of Alabama at Birmingham

Responsible Party: James Rimmer, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03207737     History of Changes
Other Study ID Numbers: IRB-170123001
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Rimmer, University of Alabama at Birmingham:
Spinal Cord Injuries
SCI
Telehealth
Mindfulness
Nutrition
Exercise

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System