Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury. (MENTOR)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MENTOR + Telehealth
Telehealth Only
Sponsored by
About this trial
This is an interventional health services research trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, SCI, Telehealth, Mindfulness, Nutrition, Exercise
Eligibility 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
Sites / Locations
- Lakeshore Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MENTOR + Telehealth
Telehealth Only
Arm Description
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.
This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03207737
First Posted
June 28, 2017
Last Updated
June 28, 2020
Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation, The Craig H. Neilsen Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03207737
Brief Title
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
Acronym
MENTOR
Official Title
A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation, The Craig H. Neilsen Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Spinal Cord Injuries, SCI, Telehealth, Mindfulness, Nutrition, Exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MENTOR + Telehealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Telehealth Only
Arm Type
Active Comparator
Arm Description
This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.
Intervention Type
Behavioral
Intervention Name(s)
MENTOR + Telehealth
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Only
Intervention Description
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 Measure Information:
Title
Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience
Description
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.
Time Frame
Change from baseline to 7 days post baseline to 1 year post baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Rimmer, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeshore Foundation
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
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