- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03207737
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury. (MENTOR)
June 28, 2020 updated by: James Rimmer, University of Alabama at Birmingham
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- Lakeshore Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 7 days post baseline to 1 year post baseline.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James Rimmer, PhD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2017
Primary Completion (Actual)
April 30, 2020
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
June 28, 2017
First Submitted That Met QC Criteria
July 1, 2017
First Posted (Actual)
July 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 30, 2020
Last Update Submitted That Met QC Criteria
June 28, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-170123001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
InVivo TherapeuticsTerminated
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
M.D. Anderson Cancer CenterActive, not recruitingMetastatic Epidural Spinal Cord CompressionUnited States
Clinical Trials on MENTOR + Telehealth
-
Kinetic MusclesEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Oregon Health and Science UniversityCompleted
-
Cornell UniversityNelson Mandela African Institute of Science and Technology; Action Aid Tanzania and other collaboratorsCompletedMalnutrition
-
Johns Hopkins Bloomberg School of Public HealthCompletedHepatitis C | HIV | Risk Reduction BehaviorUnited States
-
Yale UniversityEli Lilly and Company; Connecticut State, Department of Mental Health and Addiction...CompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Psychotic DepressionUnited States
-
NYU Langone HealthNational Institute on Disability, Independent Living, and Rehabilitation... and other collaboratorsRecruiting
-
University of Wisconsin, MadisonNational Center for Research Resources (NCRR)Completed
-
Indiana UniversityNational Institutes of Health (NIH); National Center for Advancing Translational... and other collaboratorsEnrolling by invitationStigma, Social | HIV Pre-exposure ProphylaxisKenya
-
Weill Medical College of Cornell UniversityCompletedCoronary Artery DiseaseUnited States
-
The Miriam HospitalCompleted