Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
MENTOR
A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 5, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 30, 2020
June 1, 2020
2.7 years
June 28, 2017
June 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change from baseline to 7 days post baseline to 1 year post baseline.
Study Arms (2)
MENTOR + Telehealth
EXPERIMENTALThis 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.
Telehealth Only
ACTIVE COMPARATORThis group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- SCI ≥ 1 year post injury
- Able to use arms for exercise
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Lakeshore Foundationcollaborator
- The Craig H. Neilsen Foundationcollaborator
Study Sites (1)
Lakeshore Foundation
Birmingham, Alabama, 35209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Rimmer, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 28, 2017
First Posted
July 5, 2017
Study Start
September 1, 2017
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
June 30, 2020
Record last verified: 2020-06