Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.

Spinal Cord Injuries Clinical Trial

— MENTOR  

Official title:

A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207737
• Other study ID #: IRB-170123001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation, The Craig H. Neilsen Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.