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

The University of Alabama at Birmingham

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Telehealth Only; Behavioral: MENTOR + Telehealth

Study type: Interventional

Funder types: Other

Identifiers

NCT03207737

IRB-170123001

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

MENTOR + Telehealth

Experimental group

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.

Treatment:

Behavioral: MENTOR + Telehealth

Telehealth Only

Active Comparator group

Description:

This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.

Treatment:

Behavioral: Telehealth Only