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

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Behavioral: MENTOR + Telehealth; Behavioral: Telehealth Only

• Registration Number: NCT03207737
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-01
• Study First Posted: 2017-07-05
• Study Start: 2017-09-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-28
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MENTOR + Telehealth	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.
Telehealth Only	Telehealth Only	This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program.

Primary Outcome Measures

Name	Time	Method
Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilience	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.

Trial Locations

Locations (1)

Lakeshore Foundation; 🇺🇸 Birmingham, Alabama, United States