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OpenTrials
Completed

NCT Number: NCT03207737

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

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Motor Activity Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MENTOR + Telehealth

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Lakeshore Foundation
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Acronym: MENTOR

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2017
Registry last updated
Jun 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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