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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03207737
Acronym
MENTOR
Enrollment
23
Registered
2017-07-05
Start date
2017-09-01
Completion date
2020-04-30
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries, SCI, Telehealth, Mindfulness, Nutrition, Exercise

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.

Interventions

BEHAVIORALMENTOR + 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.

BEHAVIORALTelehealth 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.

Sponsors

Lakeshore Foundation
CollaboratorOTHER
The Craig H. Neilsen Foundation
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Warwick-Edinburgh Mental Well-Being Scale Score reflecting resilienceChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026