Spinal Cord InjuriesMENTORNCT03207737
Mindfulness, Exercise and Nutrition To Optimize Resilience for Individuals With a Spinal Cord Injury.
A study testing MENTOR + Telehealth and Telehealth Only in people with Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- MENTOR + Telehealth and Telehealth Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Current use of insulin or sulfonylurea agents
- Current use of medications for psychosis or bipolar disorder
- Active pressure ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- MENTOR + Telehealth, Telehealth Only
- Keywords
- Spinal Cord Injuries, SCI, Telehealth, Mindfulness, Nutrition, Exercise
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENTOR + TelehealthBehavioural
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 OnlyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MENTOR + Telehealth | Experimental | 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. Receives: Behavioral: MENTOR + Telehealth |
| Telehealth Only | Active comparator | This group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program. Receives: Behavioral: Telehealth Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 7 days post baseline to 1 year post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation, The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
- Investigators
- James Rimmer, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207737
- Sponsor's protocol ID
- IRB-170123001
- Acronym
- MENTOR
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2017
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blended Residential/Telehealth Lifestyle Intervention to Improve Cardiovascular Health and Manage Pain in Adults With Spinal Cord Injury.
- ClinicalTrials.gov ID
- NCT03207737
- Acronym / sponsor ID
- MENTOR / IRB-170123001
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, SCI, Telehealth, Mindfulness, Nutrition, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation, The Craig H. Neilsen Foundation
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MENTOR + Telehealth | Experimental | Behavioral: MENTOR + TelehealthThis 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 | Active comparator | Behavioral: Telehealth OnlyThis group will complete baseline and 5-days post baseline testing before beginning a one-year telehealth program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MENTOR + TelehealthParticipants 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. | Behavioural | MENTOR + Telehealth |
| Telehealth OnlyParticipants 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. | Behavioural | Telehealth Only |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
Enrolling by invitation
Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
Spinal Cord Injuries, PTSD
Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Recruiting
Reticulospinal Control of Movements
Spinal Cord Injuries, Healthy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Rimmer, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MENTOR + Telehealth and Telehealth Only in people with Spinal Cord Injuries, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.