Disabled PersonsMENTORNCT06560619
Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)
A study testing MENTOR in people with Disabled Persons, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The Mindfulness, Nutrition and Exercise to Optimize Resilience (MENTOR) program is offered through the National Center on Health, Physical Activity and Disability (NCHPAD). NCHPAD is funded by the Centers for Disease Control and Prevention (CDC), is a public health practice that offers health promotion programs and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disabled Persons
- What is being tested?
- MENTOR
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lives in the United States
- People 18 years or older
- A self-reported physical disability/mobility limitation (or use an assistive device such as an ankle foot orthosis, cane, walker, scooter, or wheelchair).
- Have internet access and a mobile device (phone, tablet, laptop, desktop) to attend sessions.
Who cannot join
- Younger than 18 years old
- Living outside of the United States
- No physical disability/mobility limitation
- No internet access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan Ability Lab
Chicago, Illinois, 60611
Lorie Cashdollar, BA, 312-238-8046, lcashdolla@sralab.org
Alex Wong, PhD, wwong@sralab.org
About this study
Official title: Tele-wellness Program for People With Disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)
The Mindfulness, Nutrition and Exercise to Optimize Resilience (MENTOR) program is offered through the National Center on Health, Physical Activity and Disability (NCHPAD). NCHPAD is funded by the Centers for Disease Control and Prevention (CDC), is a public health practice that offers health promotion programs and resources to people with mobility disabilities. The purpose of this project is to provide a free-of-charge wellness program designed to improve health and wellness for people with mobility and physical disability living in the United States.
Read the detailed description
The objective of the MENTOR program is to improve wellness for people with mobility limitations. MENTOR is a free, 8-week program focusing on physical, mental, and emotional health for individuals with an existing disability or a recent diagnosis. The program provides core information on mindfulness, exercise, and nutrition. Participants get one-on-one health coaching and access to a fitness instructor, registered dietician, and mindfulness coach. The classes are virtual, and the exercise equipment needed for the classes will be mailed to participants.
The research question is to measure the effectiveness and implementation of the MENTOR program.
Participants will be asked to fill out an eligibility sign-up form on NCHPAD. If eligible, they will be consented by Shirley Ryan AbilityLab (SRAlab) via REDCap. On the same SRAlab REDCap survey link, after the consent form, they will be able to complete an interest form. If selected, participants will be asked to complete 3 surveys through NCHPAD Connect before the MENTOR program begins.
Once the 8-week MENTOR program is complete, you will be asked to complete a post-program survey for NCHPAD about your experience, and a post-program implementation survey through SRAlab.
- Conditions
- Disabled Persons
- Being tested
- MENTOR
- Keywords
- Mobility impairment, People with physical disability, Mindfulness, Exercise, Nutrition, Technology, Mobile health
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENTORBehavioural
Participants will attend a group-based, 8-week online program (a total of 40 hours) via Zoom videoconferencing. The program is split into three wellness sections (Mindfulness, Exercise, and Nutrition) and eight other sections (self-care skills, core values, outdoor time in nature, rest/relaxation, contribution to others, arts and leisure, relationships, and spiritual practice). Participants will access all assessment and intervention tools on any mobile device (phone, tablet, laptop, desktop) using a password-protected identification (ID) to log in via their devices. Health coaches can create intake flows to collect health data and track analytics. Participants can see their goals, upcoming intervention sessions, and activities through the study application (app). Features of the study app include goal setting, where participants record their goals, zoom videoconferencing links for online classes and coaching sessions, and the ability to share materials with participants.
| Study group | Role | What they receive |
|---|---|---|
| MENTOR Wellness Program | Experimental | MENTOR is an 8-week group program conducted via videoconferencing, designed for individuals with physical disabilities in the United States to enhance their health and well-being. The program includes 1 hour per week of mindfulness training, 2 hours per week of exercise, and 1 hour per week of nutrition education. Participants will also receive personalized health coaching and have access to a fitness instructor, registered dietician, and mindfulness coach. Additionally, participants will receive information on 8 other areas, including self-care skills, core values, outdoor time in nature, rest/relaxation, contributing to others, arts and leisure, relationships, and spiritual practice, all taught by a trained health coach over the 8-week period. Receives: Behavioral: MENTOR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connor-Davidson Resilience Scale (CD-RISC)
This is a resilience measure to gain a better understanding of whether the program had any benefit to improving resilience. It consists of 10 items.The response scale has a 5-point range from 0 to 4. Scores are summed to provide a total score of 40, where higher scores indicate higher resilience. It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
Secondary outcomes (5)
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
A self-report measure of physical activity. It is a 7-day recall questionnaire that contains 3 questions pertaining to light, moderate, and vigorous intensity activity. The GLTEQ can be scored either by summing all 3 intensity types (Total Activity score) after multiplying each by 3, 5, and 9, respectively, or by summing moderate and vigorous activity only (Health Promotion score). It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
Mindfulness Attention Awareness Scale (MAAS)
This is a mindfulness scale which is used to identify potential changes in mindfulness.
This scale contains 15 items that ask participants how frequently they have a certain experience, using a 6-point Likert scale from 1 to 6. The score is calculated by calculating the mean of these 15 items. Higher scores reflect more mindfulness. It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
NCHPAD Wellness Assessment (NWA)
This assessment has 3 dimensions which are physical, mental, and emotional/spiritual health. Each dimension has 5 questions, and an additional question assesses the overall wellness (16 questions total). The NWA is scored on a Likert scale from 1-5. Higher scores reflect better wellness. It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
Nutrition Questionnaire on Mindful Eating, Habits, and Knowledge
It is a survey to identify which dietary advice people find confusing. It consists of 3 domains: nutrition knowledge (24 items), mindful eating assessment (2 items), and eating habits (13 items).It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
Global Health
It is a Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Scale V1.2 for an overall evaluation of one's physical and mental health. It consists of 10 items. Raw scores can be converted to T-scores, with higher scores reflect better health. It measures the Effectiveness of the RE-AIM framework.
Measured: Pre/Post 8-week Program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disabled PersonsStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Principal investigator, Wing Wong, Shirley Ryan AbilityLab
- Investigators
- Alex Wong, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560619
- Sponsor's protocol ID
- STU00221578
- Acronym
- MENTOR
- Status last verified
- Nov 2024
- First submitted
- 14 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-wellness Program for People With Disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)
- ClinicalTrials.gov ID
- NCT06560619
- Acronym / sponsor ID
- MENTOR / STU00221578
- Conditions
- Disabled Persons
- Keywords
- Mobility impairment, People with physical disability, Mindfulness, Exercise, Nutrition, Technology, Mobile health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 19 Aug 2024 (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 Mindfulness, Nutrition and Exercise to Optimize Resilience (MENTOR) program is offered through the National Center on Health, Physical Activity and Disability (NCHPAD). NCHPAD is funded by the Centers for Disease Control and Prevention (CDC), is a public health practice that offers health promotion programs and resources to people with mobility disabilities. The purpose of this project is to provide a free-of-charge wellness program designed to improve health and wellness for people with mobility and physical disability living in the United States.
Detailed description
The objective of the MENTOR program is to improve wellness for people with mobility limitations. MENTOR is a free, 8-week program focusing on physical, mental, and emotional health for individuals with an existing disability or a recent diagnosis. The program provides core information on mindfulness, exercise, and nutrition. Participants get one-on-one health coaching and access to a fitness instructor, registered dietician, and mindfulness coach. The classes are virtual, and the exercise equipment needed for the classes will be mailed to participants.
The research question is to measure the effectiveness and implementation of the MENTOR program.
Participants will be asked to fill out an eligibility sign-up form on NCHPAD. If eligible, they will be consented by Shirley Ryan AbilityLab (SRAlab) via REDCap. On the same SRAlab REDCap survey link, after the consent form, they will be able to complete an interest form. If selected, participants will be asked to complete 3 surveys through NCHPAD Connect before the MENTOR program begins.
Once the 8-week MENTOR program is complete, you will be asked to complete a post-program survey for NCHPAD about your experience, and a post-program implementation survey through SRAlab.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MENTOR Wellness Program | Experimental | Behavioral: MENTORMENTOR is an 8-week group program conducted via videoconferencing, designed for individuals with physical disabilities in the United States to enhance their health and well-being. The program includes 1 hour per week of mindfulness training, 2 hours per week of exercise, and 1 hour per week of nutrition education. Participants will also receive personalized health coaching and have access to a fitness instructor, registered dietician, and mindfulness coach. Additionally, participants will receive information on 8 other areas, including self-care skills, core values, outdoor time in nature, rest/relaxation, contributing to others, arts and leisure, relationships, and spiritual practice, all taught by a trained health coach over the 8-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Lives in the United States
- People 18 years or older
- A self-reported physical disability/mobility limitation (or use an assistive device such as an ankle foot orthosis, cane, walker, scooter, or wheelchair).
- Have internet access and a mobile device (phone, tablet, laptop, desktop) to attend sessions.
Key exclusion criteria (4 listed)
- Younger than 18 years old
- Living outside of the United States
- No physical disability/mobility limitation
- No internet access
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 |
|---|---|---|
| MENTORParticipants will attend a group-based, 8-week online program (a total of 40 hours) via Zoom videoconferencing. The program is split into three wellness sections (Mindfulness, Exercise, and Nutrition) and eight other sections (self-care skills, core values, outdoor time in nature, rest/relaxation, contribution to others, arts and leisure, relationships, and spiritual practice). Participants will access all assessment and intervention tools on any mobile device (phone, tablet, laptop, desktop) using a password-protected identification (ID) to log in via their devices. Health coaches can create intake flows to collect health data and track analytics. Participants can see their goals, upcoming intervention sessions, and activities through the study application (app). Features of the study app include goal setting, where participants record their goals, zoom videoconferencing links for online classes and coaching sessions, and the ability to share materials with participants. | Behavioural | MENTOR Wellness Program |
Primary outcome
Connor-Davidson Resilience Scale (CD-RISC)
Time frame: Pre/Post 8-week Program
This is a resilience measure to gain a better understanding of whether the program had any benefit to improving resilience. It consists of 10 items.The response scale has a 5-point range from 0 to 4. Scores are summed to provide a total score of 40, where higher scores indicate higher resilience. It measures the Effectiveness of the RE-AIM framework.
5 secondary outcomes
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Pre/Post 8-week Program
Mindfulness Attention Awareness Scale (MAAS)
Time frame: Pre/Post 8-week Program
NCHPAD Wellness Assessment (NWA)
Time frame: Pre/Post 8-week Program
Nutrition Questionnaire on Mindful Eating, Habits, and Knowledge
Time frame: Pre/Post 8-week Program
Global Health
Time frame: Pre/Post 8-week Program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Alex Wong principal investigator
Shirley Ryan AbilityLab
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 in people with Disabled Persons, run by Shirley Ryan AbilityLab 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 27 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex Wong (3122381742, wwong@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connor-Davidson Resilience Scale (CD-RISC) (time frame: Pre/Post 8-week Program). 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 27 Nov 2024.