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Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)

Tele-wellness Program for People With Disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06560619
Acronym
MENTOR
Enrollment
300
Registered
2024-08-19
Start date
2024-10-01
Completion date
2026-08-31
Last updated
2024-11-27

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

Conditions

Disabled Persons

Keywords

Mobility impairment, People with physical disability, Mindfulness, Exercise, Nutrition, Technology, Mobile health

Brief 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 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.

Interventions

BEHAVIORALMENTOR

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.

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

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

Inclusion criteria

* 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.

Exclusion criteria

* Younger than 18 years old * Living outside of the United States * No physical disability/mobility limitation * No internet access

Design outcomes

Primary

MeasureTime frameDescription
Connor-Davidson Resilience Scale (CD-RISC)Pre/Post 8-week ProgramThis 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.

Secondary

MeasureTime frameDescription
Godin Leisure-Time Exercise Questionnaire (GLTEQ)Pre/Post 8-week ProgramA 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.
Mindfulness Attention Awareness Scale (MAAS)Pre/Post 8-week ProgramThis 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.
NCHPAD Wellness Assessment (NWA)Pre/Post 8-week ProgramThis 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.
Nutrition Questionnaire on Mindful Eating, Habits, and KnowledgePre/Post 8-week ProgramIt 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.
Global HealthPre/Post 8-week ProgramIt 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.

Other

MeasureTime frameDescription
Feasibility of Intervention Measure (FIM)Post Program (Week 8)It measures if the intervention is feasible for use, dissemination, and delivery. This is a 4-item, 5-point Likert scale. Higher scores reflect higher feasibility. It measures the Implementation domain of the RE-AIM framework.
The likelihood of continuing the use of MENTORPost Program (Week 8)It will be measured by a single question: How likely are you to continue using MENTOR? It will be rated from 1-10 scale. Higher ratings represent a higher likelihood of continuing. It measures the Maintenance domain of the RE-AIM.
Proportion of individuals who express interest in MENTORPre Program (Week 1)This measure will be a proportion of contacted individuals who complete an eligibility survey. The proportion ranges from 0 to 100 percent. Higher percentages represent a higher reach. It measures the Reach domain in the RE-AIM framework.
Degree of difficulty to continue MENTOR for 6 monthsPost Program (Week 8)It will be measured by a single question: How difficult are you to continue MENTOR for 6 months? It will be rated from the response options: extremely easy, moderately easy, slightly easy, neither easy nor difficult, slightly difficult, moderately difficult, extremely difficult. Participants choosing extremely easy, moderately easy, and slightly easy represent lower degree of difficulty, reflecting a higher maintenance. It measures the Maintenance domain of the RE-AIM.
The likelihood of recommending MENTORPost Program (Week 8)It will be measured by a single question: How likely are you to recommend MENTOR to others? It will be rated from 1-10 scale. Higher ratings represent a higher likelihood of recommending. It measures the Maintenance domain of the RE-AIM.
Representativeness of individuals who express interest in MENTORPre Program (Week 1)The sociodemographic and medical characteristics of individuals will be reviewed. It measures the Reach domain in the RE-AIM framework.
Proportion of eligible participants who begin MENTORPost Program (Week 8)This will measure the proportion of eligible participants who consent, complete a baseline survey, and start MENTOR. The proportion ranges from 0 to 100 percent. Higher percents represent a higher adoption. It measures the Adoption component of the RE-AIM framework.
Proportion of eligible participants who complete MENTORPost Program (Week 8)This will measure the proportion of eligible participants who retain and complete MENTOR. The proportion ranges from 0 to 100 percent. Higher percents represent a higher adoption. It measures the Adoption component of the RE-AIM framework.
Acceptability of Intervention Measure (AIM)Post Program (Week 8)It measures the intervention's acceptability. This is a 4-item, 5-point Likert scale. Higher scores reflect higher acceptability. It measures the Implementation domain of the RE-AIM framework.
Intervention Appropriateness Measure (IAM)Post Program (Week 8)It measures if the intervention is appropriate for intended users. This is a 4-item, 5-point Likert scale.Higher scores reflect higher appropriateness. It measures the Implementation domain of the RE-AIM framework.

Countries

United States

Contacts

Primary ContactAlex Wong
wwong@sralab.org3122381742

Outcome results

None listed

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