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

November 26, 2024 updated by: Wing Wong, Shirley Ryan AbilityLab

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Shirley Ryan Ability Lab
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alex Wong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MENTOR Wellness Program
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.
Behavioral: MENTOR
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre/Post 8-week Program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time Frame: Pre/Post 8-week Program
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.
Pre/Post 8-week Program
Mindfulness Attention Awareness Scale (MAAS)
Time Frame: Pre/Post 8-week Program

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.
Pre/Post 8-week Program
NCHPAD Wellness Assessment (NWA)
Time Frame: Pre/Post 8-week Program
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.
Pre/Post 8-week Program
Nutrition Questionnaire on Mindful Eating, Habits, and Knowledge
Time Frame: Pre/Post 8-week Program
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.
Pre/Post 8-week Program
Global Health
Time Frame: Pre/Post 8-week Program
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.
Pre/Post 8-week Program

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of individuals who express interest in MENTOR
Time Frame: Pre 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.
Pre Program (Week 1)
Representativeness of individuals who express interest in MENTOR
Time Frame: Pre Program (Week 1)
The sociodemographic and medical characteristics of individuals will be reviewed. It measures the Reach domain in the RE-AIM framework.
Pre Program (Week 1)
Proportion of eligible participants who begin MENTOR
Time Frame: Post 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.
Post Program (Week 8)
Proportion of eligible participants who complete MENTOR
Time Frame: Post 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.
Post Program (Week 8)
Acceptability of Intervention Measure (AIM)
Time Frame: 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.
Post Program (Week 8)
Intervention Appropriateness Measure (IAM)
Time Frame: 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.
Post Program (Week 8)
Feasibility of Intervention Measure (FIM)
Time Frame: 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.
Post Program (Week 8)
The likelihood of continuing the use of MENTOR
Time Frame: Post 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.
Post Program (Week 8)
The likelihood of recommending MENTOR
Time Frame: Post 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.
Post Program (Week 8)
Degree of difficulty to continue MENTOR for 6 months
Time Frame: Post 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.
Post Program (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Collaborators

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Alex Wong, Shirley Ryan AbilityLab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00221578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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