MENTOR Program for Disabilities

(MENTOR Trial)

Overseen By Alex Wong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Under 18, No disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MENTOR treatment for disabilities?

Research shows that exercise and lifestyle interventions, like those in the MENTOR program, can lead to significant health improvements for people with disabilities. Studies have found that such interventions often result in positive outcomes, especially when combined with technology and behavior change strategies. ^{1 2 3 4 5}

Is the MENTOR Program for Disabilities safe for humans?

The available research does not provide specific safety data for the MENTOR Program for Disabilities, but similar programs focusing on healthy eating, exercise, and wellness have been implemented without reported safety concerns. ^{6 7 8 9 10}

How is the MENTOR treatment different from other treatments for disabilities?

The MENTOR treatment is unique because it combines mindfulness, exercise, and nutrition to enhance resilience, focusing on empowering individuals with disabilities to manage their own health and participate in community wellness programs, unlike traditional treatments that may not address these holistic aspects. ^{4 7 8 11 12}

What is the purpose of this trial?

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.

Research Team

Alex Wong

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

The MENTOR program is for individuals living in the United States with mobility and physical disabilities. It aims to improve their health and wellness through a free-of-charge wellness program.

Inclusion Criteria

Lives in the United States

Has internet access and a mobile device (phone, tablet, laptop, desktop) to attend sessions

I use an assistive device for mobility or have a physical disability.

Exclusion Criteria

Living outside of the United States

I am under 18 years old.

No internet access

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Pre-Program Surveys

Participants complete 3 surveys through NCHPAD Connect before the MENTOR program begins

1 week

Online surveys

MENTOR Program

Participants engage in an 8-week wellness program focusing on mindfulness, exercise, and nutrition, with personalized health coaching

8 weeks

Weekly virtual sessions

Post-Program Surveys

Participants complete a post-program survey for NCHPAD and a post-program implementation survey through SRAlab

1 week

Online surveys

Follow-up

Participants are monitored for safety and effectiveness after the MENTOR program

4 weeks

Treatment Details

Interventions

• MENTOR

Trial Overview MENTOR, a wellness initiative by NCHPAD funded by the CDC, focuses on enhancing resilience among people with disabilities through mindfulness, nutrition, and exercise interventions.

Participant Groups

Group I: MENTOR Wellness Program Experimental Treatment 1 Intervention

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.

MENTOR is already approved in United States for the following indications:

Approved in United States as MENTOR for:

• Improving health and wellness for people with mobility and physical disabilities

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Findings from Research

A review of 132 studies found that 86% of the 22 studies with follow-up periods reported at least one significant health outcome maintained after exercise interventions for people with disabilities, indicating some sustainability of benefits.

Incorporating technology and behavior change strategies into exercise programs was linked to better maintenance of health and physical activity outcomes, suggesting that these elements are important for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustainability of exercise intervention outcomes among people with disabilities: a secondary review. Lai, B., Kim, Y., Wilroy, J., et al.[2020]

A physical activity counseling intervention for older adults (ages 75-81) showed a significant ability to prevent new cases of instrumental activity of daily living (IADL) disability, with a risk ratio of 0.68 for those without baseline disability.

While the intervention did not significantly reduce existing IADL disability, it suggests potential benefits in delaying the onset of disability, indicating the need for further research in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of physical activity counseling on disability in older people: a 2-year randomized controlled trial. von Bonsdorff, MB., Leinonen, R., Kujala, UM., et al.[2008]

A review of 132 studies over the past 10 years found that exercise interventions for people with physical and cognitive disabilities, particularly those with multiple sclerosis, stroke, and spinal cord injuries, primarily used randomized controlled trial designs and reported significant positive outcomes in 80% of cases.

Technology and behavioral theories were key components in these interventions, with 20% of studies incorporating technology and 18% using behavioral strategies, suggesting that these elements can enhance adherence and effectiveness in promoting physical activity among individuals with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Trends in Exercise Intervention Research, Technology, and Behavioral Change Strategies for People With Disabilities: A Scoping Review. Lai, B., Young, HJ., Bickel, CS., et al.[2022]

A 12-week community-based exercise program called FitSkills significantly reduced discomfort levels among university student mentors when interacting with individuals with disabilities, with a 32.8% reduction in discomfort scores immediately after the program.

The positive changes in attitudes towards disability were sustained for up to 15 months after completing the FitSkills program, indicating long-term benefits of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fostering positive attitudes towards interacting with young people with disability among health students: a stepped-wedge trial. Shields, N., Bhowon, Y., Prendergast, L., et al.[2023]

The 12-month lifestyle intervention for individuals with impaired mobility resulted in a significant average weight loss of 3.31 kg, demonstrating its effectiveness in promoting healthy lifestyle changes.

The program showed high feasibility with a retention rate of 74.2% and attendance of 77.7% for core sessions, indicating that participants were engaged and committed to the intervention despite their mobility challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Lifestyle Balance Adapted for Individuals With Impaired Mobility: Outcomes for 6-Month RCT and Combined Groups at 12 Months. Froehlich-Grobe, K., Betts, AC., Driver, SJ., et al.[2021]

The study involved 75 adult women with mobility limitations and assessed the effectiveness of a 6-month intervention promoting physical activity through behavioral techniques, social support, and education.

While there were no significant improvements in fitness measures or reduction in secondary conditions, the experimental group significantly increased their total weekly physical activity, demonstrating that mobility-impaired women can successfully adopt and maintain a physical activity program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting physical activity among women with mobility impairments: a randomized controlled trial to assess a home- and community-based intervention. Froehlich-Grobe, K., White, GW.[2019]

A pilot study involving 17 young adults with Autism Spectrum Disorder and intellectual disabilities showed that a year-long healthy eating and exercise program led to significant weight loss in some participants and maintenance of weight during COVID-19.

Participants and their parents reported increased knowledge and positive changes in health behaviors, indicating the program's effectiveness, although further research with control groups is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Pilot Healthy Eating and Exercise Program for Young Adults with Autism Spectrum Disorder and Intellectual Disabilities. Nabors, L., Overstreet, A., Carnahan, C., et al.[2022]

People with disabilities face significant health disparities due to inadequate access to wellness programs, leading to higher rates of secondary conditions like obesity and type 2 diabetes.

A proposed three-stage model aims to improve health equity by promoting person-centered referrals to inclusive wellness programs, empowering individuals with disabilities to manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing Disability Inequities: Let's Stop Admiring the Problem and Do Something about It. Rimmer, JH.[2023]

Support staff providing care for individuals with intellectual and developmental disabilities (IDD) showed significant improvements in health behaviors after participating in a 12-week HealthMatters Program, including increased fruit and vegetable intake and better nutrition knowledge.

The study, involving 48 IDD support staff, highlights the importance of health education programs for caregivers, suggesting that such initiatives can enhance their health and well-being, which may ultimately benefit the individuals they support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the HealthMatters Train-the-Trainer Program on the Health and Health Behaviors of Staff Supporting Adults With Intellectual and Developmental Disabilities. Marks, B., Sisirak, J., Chang, YC., et al.[2021]

In a study of 239 chemical veterans, perceived social support was identified as the strongest predictor of health-promoting behaviors, highlighting its importance in enhancing physical and mental health.

The Health Promotion Model (HPM) was found to be a poor predictor of health-promoting lifestyles, suggesting that improving social support, along with self-efficacy and reducing barriers, could lead to better health behaviors among veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Factors on Health-Promoting Lifestyle Among Iranian Chemical Veterans in 2014 Based on Health Promotion Model: A Path Analysis. Chenary, R., Noroozi, A., Tavafian, SS., et al.[2022]

A 16-week community-based fitness program for 28 children with disabilities showed high attendance (75.3%) and no reported injuries, indicating the program's safety and feasibility.

Significant improvements were observed in all measured outcomes, particularly in functional mobility, which had a large effect size of 0.87, demonstrating the program's effectiveness in enhancing physical abilities in children with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a community-based group fitness program for children with disabilities. Fragala-Pinkham, MA., Haley, SM., Goodgold, S.[2019]

The 12-week student-mentored community-based exercise program successfully engaged 19 youth with disabilities, showing high attendance (91% of sessions) and significant improvements in strength and walking endurance.

Participants experienced positive effects on their physical and psychological well-being, indicating that such programs are not only feasible but also beneficial for youth with disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A community-based exercise program to increase participation in physical activities among youth with disability: a feasibility study. Shields, N., van den Bos, R., Buhlert-Smith, K., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Sustainability of exercise intervention outcomes among people with disabilities: a secondary review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of physical activity counseling on disability in older people: a 2-year randomized controlled trial. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Current Trends in Exercise Intervention Research, Technology, and Behavioral Change Strategies for People With Disabilities: A Scoping Review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Fostering positive attitudes towards interacting with young people with disability among health students: a stepped-wedge trial. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Group Lifestyle Balance Adapted for Individuals With Impaired Mobility: Outcomes for 6-Month RCT and Combined Groups at 12 Months. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Promoting physical activity among women with mobility impairments: a randomized controlled trial to assess a home- and community-based intervention. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a Pilot Healthy Eating and Exercise Program for Young Adults with Autism Spectrum Disorder and Intellectual Disabilities. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Addressing Disability Inequities: Let's Stop Admiring the Problem and Do Something about It. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Impact of the HealthMatters Train-the-Trainer Program on the Health and Health Behaviors of Staff Supporting Adults With Intellectual and Developmental Disabilities. [2021]

10. Estonia pubmed.ncbi.nlm.nih.gov

Effective Factors on Health-Promoting Lifestyle Among Iranian Chemical Veterans in 2014 Based on Health Promotion Model: A Path Analysis. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a community-based group fitness program for children with disabilities. [2019]

12. England pubmed.ncbi.nlm.nih.gov

A community-based exercise program to increase participation in physical activities among youth with disability: a feasibility study. [2020]