Clinical trial NCT06560619: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)
Official title: Tele-wellness Program for People With Disabilities: Mindfulness, Exercise, and Nutrition To Optimize Resilience (MENTOR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Disabled Persons
Keywords: Mobility impairment
People with physical disability
Mindfulness
Exercise
Nutrition
Technology
Mobile health
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
First posted: 2024-08-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Pre/Post 8-week Program
Secondary outcomes:
measure: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
timeFrame: Pre/Post 8-week Program
measure: Mindfulness Attention Awareness Scale (MAAS)
timeFrame: Pre/Post 8-week Program
measure: NCHPAD Wellness Assessment (NWA)
timeFrame: Pre/Post 8-week Program
measure: Nutrition Questionnaire on Mindful Eating, Habits, and Knowledge
timeFrame: Pre/Post 8-week Program
measure: Global Health
timeFrame: Pre/Post 8-week Program
Other outcomes:
measure: Proportion of individuals who express interest in MENTOR
timeFrame: Pre Program (Week 1)
measure: Representativeness of individuals who express interest in MENTOR
timeFrame: Pre Program (Week 1)
measure: Proportion of eligible participants who begin MENTOR
timeFrame: Post Program (Week 8)
measure: Proportion of eligible participants who complete MENTOR
timeFrame: Post Program (Week 8)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: Post Program (Week 8)
measure: Intervention Appropriateness Measure (IAM)
timeFrame: Post Program (Week 8)
measure: Feasibility of Intervention Measure (FIM)
timeFrame: Post Program (Week 8)
measure: The likelihood of continuing the use of MENTOR
timeFrame: Post Program (Week 8)
measure: The likelihood of recommending MENTOR
timeFrame: Post Program (Week 8)
measure: Degree of difficulty to continue MENTOR for 6 months
timeFrame: Post Program (Week 8)
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Alex Wong
role: PRINCIPAL_INVESTIGATOR
References: