NCT06560619

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Oct 2024Aug 2026

First Submitted

Initial submission to the registry

August 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

August 14, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Mobility impairmentPeople with physical disabilityMindfulnessExerciseNutritionTechnologyMobile health

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre/Post 8-week Program

Secondary Outcomes (5)

  • Godin Leisure-Time Exercise Questionnaire (GLTEQ)

    Pre/Post 8-week Program

  • Mindfulness Attention Awareness Scale (MAAS)

    Pre/Post 8-week Program

  • NCHPAD Wellness Assessment (NWA)

    Pre/Post 8-week Program

  • Nutrition Questionnaire on Mindful Eating, Habits, and Knowledge

    Pre/Post 8-week Program

  • Global Health

    Pre/Post 8-week Program

Other Outcomes (10)

  • Proportion of individuals who express interest in MENTOR

    Pre Program (Week 1)

  • Representativeness of individuals who express interest in MENTOR

    Pre Program (Week 1)

  • Proportion of eligible participants who begin MENTOR

    Post Program (Week 8)

  • +7 more other outcomes

Study Arms (1)

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.

Behavioral: MENTOR

Interventions

MENTORBEHAVIORAL

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.

MENTOR Wellness Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alex Wong

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Director, Center for Rehabilitation Outcomes Research

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations