Student Wellness 2.0

NCT06804213 | Completed

• 1 other identifier: HUM00257823
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

In this randomized controlled study, investigators plan to assess the impact of a mobile health app with positive psychological combined with wellness coaching on college student mental health outcomes. The study aims to differentiate the effectiveness of combining mobile health and wellness coaching compared to wellness coaching on its own. The goal is to improve our understanding of the optimal combination of traditional in-person and digital interventions on diverse student populations, as well as better understand the causal impact of the mobile health app on well-being.

Conditions

Mental Health Issue

Keywords

mobile health; wearable sensors; college students; wellness coaching

Outcome Measures

Primary Outcomes (1)

• Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health

  Evaluate the difference between the intervention (Roadmap 2.0 + wellness coaching) arm and the control (limited Roadmap 2.0 + wellness coaching) arm by measuring the effectiveness of Roadmap 2.0 when coupled with wellness coaching. Participants will complete validated quality-of-life surveys, which measure subject-reported outcomes related to mental health.

  From enrollment to the exit survey at 4 months

Secondary Outcomes (1)

• Survey completion

  From enrollment to the exit survey at 4 months

Study Arms (2)

Wellness coaching plus mobile health app (positive activities)

EXPERIMENTAL

Participants will participate in wellness coaching and receive a wearable device, and they will be assigned to use the mobile health app with positive psychological activities installed. Additionally, participants can view their daily step count and number of hours of sleep in the mobile health app.

Behavioral: Mobile health app with positive psychological activities

Wellness coaching plus limited mobile health app (no positive activities)

NO INTERVENTION

Participants will participate in wellness coaching and receive a wearable device, but will be assigned to use the mobile health app WITHOUT positive psychological activities installed. Participants can only view their daily step count and number of hours of sleep in the mobile health app.

Interventions

Mobile health app with positive psychological activities BEHAVIORAL

Mobile health app with step tracking, sleep tracking, and positive psychological activities

Wellness coaching plus mobile health app (positive activities)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years old.
• Students must be either enrolled at the University of Michigan OR in the STEER transition program.
• Potential subjects must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials (e.g., Fitbit, compensation).
• Possess a smartphone (Apple or Android).
• Ability to understand and demonstrate willingness to remotely sign a written informed consent document

You may not qualify if:

• People who are not enrolled in classes at the University of Michigan OR people who are not members of the STEER organization.
• Unwilling or unable to comply with the study procedures

Sponsors & Collaborators

• University of Michigan: lead
• STEER for Student Athletes: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

STEER for Student Athletes

Port Chester, New York, 10573, United States

Location

Study Officials

• Sung Won Choi, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: January 27, 2025
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)