Student Wellness 2.0

July 2, 2025 updated by: Sung Won Choi, University of Michigan

A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap mHealth App and Wellness Coaching

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants will be asked to:

  1. Complete as many sessions of individual wellness coaching as they see fit
  2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
  3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study
  4. Complete an exit interview at the end of the study

Study Type

Interventional

Enrollment (Actual)

83

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 Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • Port Chester, New York, United States, 10573
        • STEER for Student Athletes

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

Yes

Description

Inclusion Criteria:

  1. Must be at least 18 years old.
  2. Students must be either enrolled at the University of Michigan OR in the STEER transition program.
  3. 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).
  4. Possess a smartphone (Apple or Android).
  5. Ability to understand and demonstrate willingness to remotely sign a written informed consent document

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wellness coaching plus mobile health app (positive activities)
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
Mobile health app with step tracking, sleep tracking, and positive psychological activities
No Intervention: Wellness coaching plus limited mobile health app (no positive activities)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health
Time Frame: From enrollment to the exit survey at 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey completion
Time Frame: From enrollment to the exit survey at 4 months
Assess survey completion rate, estimating at least 50% of participants will complete the surveys at all four time points.
From enrollment to the exit survey at 4 months

Collaborators and Investigators

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

Sponsor

University of Michigan

Collaborators

STEER for Student Athletes

Investigators

  • Principal Investigator: Sung Won Choi, MD, MS, University of Michigan

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)

January 27, 2025

Primary Completion (Actual)

May 29, 2025

Study Completion (Actual)

May 29, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HUM00257823

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

product manufactured in and exported from the U.S.

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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