Student Wellness 2.0

NCT ID: NCT06804213

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-27
• Study Completion Date: 2025-05-29

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.

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

Conditions

Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile health app with positive psychological activities

Intervention Type: BEHAVIORAL

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile health app with positive psychological activities

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

STEER for Student Athletes

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Sung Won Choi

Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung Won Choi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

STEER for Student Athletes

Port Chester, New York, United States

Countries

United States

Other Identifiers

HUM00257823

Identifier Type: -

Identifier Source: org_study_id