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Student Wellness 2.0

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06804213
Enrollment
83
Registered
2025-02-03
Start date
2025-01-27
Completion date
2025-05-29
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Issue

Keywords

mobile health, wearable sensors, college students, wellness coaching

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

Interventions

BEHAVIORALMobile health app with positive psychological activities

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

Sponsors

STEER for Student Athletes
CollaboratorUNKNOWN
University of Michigan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental healthFrom enrollment to the exit survey at 4 monthsEvaluate 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.

Secondary

MeasureTime frameDescription
Survey completionFrom enrollment to the exit survey at 4 monthsAssess survey completion rate, estimating at least 50% of participants will complete the surveys at all four time points.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026