Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching

In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: Wellness coaching plus app use

Detailed Description

Students seeking wellness coaching will have the option to participate in this study. The study will ask participants 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
5. Allow the study team to access academic records (optional)

The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Students enrolled at the University of Michigan

Description

Inclusion Criteria:

1. University of Michigan students aged 18 years or older.
2. Students must either be coming to campus for the academic year or taking classes online for the academic year.
3. For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:

1. People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
2. Unwilling or unable to comply with the study procedures.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Students at the University of Michigan; Students enrolled in the Winter 2023 academic semester at the University of Michigan	Behavioral: Wellness coaching plus app use; Participants will participate in wellness coaching and interact with apps on their smartphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wellness Coaching + App Use	To assess the primary endpoint, the investigators will evaluate participants' opinions about the uptake of Roadmap + Wellness Coaching through semi-structured qualitative interviews. The investigators will ask questions related to the feasibility and acceptability of the: 1) Roadmap 2.0 app; 2) Fitbit device; 3) completing assessments (through the app); and 4) wellness coaching. The investigators expect the net favorability (agree + totally agree) of all four components will be >50% based on answering questions on a scale of totally disagree, disagree, neutral, agree, and totally agree to be considered feasible and acceptable to participate in.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey Completion	Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points	7 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2023
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HUM00223936

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No