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

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05736445
Collaborator
(none)
50
1
7.8
6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching
Actual Study Start Date :
Jan 8, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Wellness Coaching + App Use [9 months]

    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.

Secondary Outcome Measures

  1. Survey Completion [7 months]

    Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sung Won Choi, Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics, Professor of Pediatrics, University of Michigan Medical School, University of Michigan
ClinicalTrials.gov Identifier:
NCT05736445
Other Study ID Numbers:
  • HUM00223936
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 21, 2023