NCT05537532

Brief Summary

The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,486

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

September 9, 2022

Last Update Submit

September 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average daily step count

    Participants' daily step counts are recorded through a Fitbit or an apple watch. High step counts are considered a positive outcome as it indicates more physical activity. For teams randomized into competition arm and randomized to compete on step count, their average daily step count is compared with the average step count of the opponent team.

    Daily, throughout intern year (1 year)

Secondary Outcomes (1)

  • Average daily mood score

    Daily, throughout intern year (1 year)

Study Arms (2)

Competition group

EXPERIMENTAL

Programs with at least five interns were grouped into program-based teams. Interns within the same residency institution in programs that did not meet this criterion were grouped into institution-based teams, with a minimum of five participants per team. For each week, an eligible team is randomized to either a steps competition or non-competition group with 50/50 chance. For those randomized to competition arm, teams were assigned an opponent team by total randomization, by which the opponent team was assigned regardless of institution and specialty.

Behavioral: Intern Health Study competition-related mobile notificationBehavioral: Intern Health Study mobile appBehavioral: Intern Health Study mobile app competition scoreboard and history

Non-competition group

EXPERIMENTAL

For each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance.

Behavioral: Intern Health Study mobile app

Interventions

Participants will receive three types of push notifications: 1. Alert of competition type (steps or sleep) and opponent (Sunday 9pm), 2. Competition score status update (Wednesday 9pm, Saturday 11am), and 3. Competition final results (Monday 12pm).

Competition group

The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.

Competition groupNon-competition group

Participant can view their current competition scoreboard and competition history at any time via the study app.

Competition group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Medical intern during the 2021-2022 internship year
  • Enrolled in study by the start of internship (7/1/22)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Health Records, Personal

Intervention Hierarchy (Ancestors)

Medical RecordsRecordsData CollectionEpidemiologic MethodsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomization scheme
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

April 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 13, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).

Shared Documents
ICF
Time Frame
Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.
Access Criteria
The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.
More information

Locations