NCT06019156

Brief Summary

This study explored whether exercise video distribution using metaverse space is effective in increasing physical activity among young people, along with mental health and locomotive function. This is a randomized parallel-group study. Participants will be assigned to 3 groups: a metaverse group, a YouTube group, and a control group. The metaverse group will receive eight 10-minute exercise videos each week with approximately 4 to 8 METs (metabolic equivalents of task) in the metaverse space to encourage exercise, and the YouTube group will receive access to the same exercise videos as the metaverse group. The control group was given no specific instructions. The intervention period was 8 weeks, and physical activity and other items were measured before and after the intervention. These pre- and post-intervention measurements will be used to determine whether the delivery of exercise videos via Metaverse is effective in increasing physical activity in young adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2022

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

June 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 6, 2023

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    The short form of the International Physical Activity Questionnaire Short Form was used to measure the effect of an intervention.

    The pre-measurement answered the most recent week, and the post-measurement responded to the next week after the 8 weeks intervention was finished.

Secondary Outcomes (5)

  • Well-being

    Pre- and post- 8 weeks intervention

  • Psychological distress

    Pre- and post- 8 weeks intervention

  • Locomotive syndrome risk tests

    Pre- and post- 8 weeks intervention

  • Social capital

    Pre- and post- 8 weeks intervention

  • Quality of life (QOL)

    Pre- and post- 8 weeks intervention

Study Arms (3)

metaverse group

EXPERIMENTAL
Behavioral: Exercise video distribution of Metaverse

YouTube group

ACTIVE COMPARATOR
Behavioral: Exercise video distribution of YouTube

Control group

NO INTERVENTION

Interventions

Participants received a 10-minute exercise video each week with a load of about 4 to 8 metabolic equivalents of task (METs) in the metaverse space, for eight videos delivered to encourage exercise.

metaverse group

Participants view exercise videos with the same content as the metaverse group.

YouTube group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • individuals aged 18-30 at the time of obtaining consent
  • who owned a smartphone or computer and had internet access
  • who did not belong to an exercise community, such as a sports club

You may not qualify if:

  • individuals who had a history of a disease that prohibited exercise
  • individuals whose physical activity was \> 3000 metabolic equivalents of task (METs)/week
  • pregnant (or possibly pregnant) women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, Japan

Location

Related Publications (1)

  • Mizuta R, Maeda N, Tashiro T, Suzuki Y, Kuroda S, Ishida A, Oda S, Watanabe T, Tamura Y, Komiya M, Urabe Y. Effectiveness of Metaverse Space-Based Exercise Video Distribution in Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2024 Jan 16;12:e46397. doi: 10.2196/46397.

Study Officials

  • Yukio Urabe, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Doctoral student of Graduate School of Biomedical and Health Sciences Hiroshima University

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 31, 2023

Study Start

June 13, 2022

Primary Completion

December 11, 2022

Study Completion

February 10, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

There are no plans to make Individual Participant Data (IPD) available to other researchers.

Locations