UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044868 |
|---|---|
| Receipt number | R000051247 |
| Scientific Title | Do "Stay-at-Home Exercise" Videos Induce Behavioral Changes in College Students? A Randomized Controlled Trial |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2023/07/17 09:28:09 |
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Basic information
Public title
Do "Stay-at-Home Exercise" Videos Induce Behavioral Changes in College Students? A Randomized Controlled Trial
Acronym
Do "Stay-at-Home Exercise" Videos Induce Behavioral Changes in College Students? A Randomized Controlled Trial
Scientific Title
Do "Stay-at-Home Exercise" Videos Induce Behavioral Changes in College Students? A Randomized Controlled Trial
Scientific Title:Acronym
Do "Stay-at-Home Exercise" Videos Induce Behavioral Changes in College Students? A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The coronavirus disease pandemic has led to college students spending more time at home. "Stay-at-home exercise" videos to eliminate inactivity are now available on various digital plat-forms; however, it is unclear whether these videos have led to behavioral changes among college students. This study aimed to investigate whether "stay-at-home exercises" improved physical activity (PA) among college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
physical activity, health-related quality of life, subjective well-being, psychological stress
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
participants were instructed to watch the "stay-at-home exercise" video once every day at a time of their choice during the 8-week intervention period.
Interventions/Control_2
Participants in the control group did not receive a URL after responding to the baseline intervention. No specific instructions were given on how to spend the 8-week intervention period. After completion of the 8-week intervention, the participants were asked to complete the questionnaire again.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) students who were at least 20 years old and enrolled in an undergraduate program; 2) the ability to use a computer or smart phone with Internet connection.
Key exclusion criteria
1) not having a device to view the stay-at-home exercise video; 2) not being able to complete all questionnaires.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | FUKUI |
| Last name | Urabe |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Sports Rehabilitation
Zip code
734-8553
Address
1-2-3 Minami-ku, kasumi, Hiroshima, Japan
TEL
0822575405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fukui |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Sports Rehabilitation
Zip code
734-8553
Address
1-2-3 Minami-ku, kasumi, Hiroshima, Japan
TEL
09047832814
Homepage URL
kazuki-fukui@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Musculoskeletal Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Minami-ku, kasumi, Hiroshima, Japan
Tel
08254055909
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2071-1050/13/21/11600#metrics
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2071-1050/13/21/11600#metrics
Number of participants that the trial has enrolled
150
Results
We found that only distributing and encouraging the viewing of the stay-at-home exercise videos neither resulted in college students exercising nor increased their PA, but that it significantly improved their mental health. In other words, simply distributing exercise videos on a digital platform did not increase activity additional efforts should be made to encourage exercise.
Results date posted
| 2023 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The specific inclusion criteria for undergraduate students participating in this study were as follows (1) students who were at least 20 years old and enrolled in an undergraduate program (2) the ability to use a computer or smartphone with an internet connection. In contrast, the exclusion criteria were as follows (1) students with no device to view the stay-at-home exercise videos; (2) students incapable of completing all questionnaires.
Participant flow
This study was designed as a randomized controlled trial (RCT). Participants were recruited online and first gave their consent to the study via a Google form. Participants were then randomly assigned to either an intervention group or a control group by research staff before baseline measurements were completed (single-blind method). Randomization was performed by a computer-generated sequence with an assignment ratio of 1:1. After randomization, participants who completed the baseline questionnaire were granted access to either assigned program; after the 8-week intervention period, participants were emailed to complete a post-intervention questionnaire. Before the study, all participants provided informed consent on the website that was approved by the Epidemiology Ethics Committee of Hiroshima University (approval ID: E-2250).
Adverse events
Time Limited.
Outcome measures
The outcomes were Physical activity, health-related quality of life, subjective well-being, and psychological stress.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 15 | Day |
Last modified on
| 2023 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051247
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