UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044035 |
|---|---|
| Receipt number | R000050282 |
| Scientific Title | The role of lifestyle behaviors on mental health in children during the COVID-19 lockdown |
| Date of disclosure of the study information | 2023/05/05 |
| Last modified on | 2021/04/25 17:12:13 |
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Basic information
Public title
Dr. Zameni
Acronym
Zamani
Scientific Title
The role of lifestyle behaviors on mental health in children during the COVID-19 lockdown
Scientific Title:Acronym
The role of lifestyle behaviors on mental health in children during the COVID-19 lockdown
Region
| Asia(except Japan) |
Condition
Condition
in progress
Classification by specialty
| Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A
B
Basic objectives2
Others
Basic objectives -Others
A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
there is a significant relationship between child's lifestyle and their mental health
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 4 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
being inactive through last week
Key exclusion criteria
being active through last week
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | Leila |
| Middle name | |
| Last name | Zameni |
Organization
Sari Azad University
Division name
Sari
Zip code
4816119318
Address
Sari, the Azad University
TEL
09112530053
l_zameni@yahoo.com
Public contact
Name of contact person
| 1st name | Leila |
| Middle name | |
| Last name | Zameni |
Organization
Sari Azad University
Division name
Sari Azad University
Zip code
4816119318
Address
Sari, the Azad University
TEL
09112530053
Homepage URL
l_zameni@yahoo.com
Sponsor or person
Institute
Sari Azad University
Institute
Department
Personal name
Funding Source
Organization
Sari Azad University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sari Azad University
Address
Sari, the Azad University
Tel
09112530053
l_zameni@yahoo.com
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
| 2023 | Year | 05 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
descriptive case series study
Management information
Registered date
| 2021 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050282
