UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056475 |
|---|---|
| Receipt number | R000064535 |
| Scientific Title | A pilot study on a program to improve co-ordination skills in obese children |
| Date of disclosure of the study information | 2024/12/17 |
| Last modified on | 2025/12/17 09:53:09 |
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Basic information
Public title
A pilot study on a program to improve co-ordination skills in obese children
Acronym
A pilot study on a program to improve co-ordination skills in obese children
Scientific Title
A pilot study on a program to improve co-ordination skills in obese children
Scientific Title:Acronym
A pilot study on a program to improve co-ordination skills in obese children
Region
| Japan |
Condition
Condition
obesity
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a program to enhance co-ordination skills and evaluated its feasibility
Basic objectives2
Others
Basic objectives -Others
To clarify the exercise adherence and practicality
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A questionnaire on the implementation status of the exercise program
Key secondary outcomes
A questionnaire on the adherence and frequency of the exercise program, as well as the perceived difficulty of the exercises
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
| 6 | years-old | <= |
Age-upper limit
| 13 | years-old | > |
Gender
Male and Female
Key inclusion criteria
An obesity index of 20% or higher
Key exclusion criteria
1.Patients with type 1 or type 2 diabetes
2.Patients with obvious underlying conditions causing obesity, such as hypothyroidism or Prader-Willi syndrome
3.Pacemaker recipients
4.Patients with developmental disorders accompanied by neurological impairments
5.Others deemed inappropriate as study subjects by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133231219
as-51@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sawada |
Organization
Health sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
0610293
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
TEL
0133231219
Homepage URL
as-51@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health sciences University of Hokkaido
Institute
Department
Personal name
Atsushi Sawada
Funding Source
Organization
Health sciences University of Hokkaido
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health sciences University of Hokkaido
Address
1757, Kanazawa, Tobetsu, Hokkaido, Japan
Tel
0133231211
kyo-reha@hoku-iryo-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
北海道医療大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a pilot study and will target patients attending Health Sciences University of Hokkaido Hospital.
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2025 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064535
