UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056918 |
|---|---|
| Receipt number | R000065046 |
| Scientific Title | A Study on Nutritional Education Using the Transtheoretical Model Aimed at Improving Dietary Behaviors Among High School Soccer Players |
| Date of disclosure of the study information | 2025/02/05 |
| Last modified on | 2025/02/04 18:09:14 |
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Basic information
Public title
A Study on Nutritional Education Using the Transtheoretical Model Aimed at Improving Dietary Behaviors Among High School Soccer Players
Acronym
A Study on Nutritional Education Using the Transtheoretical Model Aimed at Improving Dietary Behaviors Among High School Soccer Players
Scientific Title
A Study on Nutritional Education Using the Transtheoretical Model Aimed at Improving Dietary Behaviors Among High School Soccer Players
Scientific Title:Acronym
A Study on Nutritional Education Using the Transtheoretical Model Aimed at Improving Dietary Behaviors Among High School Soccer Players
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to examine effective follow-up methods that support participants in transitioning from the preparation stage to the maintenance stage, thereby facilitating changes in dietary behaviors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation will be conducted after the survey of the participants is completed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Conduct five individual interviews, each lasting 15 minutes, to provide feedback on the dietary heck sheet.
Distribute five PDF versions of a nutritional newsletter that include responses to participants questions and nutritional information.
Hold three progress report meetings, each lasting 15 minutes, during which participants review the achievement status of their individually set short-term goals in pairs.
Interventions/Control_2
Distribute five PDF versions of a nutritional newsletter that include responses to participants questions and nutritional information.
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
| 15 | years-old | <= |
Age-upper limit
| 17 | years-old | > |
Gender
Male
Key inclusion criteria
The study included 18 students who belonged to high school sports clubs.
Key exclusion criteria
Individuals receiving treatment for diseases that require dietary therapy will be excluded. However, participants with mild food allergies may be included if their primary physician permits participation in the study.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Takahashi |
| Middle name | |
| Last name | yuji |
Organization
tenshi college
Division name
Graduate School of Nursing and Nutrition Science, Department of Nutritional Management, Doctoral Program (Preliminary Stage)
Zip code
0650016
Address
1-25, Kit 16-jo Higashi 3-chome, Higashi-ku, Sapporo, Hokkaido, Japan
TEL
08045016796
xhaito0419@gmail.com
Public contact
Name of contact person
| 1st name | Takahashi |
| Middle name | |
| Last name | yuji |
Organization
tenshi college
Division name
Graduate School of Nursing and Nutrition Science, Department of Nutritional Management, Doctoral Pro
Zip code
0650016
Address
1-25, Kit 16-jo Higashi 3-chome, Higashi-ku, Sapporo, Hokkaido, Japan
TEL
08045016796
Homepage URL
xhaito0419@gmail.com
Sponsor or person
Institute
tenshi college
Institute
Department
Personal name
Funding Source
Organization
tenshi college
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
tenshi college
Address
1-25, Kit 16-jo Higashi 3-chome, Higashi-ku, Sapporo, Hokkaido, Japan
Tel
08045016796
xhaito0419pgmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-93
Org. issuing International ID_1
tenshi college
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | 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
17
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065046
