UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055001 |
|---|---|
| Receipt number | R000050075 |
| Scientific Title | Evaluation of the effect of dietary support using social support for university swimmers |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2024/07/17 19:33:37 |
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Basic information
Public title
Evaluation of the effect of dietary support using social support for university swimmers
Acronym
Dietary support using social support
Scientific Title
Evaluation of the effect of dietary support using social support for university swimmers
Scientific Title:Acronym
Dietary support using social support
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to implement a food support program using social support to solve problems related to the dietary habits of university student swimmers and to verify the effectiveness of the program.
Basic objectives2
Others
Basic objectives -Others
Educational effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of who eat a meal consisting of a main meal, a main dish, and a side dish at least twice a day.
Ratio of those who eat at least 5 servings of vegetable dishes per day.
Key secondary outcomes
Dietary attitude
Dietary skills
Dietary knowledge
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Dietary education
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Nothing
Key exclusion criteria
Nothing
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Tatsuta |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
154-8513
Address
3-34-1 Shimouma, Setagaya-ku, Tokyo
TEL
03-6453-1763
tatsuta.wakako@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Wakako |
| Middle name | |
| Last name | Tatsuta |
Organization
Nihon University
Division name
College of Sports Sciences
Zip code
154-8513
Address
3-34-1 Shimouma, Setagaya-ku, Tokyo
TEL
03-6453-1763
Homepage URL
tatsuta.wakako@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University
Address
3-34-1 Shimouma, Setagaya-ku, Tokyo
Tel
03-6453-1763
tatsuta.wakako@nihon-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
| 2024 | Year | 07 | Month | 30 | 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
33
Results
The program's goal of five vegetable dishes per day increased from less than 60% to about 90%. The program evaluation by the learners showed that the level of difficulty and comprehension of the program were generally good, and the program evaluation by the implementers confirmed that the program was implemented with modifications based on the evaluation of each session.
Results date posted
| 2023 | Year | 06 | Month | 29 | Day |
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
| 2021 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2024 | Year | 07 | Month | 17 | Day |
Last modified on
| 2024 | 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=R000050075
