UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054395 |
|---|---|
| Receipt number | R000062111 |
| Scientific Title | A longitudinal study on the dietary habits and mental and physical health of female elementary school children receiving nutrition education through participation in a sports club. |
| Date of disclosure of the study information | 2024/05/20 |
| Last modified on | 2025/05/15 12:57:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A longitudinal study on the dietary habits and mental and physical health of female elementary school children receiving nutrition education through participation in a sports club.
Acronym
A study on nutrition education, dietary habits, and mental and physical health of children participating in sports.
Scientific Title
A longitudinal study on the dietary habits and mental and physical health of female elementary school children receiving nutrition education through participation in a sports club.
Scientific Title:Acronym
A study on nutrition education, dietary habits, and mental and physical health of children participating in sports.
Region
| Japan |
Condition
Condition
Low nutrition
Classification by specialty
| Medicine in general | Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the actual conditions of the dietary habits, physical fitness, body composition, quality of life, and gut microbiome of elementary school children belonging to sports clubs in order to establish a nutrition education program to maintain optimal nutritional status for children to benefit from sports without the risk of Relative Energy Deficiency in Sport (RED-S) and its associated short-term and long-term health issues such as growth impairments, menstrual dysfunction in female athletes, and early onset of osteoporosis. The goal is to unveil the characteristics and relationships of these factors in order to lay the groundwork for developing a nutrition education program that ensures children maintain a state of optimal nutrition for their overall well-being in sports activities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lean body mass (at 6 months post intervention)
Key secondary outcomes
1. Evaluation of energy intake
2. Analysis of gut microbiota
3. Assessment of quality of life (QOL)
4. Measurement of grip strength
5. Shuttle run test
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
| Behavior,custom |
Interventions/Control_1
Nutrition 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
| 6 | years-old | < |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants are elementary school students who belong to youth sports clubs and have obtained the consent of their parents.
Key exclusion criteria
Those who are undergoing treatment for diseases that require dietary therapy. However, if the attending physician permits participation in the research, it is eligible. Those who have stopped exercising due to injury, etc., are excluded.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hachiya |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
0650013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
0117411051
hachiya.megumi@tenshi.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hachiya |
Organization
Tenshi College
Division name
Department of Nutrition, Faculty of Nursing and Nutrition
Zip code
0650013
Address
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
TEL
0117411051
Homepage URL
hachiya.megumi@tenshi.ac.jp
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
Kita-13, Higashi-3, Higashi-ku, Sapporo, Japan
Tel
0117411051
hachiya.megumi@tenshi.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 | 05 | Month | 20 | 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
20
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 | 05 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 14 | Day |
Last modified on
| 2025 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062111
