UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047861 |
|---|---|
| Receipt number | R000054568 |
| Scientific Title | The Effect of Using a Vegetable Intake Survey on Vegetable Intake and Obesity Levels of Children Attending Pediatric Clinics for Obesity Treatment |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2024/11/13 13:13:28 |
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Basic information
Public title
Effects on vegetable intake and obesity levels in children attending pediatrics for obesity treatment.
Acronym
Effects on vegetable intake and obesity levels in children attending pediatrics for obesity treatment.
Scientific Title
The Effect of Using a Vegetable Intake Survey on Vegetable Intake and Obesity Levels of Children Attending Pediatric Clinics for Obesity Treatment
Scientific Title:Acronym
The Effect of Vegetable Intake Study on Childhood Obesity
Region
| Japan |
Condition
Condition
Healthy children
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine if conducting a survey of vegetable intake has an effect on the vegetable intake of children attending bariatric outpatient clinics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in obesity levels before and after the start of the vegetable intake survey.
Key secondary outcomes
Changes in blood markers, QOL survey, urinary markers, and questionnaire-based awareness of vegetable intake before and after the start of the survey
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Vegetable Intake Survey
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
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children who are at least 6 years old and less than 15 years old at the time consent is obtained
2) Children with a body mass index of 20% or greater, or a body mass index that is 20% or greater at the latest compared to the minimum body mass index in the past
3) Subjects who have given free and voluntary consent to the research subjects and their surrogates.
Key exclusion criteria
1) Patients with type 1 or type 2 diabetes
2) Patients with obvious underlying diseases that cause obesity, such as hypothyroidism,Prada-Willi syndrome, etc.
3) Other patients who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Asako |
| Middle name | |
| Last name | Hayashi |
Organization
Health Sciences University of Hokkaido Hospital
Division name
pediatrics
Zip code
002-8072
Address
5, Ainosato 2-jo, Kita-ku, Sapporo, Hokkaido
TEL
011-778-7575
asako-hayashi@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Asako |
| Middle name | |
| Last name | Hayashi |
Organization
Health Sciences University of Hokkaido Hospital
Division name
pediatrics
Zip code
002-8072
Address
5, Ainosato 2-jo, Kita-ku, Sapporo, Hokkaido
TEL
011-778-7575
Homepage URL
asako-hayashi@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagome Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kagome Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committEthics committee of Health Sciences University of Hokkaido Hospitalee of Health Sciences University of Hokkaido Hospital
Address
5, Ainosato 2-jo, Kita-ku, Sapporo, Hokkaido
Tel
0117787575
asako-hayashi@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）（Health Sciences University of Hokkaido Hospital）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 25 | 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
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054568
