UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038619 |
|---|---|
| Receipt number | R000044016 |
| Scientific Title | Effect of and parents' willingness to pay for school feeding program at junior high schools in Tomohon City, Indonesia |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2022/11/23 14:09:02 |
* 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
Effect of and parents' willingness to pay for school feeding program
at junior high schools in Tomohon City, Indonesia
Acronym
Effect of and parents' willingness to pay for school feeding program
at junior high schools in Tomohon City, Indonesia
Scientific Title
Effect of and parents' willingness to pay for school feeding program
at junior high schools in Tomohon City, Indonesia
Scientific Title:Acronym
Effect of and parents' willingness to pay for school feeding program
at junior high schools in Tomohon City, Indonesia
Region
| Asia(except Japan) |
Condition
Condition
Healthy junior high school students in an obesity prevalent area and their parents
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the present study, we therefore provide school feeding toward student and conduct CV among parents of schoolchildren in Indonesia to investigate their WTP for a school feeding program, as well as the WTP change due to the program implementation. We will also investigate the effectiveness of the school feeding program to reduce obesity, to increase vegetable and fruit intake, as well as to improve school attendance among students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parents' willingness-to-pay toward school feeding program, students' BMI, vegetable and fruit intake, school absence
Key secondary outcomes
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
| Food |
Interventions/Control_1
Provision of school breakfast 5 times per week (once per day)
Breakfast menu is developed to meet 25-30% of target group recommended daily calorie allowance, referring to Indonesian recommended daily allowance.
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
| 10 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy students enrolled in target school and their parents
Key exclusion criteria
Students who cannot consume school feeding or attend school during study period due to physical or mental illness (including food allergy and intolerance), injury, or fasting and their parents
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Ichikawa |
Organization
University of Tsukuba
Division name
Medical department
Zip code
3058577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2111
masao@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ishak |
| Middle name | Halim |
| Last name | Octawijaya |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences
Zip code
3058577
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2111
Homepage URL
ishak.halim109@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
DANONE INSTITUTE OF JAPAN FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba
Tel
029-853-3022, 3429, 3308
sien.ningenss@un.tsukuba.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
| 2019 | Year | 12 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044016
