UMIN-CTR Clinical Trial

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
Email	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
Email	ishak.halim109@gmail.com

Sponsor
Institute	University of Tsukuba
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044016