UMIN-CTR Clinical Trial

Basic information
Public title	Strategies for food education of behaviour change models among female high-school students
Acronym	Food education among female high-school students
Scientific Title	Strategies for food education of behaviour change models among female high-school students
Scientific Title:Acronym	Food education among female high-school students
Region	Japan

Condition
Condition	None
Classification by specialty	Nursing Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The puroposes of this study are to influence of eating behaviour of female high-school studentes and their parent on their physical and psychological status.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the behaviour chang of health promotion at 6 months after food education intervention.
Key secondary outcomes	We evaluate the nutritional status, self efficacy, taste disorder and body composition before and after food education intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom Other
Interventions/Control_1	Lecture of food education program for sixty minutes for students for intervention group. No intervention for control group.
Interventions/Control_2	Food education program including lectures, group discussions,and newsletters for students and parent for intervention group. No intervention for control group.
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	15 years-old <=
Age-upper limit	170 years-old >
Gender	Female
Key inclusion criteria	Healthy
Key exclusion criteria	pregnant, and psychological problems
Target sample size	160

Research contact person
Last name of lead principal investigator	1st name Hiroko Middle name Last name Watanabe
Organization	Osaka University
Division name	Graduate School of Medicine, Health Science
Zip code	565-0871
Address	1-7 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-2520
Email	watanabe@sahs.med.osaka-u.ac.jp

Public contact
1st name of contact person	1st name Hiroko Middle name Last name Watanabe
Organization	Osaka University
Division name	Graduate School of Medicine, Health Science
Zip code	565-0871
Address	1-7 Ymadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-2520
Homepage URL
Email	watanabe@sahs.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Health Science
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine, Health Science
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	Ethic Review Board Osaka University Hospital
Address	2-2 Yamadaoka, Suita, Osaka 565-0871
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-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	2017 Year 05 Month 12 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	Main results already published
Date of protocol fixation	2017 Year 05 Month 11 Day
Date of IRB	2017 Year 05 Month 23 Day
Anticipated trial start date	2017 Year 05 Month 24 Day
Last follow-up date	2018 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	2017 Year 05 Month 12 Day
Last modified on	2019 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031302