UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of nutrition education to postpartum women: randomized controlled trial
Title of the study (Brief title)	The effect of nutrition education to postpartum women
Region	Japan

Condition
Condition	Healthy postpartum women
Classification by specialty	Endocrine surgery Obsterics and gynecology Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the effect of nutrition education to postpartum women on nutrient intakes and eating behavior.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nutrient intakes, eating behavior, maternal weight, physical activity, sun exposure at 1, 3 and 6 month after childbirth.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention group Intervention group is mailed their individual results of nutrient intakes and leaflets of nutritional caution investigated from self-administered diet history questionnaire. Their individual results and leaflets are mailed during one month postpartum.
Interventions/Control_2	Control group Their individual results and leaflets are mailed after postpartum 6 month investigation.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Healthy one month postpartum women who delivered living infants
Key exclusion criteria	Postpartum women who restricted diet for diabetes, high blood pressure and kidney diseases, who has serious complications and has mental disorders, and who are illiterate of Japanese.
Target sample size	400

Research contact person
Name of lead principal investigator	Masayo MATSUZAKI
Organization	The University of Tokyo
Division name	Division of Health Sciences & Nursing, Graduate school of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	+81-3-5841-3396
Email	msumi-tky@umin.ac.jp

Public contact
Name of contact person	Masayo MATSUZAKI
Organization	The University of Tokyo
Division name	Division of Health Sciences & Nursing, Graduate school of Medicine
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JAPAN
TEL	+81-3-5841-3396
Homepage URL
Email	msumi-tky@umin.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 20 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 22 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date	2016 Year 12 Month 18 Day
Date of closure to data entry	2019 Year 11 Month 11 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 20 Day
Last modified on	2017 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020431