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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017633
Receipt No. R000020431
Scientific Title The effect of nutrition education to postpartum women: randomized controlled trial
Date of disclosure of the study information 2015/05/20
Last modified on 2017/05/22

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Basic information
Public title The effect of nutrition education to postpartum women: randomized controlled trial
Acronym The effect of nutrition education to postpartum women
Scientific Title The effect of nutrition education to postpartum women: randomized controlled trial
Scientific Title:Acronym 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
1st name
Middle name
Last name Masayo MATSUZAKI
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate school of Medicine
Zip code
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
1st name
Middle name
Last name Masayo MATSUZAKI
Organization The University of Tokyo
Division name Division of Health Sciences & Nursing, Graduate school of Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 22 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020431

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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