UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017633 |
|---|---|
| Receipt number | 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 15:14:05 |
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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 | Obstetrics 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
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
msumi-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020431
