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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034762
Receipt No. R000039128
Official scientific title of the study Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/28

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Basic information
Official scientific title of the study Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Title of the study (Brief title) Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Region
Japan

Condition
Condition Low BMI pregnant women
Classification by specialty
Obsterics and gynecology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We are aiming to utilize the popularity of manga and deliver the evidence of nutritional recommendations to reduce low birthweight identified through our review with sequential art and simple text. Our target population are underweight women with a BMI below 18.5kg/squared meter as they have a higher risk of delivering a LBW infant. We expect that using manga will have a greater impact on women's behavior as it is easier to memorize than text.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LBW rate, mean birthweight, behavior change (BDHQ)
Key secondary outcomes Small-for-Gestational Age (SGA), Preterm birth (PTB), Gestational weight gain (GWG)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Women in the intervention group will receive the manga booklet providing information about maternal feud choices which effectively benefit to refuse growth during the visit at the maternal facility in early pregnancy.
Interventions/Control_2 Women in the control group will receive the standard cares during the visit at the maternal facility.
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
18 years-old <=
Age-upper limit
45 years-old >
Gender Female
Key inclusion criteria The eligibility criteria included no chronic diseases, no eating disorder, singleton pregnancy, and until 12 weeks pregnancy.
Key exclusion criteria Exclusion criteria were obstetric or medical complications of pregnancy.
Target sample size 800

Research contact person
Name of lead principal investigator Katharina da Silva Lopes
Organization St. Luke's International University
Division name Global Health Nursing
Address 10-1 Akashicho Chuo-ku, Tokyo, 104-0044 Japan
TEL 81-3-5550-4101
Email lopes@slcn.ac.jp

Public contact
Name of contact person Hitomi Suzuki
Organization St. Luke's International University
Division name Global Health Nursing
Address 10-1 Akashicho Chuo-ku, Tokyo, 104-0044 Japan
TEL 81-3-5550-4101
Homepage URL
Email 18mn303@slcn.ac.jp

Sponsor
Institute Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 順天堂大学医学部附属順天堂医院 (東京都)、順天堂大学医学部附属順天堂練馬病院 (東京都)、順天堂大学医学部附属順天堂浦安病院 (千葉県)、賛育会病院 (東京都)、はぐくみ母子クリニック (東京都)、越谷市立病院 (埼玉県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
Date of closure to data entry
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
2018 Year 11 Month 04 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039128

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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