UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034762 |
|---|---|
| Receipt number | R000039128 |
| Scientific Title | 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 | 2023/05/09 10:24:17 |
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Basic information
Public title
Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Acronym
Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Scientific Title
Knowledge translation to reduce low birthweight infants in low BMI Japanese pregnant women using a comic book: a randomized control trial
Scientific Title:Acronym
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
| Obstetrics 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
| 1st name | Katharina |
| Middle name | |
| Last name | da Silva Lopes |
Organization
St. Luke's International University
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku, Tokyo, 104-0044 Japan
TEL
81-3-5550-4101
lopes@slcn.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Hitomi |
Organization
St. Luke's International University
Division name
Global Health Nursing
Zip code
104-0044
Address
10-1 Akashicho Chuo-ku, Tokyo, 104-0044 Japan
TEL
81-3-5550-4101
Homepage URL
18mn303@slcn.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
St. Luke's international university
Address
10-1 Akashicho Chuo-ku, Tokyo, 104-0044 Japan
Tel
81-3-5550-4101
no
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 |
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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039128
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
