UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041216 |
|---|---|
| Receipt number | R000046964 |
| Scientific Title | Verification of the effect of intervention using an individualized education program that promote proper nutrition of pregnant women |
| Date of disclosure of the study information | 2020/07/28 |
| Last modified on | 2024/10/23 13:04:35 |
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Basic information
Public title
Verification of the effect of intervention using an individualized education program that promote proper nutrition of pregnant women
Acronym
Verification of the effect of intervention using an individualized education program that promote proper nutrition of pregnant women
Scientific Title
Verification of the effect of intervention using an individualized education program that promote proper nutrition of pregnant women
Scientific Title:Acronym
Verification of the effect of intervention using an individualized education program that promote proper nutrition of pregnant women
Region
| Japan |
Condition
Condition
Pregnant
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Implement individualized education program to promote proper nutrition of pregnant women, verifying the effectiveness of interventions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
After intervention protein intake.
Key secondary outcomes
Energy, carbohydrates, lipids, folic acid + iron intake, Difference in protein intake before and after the start of the education program (32-36 weeks gestation)
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
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Conduct a nutrition education program twice during pregnancy.
Interventions/Control_2
Control group
Conduct a questionnaire survey at the same time as the intervention group.
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
1.Pregnant women who are single pregnancy and classified as under weight or normal range by prepregnancy BMI .
2.Japanese who can answer Japanese question papers.
Key exclusion criteria
1.Pregnant women classified as over weight by prepregnancy BMI
2.Uterine malformation
3.Maternal complications that affect fetal development (diabetes, heart disease, severe anemia, etc.)
4.Placenta previa*
5.Hypertensive disorders of pregnancy
6.Fetal abnormality (chromosome aberration, malformation, etc.)
Target sample size
136
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Fujimoto |
Organization
Yokohama City University Graduate School
Division name
Graduate School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
TEL
045-370-7627
t196707a@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Fujimoto |
Organization
Yokohama City University Graduate School
Division name
Graduate School of Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
TEL
045-370-7627
Homepage URL
t196707a@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University
Address
3-9 Fukuura, Kanazawa, Yokohama-City, Kanagawa
Tel
045-370-7627
ynextedu@yokohama-cu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/jjns.12599
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/jjns.12599
Number of participants that the trial has enrolled
136
Results
Of the 130 participants, 66 were assigned to the intervention group
and 64 to the control group. There was no difference in protein intake between
the two groups after the intervention (p = .051, 95% CI [0.021, 12.4]).
Comparing the increase in protein intake before and after intervention, the
intervention group was 7.4 g/day higher than that of the control group
(p = .040; F = 4.31; effect size = 0.36).
Results date posted
| 2024 | Year | 10 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study participants are pregnant women who visited the outpatient clinic of the Comprehensive Perinatal Maternal and Child Health Care Center and agreed to participate in this study.
Selection criteria were pregnant women aged 20-30 years with a BMI of 18.5-25 who visited the outpatient clinic between 8 and 12 weeks' gestation.
Pregnant women who were already receiving special nutritional guidance, those who were deemed by their physicians to be unsuitable for the study due to complications affecting fetal development, and those who had miscarried or transferred to another hospital during pregnancy were excluded.
Participant flow
142 were recruited, 6 were excluded due to miscarriage or transfer before allocation, and 136 were assigned to the intervention (68) and control (68) groups.
After assignment, 2 patients were excluded from the intervention group and 4 from the control group. 130 patients (66 in the intervention group and 64 in the control group) completed the RCT.
Adverse events
None of the above
Outcome measures
Primary Outcome
Protein intake after intervention.
Secondary Outcome
Increased protein intake before and after intervention.
Energy intake and intake of carbohydrates, iron, and folic acid after intervention.
Increased energy intake and intake of carbohydrates, iron, and folate before and after intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046964
