UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057366 |
|---|---|
| Receipt number | R000064296 |
| Scientific Title | Development and validation of a face-to-face and online gestational diabetes mellitus education program |
| Date of disclosure of the study information | 2025/03/23 |
| Last modified on | 2025/10/08 17:48:19 |
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Basic information
Public title
Development of gestational diabetes mellitus education program
Acronym
Development of gestational diabetes mellitus education program
Scientific Title
Development and validation of a face-to-face and online gestational diabetes mellitus education program
Scientific Title:Acronym
Development and validation of a face-to-face and online gestational diabetes mellitus education program
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will develop a face to face and online gestational diabetes education program as an opportunity for pregnant women with gestational diabetes, their families, midwives, doctors, and nutritionists to interact with each other, and will verify its effectiveness in terms of diabetes treatment behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brief-type Self-administered Diet History Questionnaire : BDHQ
Key secondary outcomes
Blood glucose levels
Self efficacy scale for self management of eating habits
Revised version of the Diabetes Related Quality of Life Scale
Incidence of perinatal complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Watch videos on the condition of GDM, balancing lifestyle and diet therapy, etc., created originally by doctors, nutritionists, and midwives.
Interventions/Control_2
Participation in an exchange meeting for pregnant women with gestational diabetes
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant woman diagnosed with gestational diabetes who can understand Japanese.
Key exclusion criteria
Pregnant woman who cannot understand Japanese
Young people under 18 years of age
Pregnant women with type 1 or type 2 diabetes
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Nomachi |
Organization
University of Hyogo
Division name
College of Nursing Art and Science
Zip code
673-8588
Address
13-71 Kitaoji-cho, Akashi, Hyogo, Japan
TEL
078-925-9446
snomachi@cnas.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Shinobu |
| Middle name | |
| Last name | Nomachi |
Organization
University of Hyogo
Division name
College of Nursing Art and Science, Perinatal Care Research Center
Zip code
660-8550
Address
2-17-77, Higashinanba-cho, Amagasaki, Hyogo, Japan
TEL
06-6401-7078
Homepage URL
pericare@cnas.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Shinobu Nomachi
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
Hyogo Prefectural Amagasaki General Medical Center
Osaka University Graduate School of Medicine
University of Tsukuba, Graduate School of Medicine and Medical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Hyogo, College of Nursing Art and Science, Perinatal Care Research Center
Address
2-17-77, Higashinanba-cho, Amagasaki, Hyogo, Japan
Tel
06-6401-7078
pericare@cnas.u-hyogo.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
兵庫県立尼崎総合医療センター
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064296
