UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049298 |
|---|---|
| Receipt number | R000056090 |
| Scientific Title | A pilot study of satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus. |
| Date of disclosure of the study information | 2022/10/25 |
| Last modified on | 2025/01/29 21:02:46 |
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Basic information
Public title
A pilot study of satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus.
Acronym
A pilot study of satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus.
Scientific Title
A pilot study of satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus.
Scientific Title:Acronym
A pilot study of satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus.
Region
| Japan |
Condition
Condition
Gestational Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of satisfaction with in-parson and remote nutrition guidance for gestational diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus.
Key secondary outcomes
Subjective evaluation of remote nutrition guidance, burden level, and content of guidance.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Have received both in-person and remote nutrition guidance for gestational diabetes mellitus at the National Hospital Organization Kyoto Medical Center.
Key exclusion criteria
Under 20 years of age at the time of registration.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiwa |
| Middle name | |
| Last name | Tanaka |
Organization
Doshisha Women's College Graduate School of Liberal Arts
Division name
Human Life and Science
Zip code
602-0893
Address
Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto 602-0893, Japan
TEL
075-251-4111
is22004@dwc.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Kiwa |
| Middle name | |
| Last name | Tanaka |
Organization
Doshisha Women's College Graduate School of Liberal Arts
Division name
Human Life and Science
Zip code
602-0893
Address
Teramachi-nishiiru, Imadegawa-dori, Kamigyo-ku, Kyoto 602-0893, Japan
TEL
075-251-4111
Homepage URL
is22004@dwc.doshisha.ac.jp
Sponsor or person
Institute
Doshisha Women's College Graduate School of Liberal Arts
Institute
Department
Personal name
Funding Source
Organization
Doshisha Women's College Graduate School of Liberal Arts
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
Ethics Committee of Doshisha Women's College of Liberal Arts for Human Subject Research
Address
97-1 Minamihokodate, Kyotanabe, Kyoto 610-0395, Japan
Tel
0774-65-8679
research@dwc.doshisha.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-18
Org. issuing International ID_1
Ethics Committee of Doshisha Women's College of Liberal Arts for Human Subject Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
同志社女子大学（京都府）、国立病院機構京都医療センター（京都府）/ Doshisha Women's College (Kyoto), National Hospital Organization Kyoto Medical Center (Kyoto)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/asindtj/18/1/18_1/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/asindtj/18/1/18_1/_pdf/-char/ja
Number of participants that the trial has enrolled
30
Results
There was no significant difference in satisfaction between remote nutrition guidance and in-person nutrition guidance for gestational diabetes mellitus. Remote nutrition guidance was less of a burden on the body and time than in-person nutrition guidance, but that showed a lower level of understanding. Satisfaction with remote nutritional guidance compared to in-person nutritional guidance was related to lack of talk and connection to practice.
Results date posted
| 2025 | Year | 01 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 06 | Month | 05 | Day |
Baseline Characteristics
Gestational diabetes patients who have received both in-person and telephone remote nutritional guidance
Participant flow
Patients who visited the National Hospital Organization Kyoto Medical Center for follow-up of gestational diabetes after delivery were asked if they were eligible to participate in this study. Subjects who gave informed consent were asked to complete a questionnaire about their satisfaction with the nutritional guidance they received during their pregnancy.
Adverse events
no
Outcome measures
Primary outcome was satisfaction with remote nutrition guidance compared with in- person nutrition guidance for gestational diabetes mellitus, measured using a 150- mm visual analogue scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 24 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 08 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 08 | Day |
Other
Other related information
Primary outcome is the satisfaction with in-person and remote nutrition guidance for patients with gestational diabetes mellitus. Key secondary outcomes are subjective evaluation of remote nutrition guidance, burden level, and content of guidance.
Management information
Registered date
| 2022 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056090
