UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052497 |
|---|---|
| Receipt number | R000059907 |
| Scientific Title | Development of IoT-based weight management in women's healthcare promotion |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/06/22 14:30:42 |
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Basic information
Public title
Research for IoT-based weight management in Interpregnancy care
Acronym
Research for women's health
Scientific Title
Development of IoT-based weight management in women's healthcare promotion
Scientific Title:Acronym
Weight management in women's healthcare promotion
Region
| Japan |
Condition
Condition
Postpartum women
Classification by specialty
| Medicine in general | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aims to develop more practical and effective methods of postpartum weight management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monthly weight loss from 1 to 24 months after birth will be analyzed using t-tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
In inter-pregnancy care, we will use the prediction model we have developed to set more practical weight management goals, and for follow-up, we will use IoT devices and combine it with a lifestyle improvement program using AI.
Interventions/Control_2
From the data of pregnant women among existing SmartBathMat users participating in the clinical study "Establishing a foundation for women's health promotion using IoT (2023-0328)", women using Smart Daily will be excluded, and a matching cohort matched for age and pre-pregnancy BMI will be used as the control 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Women with a pre-pregnancy BMI of 25.0 kg/m2 or higher who delivered at a collaborating institution
Key exclusion criteria
Women with a history of spontaneous preterm birth
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Kotani |
Organization
Nagoya University
Division name
Department of Obstetrics and Gynecology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442262
itoto@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Tano |
Organization
Nagoya University
Division name
Department of Obstetrics and Gynecology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
0527442262
Homepage URL
tano.sho@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOYOTA Memorial Hospital, Anjo Kosei Hospital, Toyohashi Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics board of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
0527442261
ethics@med.nagoya-u.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
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 10 | 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
| 2023 | Year | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059907
