UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051235 |
|---|---|
| Receipt number | R000058427 |
| Scientific Title | Behavior change by TrustWorthy information using INternet of health things from Keio sfc for Ladies Expecting babies |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/06/01 23:01:11 |
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Basic information
Public title
Behavior change by TrustWorthy information using INternet of health things from Keio sfc for Ladies Expecting babies
Acronym
Behavior change by TrustWorthy information using INternet of health things from Keio sfc for Ladies Expecting babies
Scientific Title
Behavior change by TrustWorthy information using INternet of health things from Keio sfc for Ladies Expecting babies
Scientific Title:Acronym
Behavior change by TrustWorthy information using INternet of health things from Keio sfc for Ladies Expecting babies
Region
| Japan |
Condition
Condition
pregnant woman
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on the hypothesis that authoritative information promotes behavior change and actually changes the body, the purpose of this study is to evaluate, from the viewpoint of the effectiveness of resource information (information provider (authority)), whether the daily living behavior of pregnant and nursing mothers from the middle of pregnancy (20 weeks gestation) to one month postpartum is changed in two groups: one group is informed of health information with an explicit source by an expert, and the other group is informed of the same health information without explicit source.
Basic objectives2
Others
Basic objectives -Others
In order to promote health behaviors among pregnant women, it is necessary not only to provide them with health information but also to motivate them toward health and to enhance their skills to perform health behaviors.
Therefore, this study uses the "Information-Motivation-Behavioral skills model" as the theoretical basis and assumes that the three factors of "information," "motivation," and "behavioral skills" are necessary to promote pregnant women's health behaviors, and aims to conduct and evaluate an intervention to promote pregnant women's health behaviors. The purpose of the study is to evaluate the results of the intervention to promote pregnant women's health behaviors.
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Blood vitamin D levels (24 weeks gestation, 36 weeks gestation, and at delivery)
Key secondary outcomes
Blood data (mid- and late-term pregnancy: bone metabolism (vitamin D concentration, PTH intact, zinc, alkaline phosphatase), glucose metabolism (blood glucose)
Lipid metabolism (total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol), iron metabolism (hemoglobin), protein metabolism (total albumin)
Bone density, body weight, body composition, systolic and diastolic blood pressure, energy intake, nutrient intake, food intake ((20 weeks gestation, 24 weeks gestation, 28 weeks gestation, 36 weeks gestation, 1 month postpartum)
Questionnaire on motivational attitudes regarding time outside, vitamin D production from questionnaire, bone literacy, and general health (20 weeks gestation, 24 weeks gestation, 28 weeks gestation, 36 weeks gestation, and 1 month postpartum)
Questionnaire on attitudes toward self-management skills (16-19 weeks gestation, 20 weeks gestation, 28 weeks gestation, 34 weeks gestation, 1 month postpartum)
Questionnaire on whether or not the woman is prone to depression
Questionnaire on the progress of the pregnancy and postpartum period and the nutritional status of the child
Questionnaire asking about the physical condition and lifestyle of the child and the mother during the first month postpartum (first month postpartum)
App usage history (registration information, input information, operation history, etc.)
Location information (GPS, Wi-Fi access points)
Number of steps taken during pregnancy
Date of delivery, weight just before delivery, method of delivery, amount of blood loss, height and weight of the baby, sex, life and death of the baby, presence or absence of gestational diabetes (presence or absence of gestational hypertension (if present, whether or not antihypertensive medication is taken), educational background, annual income, and impressions of participation
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The research subjects in Group A (authorizing group) are clearly advised and advised that the expert (physician) is the informant.
Interventions/Control_2
The same information is advised to the research subjects in group B (non-authorization group) without mentioning the informant.
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
First-time mothers with a gestational age of at least 16 weeks and a pre-pregnancy BMI of 18.5 to 24.9 kg/m2. Among all pregnant women who visited the research facility (Juntendo Nerima Hospital), pregnant women who meet all of the following selection criteria and none of the exclusion criteria will be included in the study.
1. be less than 20 weeks' gestation (16-19 weeks' gestation) at the time of consent
2. have a pre-pregnancy BMI of 18.5-24.9 kg/m2
3. have a singleton pregnancy
4. you must use an iPhone on a daily basis
5. have all checkups at the facility until the 1-month postpartum checkup
Key exclusion criteria
1. age less than 20 years old
2. have a multiple pregnancy
3. not using an iphone with ios 14.1 or later
4. who have been diagnosed with diabetes prior to pregnancy or obvious diabetes or pregnancy complications during pregnancy
5. who have any disease or complication and are receiving nutritional guidance
6. Pre-pregnancy BMI greater than I18.5 or less than 25
7. who are not able to communicate in Japanese
8. who are judged to be inappropriate for this study by the physician in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jin |
| Middle name | |
| Last name | Nakazawa |
Organization
Keio University
Division name
Faculty of Environment and Information Studies
Zip code
252-0882
Address
Delta S213, Keio University, Endo 5322, Fujisawa, Kanagawa
TEL
0466-47-0836
jin@sfc.keio.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Honda |
Organization
Keio University
Division name
Faculty of Environment and Information Studies
Zip code
252-0882
Address
Delta S213, Keio University, Endo 5322, Fujisawa, Kanagawa
TEL
0466-47-0836
Homepage URL
yukahon@sfc.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Jin Nakazawa
Funding Source
Organization
KDDI Research, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Juntendo University Nerima Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hongo-rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E22-0265-N01
Org. issuing International ID_1
Research Ethics Committee Faculty of Medicine, Juntendo University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属練馬病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058427
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