UMIN-CTR Clinical Trial

Basic information
Public title	Intervention study to reduce postpartum weight retention by internet of things and mobile application in obesity mothers
Acronym	SpringMom
Scientific Title	Intervention study to reduce postpartum weight retention by internet of things and mobile application in obesity mothers
Scientific Title:Acronym	SpringMom
Region	Japan

Condition
Condition	Overweight/Obese pre-pregnancy BMI
Classification by specialty	Endocrinology and Metabolism Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether an intervention using internet of things and mobile application during pregnancy through one year postpartum is more effective than without intervention to cause weight loss in women with overweight/obese pre-pregnancy BMI.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Maternal weight change from pre-pregnancy to 12 months postpartum
Key secondary outcomes	1. Health Outcome -Pregnancy outcomes (gestational age at delivery, rate of cesarean section, rate of preterm birth, birth height, birth weight, SD value, rate of LGA(Large-for-gestational age) , rate of pregnancy-induced hypertension, rate of gestational diabetes mellitus) -gestational weight gain -Maternal weight change from pre-pregnancy to 24 months postpartum (measured at 1,6,12,24 months) -Rate of maternal weight change from pre-pregnancy to postpartum 24 months (measured at 1,6,12,24 months) (%) -Rate of achievement of weight goal (at 6,12,24 months postpartum) -Change in percent body fat composition from 1 month postpartum to 6,12,24 months postpartum -Rate of hypertension (6,12,24 months postpartum) -Rate of postpartum blood pressure normalization in women with hypertension before pregnancy -Rate of progression to impaired glucose tolerance or T2DM (at 6,12,24 months postpartum) 2. Behavior change -Attitude and knowledge -Average total energy, carbohydrate,lipid, protein intake -Proportion of carbohydrate , lipid, protein intake to total energy intake -Average dietary fiber intake -Average salt intake -Number of steps per day -Total sleep time, nap time -Breastfeeding rate -Breastfeeding duration -Lactation process indicators, Breastfeeding wishes 3. Use of IoT device/mobile application -Installation and measurement rate of IoT devices (activity meter, weight/body composition meter) -Average number of logins to mobile application/day, browsing time/day -Upload status of meal image/contents -Breast milk video viewing status -Intervention program continuation rate -Ease of use of equipment -Adherence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Device,equipment
Interventions/Control_1	< Intervention arm> Participants in the intervention group will conduct self-monitoring using the IoT devices (weight/body composition meter, activity/sleep meter), enter a meal record and meal photo in as much detail as possible daily, using a mobile application. They will receive automatic advice on the mobile application based on the IoT information or the meal record or meal photo recorded by the mobile application. Also, they will be provided with a column related to obesity (diet, exercise, breastfeeding promotion, gestational diabetes mellitus, pregnancy induced hypertension etc.) on their mobile application. Intervention will last from during pregnancy to 1 year postpartum.
Interventions/Control_2	<control arm > Participants in the control arm are expected to wear IoT devices at the time of data collection (start of study, 1 month postpartum, 6 months postpartum, 12 months postpartum, 24 months postpartum). The column related to obesity will be provided on the website when they wish.
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	Women who: (1) are less than 30 weeks of gestation at the time of obtaining consent (2) have pre-pregnancy BMI>=25
Key exclusion criteria	Women who: (1) are under 20 years of age and are not married (2) do not use the mobile application, or whose smartphone's iOS is less than 8.0 and less than Android 4.4 (3) have a history of diabetes (including overt diabetes in pregnancy); (4) weigh 120 kg or more at the time of obtaining consent (5) cannot communicate in Japanese (6) the doctor determined to be inappropriate for this study
Target sample size	270

Research contact person
Name of lead principal investigator	1st name Naoko Middle name Last name Arata
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	Division of Maternal Medicine, Center for Maternal-Fetal-Neonatal and Reproductive Medicine
Zip code	187-8535
Address	2-10-1, Okura, Setagayaku, Tokyo, 157-8538, JAPAN
TEL	03-3416-0181
Email	springmom@ncchd.go.jp

Public contact
Name of contact person	1st name Maki Middle name Last name Kawasaki
Organization	National Center for Child Health and Development, Tokyo, Japan
Division name	Division of Maternal Medicine, Center for Maternal-Fetal-Neonatal and Reproductive Medicine
Zip code	187-8535
Address	2-10-1, Okura, Setagayaku, Tokyo, 157-8538, JAPAN
TEL	03-3416-0181
Homepage URL
Email	springmom@ncchd.go.jp

Sponsor
Institute	National Center for Child Health and Development, Tokyo, Japan
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Center for Child Health and Development, Tokyo, Japan
Address	2-10-1, Okura, Setagayaku, Tokyo, 157-8538, JAPAN
Tel	03-3416-0181
Email	springmom@ncchd.go.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	大阪母子医療センター 佐藤病院 愛媛県立中央病院

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 07 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	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 03 Month 27 Day
Anticipated trial start date	2020 Year 09 Month 09 Day
Last follow-up date	2024 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	2020 Year 08 Month 18 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047278

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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