UMIN-CTR Clinical Trial

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

Overweight/Obese pre-pregnancy BMI

Classification by specialty

Endocrinology and Metabolism

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

National Center for Child Health and Development, Tokyo, Japan

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪母子医療センター
佐藤病院
愛媛県立中央病院

Date of disclosure of the study information

2020

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

08

Month

18

Day

Last modified on

2021

Year

02

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047278