Overweight/Obese pre-pregnancy BMI
Conditions
Interventions
<
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
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).
Sponsors
National Center for Child Health and Development, Tokyo, Japan
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women who: (1) are less than 30 weeks of gestation at the time of obtaining consent (2) have pre-pregnancy BMI>=25
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal weight change from pre-pregnancy to 12 months postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMaki Kawasaki
National Center for Child Health and Development, Tokyo, Japan Division of Maternal Medicine, Center for Maternal-Fetal-Neonatal and Reproductive Medicine
Outcome results
None listed