Gestational Weight Gain
Conditions
Interventions
Intervention group: The starting point of the study is the date on which baseline data on blood glucose and dietary nutrients begin to be recorded. (Period from 16 weeks and 0 days of pregnancy to 19
s nutritional recommendations during pregnancy, and also uses ingredients with low GI values to control the GL value.
Study participants in the intervention group will receive one serving of intervent
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1 Pregnant women who visited this hospital for within 16 weeks and 6 days of pregnancy and are planning to give birth at this hospital. 2 Pregnant women with singleton pregnancies 3 The pregnant woman's age must be over 20 years old and under 45 years old at the time of registration. 4 Pregnant women with pre-pregnancy BMI under 20 5 Pregnant women with any of the following high-risk factors: a. Pregnant women with a history of gestational diabetes b. Pregnant women over 35 years old c. Pregnant women with a family history of type 2 diabetes first degree kinship d. Pregnant women with a history of polycystic ovary syndrome e. Pregnant women who gave birth to a low birth weight baby f. Pregnant women with high blood pressure <systolic blood pressure of 130 mmHg or more and less than 140 mmHg, diastolic blood pressure of 80 mmHg or more and less than 90 mmHg> g. Pregnant women with a family history of hypertension <first degree kinship or sibling> 6 Agree to the use of monitoring equipment (smartphone, app, Fitbits, Replay Pro) in this study. 7 Obtain written consent from the pregnant woman.
Exclusion criteria
Exclusion criteria: 1. Habitual miscarriage (miscarriage occurs three or more times, stillbirth and early neonatal death are not included) 2. Pregnancy complicated by type 1 diabetes 3. Pregnancy complicated by type 2 diabetes 4. Pregnancy complicated by hypertension 5. Already diagnosed with gestational diabetes 6. Pregnancy complicated by untreated thyroid disease and active Graves' disease 7. Uterine malformations (duplicate uterus, bicornuate uterus, septate uterus, arcuate uterus, unicornuate uterus, etc.) 8. Have a history of stillbirth 9. History of giving birth to a child less than 1,500g 10. History of preterm birth less than 34 weeks 11. Food allergy history (egg, milk, wheat, shrimp, crab, peanut, buckwheat) 12. Severe hyperemesis 13. Pregnant women with serious underlying diseases being treated (SLE, rheumatoid arthritis, congenital heart disease, CKD, nephrotic syndrome, congenital polycystic kidney disease, Sjogren's syndrome, antiphospholipid antibody syndrome, ulcerative disease) colitis, reflux esophagitis, ITP) 14. Steroids use 15. Have uncontrolled psychoeclampsia 16. Smoking after finding out pregnant 17. Drinking after finding out pregnant 18. Drug use 19. FGR diagnosed 20. Fetal malformation or chromosomal abnormality <at the time of registration> was already revealed at the time of registration. 21. BMI<16 at registration 22. Subjects with extremely low dietary intake <based on FFQ for one year before pregnancy, energy intake and protein intake are less than half> 23. Extremely unbalanced lifestyle habits 24. History of abnormal eating behavior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gestatoinal weight gain | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Completion rate of intervention meal 2. Changes in eating behavior 3. SGA birth rate 4. Incidence of gestational diabetes 5. Incidence of gestational hypertension syndrome 6. Incidence of gestational hypertension and preeclampsia 7. Rate of preterm birth 8. Rate of spontaneous preterm birth 9. Late preterm percentage 10. Miscarriage rate for stillbirths less than 22 weeks 11. Percentage of AGA 12. Percentage of LGA 13. Percentage of macrosomia 14. Birth weight and SD score 15. Cord blood pH value 16. APGAR score 17. NICU admission rate 18. Rate of change in blood glucose levels during the second and third trimesters 19. 1 hour glucose level in GCT during the second trimester 20. Glucose level at OGTT 21. Postpartum glucose and HbA1c level 22. Rate of postpartum glucose intolerance among pregnant women with gestational diabetes 23. Percentage of study subjects who received insulin treatment for gestational diabetes. 24. Blood pressure during the second and third trimesters and delivery 25. Rate of intrapartum hypertension 26. Blood pressure of research subjects in the early postpartum period 27. Hypertension in the early postpartum period 28. Blood pressure of study subjects 1 month postpartum 29. Percentage of taking oral medication one month after giving birth 30. Prevalence of hypertension among study subjects at 1 month postpartum 31.Postnatal use of antihypertensive drugs 32. Proportion of appropriate GWG by pre-pregnancy BMI 33. Proportion of insufficient increase of GWG by pre-pregnancy BMI 34. Postpartum weight 35. Early postnatal developmental status of the child 36. Changes in intestinal flora of pregnant women before and after dietary intervention 37. Changes in the child's intestinal flora 38. Changes in protein in breast milk 39. Changes in lipids in breast milk 40. Exclusive breastfeeding rate up to 1 month postpartum 41. Breastfeeding rate up to 1 month postpartum 42. Risk of postpartum depression | — |
Countries
Japan
Contacts
Public ContactNaoko Arata
National Center for Child Health and Development Division of Maternal Medicine
Outcome results
None listed