Unique ID issued by UMIN | UMIN000053219 |
---|---|
Receipt number | R000060732 |
Scientific Title | A single-center, open-label, randomized parallel-group pilot trial to examine the impact of dietary intervention on the risk of small for gestational age in high-risk pregnancies |
Date of disclosure of the study information | 2024/04/11 |
Last modified on | 2024/04/11 22:04:23 |
Assess the effect of dietary intervention on the risk of small for gestational age in high-risk pregnancies
ARATA
A single-center, open-label, randomized parallel-group pilot trial to examine the impact of dietary intervention on the risk of small for gestational age in high-risk pregnancies
A single-center, open-label, randomized parallel-group pilot trial to examine the impact of dietary intervention on the risk of small for gestational age in high-risk pregnancies
Japan |
Gestational Weight Gain
Obstetrics and Gynecology | Adult | Child |
Others
NO
For non-obese singleton pregnant women with pre-pregnancy BMI of 20 or less, we provide guidance on replacing one out of three meals a day during pregnancy with a dietary balanced, nutritious and low GI diet intervention. The purpose of this study is to verify whether the increase of gestational weight gain (GWG) can be improved without increasing the risk of gestational diabetes and gestational hypertension.
Efficacy
Exploratory
Others
Not applicable
gestatoinal weight gain
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is considered as a block.
YES
Numbered container method
2
Prevention
Food |
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 weeks and 6 days of pregnancy). After baseline blood glucose and dietary nutrient data were collected for 10 days from 16 weeks 0 day of gestation to 19 weeks 6 days of gestation, dietary intervention was initiated at 20 weeks of gestation (0 to 6 days). Glyco food is a boxed lunch that is manufactured in accordance with the Ministry of Health, Labor and Welfare'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 intervention food per day. The dietary intervention begins at 20 weeks of pregnancy and continues until 1 month postpartum. At the same time, nutritional surveys of research subjects were conducted for 10 days from 16 weeks 0 days of gestation to 19 weeks 6 days of gestation, 10 days from 24 weeks 0 days of gestation to 32 weeks 6 days of gestation, and from 33 weeks 0 days of gestation to 35 weeks 6 days of gestation.Three meals a day will be photographed three times, collected using an app, and analyzed by experts. During other periods, the intake of the intervention food will be confirmed by taking photographs before and after eating the intervention food every day. Research subjects will receive dietary explanations within the scope of normal medical treatment, as well as guidance on diet and weight gain, from the hospital.
20 | years-old | <= |
45 | years-old | > |
Female
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.
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
68
1st name | Naoko |
Middle name | |
Last name | Arata |
National Center for Child Health and Development
Division of Maternal Medicine
157-8535
2-10-1 Okura,Setagaya-ku,Tokyo
+81-3-3416-0181
arata-n@ncchd.go.jp
1st name | Naoko |
Middle name | |
Last name | Arata |
National Center for Child Health and Development
Division of Maternal Medicine
157-8535
2-10-1 Okura,Setagaya-ku,Tokyo
03-3416-0181
arata-n@ncchd.go.jp
National Center for Child Health and Development
Naoko Arata
Ezaki Glico Co., Ltd.
Profit organization
National Center for Child Health and Development
2-10-1 Okura,Setagaya-ku,Tokyo
03-3416-0181
arata-n@ncchd.go.jp
NO
国立成育医療研究センター(東京都)
2024 | Year | 04 | Month | 11 | Day |
Unpublished
Preinitiation
2013 | Year | 12 | Month | 25 | Day |
2024 | Year | 05 | Month | 01 | Day |
2027 | Year | 12 | Month | 31 | Day |
2023 | Year | 12 | Month | 25 | Day |
2024 | Year | 04 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060732