Assess the effect of dietary intervention on the risk of small for gestational age in high-risk pregnancies

UMIN ID: UMIN000053219

Registered date:11/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Gestational Weight Gain
• Date of first enrollment: 2024/05/01
• Target sample size: 68
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: gestatoinal weight gain
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 45years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: National Center for Child Health and Development
• Source(s) of Monetary Support: Ezaki Glico Co., Ltd.