UMIN-ICDS Clinical Trial

Public title

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

Acronym

ARATA

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

Scientific Title:Acronym

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

Region

Japan

Condition

Gestational Weight Gain

Classification by specialty

Obstetrics and Gynecology	Adult	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

gestatoinal weight gain

Key secondary outcomes

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

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 considered as a block.

Blocking

YES

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

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.

Interventions/Control_2

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.

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

45

years-old

>

Gender

Female

Key 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.

Key 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

Target sample size

68

Name of lead principal investigator

1st name	Naoko
Middle name
Last name	Arata

Organization

National Center for Child Health and Development

Division name

Division of Maternal Medicine

Zip code

157-8535

Address

2-10-1 Okura,Setagaya-ku,Tokyo

TEL

+81-3-3416-0181

Email

arata-n@ncchd.go.jp

Name of contact person

1st name	Naoko
Middle name
Last name	Arata

Organization

National Center for Child Health and Development

Division name

Division of Maternal Medicine

Zip code

157-8535

Address

2-10-1 Okura,Setagaya-ku,Tokyo

TEL

03-3416-0181

Homepage URL

Email

arata-n@ncchd.go.jp

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Naoko Arata

Organization

Ezaki Glico Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Child Health and Development

Address

2-10-1 Okura,Setagaya-ku,Tokyo

Tel

03-3416-0181

Email

arata-n@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

国立成育医療研究センター（東京都）　

Date of disclosure of the study information

2024

Year

04

Month

11

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

Preinitiation

Date of protocol fixation

2013

Year

12

Month

25

Day

Date of IRB

Anticipated trial start date

2024

Year

05

Month

01

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

25

Day

Last modified on

2024

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060732