臨床研究等提出・公開システム

Early Nutritional Intervention in Obese Pregnant Women: A Feasibility and Safety Pilot Study (EARLY-OP Study)

A Study of Early Nutritional Guidance in Obese Pregnant Women (EARLY-OP Study)

Masuyama Hisashi

Department of Obstetrics and Gynecology, Okayama University Faculty of Medicine, Dentistry and Pharmaceutical Sciences

2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan

masuyama@cc.okayama-u.ac.jp

Kato Masakazu

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan

+81-86-235-7320

katomasa@okayama-u.ac.jp

Recruiting

May. 11, 2026

Interventional

single arm study

single blind

uncontrolled control

single assignment

other

Pregnant women with pre-pregnancy body mass index (BMI) >=30 kg/m2 and a singleton pregnancy

Maternal criteria
>Pre-existing diabetes mellitus or overt diabetes diagnosed during pregnancy
>Current use of insulin or oral antidiabetic medications
>Pregnancies complicated by maternal heart disease
>Current smoking or alcohol consumption
>Participation in another interventional or clinical trial
Fetal criteria
>Known fetal chromosomal abnormalities diagnosed by NIPT, chorionic villus sampling, or amniocentesis
>Suspected fetal infection associated with fetal growth restriction

Female

Maternal obesity (pre-pregnancy BMI >=30 kg/m2)

Nutritional intervention provided by a registered dietitian three times during pregnancy. Includes oral guidance based on the Japanese Society of Obstetrics and Gynecology recommendations for gestational weight gain, and individualized dietary energy intake guidance calculated as: standard body weight (height x height x 22) x 30 kcal/day.

Maternal obesity

Obese pregnant women Gestational Weight Gain

O99.21

05

Incidence of infants with birth weight below the 10th percentile for gestational age

Total gestational weight gain
Proportion of participants achieving the target gestational weight gain
Incidence of gestational diabetes mellitus (GDM)
Incidence of hypertensive disorders of pregnancy (HDP)
Rate of emergency cesarean section
Rate of operative vaginal delivery (forceps or vacuum delivery)
Neonatal anthropometric measurements (birth weight [g], length [cm], and gestational age)
Proportion of heavy-for-dates infants
Changes in maternal body composition up to 1 month postpartum
Changes in dietary patterns assessed by the Brief-type Self-administered Diet History Questionnaire (BDHQ)

+81-86-235-6503

April. 28, 2026

Yes

When receiving data from the two collaborating research institutions, we will anonymize the data before transferring it.

none