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A Study of Early Nutritional Guidance in Obese Pregnant Women

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1060260018
Enrollment
30
Registered
2026-05-11
Start date
2026-05-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 gestatio
Obese pregnant women Gestational Weight Gain

Sponsors

Masuyama Hisashi
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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)

Contacts

Public ContactMasakazu Kato

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

katomasa@okayama-u.ac.jp+81-86-235-7320

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026