NIPH Clinical Trials Search

A Study of Early Nutritional Guidance in Obese Pregnant Women

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Maternal obesity (pre-pregnancy BMI >=30 kg/m2)
Date of first enrollment	11/05/2026
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	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.

Outcome(s)

Primary Outcome

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

Secondary Outcome

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)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 45age old
Gender	Female
Include criteria	Pregnant women with pre-pregnancy body mass index (BMI) >=30 kg/m2 and a singleton pregnancy
Exclude 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