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A Randomized Controlled Clinical Trial on the Effects of Dietary Intervention on Pregnancy Outcomes and Offspring Development in Overweight/Obese Pregnant Women via Modulation of Placental and Systemic Metabolism

A Randomized Controlled Clinical Trial on the Effects of Dietary Intervention on Pregnancy Outcomes and Offspring Development in Overweight/Obese Pregnant Women via Modulation of Placental and Systemic Metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116405
Enrollment
Unknown
Registered
2026-01-09
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Pre-Pregnancy Overweight and Obesity

Interventions

Standard Nutrition Guidance Group:Receive routine prenatal nutrition management at the hospital. Based on the Chinese Dietary Guidelines for residents and the latest clinical diagnosis and treatment s
for obese women (BMI >=28 kg/m^2), 1,600–1,800 kcal/day
protein intake is 1.1 g/kg/day, fat 25–35%, and carbohydrates 45–55%, following the pregnancy edition of the 'Chinese Dietary Guidelines for Residents,' emphasizing dietary diversity without the need
Hypocaloric Diet Intervention Group:Follow an individualized low-calorie dietary plan, reducing energy intake by 20–30% compared to the conventional pregnancy recommendations, while ensuring protein >

Sponsors

Obstetrics and Gynecology Hospital Affiliated to Tongji University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy, including early, mid, and late stages; 2. Ages 19-40; 3. Pre-pregnancy BMI >=24; 4. Signed written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of infectious diseases: HIV, hepatitis B or C, history of active pulmonary tuberculosis or active pulmonary tuberculosis; 2. Secondary metabolic dysfunction, such as Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity, polycystic ovary syndrome, etc.; 3. History of malignant tumors; 4. Severe liver dysfunction (aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal) or chronic kidney disease (estimated glomerular filtration rate < 30 ml/min/1.73m²), or history of severe cardiovascular or cerebrovascular disease within the past 6 months to pregnancy, or history of severe gastrointestinal disease or gastrointestinal surgery within the past 12 months to pregnancy; 5. History of habitual miscarriage or multiple induced abortions; 6. History of smoking within 3 months before pregnancy to pregnancy; 7. History of taking medications that affect weight or energy intake/energy expenditure within 6 months before pregnancy to pregnancy, including weight loss drugs, antipsychotic medications, etc.; 8. Participation in a weight loss program during pregnancy, or weight change greater than 5% of current body weight in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Incidence of macrosomia;Neonatal body-fat percentage;BMI Z-score;Incidence of neurodevelopmental delay;

Secondary

MeasureTime frame
Hemoglobin A1c;fasting lipid (TC,TG,HDL-C,LDL-C);fasting plasma glucose;C-Reactive Protein;Mode of delivery;Incidence of large-for-gestational-age (LGA) ;Incidence of neonatal hypoglycaemia;Incidence of shoulder dystocia;Incidence of pre-labour rupture of membranes;Post-partum blood loss;1-minute Apgar score;Umbilical-artery blood pH;NICU admission rate;Incidence of neonatal respiratory distress syndrome;

Countries

China

Contacts

Public ContactQiaoling Du

Obstetrics and Gynecology Hospital Affiliated to Tongji University

qldu2024@126.com+86 150 2162 8612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026