Skip to content

Prevention of GDM through an individualized nutritional intervention and a wearable device-based exercise intervention from early pregnancy in a high-risk population--a multicentre, randomised controlled trial

Screening and intervention of GDM high-risk people based on prediction model

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065737
Enrollment
Unknown
Registered
2022-11-14
Start date
2022-11-14
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Gestational diabetes mellitus

Interventions

Intervention group:Individualized nutritional intervention based on ''Eastern health dietary pattern'' and wearable device-based exercise intervention
Control group:Routine prenatal examination

Sponsors

Hospital of Obstetrics and Gynecology, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pregnant women need to be examined and delivered in Obstetrics and Gynecology Hospital Affiliated to Fudan University or other sub-central hospitals. 2. The high risk group of GDM was selected by GDM prediction model. 3. The gestational age of the group was not more than 10 weeks + 6 days. 4. Aged >= 18 years. 5. Pregnant women have the ability to read, understand and sign informed consent forms. 6. Single pregnancy.

Exclusion criteria

Exclusion criteria: 1. Prepregnancy diabetes mellitus (PGDM), including diabetes diagnosed before pregnancy or fasting blood glucose >=7.0mmol/L or glycosylated hemoglobin (HbA1c) >=6.5% in early pregnancy, or typical hyperglycemic symptoms, or hyperglycemic crisis symptoms with arbitrary blood glucose value >=11.1 mmol/L. 2. Other cases of abnormal glucose tolerance, including fasting blood glucose >=5.6mmol/L in the first trimester. 3. Currently or recently taking drugs that affect glucose metabolism (such as metformin, glucocorticoids, etc.). 4. Severe complications, such as hypertension, heart disease, kidney disease, autoimmune disease, thyroid dysfunction, mental illness, past or present malignant tumor, etc. 5. Known severe fetal malformations or chromosomal abnormalities. 6. Cervical insufficiency, including cervical length < 25mm as measured by ultrasound before 24 weeks of this pregnancy, or history of spontaneous preterm labor at 14 to 36 weeks of previous pregnancy, or cervical dilation found in the past or during this pregnancy. 7. Other movement contraindication syndromes: persistent vaginal bleeding, threatened premature delivery, placenta previa, premature rupture of membranes, severe anemia, FGR, etc. 8. Drug abuse.

Design outcomes

Primary

MeasureTime frame
Incidence of GDM;

Secondary

MeasureTime frame
Maternal pregnancy outcome;Neonatal outcome;Maternal biochemistry indicators of glucose and lipid metabolism;Cord blood indicators of glucose and lipid metabolism;Edinburgh Postnatal Depression Scale Score;

Countries

China

Contacts

Public ContactHuang Hefeng

Hospital of Obstetrics and Gynecology, Fudan University

huanghefg@hotmail.com+86 180 1731 0186

Outcome results

None listed

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