Born In Guangzhou Intervention Study (BIGIS)

Guangzhou Women and Children's Medical Center

Status: Enrolling

Conditions: Pregnancy Complications; Child Development; Pregnancy Outcomes

Treatments: Behavioral: Lifestyle modification

Study type: Interventional

Funder types: Other

Identifiers

NCT05503849

2022390B00

Details and patient eligibility

About

The main objective of this study is to test the efficacy of an intervention package (dietary, physical and lifestyle modification) during pregnancy in improving the clinical outcomes of mother-infant dyads.

Enrollment: 1,160 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women attending prenatal care at Guangzhou Women and Children's Medical Center (GWCMC) <20 weeks' gestation
• Pregnant women plan to deliver at GWCMC
• Pregnant women intend to reside in Guangzhou for at least 3 years

Exclusion criteria

• Multiple pregnancies
• Existing medical conditions (uncontrolled diabetes, hypertension or thyroid disease; other serious cardiovascular diseases, respiratory or systematic disorders)
• Use of drugs (aspirin, metformin, low molecular weight heparin)
• Women with reading and/or writing difficulties
• Women with serious mental disorders
• Women with eating disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,160 participants in 2 patient groups

Proactive management during pregnancy

Experimental group

Description:

A combination of dietary, physical activity and lifestyle modification.

Treatment:

Behavioral: Lifestyle modification

Standard Care

No Intervention group

Description:

No additional intervention beyond standard care procedure.