Born In Guangzhou Intervention Study

Child Development Clinical Trial

— BIGIS  

Official title:

Born In Guangzhou Intervention Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05503849
• Other study ID #: 2022390B00
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2032

Study information

• Verified date: February 2024
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu
• Phone: 86-020-38367160
• Email: xiu.qiu[@]bigcs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1160
• Est. completion date: September 2032
• Est. primary completion date: September 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Pregnancy Complications
• Pregnancy Outcomes

Intervention

Behavioral:
• Lifestyle modification
This lifestyle modification aiming to provide proactive health management during pregnancy, which contains the following: 1) balanced dietary intake based on the Chinese Dietary Guideline; 2) sufficient physical activity; 3) changes in lifestyles (e.g. sleep, sun exposure etc.)

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center, China	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

References & Publications (1)

Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal gestational weight change	Maternal weight prior to pregnancy (or within 8 weeks of pregnancy), at around 20, 26, 32 weeks' gestation, before delivery and one month postpartum will be determined by digital scales, changes in maternal weight during pregnancy will be recorded in kg.	From pregnancy until one month postpartum
Primary	Newborn size	Weight (kg) will be measured with digital scales and height/length (cm) will be measured in supine with tape, comparing against reference to derived gestational age and sex-specific growth parameter Z-scores. To identify whether the neonates was small/appropriate/large for gestational age.	Day 1 after birth
Primary	Neonatal skinfold thickness (at birth)	Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.	Day 1 after birth
Primary	Maternal blood lipid profile postpartum (3 years)	Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.	Three years after delivery
Primary	Maternal blood glucose profile postpartum (3 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	Three years after delivery
Primary	Maternal blood insulin profile postpartum (3 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	Three years after delivery
Primary	Child blood lipid profile (3 years)	Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.	At three years of age
Primary	Child blood glucose profile (3 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	At three years of age
Primary	Child blood insulin profile (3 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	At three years of age
Primary	Child growth parameters (3 years)	Weight measured with digital scales in kg, length measured in standing position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.	At three years of age
Primary	Incidence of pregnancy complications	Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders	From 20 weeks' gestation until one month postpartum
Secondary	Child skinfold thickness (6 months)	Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.	At six months of age
Secondary	Child skinfold thickness (1 year)	Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.	At one year of age
Secondary	Child skinfold thickness (3 years)	Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.	At three years of age
Secondary	Child skinfold thickness (6 years)	Measured with skinfold caliper, a summation of skinfold thickness at several body sites including triceps, biceps, subscapular, suprailiac and thigh, will be derived in cm.	At six years of age
Secondary	Child growth parameters (6 months)	Weight measured with digital scales in kg, length measured with tape in supine position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.	At six months of age
Secondary	Child growth parameters (1 year)	Weight measured with digital scales in kg, length measured with tape in supine position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.	At one year of age
Secondary	Child growth parameters (6 years)	Weight measured with digital scales in kg, length measured in standing position in cm, using weight and length to derived body mass index, comparing against age and sex-specific references for Z-score.	At six years of age
Secondary	Child blood lipid profile (6 years)	Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L	At six years of age
Secondary	Child blood sugar profile (6 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	At six years of age
Secondary	Child blood insulin profile (6 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	At six years of age
Secondary	Neurological development of child (1 year)	Assessed by using Gesell testing, which measures the child's cognitive, language, motor (gross & fine) and social-emotional responses. Higher score in each domain is desired, there is no upper limit. Overall score of less than 86 indicates suspected developmental retardation.	At one year of age
Secondary	Neurological development of child (3 years)	Assessed by Ages & Stages Questionnaires, including adaptive, motor (gross & fine), language, and social function domains, overall score being less than -2SD of age specific mean indicates suspected developmental retardation.	At three years of age
Secondary	Maternal hand grip strength during pregnancy	Measured by high precision digital hand dynamometer, in kg	Between 32-34 weeks' gestation
Secondary	Maternal hand grip strength after delivery	Measured by high precision digital hand dynamometer, in kg	At one month postpartum
Secondary	Maternal body composition postpartum	Measured by dual-energy X-ray absorptiometry by trained physician, fat mass (kg), fat free mass (kg), and relative proportion (%) and distribution of fat mass will be described.	At one month postpartum
Secondary	Maternal blood lipid profile postpartum (6 years)	Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.	Six years after delivery
Secondary	Maternal blood sugar profile postpartum (6 years)	Measured by autoanalyzer, blood glucose level in mmol/L.	Six years after delivery
Secondary	Maternal blood insulin profile postpartum (6 years)	Measured by commercial ELIZA kit, total and free insulin in pmol/L.	Six years after delivery