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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05503849
Other study ID # 2022390B00
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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