Born In Guangzhou Intervention Study

Study Overview
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Brief Summary
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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.

Official Title
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Born In Guangzhou Intervention Study

Conditions
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Pregnancy Outcomes, Child Development, Pregnancy Complications

Intervention / Treatment
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* Behavioral: Lifestyle modification


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proactive management during pregnancy<br>A combination of dietary, physical activity and lifestyle modification. | Behavioral: Lifestyle modification<br>* 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.)<br>|
| No Intervention: Standard Care<br>No additional intervention beyond standard care procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Maternal blood glucose profile postpartum (3 years) | Measured by autoanalyzer, blood glucose level in mmol/L. | Three years after delivery | 
| Maternal blood insulin profile postpartum (3 years) | Measured by commercial ELIZA kit, total and free insulin in pmol/L. | Three years after delivery | 
| 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 | 
| Child blood glucose profile (3 years) | Measured by autoanalyzer, blood glucose level in mmol/L. | At three years of age | 
| Child blood insulin profile (3 years) | Measured by commercial ELIZA kit, total and free insulin in pmol/L. | At three years of age | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Child blood sugar profile (6 years) | Measured by autoanalyzer, blood glucose level in mmol/L. | At six years of age | 
| Child blood insulin profile (6 years) | Measured by commercial ELIZA kit, total and free insulin in pmol/L. | At six years of age | 
| 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 | 
| 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 | 
| Maternal hand grip strength during pregnancy | Measured by high precision digital hand dynamometer, in kg | Between 32-34 weeks' gestation | 
| Maternal hand grip strength after delivery | Measured by high precision digital hand dynamometer, in kg | At one month postpartum | 
| 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 | 
| 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 | 
| Maternal blood sugar profile postpartum (6 years) | Measured by autoanalyzer, blood glucose level in mmol/L. | Six years after delivery | 
| Maternal blood insulin profile postpartum (6 years) | Measured by commercial ELIZA kit, total and free insulin in pmol/L. | Six years after delivery |