Child Development, Pregnancy Complications, Pregnancy Outcomes
Conditions
Brief 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.
Interventions
BEHAVIORALLifestyle 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.)
Sponsors
Guangzhou Women and Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal gestational weight change | From pregnancy until one month postpartum | 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. |
| Newborn size | Day 1 after birth | 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. |
| Neonatal skinfold thickness (at birth) | Day 1 after 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. |
| Maternal blood lipid profile postpartum (3 years) | Three years after delivery | Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L. |
| Maternal blood glucose profile postpartum (3 years) | Three years after delivery | Measured by autoanalyzer, blood glucose level in mmol/L. |
| Maternal blood insulin profile postpartum (3 years) | Three years after delivery | Measured by commercial ELIZA kit, total and free insulin in pmol/L. |
| Child blood lipid profile (3 years) | At three years of age | Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L. |
| Child blood glucose profile (3 years) | At three years of age | Measured by autoanalyzer, blood glucose level in mmol/L. |
| Child blood insulin profile (3 years) | At three years of age | Measured by commercial ELIZA kit, total and free insulin in pmol/L. |
| Child growth parameters (3 years) | At three years of age | 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. |
| Incidence of pregnancy complications | From 20 weeks' gestation until one month postpartum | Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child skinfold thickness (6 months) | At six months of age | 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. |
| Child skinfold thickness (1 year) | At one year of age | 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. |
| Child skinfold thickness (3 years) | At three years of age | 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. |
| Child skinfold thickness (6 years) | At six years of age | 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. |
| Child growth parameters (6 months) | At six months of age | 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. |
| Child growth parameters (1 year) | At one year of age | 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. |
| Child growth parameters (6 years) | At six years of age | 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. |
| Child blood lipid profile (6 years) | At six years of age | Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L |
| Child blood sugar profile (6 years) | At six years of age | Measured by autoanalyzer, blood glucose level in mmol/L. |
| Child blood insulin profile (6 years) | At six years of age | Measured by commercial ELIZA kit, total and free insulin in pmol/L. |
| Neurological development of child (1 year) | At one year of age | 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. |
| Neurological development of child (3 years) | At three years of age | 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. |
| Maternal hand grip strength during pregnancy | Between 32-34 weeks' gestation | Measured by high precision digital hand dynamometer, in kg |
| Maternal hand grip strength after delivery | At one month postpartum | Measured by high precision digital hand dynamometer, in kg |
| Maternal body composition postpartum | At one month 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. |
| Maternal blood lipid profile postpartum (6 years) | Six years after delivery | Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L. |
| Maternal blood sugar profile postpartum (6 years) | Six years after delivery | Measured by autoanalyzer, blood glucose level in mmol/L. |
| Maternal blood insulin profile postpartum (6 years) | Six years after delivery | Measured by commercial ELIZA kit, total and free insulin in pmol/L. |
Countries
China
Contacts
CONTACTQiu Qiu, Dr.
CONTACTSongying Shen, Msc.
Outcome results
None listed