Born In Guangzhou Intervention Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorGuangzhou Women and Children's Medical Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lifestyle modification
BehavioralThis 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.)
Treatment groups
1,160 Participants
are divided into 2 treatment groupsGroup A: Proactive management during pregnancyExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From pregnancy until one month postpartum2
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.
Time frame
Day 1 after birth3
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.
Time frame
Day 1 after birth4
Maternal blood lipid profile postpartum (3 years)
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time frame
Three years after deliverySecondary outcomes
1
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.
Time frame
At six months of age2
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.
Time frame
At one year of age3
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.
Time frame
At three years of age4
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.
Time frame
At six years of ageSponsors and contacts
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Source ClinicalTrials.gov