NCT Number: NCT05503849
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
Fuying Campus, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China, Guangzhou, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Three years after delivery
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time frame: Three years after delivery
Measured by autoanalyzer, blood glucose level in mmol/L.
Time frame: Three years after delivery
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time frame: At three years of age
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time frame: At three years of age
Measured by autoanalyzer, blood glucose level in mmol/L.
Time frame: At three years of age
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time frame: 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.
Time frame: From 20 weeks' gestation until one month postpartum
Incidence of physician-diagnosed pregnancy complications, including gestational diabetes mellitus, hypertensive disorders
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At six years of age
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L
Time frame: At six years of age
Measured by autoanalyzer, blood glucose level in mmol/L.
Time frame: At six years of age
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Time frame: 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.
Time frame: 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.
Time frame: Between 32-34 weeks' gestation
Measured by high precision digital hand dynamometer, in kg
Time frame: At one month postpartum
Measured by high precision digital hand dynamometer, in kg
Time frame: 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.
Time frame: Six years after delivery
Measured by autoanalyzer, total lipids (total cholesterol, triglycerides, high/low density protein cholesterol) expressed in mmol/L.
Time frame: Six years after delivery
Measured by autoanalyzer, blood glucose level in mmol/L.
Time frame: Six years after delivery
Measured by commercial ELIZA kit, total and free insulin in pmol/L.
Contact information is provided by the study sponsor or research team.
Guangzhou Women and Children's Medical Center
Other
Acronym: BIGIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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