Early Tracking of Childhood Health Determinants Study
概览
- 阶段
- 不适用
- 干预措施
- Children
- 疾病 / 适应症
- Diabetes Mellitus
- 发起方
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- 入组人数
- 1500
- 试验地点
- 1
- 主要终点
- Infant BMI
- 状态
- 招募中
- 最后更新
- 8天前
概览
简要总结
Background:
Children s weight has increased sharply in recent years. This may put them at higher risk for health problems. High blood glucose in a pregnant mother and too much weight gain during pregnancy also may have long-term effects on the child s health. Children who become overweight or obese during childhood tend to remain so as adults. Researchers want to study many risk factors during and after pregnancy, and how these affect a child s development. They will also follow the mother s health and well-being after pregnancy.
Objectives:
To learn how a pregnant mother s environment, lifestyle, and health conditions may affect her child s growth and development from birth until adulthood.
Eligibility:
American Indian/Alaska Native (AI/AN) or Hispanic adult pregnant women and their offspring.
Design:
Mothers will have 3 visits during pregnancy.
In the child s first year, mothers will have 2 visits and their child will have 4.
Children will have 2 visits in their second year and 1 each year until they turn 18.
Mothers will have a visit 2 years after birth and 4-5 years later.
Both the mother and child s medical records will be reviewed. They will have physical exams and give blood and stool samples.
Mothers may give cord blood and placenta samples. They will give breastmilk and urine samples. They will fill out questionnaires.
They will have an ultrasound. They may get an activity monitor.
Mother and child will be followed until the child s 18th birthday.
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详细描述
Study Description: The current project will establish a longitudinal cohort of mother/infant/child dyads among American Indian/Alaska Native (AI/AN) and Hispanic ethnic groups, to study the role of a combination of biological and environmental factors on infant/childhood obesity and cardio metabolic risk. Objectives: Primary Objective: Primary Objective: To study the associations of maternal risk factors, including pre-pregnancy body mass index, gestational weight gain, and glycemia during pregnancy with offspring birth weight, length, and age/sex adjusted Body Mass Index (BMI) percentile and z-score up to 24-months of age. Secondary Objectives: 1. To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age). 2. To study the role of maternal clinical, genetic, biochemical, lifestyle, and psychosocial factors during pregnancy in mediating the associations between maternal risk factors and birth weight of the offspring, and weight, adiposity, metabolic profile, and neurodevelopment during infancy, childhood and adolescence. 3. To examine the role of family, socioeconomic, and environmental factors influencing child growth patterns, body composition and neurodevelopment in infancy and childhood. 4. To assess the frequency of hepatic steatosis in children and its association with BMI and biochemical changes 5. To examine the relationship between maternal risk factors, early childhood exposures and changes in gut microbiome during, infancy, childhood and adolescence. 6. To study the associations of maternal risk factors, including pre-pregnancy BMI, gestational weight gain, and glycemia and placental function, methylome, transcriptome, proteome and metabolome with weight, adiposity, and physical growth patterns during childhood and adolescence (2 to 18 years of age). Endpoints: Primary Endpoint: Birth weight, length, and age/sex adjusted BMI percentile and z-score up to 24-months of age (time points: 6-12 weeks, 4, 6, 12, 18, and 24 months). Secondary Endpoints: BMI percentile and z-scores 2 years to 18 years, biochemical measures, stool microbiome, neurocognitive development.
研究者
入排标准
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination)
- •American Indian or Hispanic by self-report
- •Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery.
- •In case where a pregnant mother is carrying multiple fetuses (multiple pregnancy), she will be eligible to participate in this study and all her live newborns, as a result of that pregnancy, will be eligible for participation in this study. Mothers will also be eligible to participate with any consecutive pregnancies.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Women who are incarcerated or are unable to consent.
- •Women whose fetus is not viable or are not planning to continue the pregnancy.
研究组 & 干预措施
Children
Children of mothers enrolled in the study
Pregnant women and mothers
Pregnant women/mothers
结局指标
主要结局
Infant BMI
时间窗: Birth, 6 weeks, and 4, 6, 12, 18 and 24 months
Birth weight, length, and age/sex adjusted BMI percentile and z-score up to 24-months of age (time points: 6-12 weeks, 4, 6, 12, 18 and 24 months).
次要结局
- Child BMI(annually from age 2 to 18)