GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study

Study Overview
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Brief Summary
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GraviD is a multi-ethnic population-based pregnancy cohort. Pregnant women were invited to participate in the GraviD study when registering for antenatal care in parts of the region of Västra Götaland in Sweden in 2013-2014. All women registering for antenatal care were eligible for inclusion, as long as the pregnancy had not exceeded 16 gestational weeks. In total, 2125 pregnant women were recruited in gestational week 12 during two time-periods; fall 2013 and spring 2014. Blood sampling was performed in gestational week <17 and again at gestational week >31 by midwifes. After delivery, the maternity records were obtained, to collect information on child's gender, birth weight and length and other possible birth outcomes.

Detailed Description
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In the GraviD-child study, all healthy singleton children born within the GraviD study will be invited to participate in a single clinical follow up. The follow-up will be conducted when all children are between 7-8 years of age. The study centre is located at the Queen Silvia Children´s hospital in Gothenburg, Sweden. The follow up consist of several parts: Measurement of body weight and height, and waist circumference. A questionnaire regarding health, physical activity, sleeping habits and diet. Endothelial function, a measure of how well the blood vessels dilute. Ultra sound of the thickness of the vessels on the neck, wrist and foot Pulse wave velocity, to measure the elasticity of the vessels on the neck and groin. Body composition using bioelectrical impedance. Blood pressure A venous blood sample of maximum 18 ml will be drawn to analyze markers of cardiovascular health. Blood lipids (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol), lipoprotein A, apolipoproteins (Apo A1 and Apo B), liver enzymes, glucose, insulin, HbA1c, c-reactive protein, leptin, adiponectin, nutritional biomarkers (such as 25-hydroxyvitamin D) will be analyzed. The study hypothesis is that a low maternal vitamin D status increase the risk of an unfavorable child cardiometabolic risk profile, vascular health and body composition. Recruitment start in January 2022 and will run for about a year.

Official Title
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GraviD-child Follow-up of the Children´s Health, Growth and Development Within the GraviD-study

Conditions
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Vitamin D Deficiency, Body Composition, Vascular Health, Cardiometabolic Risk

Intervention / Treatment
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* Other: Maternal vitamin D status


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Born within the GraviD study Healthy Singleton Exclusion Criteria: Chromosomal abnormality Hyper-/Hypothyroidism

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Maternal vitamin D status|Maternal vitamin D status (serum 25-hydroxyvitamin D) was collected during the GraviD study, while the woman was pregnant with the child now being followed-up in the GraviD-child study|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Fat mass, derived from bioelectrical impedance, will be studied as percentage (%) of the total body weight. | At 7-9 years of age | 
| Waist circumference | Measurements of waist circumference (in cm) will be assessed. | At 7-9 years of age | 
| Blood pressure | Blood pressure in mm Hg will be assessed. | At 7-9 years of age | 
| Blood lipids | Triglycerides in nmol/L will be assessed from a venous blood sample | At 7-9 years of age | 
| Blood glucose | Glucose in mmol/L will be analyzed from a venous blood sample | At 7-9 years of age | 
| Endothelial function | Endothelial function will be assessed as reactive hyperemia (RH)-index | At 7-9 years of age | 
| Pulse wave velocity | Pulse wave velocity (neck to thigh) will be measured in meters per second | At 7-9 years of age | 
| Ultrasound | Ultra-high frequency ultrasound of dorsalis pedis (in mm) will be measured | At 7-9 years of age | 
| Ultrasound | Ultra-high frequency ultrasound of radialis (in mm) will be measured | At 7-9 years of age | 
| Blood lipids | HDL-cholesterol in nmol/L will be assessed from a venous blood sample | At 7-9 years of age |