Prenatal Programming of Childhood Obesity and Cardio Metabolic Disorders
NCT ID: NCT05223530
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2022-02-25
2026-12-31
Brief Summary
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Detailed Description
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Research methods:
1. Maternal cardiometabolic conditions during pregnancy (data available): is defined by maternal pre-pregnancy BMI extracted from the Medical Birth; gestational weight gain calculated from maternal weight at childbirth derived from antenatal cards; blood pressure and proteinuria from antenatal cards, and results of 2-h oral glucose tolerance test and diagnoses of gestational diabetes and hypertensive disorders (chronic hypertension, gestational hypertension, preeclampsia) extracted from medical records and verified by an expert jury comprising two medical doctors and a research nurse with expertise in obstetrics.
2. Maternal and fetal metabolome (data available): is quantified by using high-throughput proton nuclear magnetic resonance (NMR) metabolomics platform (Nightingale Health Ltd, Helsinki, Finland). In total 220 metabolites were quantified covering multiple metabolic pathways, including lipoprotein lipids and subclasses, apolipoproteins, fatty and amino acids, ketone bodies, glycolysis and gluconeogenesis-related metabolites, fluid balance and inflammation.
3. Child's overweight/obesity and cardiometabolic health in childhood (data available): Child's weight and height have been derived from the child health center registry with data available from birth to 7-11 years in PREDO and from birth to 5 years in RADIEL. The 24-h ambulatory blood pressure data are available in the PREDO study from the child follow-up at age 7-11 years, and in the RADIEL study from the 5-year follow-up visit.
4. Child's overweight/obesity and cardiometabolic health in adolescence (11-17yrs): (data entry and quality control 1/22-6/24) will include
* Body weight, height, blood pressure, pulse
* Tanner stage
* Body fat percentage (bioimpedance, InBody)
* Digital questionnaires: Background, and Assessment of the psychological development of the child: Child Behavior Checklist for Ages 6-18 (CBCL), Strengths and Difficulties Questionnaire (SDQ), and Sleep Disturbance Scale for Children (SDSC) substance abuse, Level of Puberty (Tanner scale), Food frequency questionnaire (FFQ)
* ActiGraph (acceleration sensor), assessment of physical activity and sleep for 7 days
* Blood samples for analyses of: glucose and insulin metabolism, vitamin D, Calcium, Phosphate, AFOS and PTH, blood samples for assessment of lipidomics and metabonomics, DNA-sample (blood and buccal) and samples for adipocytokines and inflammation marker assessment
* Endothelial function and pulse wave velocity (PWV) will be assessed
* An epigenome-wide association study (EWAS) will be performed in the offspring according to maternal obesity and GDM status.
* Continuous glucose monitoring (CGM, Dexcom G6, Dexcom®, USA) will be assessed in a subpopulation of 150 children, aged 11-14 yrs: 50 overweight/obese and 50 normal weight children from high-risk pregnancies (RADIEL) and 50 normal weight controls form normal pregnancies (PREDO).
5. The following maternal data will be collected 11-17 years post partum (data entry and quality control 1/22-6/24):
* Blood pressure, pulse, weight, height, BMI, waist and hip circumference
* Body fat percentage (bioimpedance, InBody).
* Laboratory tests: OGTT, insulin, glucose, HbA1c, ALAT, lipids, TSH, free T4, DNA sample (blood)
* DNA sample from buccal mucosa
* Spare blood for future analyses (metabonomics and lipidonomics studies, inflammatory markers incl, P-hCRP, P-IL-6, adiponectin, TNFa)
* Digital questionnaires: background, diet (FFQ) and physical activity, psychological questionnaires: Center of Epidemiological Studies Depression Scale (CES-D), Beck Anxiety Inventory II (BDI-II), Pittsburgh Sleep Quality Index (PSQI), Cohen Perceived Stress Scale (PSS5), PANAS-10 (Positive and negative affect schedule), VAS Social Support (Visual Analogue Scale for Social Support), and STAI state (Spielberger State-Trait-Anxiety-Inventory-state version
* food frequency questionnaire (FFQ)
* ActiGraph (acceleration sensor), assessment of physical activity and sleep for 7 days
* Endothelial function and pulse wave velocity (PWV)
6. National registries and patient records on the course of pregnancy, the growth and development of the child and related diseases or their risk factors
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prevention of Pre-eclampsia and Intrauterine Growth Restriction (PREDO)
The PREDO study is a cohort study that was started in 2005 in the Helsinki metropolitan area and Northern Karelia. In 2005-2009, it recruited a total of 4,777 women in the early pregnancy. Almost all subjects participated in stress monitoring during pregnancy. In addition, some mothers participated in either genetic, ultrasound, or drug research to develop methods for predicting and preventing pre-eclampsia and fetal growth retardation, and for identifying related factors.
Some key objectives have been to determine whether the physical and mental well-being of the pregnant women could be relevant with hereditary factors for the course of pregnancy and the subsequent physical and mental development and health of the child.
The previous follow-up phases have been performed 2 weeks and 6 months after the birth in 2006-2011 and at the age of approximately 2-6 and 7-12 years. More than 2,500 families participated in the most recent follow-up phase. Now it is 11-17 years of follow-up.
No interventions assigned to this group
Finnish Gestational Diabetes Prevention (RADIEL)
The RADIEL study is a randomized multicenter study that was launched in 2008 in Helsinki, Espoo, Vantaa and Lappeenranta. Between 2008 and 2011, we recruited a total of 729 women for gestational diabetes prevention research. Subjects either planned to become pregnant or were in early pregnancy at the time of the study. Subjects were randomized to either receive diet and exercise intervention (active group) or to continue with normal counseling follow-up (control group). Study visits occurred every three months before pregnancy (if recruited before pregnancy), once in each trimester of pregnancy, and at 6 weeks, 6 months, and 12 months after delivery. The effectiveness of the intervention was measured with a variety of metrics.
In 2013-2017, we invited mothers and children who participated in the RADIEL study to a 5-year follow-up of the project, and nearly 350 mother-child pairs participated. Now it is 11-17 years of follow-up.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
11 Years
55 Years
ALL
Yes
Sponsors
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University of Helsinki
OTHER
University of Oulu
OTHER
University of Edinburgh
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Saila Koivusalo
Principal Investigator
Locations
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Saila Koivusalo
Helsinki, , Finland
Countries
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Central Contacts
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Facility Contacts
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Saila B Koivusalo, prof
Role: primary
Katri Räikkönen, prof
Role: backup
Other Identifiers
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HUS
Identifier Type: -
Identifier Source: org_study_id