Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Programmazione prenatale dell'obesità infantile e dei disturbi cardiometabolici

23 settembre 2026 aggiornato da: Saila Koivusalo, Helsinki University Central Hospital

Programmazione prenatale dell'obesità infantile e dei disturbi cardiometabolici - Ruolo dell'obesità materna, delle complicanze della gravidanza e del metabolismo materno-fetale

This is a prospective 11-17 -years follow-up of two existing pregnancy cohort (PREDO) and prevention (RADIEL) studies. The main objective is to investigate the associations between maternal overweight, obesity, hypertensive disorders in pregnancy, gestational diabetes, and maternal-fetal metabolome, child's birth outcomes, and overweight and obesity and cardio metabolic health outcomes in childhood and adolescence. During this follow-up study, the mothers and their 11-17-year-old children are invited for a study visit and their cardio metabolic health is studied by many different methods.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

The study comprises two Finnish pregnancy cohort /prevention studies, in which mother-child pairs have already been followed from early pregnancy until the threshold of adolescence. During this project period the follow-up of PREDO and RADIEL mothers and children will be extended until 11-17 and 11-14 years of age, respectively. This adolescence follow-up will include detailed measurements of overweight/obesity, body composition, and cardiovascular and metabolic health as well as lifestyle factors.

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

Tipo di studio

Osservativo

Iscrizione (Stimato)

750

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 11 anni a 55 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population comprises two Finnish pregnancy cohort /prevention studies, in which mother-child pairs have already been followed from early pregnancy until the threshold of adolescence.

Women for the PREDO study were enrolled at 12-14 gestational weeks and for the RADIEL study before conception or at 10-12 gestational weeks. They gave birth to a singleton live infant between 2006-2010 (PREDO) and 2008-2014 (RADIEL).

Descrizione

Inclusion Criteria:

  • all mothers participated originally in the PREDO or the RADIEL studies during pregnancy and with delivery during this index pregnancy

Exclusion Criteria:

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body fat percentage
Lasso di tempo: one measure at follow-up study visit:11-17 years after pregnancy

Measured by Inbody 720 (bioimpedance)

one measure at follow-up study visit:11-17 years after pregnancy

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Blood pressure
Lasso di tempo: 2-3 measurements at follow-up study visit: 11-17 years after pregnancy

Both systolic and diastolic pressures are measured by Omron HBP-1320

2-3 measurements at follow-up study visit: 11-17 years after pregnancy
Body mass index
Lasso di tempo: one measure at follow-up study visit: 11-17 years after pregnancy

weight (kg) / height (m)2

one measure at follow-up study visit: 11-17 years after pregnancy
Pulse wave velocity
Lasso di tempo: one measure at follow-up study visit: 11-17 years after pregnancy

Measured by Complior Analyse, Alarm Medical

one measure at follow-up study visit: 11-17 years after pregnancy
Time in target he percentage of time spent within the gestational diabetes glucose target range (<7,8 mmol/l)
Lasso di tempo: 10 days measurements related to the 11-17 years follow-up study visit

Dexcom G6 CGM (continuous glucose monitoring)

10 days measurements related to the 11-17 years follow-up study visit
Body weight
Lasso di tempo: one measurement at follow-up study visit: 11-17 years after pregnancy

Measured with Seca Mod 878DR (scale)

one measurement at follow-up study visit: 11-17 years after pregnancy

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 febbraio 2022

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

18 gennaio 2022

Primo inviato che soddisfa i criteri di controllo qualità

3 febbraio 2022

Primo Inserito (Effettivo)

4 febbraio 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi