Prenatal Programming of Childhood Obesity and Cardio Metabolic Disorders

NCT05223530 | Recruiting

• 1 other identifier: HUS
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiometabolic Diseases; Obesity

Outcome Measures

Primary Outcomes (1)

• Body fat percentage

  Measured by Inbody 720 (bioimpedance)

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

Secondary Outcomes (5)

• Blood pressure

  2-3 measurements at follow-up study visit: 11-17 years after pregnancy

• Body mass index

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

• Pulse wave velocity

  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)

  10 days measurements related to the 11-17 years follow-up study visit

• Body weight

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 11 Years - 55 Years
• Gender Eligibility Details: Follow-up of pregnant women and their 11-17 year-old children
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• University of Helsinki: collaborator
• University of Oulu: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Saila Koivusalo

Helsinki, 00290, Finland

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Saila B Koivusalo, prof

CONTACT

+358407250620; saila.koivusalo@hus.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 4, 2022
• Study Start: February 25, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

FI (1)