Long-term Follow-up on Childhood Adiposity After Randomized Controlled Lifestyle Interventions in Pregnancy - The FitKids Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The FitKids study is a mother-child observational cohort study on obesity and metabolism in children three years of age. The study will follow up on the FitMum and FitBaby studies, conducted from 2018-2022. The children in FitKids are born by mothers who completed the FitMum study, a single-site three-armed RCT, targeting physical activity during pregnancy. 220 pregnant women were randomly assigned to one of three arms during pregnancy: structured supervised exercise training, motivational counselling supported by health technology, or a control group receiving standard treatment. From inclusion and until one-year post-partum, the women wore an activity tracker 24/7 providing important information about adherence to the prescribed intervention. The primary objective of the FitKids study is to investigate the effect of lifestyle interventions during pregnancy on body composition (fat percentage measured by dual energy x-ray absorptiometry) and risk of childhood obesity in off-springs. The secondary objectives are to investigate the effect of lifestyle interventions during pregnancy on obesity-associated dys-metabolic traits and mental health in off-springs as well as to gain insight into presumed causal factors for overweight and obesity in children. The investigators hypothesize that children of mothers, who during their participation in FitMum, received an intervention will have a healthier body composition expressed as a fat percentage within the normal range for a 3-year-old child compared to children of mothers in the control group.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 3
View:

• Written informed consent obtained from custody holders before any study related procedures are performed

• The participants must be born by mothers participating in FitMum and born during the intervention period.

Locations
Other Locations
Denmark
Nordsjaellands Hospital
Recruiting
Hillerød
Contact Information
Primary
Grete K Teilmann
grete.katrine.teilmann@reigonh.dk
+45 48294333
Backup
Steffie V Gundersen, MD
steffie.vang.gundersen@regionh.dk
Time Frame
Start Date: October 10, 2022
Estimated Completion Date: March 2024
Participants
Target number of participants: 178
Sponsors
Leads: Nordsjaellands Hospital
Collaborators: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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