Long-term Follow-up on Childhood Adiposity - The FitKids Study

NCT05570396 | Unknown

• 1 other identifier: H-22018855
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Child Obesity; Metabolic Syndrome; Physical Activity; Pregnancy Related; Child Health

Outcome Measures

Primary Outcomes (1)

• fat percentage

  fat percentage in three-year-old children of mothers who gave birth while still participating in the FitMum study measured by dual energy x-ray absorptiometry and Air Displacement Plethysmography technology

  Collection from October 2022 until June 2024

Secondary Outcomes (17)

• BMI

  Collection from October 2022 until June 2024

• Waist-hip ratio

  Collection from October 2022 until June 2024

• Skinfolds

  Collection from October 2022 until June 2024

• Blood pressure

  Collection from October 2022 until June 2024

• Heart rate

  Collection from October 2022 until June 2024

Eligibility Criteria

• Age: 36 Months - 47 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The research team is still in contact with the participants in FitMum and all children of mothers who completed FitMum will be invited to participate in the FitKids study. The FitMum cohort is 'loyal' as 81% of participants have remained in the study at least until delivery. Therefore, 178 children will be eligible for inclusion and receive an invitation to participate in the FitKids study. A subgroup of the children (n = 147) participated in or are currently participating in the FitBaby study at one year of age.

You may qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Nordsjaellands Hospital

Hillerød, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Metabolic Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior

Study Officials

• Grete K Teilmann

  Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grete K Teilmann

CONTACT

+45 48294333; grete.katrine.teilmann@reigonh.dk

Steffie V Gundersen, MD

CONTACT

steffie.vang.gundersen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 6, 2022
• Study Start: October 10, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

DK (1)