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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05570396
Recruitment Status : Recruiting
First Posted : October 6, 2022
Last Update Posted : October 12, 2022
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Grete Katrine Teilmann, Nordsjaellands Hospital

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.


Condition or disease
Child Obesity Metabolic Syndrome Physical Activity Pregnancy Related Child Health

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up on Childhood Adiposity After Randomized Controlled Lifestyle Interventions in Pregnancy - The FitKids Study
Actual Study Start Date : October 10, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024



Primary Outcome Measures :
  1. fat percentage [ Time Frame: Collection from October 2022 until June 2024 ]
    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


Secondary Outcome Measures :
  1. BMI [ Time Frame: Collection from October 2022 until June 2024 ]
    Stature will be measured to the nearest 0.1 cm using a wall stadiometer, and body mass will be measured to the nearest 0.1 kg using a standard balance beam scale.

  2. Waist-hip ratio [ Time Frame: Collection from October 2022 until June 2024 ]
    Waist, hip and abdominal circumference will be measured to the nearest 0.1 cm using a measuring tape.

  3. Skinfolds [ Time Frame: Collection from October 2022 until June 2024 ]
    Triceps and subscapular skinfolds will be measured to the nearest millimeter with a skinfold caliper.

  4. Blood pressure [ Time Frame: Collection from October 2022 until June 2024 ]
    Both systolic and diastolic blood pressure, will be measured after standard procedures. Before measuring the blood pressure, the child is to sit still on a chair with both feet flat on the ground or lie down for at least five minutes. The right cuff size is picked out by measuring the circumference of the upper arm midway between olecranon (elbow) and acromion (shoulder).

  5. Heart rate [ Time Frame: Collection from October 2022 until June 2024 ]
    Heart rate will be measured when measuring the blood pressure after standard procedures. Before measuring the heart rate, the child is to sit still on a chair with both feet flat on the ground or lie down for at least five minutes.

  6. Metabolic markers [ Time Frame: Collection from October 2022 until June 2024. ]
    Plasma metabolites and hormones (e.g. glucose, total cholesterol, triglycerides, lipoproteins and Thyroid stimulating hormone) will be measured in blood samples collected by venipuncture after an overnight fast.

  7. Epigenetics [ Time Frame: Collection from October 2022 until June 2024. ]
    Epigenetic analyses will be perfomed on blood samples collected by venipuncture after an overnight fast.

  8. Mesoscale analyses [ Time Frame: Collection from October 2022 until June 2024. ]
    Mesoscale analyses will be performed on plasma from blood samples collected by venipuncture after an overnight fast.to detect protein and peptide concentrations.

  9. Hair samples for cortisol levels [ Time Frame: Collection from October 2022 until June 2024 ]
    One hair sample from the child for measurements of cortisol levels.

  10. Continuous glucose monitoring (CGM) [ Time Frame: Collection from October 2022 until June 2024 ]
    Fasting glucose, post prandial glucose values, glucose variability (7 days). Glucose metabolism will be measured through seven-day CGM (Dexcom G6). The CGM will provide information on fasting, prandial and postprandial glucose excursions as well as overall glycaemic variability

  11. Physical activity behaviour [ Time Frame: Collection from October 2022 until June 2024 ]
    Physical Activity level will be measured in all participants by 7 days of 24-h activity tracking (Actigraphs GT3X+) placed around the wrist.

  12. Sleep pattern [ Time Frame: Collection from October 2022 until June 2024 ]
    Sleep pattern will be measured in all participants by 7 days of 24-h activity tracking (Actigraphs GT3X+) placed around the wrist.

  13. Food Frequency Questionnaire (FFQ) [ Time Frame: Collection from October 2022 until June 2024 ]
    Dietary habits will be assessed by the Food Frequency Questionnaire (FFQ) answered by a parent.

  14. Ages & Stages Questionnaire (ASQ) [ Time Frame: Collection from October 2022 until June 2024 ]
    The psycho-motor development will be assessed by the Ages & Stages Questionnaire (ASQ) answered by a parent.

  15. Strength and Difficulties Questionnaire (SDQ) [ Time Frame: Collection from October 2022 until June 2024 ]
    Mental health will be assessed by the Strength and Difficulties Questionnaire (SDQ) answered by a parent.

  16. Pregnancy Physical Activity Questionnaire (PPAQ) [ Time Frame: Collection from October 2022 until June 2024 ]
    Physical activity in the birth mother will be assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) answered by the birth mother.

  17. Glucose challenge test [ Time Frame: Collection from October 2022 until June 2024 ]
    During CGM-recording, a standardized home setting non-invasive oral glucose challenge will be performed. The test runs over a period of two hours and the child must be fasting both before the test and not eat or drink during the test. The child will be offered 1 dl of sugar water containing 1.75 g glucose/kg; max 75g. Flavour in the form of sugar free soft drinks can be added to improve the taste. The sugar water is to be consumed in five min. Over the next two hours the caregiver must note the sensor glucose at time 0 minutes; 30 minutes and 120 minutes.



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Ages Eligible for Study:   36 Months to 47 Months   (Child)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  1. Written informed consent obtained from custody holders before any study related procedures are performed
  2. The participants must be born by mothers participating in FitMum and born during the intervention period.

Exclusion Criteria:

There are no established exclusion criteria. If a potential participant suffers from a physical or mental illness the decision about participation will be decided together with the parent(s)/custody holder(s).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05570396


Contacts
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Contact: Grete K Teilmann +45 48294333 grete.katrine.teilmann@reigonh.dk
Contact: Steffie V Gundersen, MD steffie.vang.gundersen@regionh.dk

Locations
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Denmark
Nordsjaellands Hospital Recruiting
Hillerød, Denmark, 2400
Contact: Grete Teilmann, PhD         
Sponsors and Collaborators
Nordsjaellands Hospital
Novo Nordisk A/S
Investigators
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Principal Investigator: Grete K Teilmann Nordsjaellands Hospital
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Responsible Party: Grete Katrine Teilmann, Clinical Associate Professor, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT05570396    
Other Study ID Numbers: H-22018855
First Posted: October 6, 2022    Key Record Dates
Last Update Posted: October 12, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Pediatric Obesity
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight