Child ObesityNCT05570396
Long-term Follow-up on Childhood Adiposity - The FitKids Study
An observational study of Child Obesity and Metabolic Syndrome, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 36 to 47 months
- Conditions the study is for
- Child Obesity, Metabolic Syndrome, Physical Activity
- How many people
- 178 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2022to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 47 months
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Steffie V Gundersen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Nordsjaellands Hospital
Hillerød, 2400
Grete Teilmann, PhD
About this study
Official title: Long-term Follow-up on Childhood Adiposity After Randomized Controlled Lifestyle Interventions in Pregnancy - The FitKids Study
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.
Read the detailed description
Worldwide obesity has nearly tripled since 1975. In 2020, 39 million children under the age of five were overweight or obese. In Denmark approximately 13% of children are overweight or severely overweight by the time they start school.
Overweight is generally defined as abnormal fat accumulation and obesity as excessive fat accumulation that may impair health. For children under five years of age, overweight is defined as weight-for-height greater than two standard deviations above World Health Organization (WHO) Child Growth Standards median. Obesity is defined as weight-for-height greater than three standard deviations above the WHO Child Growth Standards median. Childhood obesity is associated with an increased risk of adult obesity, type 2 diabetes, metabolic syndrome, early death and reduced mental health. The large scale of obesity and the serious health problems associated with it calls for more knowledge within the field to prevent children from becoming overweight.
Body growth, physical activity, diet, and mental health are focus areas with respect to prevention and treatment of childhood obesity. Current knowledge about both pre- and postnatal factors indicates that being exposed to an adverse fetal environment, including maternal obesity, enhances propagation of obesity and associated cardiometabolic comorbidities, including type 2 diabetes. Still, the evidence is inconsistent and leaves most questions unanswered.
Many studies have found strong associations between maternal BMI and their child's BMI. One study showed distinct differences between associations of child BMI with maternal BMI compared to paternal BMI at birth but with the difference between associations diminishing over time. Another study showed associations between maternal pre-pregnancy BMI and child BMI at age five - six years of age. Given this it seems reasonable to suggest that the intrauterine environment is likely associated with the growth trajectory of the young child.
It is known that intrauterine exposure to diabetes and size at birth are risk factors for developing type 2 diabetes mellitus later in life, but several studies have also shown that children of mothers with obesity and overweight/obese children are at risk of having early markers of metabolic syndrome, i.e., increased insulin resistance, disturbed lipid profiles and high blood pressure.
Lifestyle interventions (physical activity and/or diet) in pregnant women have shown potential to reduce gestational weight gain and are associated with epigenetic changes in the child, potentially influencing the child's lean mass and early growth. However, in a recent metanalysis, prenatal lifestyle interventions were not shown to influence childhood weight or growth, but adherence to prescribed interventions was not systematically considered in the included studies, and only few studies reported data on body composition and metabolism in the child. Therefore, previous studies may not capture more specific effects of prenatal exposures on child fat accretion. Detailed knowledge about maternal lifestyle during pregnancy, combined with advanced measurement of body-composition in children, may contribute to a deeper understanding of how peri- and postnatal factors influence risk of childhood obesity.
Body Mass Index (BMI) is strongly correlated with adiposity and the use of age and gender adjusted Body Mass Index (z-BMI) is a crude approximation of excess fat mass. However, BMI z-scores may in some children lead to misclassification of overweight or obesity. BMI has high specificity but low sensitivity to detect excess adiposity and fails to identify more than 25% of children with excess body fat percentage. To overcome the pitfalls associated with BMI, body composition can be measured. Body weight is the sum of fat-mass (FM) and fat-free mass (FFM), and body composition describes the relative proportion of fat-mass and fat-free mass in the body. Experts have not yet identified or agreed upon a definition of obesity that uses an absolute cut-off or threshold for increased body fat mass during childhood. Measuring fat percentage in children is challenging and requires the child to cooperate to the examinations. While Dual-energy X-ray Absorptiometry (DXA) scan is the gold standard, it is well recognized that compliance and cooperation in general is varying in younger children. Therefore, the use of other methods, e.g., air displacement plethysmography (BodPod), may be included in research of childhood obesity.
The FitKids-Cohort:
The FitKids study is a mother-child observational cohort study on health in children three years of age. The study will follow up on the FitMum (19) 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 randomized controlled trial (RCT), targeting physical activity during pregnancy. 220 previously sedentary, healthy, pregnant women were included in the trial before gestational age (GA) week 15+0. The women had a BMI between 18.5-45 kg/m2 or a weight below 150 kg calculated from pre-pregnancy weight or first measured weight in pregnancy and all had a singleton pregnancy. Included women were randomly assigned to one of three arms during pregnancy: structured supervised exercise training (EXE), motivational counselling supported by health technology (MOT), or a control group receiving standard treatment (CON). From inclusion and until one-year post-partum, the women wore an activity tracker 24/7. This, providing important information about adherence to the prescribed intervention during pregnancy and their general level of activity both during pregnancy and one-year post-partum.
All children were invited to participate in The FitBaby study, which includes children who were born by FitMum participants and aims to evaluate the effects of maternal physical activity during pregnancy on health of the child at 12 months.
In FitMum and FitBaby, the effects of structured supervised exercise training and motivational counselling during pregnancy on physical activity level and health of mother and child are studied. 44% of FitMum participants were overweight or obese before conception and data regarding gestational weight gain as well as maternal weight during the first-year post-partum have been rigorously collected. The cohort is currently followed up during first year of life in the FitBaby study, and further follow-up in FitKids will add important knowledge about long term effects of the intra- and extrauterine environment on the risk of developing childhood overweight as well as growth, body composition, metabolism, and mental health.
The FitKids study is part of The LiP-TOP-Fit consortium consisting of three follow-up studies; LiPO Teen, a follow-up on the 14-15 year-old teenage offspring from the mothers of The Lifestyle in Pregnancy (LiP) study, TOP12, a follow-up on the 12 year old offspring from The Treatment of Obese Pregnant women (TOP) study and FitKids. Together with the FitKids follow up study the synergistic effect of the three follow-up programs in the LiP-TOP-Fit study entails a unique opportunity to understand long-term causal mechanisms of childhood obesity with possible substantially impact for future preventive strategies.
Expected outcomes:
The FitKids study provides a comprehensive assessment of childhood health, including whole body composition assessed by children anthropometric measures, dual energy x-ray absorptiometry (DXA) and BodPod as well as early markers of metabolic disease assessed by seven-day free-living continuous glucose monitoring, physical activity, blood samples and hair cortisol levels.
The children are uniquely well characterized using data from the biological mother during pregnancy and the child from birth until three years of age. Thus, allowing for assessment of fetal and postnatal programming effects. Hence, based on information from the FitMum and FitBaby studies the investigators can investigate early risk factors of later obesity. The longitudinal design allows for investigating trajectories and timing of risk factors, including level of physical activity, body composition and markers of metabolic disease e.g., insulin resistance. The investigators expect that the FitKids study will provide new insights in how body weight and composition in childhood track back to the intrauterine or early postnatal environment.
Expected significance of the project to deliver evidence of causal factors:
Building upon the RCT design in the FitMum study and the ongoing FitBaby study, the investigators seek to investigate causal relations between the pre- and postnatal environment and childhood health.
This can lead to the development of targeted interventions in the prevention of childhood obesity to be implemented at obstetric and/or paediatric departments
- Medical subject headings
- Pediatric Obesity, Metabolic Syndrome, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Collection from October 2022 until June 2024
Secondary outcomes (17)
BMI
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.
Measured: Collection from October 2022 until June 2024
Waist-hip ratio
Waist, hip and abdominal circumference will be measured to the nearest 0.1 cm using a measuring tape.
Measured: Collection from October 2022 until June 2024
Skinfolds
Triceps and subscapular skinfolds will be measured to the nearest millimeter with a skinfold caliper.
Measured: Collection from October 2022 until June 2024
Blood pressure
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).
Measured: Collection from October 2022 until June 2024
Heart rate
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.
Measured: Collection from October 2022 until June 2024
Metabolic markers
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.
Measured: Collection from October 2022 until June 2024.
Epigenetics
Epigenetic analyses will be perfomed on blood samples collected by venipuncture after an overnight fast.
Measured: Collection from October 2022 until June 2024.
Mesoscale analyses
Mesoscale analyses will be performed on plasma from blood samples collected by venipuncture after an overnight fast.to detect protein and peptide concentrations.
Measured: Collection from October 2022 until June 2024.
Hair samples for cortisol levels
One hair sample from the child for measurements of cortisol levels.
Measured: Collection from October 2022 until June 2024
Continuous glucose monitoring (CGM)
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
Measured: Collection from October 2022 until June 2024
Physical activity behaviour
Physical Activity level will be measured in all participants by 7 days of 24-h activity tracking (Actigraphs GT3X+) placed around the wrist.
Measured: Collection from October 2022 until June 2024
Sleep pattern
Sleep pattern will be measured in all participants by 7 days of 24-h activity tracking (Actigraphs GT3X+) placed around the wrist.
Measured: Collection from October 2022 until June 2024
Food Frequency Questionnaire (FFQ)
Dietary habits will be assessed by the Food Frequency Questionnaire (FFQ) answered by a parent.
Measured: Collection from October 2022 until June 2024
Ages & Stages Questionnaire (ASQ)
The psycho-motor development will be assessed by the Ages \& Stages Questionnaire (ASQ) answered by a parent.
Measured: Collection from October 2022 until June 2024
Strength and Difficulties Questionnaire (SDQ)
Mental health will be assessed by the Strength and Difficulties Questionnaire (SDQ) answered by a parent.
Measured: Collection from October 2022 until June 2024
Pregnancy Physical Activity Questionnaire (PPAQ)
Physical activity in the birth mother will be assessed by the Pregnancy Physical Activity Questionnaire (PPAQ) answered by the birth mother.
Measured: Collection from October 2022 until June 2024
Glucose challenge test
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.
Measured: Collection from October 2022 until June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start10 Oct 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Grete Katrine Teilmann, Nordsjaellands Hospital
- Investigators
- Grete K Teilmann, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570396
- Sponsor's protocol ID
- H-22018855
- Status last verified
- Oct 2022
- First submitted
- 26 Sep 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up on Childhood Adiposity After Randomized Controlled Lifestyle Interventions in Pregnancy - The FitKids Study
- ClinicalTrials.gov ID
- NCT05570396
- Acronym / sponsor ID
- H-22018855
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Worldwide obesity has nearly tripled since 1975. In 2020, 39 million children under the age of five were overweight or obese. In Denmark approximately 13% of children are overweight or severely overweight by the time they start school.
Overweight is generally defined as abnormal fat accumulation and obesity as excessive fat accumulation that may impair health. For children under five years of age, overweight is defined as weight-for-height greater than two standard deviations above World Health Organization (WHO) Child Growth Standards median. Obesity is defined as weight-for-height greater than three standard deviations above the WHO Child Growth Standards median. Childhood obesity is associated with an increased risk of adult obesity, type 2 diabetes, metabolic syndrome, early death and reduced mental health. The large scale of obesity and the serious health problems associated with it calls for more knowledge within the field to prevent children from becoming overweight.
Body growth, physical activity, diet, and mental health are focus areas with respect to prevention and treatment of childhood obesity. Current knowledge about both pre- and postnatal factors indicates that being exposed to an adverse fetal environment, including maternal obesity, enhances propagation of obesity and associated cardiometabolic comorbidities, including type 2 diabetes. Still, the evidence is inconsistent and leaves most questions unanswered.
Many studies have found strong associations between maternal BMI and their child's BMI. One study showed distinct differences between associations of child BMI with maternal BMI compared to paternal BMI at birth but with the difference between associations diminishing over time. Another study showed associations between maternal pre-pregnancy BMI and child BMI at age five - six years of age. Given this it seems reasonable to suggest that the intrauterine environment is likely associated with the growth trajectory of the young child.
It is known that intrauterine exposure to diabetes and size at birth are risk factors for developing type 2 diabetes mellitus later in life, but several studies have also shown that children of mothers with obesity and overweight/obese children are at risk of having early markers of metabolic syndrome, i.e., increased insulin resistance, disturbed lipid profiles and high blood pressure.
Lifestyle interventions (physical activity and/or diet) in pregnant women have shown potential to reduce gestational weight gain and are associated with epigenetic changes in the child, potentially influencing the child's lean mass and early growth. However, in a recent metanalysis, prenatal lifestyle interventions were not shown to influence childhood weight or growth, but adherence to prescribed interventions was not systematically considered in the included studies, and only few studies reported data on body composition and metabolism in the child. Therefore, previous studies may not capture more specific effects of prenatal exposures on child fat accretion. Detailed knowledge about maternal lifestyle during pregnancy, combined with advanced measurement of body-composition in children, may contribute to a deeper understanding of how peri- and postnatal factors influence risk of childhood obesity.
Body Mass Index (BMI) is strongly correlated with adiposity and the use of age and gender adjusted Body Mass Index (z-BMI) is a crude approximation of excess fat mass. However, BMI z-scores may in some children lead to misclassification of overweight or obesity. BMI has high specificity but low sensitivity to detect excess adiposity and fails to identify more than 25% of children with excess body fat percentage. To overcome the pitfalls associated with BMI, body composition can be measured. Body weight is the sum of fat-mass (FM) and fat-free mass (FFM), and body composition describes the relative proportion of fat-mass and fat-free mass in the body. Experts have not yet identified or agreed upon a definition of obesity that uses an absolute cut-off or threshold for increased body fat mass during childhood. Measuring fat percentage in children is challenging and requires the child to cooperate to the examinations. While Dual-energy X-ray Absorptiometry (DXA) scan is the gold standard, it is well recognized that compliance and cooperation in general is varying in younger children. Therefore, the use of other methods, e.g., air displacement plethysmography (BodPod), may be included in research of childhood obesity.
The FitKids-Cohort:
The FitKids study is a mother-child observational cohort study on health in children three years of age. The study will follow up on the FitMum (19) 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 randomized controlled trial (RCT), targeting physical activity during pregnancy. 220 previously sedentary, healthy, pregnant women were included in the trial before gestational age (GA) week 15+0. The women had a BMI between 18.5-45 kg/m2 or a weight below 150 kg calculated from pre-pregnancy weight or first measured weight in pregnancy and all had a singleton pregnancy. Included women were randomly assigned to one of three arms during pregnancy: structured supervised exercise training (EXE), motivational counselling supported by health technology (MOT), or a control group receiving standard treatment (CON). From inclusion and until one-year post-partum, the women wore an activity tracker 24/7. This, providing important information about adherence to the prescribed intervention during pregnancy and their general level of activity both during pregnancy and one-year post-partum.
All children were invited to participate in The FitBaby study, which includes children who were born by FitMum participants and aims to evaluate the effects of maternal physical activity during pregnancy on health of the child at 12 months.
In FitMum and FitBaby, the effects of structured supervised exercise training and motivational counselling during pregnancy on physical activity level and health of mother and child are studied. 44% of FitMum participants were overweight or obese before conception and data regarding gestational weight gain as well as maternal weight during the first-year post-partum have been rigorously collected. The cohort is currently followed up during first year of life in the FitBaby study, and further follow-up in FitKids will add important knowledge about long term effects of the intra- and extrauterine environment on the risk of developing childhood overweight as well as growth, body composition, metabolism, and mental health.
The FitKids study is part of The LiP-TOP-Fit consortium consisting of three follow-up studies; LiPO Teen, a follow-up on the 14-15 year-old teenage offspring from the mothers of The Lifestyle in Pregnancy (LiP) study, TOP12, a follow-up on the 12 year old offspring from The Treatment of Obese Pregnant women (TOP) study and FitKids. Together with the FitKids follow up study the synergistic effect of the three follow-up programs in the LiP-TOP-Fit study entails a unique opportunity to understand long-term causal mechanisms of childhood obesity with possible substantially impact for future preventive strategies.
Expected outcomes:
The FitKids study provides a comprehensive assessment of childhood health, including whole body composition assessed by children anthropometric measures, dual energy x-ray absorptiometry (DXA) and BodPod as well as early markers of metabolic disease assessed by seven-day free-living continuous glucose monitoring, physical activity, blood samples and hair cortisol levels.
The children are uniquely well characterized using data from the biological mother during pregnancy and the child from birth until three years of age. Thus, allowing for assessment of fetal and postnatal programming effects. Hence, based on information from the FitMum and FitBaby studies the investigators can investigate early risk factors of later obesity. The longitudinal design allows for investigating trajectories and timing of risk factors, including level of physical activity, body composition and markers of metabolic disease e.g., insulin resistance. The investigators expect that the FitKids study will provide new insights in how body weight and composition in childhood track back to the intrauterine or early postnatal environment.
Expected significance of the project to deliver evidence of causal factors:
Building upon the RCT design in the FitMum study and the ongoing FitBaby study, the investigators seek to investigate causal relations between the pre- and postnatal environment and childhood health.
This can lead to the development of targeted interventions in the prevention of childhood obesity to be implemented at obstetric and/or paediatric departments
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 36 to 47 months
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
17 secondary outcomes
BMI
Time frame: Collection from October 2022 until June 2024
Waist-hip ratio
Time frame: Collection from October 2022 until June 2024
Skinfolds
Time frame: Collection from October 2022 until June 2024
Blood pressure
Time frame: Collection from October 2022 until June 2024
Heart rate
Time frame: Collection from October 2022 until June 2024
Metabolic markers
Time frame: Collection from October 2022 until June 2024.
Epigenetics
Time frame: Collection from October 2022 until June 2024.
Mesoscale analyses
Time frame: Collection from October 2022 until June 2024.
Hair samples for cortisol levels
Time frame: Collection from October 2022 until June 2024
Continuous glucose monitoring (CGM)
Time frame: Collection from October 2022 until June 2024
Physical activity behaviour
Time frame: Collection from October 2022 until June 2024
Sleep pattern
Time frame: Collection from October 2022 until June 2024
Food Frequency Questionnaire (FFQ)
Time frame: Collection from October 2022 until June 2024
Ages & Stages Questionnaire (ASQ)
Time frame: Collection from October 2022 until June 2024
Strength and Difficulties Questionnaire (SDQ)
Time frame: Collection from October 2022 until June 2024
Pregnancy Physical Activity Questionnaire (PPAQ)
Time frame: Collection from October 2022 until June 2024
Glucose challenge test
Time frame: Collection from October 2022 until June 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffie V Gundersen, MD contact
Grete K Teilmann principal investigator
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Obesity and Metabolic Syndrome, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grete K Teilmann (+45 48294333, grete.katrine.teilmann@reigonh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat percentage (time frame: Collection from October 2022 until June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.