Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05570396 |
| Other study ID # |
H-22018855 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 10, 2022 |
| Est. completion date |
March 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Nordsjaellands Hospital |
| Contact |
Grete K Teilmann |
| Phone |
+45 48294333 |
| Email |
grete.katrine.teilmann[@]reigonh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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
