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临床试验/NCT05570396
NCT05570396招募中不适用

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

Nordsjaellands Hospital1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2022年10月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
178
试验地点
1
主要终点
fat percentage

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
36 Months 至 47 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

fat percentage

时间窗: 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

次要结局

  • BMI(Collection from October 2022 until June 2024)
  • Metabolic markers(Collection from October 2022 until June 2024.)
  • Food Frequency Questionnaire (FFQ)(Collection from October 2022 until June 2024)
  • Strength and Difficulties Questionnaire (SDQ)(Collection from October 2022 until June 2024)
  • Glucose challenge test(Collection from October 2022 until June 2024)
  • Skinfolds(Collection from October 2022 until June 2024)
  • Blood pressure(Collection from October 2022 until June 2024)
  • Continuous glucose monitoring (CGM)(Collection from October 2022 until June 2024)
  • Sleep pattern(Collection from October 2022 until June 2024)
  • Pregnancy Physical Activity Questionnaire (PPAQ)(Collection from October 2022 until June 2024)
  • Waist-hip ratio(Collection from October 2022 until June 2024)
  • Heart rate(Collection from October 2022 until June 2024)
  • Epigenetics(Collection from October 2022 until June 2024.)
  • Mesoscale analyses(Collection from October 2022 until June 2024.)
  • Hair samples for cortisol levels(Collection from October 2022 until June 2024)
  • Physical activity behaviour(Collection from October 2022 until June 2024)
  • Ages & Stages Questionnaire (ASQ)(Collection from October 2022 until June 2024)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Grete Katrine Teilmann

Clinical Associate Professor

Nordsjaellands Hospital

研究点 (1)

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