<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02992106</url>
  </required_header>
  <id_info>
    <org_study_id>EFFECTOR</org_study_id>
    <nct_id>NCT02992106</nct_id>
  </id_info>
  <brief_title>Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring</brief_title>
  <acronym>EFFECTOR</acronym>
  <official_title>Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitair Ziekenhuis Brussel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universitair Ziekenhuis Brussel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rising worldwide prevalence of obesity and its subsequently rising incidence of&#xD;
      concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the&#xD;
      health care and associated health care costs of future generations. Obese pregnant women are&#xD;
      a growing population of interest because their offspring is at risk for childhood obesity, an&#xD;
      adverse metabolic and inflammatory profile and possible endothelial dysfunction. However,&#xD;
      strong evidence is still lacking regarding the hypotheses on the early origin of these&#xD;
      long-term health consequences.&#xD;
&#xD;
      Consequently there is no comprehensive data available on the contribution of changing&#xD;
      maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse&#xD;
      metabolic and endothelial programming of the offspring.&#xD;
&#xD;
      The investigators of this study want to provide additional data on the body composition,&#xD;
      metabolic and inflammatory state as well as endothelial function of children of obese&#xD;
      pregnant women women and compare the outcome with children born from normal weight women.&#xD;
      Furthermore, the investigators of this study will stratify the obese pregnant women into 3&#xD;
      groups: women who did not underwent an intervention, women who underwent a weight changing&#xD;
      intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent&#xD;
      bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the&#xD;
      diverse groups of participating children, except the control group, there will be a certain&#xD;
      grade of endothelial dysfunction, even if there was a normalization of weight, insulin&#xD;
      sensitivity and inflammation before conception or delivery in the mother.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2017</start_date>
  <completion_date type="Actual">March 18, 2019</completion_date>
  <primary_completion_date type="Actual">March 18, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reactive Hyperemia Index (EndoPAT)</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Albumin to creatinin ratio in urine</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak response after occlusion (EndoPAT)</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>Determination of the peak response using 30s average of amplitude intervals./ In children considered as an important measurement regarding assessment of the endothelial cell function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI (kg/m²)</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>The BMI is considered one of the parameters regarding obtaining information on the body composition of children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body fat percentage</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin resistance</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory state of the child (hs-CRP and IL-6)</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid state in blood</measure>
    <time_frame>Through study completion, average of 18 months</time_frame>
    <description>The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Endothelial Dysfunction</condition>
  <condition>Childhood Obesity</condition>
  <arm_group>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Offspring of 156 women with a normal weight during their pregnancy recruited by Bogaerts et al, in 3 belgian hospitals. Results of maternal data published in 2013. Now the children will be recruited. This group wil function as a control group.&#xD;
All participating children will undergo the same examinations:&#xD;
Parental questionnaires&#xD;
Blood sample&#xD;
Urine sample&#xD;
Anthropometric measurements&#xD;
Abdominal ultrasound (fat mass)&#xD;
EndoPAT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This subgroup will be compiled of the offspring of women recruited in two different studies. First of all there is the offspring of 65 women from the cohort that was recruited by Guelinckx et al, data published in 2010. This population was recruited in the University hospital of Leuven as control group for women receiving lifestyle interventions during pregnancy. Secondly there are children of 63 women from the cohort of Bogaerts et al of 2013 that had a BMI &gt; 29 kg/m² during their singleton pregnancy.&#xD;
All participating children will undergo the same examinations:&#xD;
Parental questionnaires&#xD;
Blood sample&#xD;
Urine sample&#xD;
Anthropometric measurements&#xD;
Abdominal ultrasound (fat mass)&#xD;
EndoPAT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This one will also be a composition of study subjects of two different study cohorts. Firstly there are children of about 100 Belgian women that were included in the DALI cohort, a European randomized controlled trial. All of them underwent a lifestyle intervention during pregnancy, concerning diet and/ or exercise. Secondly there is the offspring of the other subgroup of the cohort recruited by Guelinckx et al. 130 women were divided into 2 groups which underwent lifestyle interventions during pregnancy.&#xD;
All participating children will undergo the same examinations:&#xD;
Parental questionnaires&#xD;
Blood sample&#xD;
Urine sample&#xD;
Anthropometric measurements&#xD;
Abdominal ultrasound (fat mass)&#xD;
EndoPAT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The PABAS cohort (Pregnancy After Bariatric Surgery) provides children of 49 women who underwent bariatric surgery before their singleton pregnancy. The women were included in five Flemish hospitals before 15 weeks of pregnancy. Furthermore we will recruit the offspring of 200 women that are recruited in the ongoing AURORA cohort (bAriatric sUrgery Registration in women Of Reproductive Age). Women in this cohort are recruited from the start of their process undergoing bariatric surgery and are followed until after their pregnancy.&#xD;
All participating children will undergo the same examinations:&#xD;
Parental questionnaires&#xD;
Blood sample&#xD;
Urine sample&#xD;
Anthropometric measurements&#xD;
Abdominal ultrasound (fat mass)&#xD;
EndoPAT</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parental questionnaires</intervention_name>
    <description>We will provide parents with questionnaires depending on the age of their children:&#xD;
Children aged 0-6 years old:&#xD;
Questionnaire on socio-demographic characteristics&#xD;
Dutch Eating Behaviour Questionnaire&#xD;
Food Frequency Questionnaire&#xD;
Ages and Stages Questionnaire&#xD;
Strengths and Difficulties Questionnaire&#xD;
Questionnaire on developmental milestones&#xD;
Questionnaire on behaviour&#xD;
Children older than 6 years:&#xD;
Questionnaire on socio-demographic characteristics&#xD;
Dutch Eating Behaviour Questionnaire&#xD;
Food Frequency Questionnaire&#xD;
Pediatric Quality of Life Questionnaire&#xD;
Children's Behaviour Questionnaire in Dutch&#xD;
Questionnaire on developmental milestones&#xD;
Developmental Coordination Disorder Questionnaire&#xD;
Strengths and Difficulties Questionnaire</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Urine sample</intervention_name>
    <description>We will take a urine sample to evaluate the albumin to creatinin ratio.</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anthropometric measurements</intervention_name>
    <description>We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>We will do an abdominal ultrasound to measure the abdominal fat accumulation</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EndoPAT</intervention_name>
    <description>We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Faces Pain Scale</intervention_name>
    <description>After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain</description>
    <arm_group_label>History of bariatric surgery</arm_group_label>
    <arm_group_label>Normal weight during pregnancy</arm_group_label>
    <arm_group_label>Obese mothers &amp; lifestyle intervention</arm_group_label>
    <arm_group_label>Obese mothers without intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children of women who previously participated in different cohort studies conducted in&#xD;
             Flanders concerning maternal obesity are included after contacting the mothers again.&#xD;
             During the initial clinical trials the mothers were informed of possible follow-up&#xD;
             studies on their offspring.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no absolute exclusion criteria formulated.&#xD;
&#xD;
          -  For the peripheral pulse wave amplitude measurement we exclude children on growth&#xD;
             hormone therapy.&#xD;
&#xD;
          -  We postpone the examination for 2 weeks if there is an ongoing infection.&#xD;
&#xD;
          -  We document the use of specific medication, but the use of it doesn't implicate&#xD;
             exclusion of the participating children.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roland Devlieger, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Inge Gies, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Brussels</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karolien Van De Maele, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital of Brussels</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Brussels</name>
      <address>
        <city>Brussels</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitair Ziekenhuis Brussel</investigator_affiliation>
    <investigator_full_name>Inge Gies</investigator_full_name>
    <investigator_title>Pediatric Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>Maternal Obesity</keyword>
  <keyword>Endothelial Dysfunction</keyword>
  <keyword>Childhood Obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992106
org study id: EFFECTOR
nct id: NCT02992106
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rising worldwide prevalence of obesity and its subsequently rising incidence of
      concommitant diseases as diabetes and cardiovascular events impose a defiant obstacle for the
      health care and associated health care costs of future generations. Obese pregnant women are
      a growing population of interest because their offspring is at risk for childhood obesity, an
      adverse metabolic and inflammatory profile and possible endothelial dysfunction. However,
      strong evidence is still lacking regarding the hypotheses on the early origin of these
      long-term health consequences.

      Consequently there is no comprehensive data available on the contribution of changing
      maternal weight through lifestyle interventions or bariatric surgery and an eventual adverse
      metabolic and endothelial programming of the offspring.

      The investigators of this study want to provide additional data on the body composition,
      metabolic and inflammatory state as well as endothelial function of children of obese
      pregnant women women and compare the outcome with children born from normal weight women.
      Furthermore, the investigators of this study will stratify the obese pregnant women into 3
      groups: women who did not underwent an intervention, women who underwent a weight changing
      intervention during pregnancy e.g. diet or lifestyle intervention and women who underwent
      bariatric surgery before pregnancy. The overall aim of the study is to prove that in all the
      diverse groups of participating children, except the control group, there will be a certain
      grade of endothelial dysfunction, even if there was a normalization of weight, insulin
      sensitivity and inflammation before conception or delivery in the mother.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Reactive Hyperemia Index (EndoPAT)
time frame: Through study completion, average of 18 months
description: Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function
measure: Albumin to creatinin ratio in urine
time frame: Through study completion, average of 18 months
description: Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction
measure: Peak response after occlusion (EndoPAT)
time frame: Through study completion, average of 18 months
description: Determination of the peak response using 30s average of amplitude intervals./ In children considered as an important measurement regarding assessment of the endothelial cell function
measure: BMI (kg/m²)
time frame: Through study completion, average of 18 months
description: The BMI is considered one of the parameters regarding obtaining information on the body composition of children
measure: Body fat percentage
time frame: Through study completion, average of 18 months
description: To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account
measure: Insulin resistance
time frame: Through study completion, average of 18 months
description: The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)
measure: Inflammatory state of the child (hs-CRP and IL-6)
time frame: Through study completion, average of 18 months
description: The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account
measure: Lipid state in blood
time frame: Through study completion, average of 18 months
description: The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account
arm group label: Normal weight during pregnancy
arm group type: Other
description: Offspring of 156 women with a normal weight during their pregnancy recruited by Bogaerts et al, in 3 belgian hospitals. Results of maternal data published in 2013. Now the children will be recruited. This group wil function as a control group.
All participating children will undergo the same examinations:
Parental questionnaires
Blood sample
Urine sample
Anthropometric measurements
Abdominal ultrasound (fat mass)
EndoPAT
arm group label: Obese mothers without intervention
arm group type: Other
description: This subgroup will be compiled of the offspring of women recruited in two different studies. First of all there is the offspring of 65 women from the cohort that was recruited by Guelinckx et al, data published in 2010. This population was recruited in the University hospital of Leuven as control group for women receiving lifestyle interventions during pregnancy. Secondly there are children of 63 women from the cohort of Bogaerts et al of 2013 that had a BMI > 29 kg/m² during their singleton pregnancy.
All participating children will undergo the same examinations:
Parental questionnaires
Blood sample
Urine sample
Anthropometric measurements
Abdominal ultrasound (fat mass)
EndoPAT
arm group label: Obese mothers & lifestyle intervention
arm group type: Other
description: This one will also be a composition of study subjects of two different study cohorts. Firstly there are children of about 100 Belgian women that were included in the DALI cohort, a European randomized controlled trial. All of them underwent a lifestyle intervention during pregnancy, concerning diet and/ or exercise. Secondly there is the offspring of the other subgroup of the cohort recruited by Guelinckx et al. 130 women were divided into 2 groups which underwent lifestyle interventions during pregnancy.
All participating children will undergo the same examinations:
Parental questionnaires
Blood sample
Urine sample
Anthropometric measurements
Abdominal ultrasound (fat mass)
EndoPAT
arm group label: History of bariatric surgery
arm group type: Other
description: The PABAS cohort (Pregnancy After Bariatric Surgery) provides children of 49 women who underwent bariatric surgery before their singleton pregnancy. The women were included in five Flemish hospitals before 15 weeks of pregnancy. Furthermore we will recruit the offspring of 200 women that are recruited in the ongoing AURORA cohort (bAriatric sUrgery Registration in women Of Reproductive Age). Women in this cohort are recruited from the start of their process undergoing bariatric surgery and are followed until after their pregnancy.
All participating children will undergo the same examinations:
Parental questionnaires
Blood sample
Urine sample
Anthropometric measurements
Abdominal ultrasound (fat mass)
EndoPAT
intervention type: Other
intervention name: Parental questionnaires
description: We will provide parents with questionnaires depending on the age of their children:
Children aged 0-6 years old:
Questionnaire on socio-demographic characteristics
Dutch Eating Behaviour Questionnaire
Food Frequency Questionnaire
Ages and Stages Questionnaire
Strengths and Difficulties Questionnaire
Questionnaire on developmental milestones
Questionnaire on behaviour
Children older than 6 years:
Questionnaire on socio-demographic characteristics
Dutch Eating Behaviour Questionnaire
Food Frequency Questionnaire
Pediatric Quality of Life Questionnaire
Children's Behaviour Questionnaire in Dutch
Questionnaire on developmental milestones
Developmental Coordination Disorder Questionnaire
Strengths and Difficulties Questionnaire
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: Blood sample
description: We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: Urine sample
description: We will take a urine sample to evaluate the albumin to creatinin ratio.
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: Anthropometric measurements
description: We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: Ultrasound
description: We will do an abdominal ultrasound to measure the abdominal fat accumulation
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: EndoPAT
description: We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
intervention type: Other
intervention name: Faces Pain Scale
description: After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
arm group label: History of bariatric surgery
arm group label: Normal weight during pregnancy
arm group label: Obese mothers & lifestyle intervention
arm group label: Obese mothers without intervention
criteria: 
gender: All
minimum age: 6 Months
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Roland Devlieger, Professor
role: Study Director
affiliation: Universitaire Ziekenhuizen KU Leuven
last name: Inge Gies, Professor
role: Principal Investigator
affiliation: University Hospital of Brussels
last name: Karolien Van De Maele, M.D.
role: Study Director
affiliation: University Hospital of Brussels
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitair Ziekenhuis Brussel
investigator full name: Inge Gies
investigator title: Pediatric Endocrinologist
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No