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Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring (EFFECTOR)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02992106
Recruitment Status : Completed
First Posted : December 14, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Inge Gies, Universitair Ziekenhuis Brussel

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Childhood Obesity Other: Parental questionnaires Other: Blood sample Other: Urine sample Other: Anthropometric measurements Other: Ultrasound Other: EndoPAT Other: Faces Pain Scale Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evolution of Maternal Weight During Pregnancy and Influence on the Endothelial Function in Her Offspring
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : March 18, 2019
Actual Study Completion Date : March 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Normal weight during pregnancy

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
Other: Parental questionnaires

We will provide parents with questionnaires depending on the age of their children:

  • Children aged 0-6 years old:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Ages and Stages Questionnaire
    5. Strengths and Difficulties Questionnaire
    6. Questionnaire on developmental milestones
    7. Questionnaire on behaviour
  • Children older than 6 years:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Pediatric Quality of Life Questionnaire
    5. Children's Behaviour Questionnaire in Dutch
    6. Questionnaire on developmental milestones
    7. Developmental Coordination Disorder Questionnaire
    8. Strengths and Difficulties Questionnaire

Other: Blood sample
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.

Other: Urine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.

Other: Anthropometric measurements
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

Other: Ultrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation

Other: EndoPAT
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

Other: Faces Pain Scale
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

Obese mothers without intervention

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
Other: Parental questionnaires

We will provide parents with questionnaires depending on the age of their children:

  • Children aged 0-6 years old:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Ages and Stages Questionnaire
    5. Strengths and Difficulties Questionnaire
    6. Questionnaire on developmental milestones
    7. Questionnaire on behaviour
  • Children older than 6 years:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Pediatric Quality of Life Questionnaire
    5. Children's Behaviour Questionnaire in Dutch
    6. Questionnaire on developmental milestones
    7. Developmental Coordination Disorder Questionnaire
    8. Strengths and Difficulties Questionnaire

Other: Blood sample
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.

Other: Urine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.

Other: Anthropometric measurements
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

Other: Ultrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation

Other: EndoPAT
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

Other: Faces Pain Scale
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

Obese mothers & lifestyle intervention

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
Other: Parental questionnaires

We will provide parents with questionnaires depending on the age of their children:

  • Children aged 0-6 years old:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Ages and Stages Questionnaire
    5. Strengths and Difficulties Questionnaire
    6. Questionnaire on developmental milestones
    7. Questionnaire on behaviour
  • Children older than 6 years:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Pediatric Quality of Life Questionnaire
    5. Children's Behaviour Questionnaire in Dutch
    6. Questionnaire on developmental milestones
    7. Developmental Coordination Disorder Questionnaire
    8. Strengths and Difficulties Questionnaire

Other: Blood sample
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.

Other: Urine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.

Other: Anthropometric measurements
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

Other: Ultrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation

Other: EndoPAT
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

Other: Faces Pain Scale
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

History of bariatric surgery

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
Other: Parental questionnaires

We will provide parents with questionnaires depending on the age of their children:

  • Children aged 0-6 years old:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Ages and Stages Questionnaire
    5. Strengths and Difficulties Questionnaire
    6. Questionnaire on developmental milestones
    7. Questionnaire on behaviour
  • Children older than 6 years:

    1. Questionnaire on socio-demographic characteristics
    2. Dutch Eating Behaviour Questionnaire
    3. Food Frequency Questionnaire
    4. Pediatric Quality of Life Questionnaire
    5. Children's Behaviour Questionnaire in Dutch
    6. Questionnaire on developmental milestones
    7. Developmental Coordination Disorder Questionnaire
    8. Strengths and Difficulties Questionnaire

Other: Blood sample
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.

Other: Urine sample
We will take a urine sample to evaluate the albumin to creatinin ratio.

Other: Anthropometric measurements
We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.

Other: Ultrasound
We will do an abdominal ultrasound to measure the abdominal fat accumulation

Other: EndoPAT
We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).

Other: Faces Pain Scale
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




Primary Outcome Measures :
  1. Reactive Hyperemia Index (EndoPAT) [ Time Frame: Through study completion, average of 18 months ]
    Reactive Hyperemia Index is one of the outcome parameters of the EndoPAT assessment of endothelial cell function

  2. Albumin to creatinin ratio in urine [ Time Frame: Through study completion, average of 18 months ]
    Albumin to creatinin ratio is considered an early marker of endothelial cell dysfunction

  3. Peak response after occlusion (EndoPAT) [ Time Frame: Through study completion, average of 18 months ]
    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


Secondary Outcome Measures :
  1. BMI (kg/m²) [ Time Frame: Through study completion, average of 18 months ]
    The BMI is considered one of the parameters regarding obtaining information on the body composition of children

  2. Body fat percentage [ Time Frame: Through study completion, average of 18 months ]
    To assess body fat percentage the results of the BIA, abdominal ultrasound and skinfold measurements will be taken into account

  3. Insulin resistance [ Time Frame: Through study completion, average of 18 months ]
    The assessment of insulin resistance will be made possible through the analysis of the blood sample (glucose and insulin level are measured)

  4. Inflammatory state of the child (hs-CRP and IL-6) [ Time Frame: Through study completion, average of 18 months ]
    The assessment of inflammatory state will be an assessment of the hs-CRP and IL-6 levels taken into account

  5. Lipid state in blood [ Time Frame: Through study completion, average of 18 months ]
    The assessment of lipid state will be an assessment of the total cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerids taken into account



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children of women who previously participated in different cohort studies conducted in Flanders concerning maternal obesity are included after contacting the mothers again. During the initial clinical trials the mothers were informed of possible follow-up studies on their offspring.

Exclusion Criteria:

  • There are no absolute exclusion criteria formulated.
  • For the peripheral pulse wave amplitude measurement we exclude children on growth hormone therapy.
  • We postpone the examination for 2 weeks if there is an ongoing infection.
  • We document the use of specific medication, but the use of it doesn't implicate exclusion of the participating children.

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): NCT02992106


Locations
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Belgium
University Hospital of Brussels
Brussels, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Universitaire Ziekenhuizen Leuven
Investigators
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Study Director: Roland Devlieger, Professor Universitaire Ziekenhuizen Leuven
Principal Investigator: Inge Gies, Professor University Hospital of Brussels
Study Director: Karolien Van De Maele, M.D. University Hospital of Brussels

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inge Gies, Pediatric Endocrinologist, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02992106     History of Changes
Other Study ID Numbers: EFFECTOR
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inge Gies, Universitair Ziekenhuis Brussel:
Maternal Obesity
Endothelial Dysfunction
Childhood Obesity
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms