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

NCT ID: NCT02992106

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2019-03-18

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.

Conditions

Endothelial Dysfunction; Childhood Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Parental questionnaires

Intervention Type: OTHER

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

Blood sample

Intervention Type: OTHER

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.

Urine sample

Intervention Type: OTHER

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

Anthropometric measurements

Intervention Type: OTHER

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

Ultrasound

Intervention Type: OTHER

We will do an abdominal ultrasound to measure the abdominal fat accumulation

EndoPAT

Intervention Type: OTHER

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

Faces Pain Scale

Intervention Type: OTHER

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

Group Type: OTHER

Parental questionnaires

Intervention Type: OTHER

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

Blood sample

Intervention Type: OTHER

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.

Urine sample

Intervention Type: OTHER

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

Anthropometric measurements

Intervention Type: OTHER

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

Ultrasound

Intervention Type: OTHER

We will do an abdominal ultrasound to measure the abdominal fat accumulation

EndoPAT

Intervention Type: OTHER

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

Faces Pain Scale

Intervention Type: OTHER

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

Group Type: OTHER

Parental questionnaires

Intervention Type: OTHER

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

Blood sample

Intervention Type: OTHER

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.

Urine sample

Intervention Type: OTHER

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

Anthropometric measurements

Intervention Type: OTHER

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

Ultrasound

Intervention Type: OTHER

We will do an abdominal ultrasound to measure the abdominal fat accumulation

EndoPAT

Intervention Type: OTHER

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

Faces Pain Scale

Intervention Type: OTHER

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

Group Type: OTHER

Parental questionnaires

Intervention Type: OTHER

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

Blood sample

Intervention Type: OTHER

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.

Urine sample

Intervention Type: OTHER

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

Anthropometric measurements

Intervention Type: OTHER

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

Ultrasound

Intervention Type: OTHER

We will do an abdominal ultrasound to measure the abdominal fat accumulation

EndoPAT

Intervention Type: OTHER

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

Faces Pain Scale

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Urine sample

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

Intervention Type: OTHER

Anthropometric measurements

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

Intervention Type: OTHER

Ultrasound

We will do an abdominal ultrasound to measure the abdominal fat accumulation

Intervention Type: 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).

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Inge Gies

Pediatric Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roland Devlieger, Professor

Role: STUDY_DIRECTOR

Universitaire Ziekenhuizen KU Leuven

Inge Gies, Professor

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Karolien Van De Maele, M.D.

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Locations

University Hospital of Brussels

Brussels, , Belgium

Countries

Belgium

References

Van De Maele K, Gies I, Devlieger R. Effect of bariatric surgery before pregnancy on the vascular function in the offspring: protocol of a cross-sectional follow-up study. BMJ Paediatr Open. 2019 Jan 31;3(1):e000405. doi: 10.1136/bmjpo-2018-000405. eCollection 2019.

Reference Type: DERIVED

PMID: 30815589 (View on PubMed)

Other Identifiers

EFFECTOR

Identifier Type: -

Identifier Source: org_study_id