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AzTrials

Overweight and ObesityPREPARE CHILDNCT05798494

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus

A study testing Weight loss intervention in people with Overweight and Obesity and Weight Loss, run by Ulla Kampmann Opstrup at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m^2). Read more about this study

Who is it for?
Ages 18 to 38 yearsHealthy volunteers can take part
What is being tested?
Weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteDenmark
Study dates
1 Jun 2023to 11 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Maternal inclusion Criteria:

  • Maternal pre-pregnancy BMI 27.0-44.9 kg/m^2
  • Maternal age range 18-38 years
  • Connected to Aarhus University Hospital as place of birth
  • Pregnant

Paternal Inclusion Criteria:

  • Paternal pre-pregnancy BMI 18.5-44.9 kg/m^2
  • Paternal age range 18-55 years

Parental Inclusion Criteria:

  • Couples (male and female)
  • Planning pregnancy within 3 years
  • Provided voluntary informed consent
  • Danish or English speaking
  • Intention to permit the planned offspring to participate in the follow-up study
  • Able to store biological samples from the offspring at home in the freezer in a box given by the study personnel

Parental Exclusion Criteria:

  • Diabetes mellitus (Type 1 or 2)
  • Previous or present eating disorder
  • Allergy towards ingredients in the very low calorie diet products
  • Severe heart, liver or kidney disease
  • Conception by in vitro fertilization
  • Any medical condition or concomitant medication as judged by the medical responsible
  • Adherence to vegan diets or other diets interfering with the dietary guidelines in the study
  • Participation in other clinical trial that can affect the results of the current study
  • Engagement in elite sports or similar strenuous exercise ≥5 h/week at inclusion
  • Blood donation or transfusion within the past month before screening
  • Blood donation during the study
  • Inability or unwillingness to follow the study protocol and instructions given by the study personnel

A detailed description of the exclusion criteria is given below:

Medical conditions as known by the participant:

  • Diabetes mellitus (type 1 and 2)
  • History or diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating)
  • Any significant medical condition as assessed by the investigator (e.g. dysregulated thyroid disease or reproductive diseases)
  • Any significant psychiatric disorder (i.e. schizophrenia, bipolar disease or depression) as assessed by the investigator
  • Severe chronic heart, liver and kidney disease
  • Polycystic ovary syndrome with irregular cycle

Medication:

  • Current use of medication or use within the previous three months with a potential to affect body weight or pregnancy as judged by the investigator (e.g. systemic corticoids)

Personal/other:

  • Severe food allergies, food intolerances or dislike expected to interfere with the study, including allergy towards ingredients in the VLCD products
  • Engagement in elite sports or similar strenuous exercise ≥5 h/week
  • Blood donation or transfusion within the past month before screening
  • Planned blood donation for other purpose than this study during participation
  • Alcohol abuse, as judged by the investigator, within the previous 12 months
  • Drug abuse, as judged by the investigator, within the previous 12 months
  • Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the study protocol
  • Participation in other clinical trials within the past three months or intention to do so during the study, which are judged by the investigator to affect the present study
  • Unable to consume the interventional product for religious reasons, swallowing disorders, other physiological reasons or any other reasons for not being able to follow the recommended diet
  • Inability or unwillingness to give written informed consent or communicate with study personnel
  • Inability or unwillingness to follow the study protocol and instructions given by the study personnel
  • Illiteracy or inadequate understanding of Danish or English language.
  • Any other condition that judged by the investigator may interfere with the adherence to the study protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ulla K Opstrup, MD, PhD contact

+4522370857

ullaopst@rm.dk

Louise Rasmussen, MSc contact

+4528731648

louisesuder@clin.au.dk

Denmark1 site, 1 recruiting

  • Aarhus University Hospital

    Aarhus, 8200

    Ulla K Opstrup

    Ulla K Opstrup, MD, PhD

    Recruiting

Other trials in Denmark

About this study

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight, and adiposity and its complications compared to a control group.

Read the detailed description

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant (recruited at gestational age 18-36), overweight or obese (BMI 27-44.9 kg/m^2), between 18-38 years and planning an additional pregnancy within the following 3 years.

The investigators will recruit a total of 140 healthy pregnant couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI and previous or present diagnosis of gestational diabetes.

The couples in intervention group will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The goal is to achieve a healthy lifestyle and a moderate weight loss of 10% according to pre-pregnancy weight during the first year. Hereafter, the couples will be guided in weight maintenance until pregnancy of the second child. During pregnancy the goal is to achieve a healthy weight gain. Couples in intervention group will also participate in physical activity sessions every 2nd week and advised to walk with moderate intensity at least 2-4 times a week for at least half an hour.

The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight, and adiposity and its complications compared to a control group. The 1st baby born before intervention is started will be the "index child" and the metabolic and anthropometric parameters of the 1st child will be compared to parameters of the second child to assess the effect of the parent's healthy lifestyle between the two pregnancies.

The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses and energy expenditure compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a short-term reduction in the risk of being born large for gestational age with excessive fat mass and a long-term reduction in the risk of developing overweight or obesity as a consequence of both social (family approach) and biological (epigenetic modifications) pathways.

Being tested
Weight loss intervention
Keywords
Overweight, Pregnancy, Weight loss, Diet, Reducing, Epigenetics, Healthy Lifestyle, DNA Methylation, Exercise, Offspring's neonatal fat mass, Pea Pod, Infant, Large for Gestational Age, Body Fat Distribution
Medical subject headings
Overweight, Obesity, Weight Loss, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Weight loss interventionBehavioural

    Subjects will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother (and father if overweight, BMI ≥25 kg/m^2) will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and power walk 2-4 times a week for a half an hour and attend physical activity sessions every 2nd week to attain a minimum weight loss of approximately 0,5-1,0 kg/week. The weight loss will last until a 10% weight loss (according to pre-pregnancy weight) has been achieved or until 1-year post-partum. If the subject has not achieved a weight loss of 10%, she or he will receive Very low-calorie diet (VLCD) until target weight loss is reached, though no longer than 8 weeks. After weight loss subjects will receive counseling to maintain weight loss and healthy weight gain during pregnancy until birth of the 2nd child.

Study groups in NCT05798494
Study groupRoleWhat they receive
InterventionExperimentalIntervention group will receive dietary counseling by a trained dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and attend physical activity sessions to attain a 10 % weight loss according to pre-pregnancy weight. If the father is also overweight or obese, he will receive the same advice.
Receives: Behavioral: Weight loss intervention
ControlNo interventionThe control group will receive standard care and will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice according to standard care which means no counselling from a dietitian unless there are special needs (e.g., gestational diabetes), then they will receive counseling from a dietitian in accordance with standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal fat mass

    Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)

    Measured: Collected within the first week of birth (strived <48 hours)

  2. Difference in epigenetic changes in child 1 and 2

    Cord blood from offspring will be collected at birth and stored at -80 °C until use. At the Department of Molecular Medicine AUH genomic DNA will be extracted from peripheral blood using standard methods e.g., QIAmp® Mini Kit (Qiagen, Germany). 1 μg of genomic DNA will be bisulfide converted using Illumina iScan (platform). The methylation level will be measured using Infinium MethylationEPIC DNA Analysis BeadChip (Array type) at Eurofins Genomics AS (Denmark) or similar methods.

    The stated required sample size (140 couples) is calculated based on the neonatal fat mass. As no other studies have performed methylation analysis using WGBS in similar cohorts, precise power calculations on epigenetic changes are impractical. However, since the EPICOM study found differentially methylated regions in only 20 cases and 20 controls using Illumina's 450K methylation assay, the power to elucidate epigenetic changes is considered sufficient in the planned study.

    Measured: Assessed at birth

Secondary outcomes (145)

  1. Obstetrics outcome - length of gestational age

    Length of gestational age

    Measured: Assessed at birth of both offsprings

  2. Obstetric - medication use

    Medication use during labor

    Measured: Collected from initiation of labor until completed birth of both offsprings

  3. Obstetric - delivery mode

    Delivery mode (rupture of membranes or premature contractions, vaginal, cesarean section, instrumental delivery, miscarriage and stillbirth).

    Measured: Collected at birth of both offsprings

  4. Obstetric - pregnancy complications

    Pregnancy complications e.g. miscarriage, abortion (induced and indication for abortion), hydramnios, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, urinary tract infection) will be collected from medical record.

    Measured: Collected at gestational age (GA) 34-36 and after birth of both offsprings

  5. Obstetric - Neonatal unit admissions

    Neonatal unit admissions

    Measured: Collected at birth and until 12 months after birth of both offsprings

  6. Obstetric - obstetrics complications

    Obstetrics complications (e.g. preterm prelabour rupture of the membranes, shoulder dystocia, birth trauma (perinatal rupture), postpartum hemorrhage, maternal infections, maternal hospitalization).

    Measured: Collected at birth of both offsprings

  7. Obstetrics - birth defects/abnormalities

    Birth defects/abnormalities

    Measured: Collected at birth of both offsprings

  8. Neonatal morbidities

    Neonatal morbidity (e.g. major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment), birth injury, respiratory distress, transient tachypnoea, neonatal hypoglycemia, systemic infections, admission to neonatal intensive care unit, number of admission days, hyperbilirubinemia), deaths.

    Measured: Collected at birth of both offsprings

  9. Fetal and offspring growth - body weight

    Fetal body weight will be measured with ultrasound during pregnancy and offspring body weight will be measured using an electronic scale.

    Measured: Collected from medical record during pregnancy, measured in gestational age (GA) GA34-GA36 via ultrasound in both pregnancies, at birth and 3, 12 and 18 months after birth of both offsprings

  10. Fetal and offspring growth - length

    Fetal length will be measured with ultrasound during pregnancy and offspring length will be measured using an infantometer as appropriate for measuring infant, baby and toddler length.

    Measured: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings

  11. Fetal and offspring growth - abdominal circumference

    Abdominal circumference will be measured with ultrasound during pregnancy and offspring abdominal circumference will be measured three times to the nearest 0.1 cm using a stretch-resistant measuring tape

    Measured: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings

  12. Fetal and offspring growth - crown circumference

    Crown circumference will be measured with ultrasound during pregnancy

    Measured: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies

  13. Fetal and offspring growth - femur length

    Femur length will be measured with ultrasound during pregnancy

    Measured: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,

  14. Fetal growth - fractional limb volume

    Fractional limb volume will be measured with ultrasound during pregnancy

    Measured: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,

  15. Offspring growth - BMI z-score

    Offspring body mass index (BMI) z-score (BMI adjusted for age and sex).

    Measured: Collected at birth and 3, 12 and 18 months after birth of both offsprings

  16. Offspring growth - weight for gestational age

    Weight for gestational age. Measured as percent of normal weight related to gestational age.

    Measured: Collected at birth and 3, 12 and 18 months after birth of both offsprings

  17. Offspring growth - large for gestational age

    Large for gestational age. Prevalence of infants being large for gestational age (LGA).

    Measured: Collected at birth of both offsprings

  18. Offspring growth - small for gestational age

    Small for gestational age. Prevalence of offspring being small for gestational age (SGA).

    Measured: Collected at birth of both offsprings

  19. Offspring growth - apgar score

    Apgar score (0-10). The higher the score, the better health condition of the offspring)

    Measured: Collected at birth of offspring of both offsprings

  20. Offspring growth

    Offspring circumference (thigh and upper arm) and skinfold (triceps, subscapularis and suprailiac). Circumferences will be measured to the nearest 0.1 cm using a stretch-resistant measuring tape and skinfolds are measured to the nearest 0.02 cm using a caliper to lightly pinch the skin and the underlying fat.

    Measured: Collected at birth and 3, 12 and 18 months after birth of offspring.

  21. Offspring growth - body composition by the POD system

    Offspring fat free mass (g) and fat mass (g) will be assessed by air displacement plethysmography using the POD system (Pea POD for 1-8kg)

    Measured: Collected within the first week of birth and 3 months post partum in both offsprings

  22. Offspring blood pressure

    Offspring blood pressure (diastolic and systolic blood pressure) will be measured three times after 10 minutes rest using an automated device placed on the arm and in direct contact with the skin.

    Measured: Collected 12 and 18 months after birth of both offsprings

  23. Offspring heart rate

    Offspring heart rate will be measured three times after 10 minutes rest using an automated device placed on the arm and in direct contact with the skin.

    Measured: Collected 12 and 18 months after birth of both offsprings

  24. Offspring growth - self-reported body weight

    Self-reported body weight

    Measured: 18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 18 of age

  25. Offspring growth - self-reported height

    Self-reported height

    Measured: 18 months after birth the study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 18 of age

  26. Adult weight

    Adult body weight is measured to the nearest 0.1 kg using a calibrated scale

    Measured: Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child)

  27. Adult Height

    Adult height will be measured to the nearest 0.5 cm using a wall-mounted stadiometer.

    Measured: Collected in GA34-GA36 in index pregnancy

  28. Adult BMI

    Calculated as weight (kg)/height(m)^2

    Measured: Collected in GA34-36 in 1st pregnancy, study visits 3, 12 and 24mo. pp after 1st child, GA34-36 in 2nd pregnancy and at follow up vist (3, 12 and 18mo. pp of 2nd child).

  29. Adult anthropometric

    Waist- and hip circumference will be measured to the nearest 0.1 cm. During pregnancy and at birth the waist of the female will not be measured.

    Measured: Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child)

  30. Adult blood pressure

    Blood pressure (diastolic and systolic blood pressure) will be measured three times with two minutes apart in right arm after 15 minutes rest using a validated automatic device. The reading is recorded to the nearest 1 mmHg.

    Measured: Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child

  31. Adult heart rate

    Heart rate will be measured three times with two minutes apart in right arm after 5-10 minutes rest using a validated automatic device. The reading is recorded to the nearest 1 beats/minute for heart rate

    Measured: Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child

  32. Adult resting metabolic rate

    Resting metabolic rate (calories/24-h) will be measured by indirect calorimetry using a ventilated hood system. Participants will lie in the supine position and rest for at least 30 min before measurements commence. The measurement will last for 20 min.

    Measured: Collected at study visit 3, 12, and 24 months pp after 1st child.

  33. Adult resting respiratory quotient + substrate

    Resting respiratory quotient (RQ), will be measured by indirect calorimetry using a ventilated hood system. Participants will lie in the supine position and rest for at least 30 min before measurements commence. The measurement will last for 20 min. Lipid, glucose and protein oxidation will be estimated.

    Measured: Collected at study visit 3, 12, and 24 months pp after 1st child.

  34. Adult medication use

    Use of medication will be collected throughout the study and for each medication the start date, stop date or continuing, form and indication will be noted in appropriate form.

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st. child

  35. Offspring medication use

    Use of medication will be collected throughout the study and for each medication the start date, stop date or continuing, form and indication will be noted in appropriate form.

    Measured: Birth, after 3, 12, and 18 months after birth of both offsprings

  36. Adult reproduction - Time to pregnancy

    Duration of time to conception defined from selfreported time point they started to try get pregnant to registration of pregnancy. The time of conception will be calculated from the ultrasound scan in week 12

    Measured: Registration of 2nd. pregnancy (up to tree years from birth of 1.st. child)

  37. Adult glucose metabolism (OGTT)

    3-h oral glucose tolerance test (OGTT) will be performed at with 75g of glucose dissolved in 250 ml of water and added 1 gram of paracetamol. Blood will collected for measurements of blood glucose, hormones (insulin, C-Peptide, glucagon), paracetamol, glucagon-like-peptide-1 (GLP-1), Glucose insulinotropic polypeptide (GIP) and metabolites (FFA). Blood samples will be drawn at time 0, 15, 30, 45, 60, 90, 120 and 180 min

    Measured: Performed at study visits 3, 12 and 24 months pp of 1st. child

  38. Adult Oral Glucose Tolerance Test (OGTT) during pregnancy (only female)

    OGTT performed during pregnancy according to the screening guidelines for GDM will be obtained from the mother's medical journal in both pregnancies.

    Measured: Collected in GA28 of 1st and 2nd pregnancy (performed after risk score at gestational age~20 and ~28 or only ~28)

  39. Placenta - weight (gram)

    Placenta will be weighted after birth

    Measured: Collected at birth of both offsprings

  40. VO2-max adult - cardiorespiratory fitness

    The VO2-max test will be performed as an incremental exercise test on a bicycle ergometer.

    Measured: Collected at study visit 3, 12 and 24 months pp after birth of 1st child

  41. Cardiac function offspring - Left ventricular and right ventricular morphology

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of Interventricular septal thickness diastole and valve- and chamber dimensions will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  42. Cardiac function offspring - left centricular ejection fraction

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of left ventricular ejection fraction will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  43. Cardiac function offspring - fractional shortening

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of fractional shortening will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  44. Cardiac function offspring - Systolic function, strain

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of strain will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  45. Cardiac function offspring - Systolic function, strain rate

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of strain rate will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  46. Cardiac function offspring - TAPSE and RV fractional area change

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of TAPSE and RV fractional area change will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  47. Cardiac function offspring - Diastolic function, left ventricular E/A-ratio

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of left ventricular E/A-ratio will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  48. Cardiac function offspring - Diastolic function, tissue velocities (E', A', S')

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of tissue velocities (E', A', S') will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  49. Cardiac function offspring - Diastolic function, strain

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of strain will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  50. Cardiac function offspring - Overall cardiac function

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of Myocardial performance index (MPI) and cardiac torsion will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  51. Cardiac function offspring - Pulmonary artery acceleration time

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of Pulmonary artery acceleration time will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  52. Cardiac function offspring - Pulmonary artery pressure

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of Pulmonary artery pressure will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  53. Cardiac function offspring - Persistent ductus arteriosus (PDA)

    ECG and echocardiography will be performed according to standard imaging protocol. Assessment of PDA open or closed and PDA shunt will be done.

    Measured: Collected at birth and at 12 months follow up visit after birth of each child

  54. Cord blood - Telomore length

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Telomore length.

    Measured: Collected at birth of both offsprings

  55. Cord blood - pH

    Cord blood will be drawn immediately after birth. pH will be assessed.

    Measured: Collected at birth

  56. Cord blood - Epigenetics

    Epigenetics analyses from whole blood. Will be analysed for methylation changes. metabolomics and exosome.

    Measured: Collected at birth of both offsprings

  57. Adult body composition by DEXA scan

    Lean mass (g), fat mass (g), abdominal fat (g), visceral fat (g) assessed by a Dual-energy X-ray absorptiometry (DEXA) -scan .

    Measured: Collected at study visits 3, 12 and 24 months pp. of 1st child

  58. Adult bone markers by DEXA scan - bone mineral content

    Bone mineral content (g) assessed by a Dual-energy X-ray absorptiometry-scan.

    Measured: Collected at study visits 3, 12 and 24 months pp. of 1st child

  59. Adult bone markers by DEXA scan - bone area

    Bone area (cm^2) assessed by a Dual-energy X-ray absorptiometry-scan.

    Measured: Collected at study visits 3, 12 and 24 months pp. of 1st child

  60. Adult bone markers by DEXA scan - bone mineral density

    Bone mineral density (g/cm^2) assessed by a Dual-energy X-ray absorptiometry-scan.

    Measured: Collected at study visits 3, 12 and 24 months pp. of 1st child

  61. Adult blood sample - glucose

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for glucose

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  62. Adult blood sample - CD163

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for CD163

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  63. Adult blood sample - HbA1c

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for markers of glucose metabolism HbA1c

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  64. Adult blood sample - Kreatinin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for kreatinin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  65. Adult blood sample - eGFR

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for kreatinin and GFR will be estimated

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  66. Adult blood sample - C-reaktivt protein (CRP)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for CRP

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  67. Adult blood sample - Alanintransaminase (ALAT)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for ALAT

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  68. Adult blood sample - Gamma-GT (GGT)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for GGT

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  69. Adult blood sample - Basisk fosfatase (BASP)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for BASP

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  70. Adult blood sample - Bilirubin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Bilirubin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  71. Adult blood sample - Ferritin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Ferritin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  72. Adult blood sample - Hemoglobin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Hemoglobin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  73. Adult blood sample - Leukocytter

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Leucocytter

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  74. Adult blood sample - platelets

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for platelets

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  75. Adult blood sample - Triglyceride

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for triglyceride

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  76. Adult blood sample - Cholesterol HDL

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Cholesterol HDL

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  77. Adult blood sample - Cholesterol LDL

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Cholesterol LDL

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  78. Adult blood sample - Total Cholesterol

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Total Cholesterol

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  79. Adult blood sample - vitamin B12

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for B12

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  80. Adult blood sample - vitamin D3

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for vitamin D3

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  81. Adult blood sample - c-peptide

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for c-peptide

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  82. Adult blood sample - Insulin-like Growth Factor-1 (IGF-1)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IGF-1

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  83. Adult blood sample - Insulin-like growth factor-binding protein-1 (IGFBP-1)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IGFBP-1

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  84. Adult blood sample - Insulin-like growth factor-binding protein-3 (IGFBP-3)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IGFBP-3

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  85. Adult blood sample - Fibroblast growth factor 21 (FGF-21)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for FGF-21

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  86. Adult blood sample - Leptin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Leptin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  87. Adult blood sample - Adiponectin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Adiponectin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  88. Adult blood sample - Ghrelin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Ghrelin

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  89. Adult blood sample - Growth Hormone (GH)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for GH

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  90. Adult blood sample - Free fatty Acids (FFA)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for FFA

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  91. Adult blood sample - Interleukin 6 (IL-6)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IL-6

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  92. Adult blood sample - Interleukin 6 (IL-10)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IL-10

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  93. Adult blood sample - Interleukin-1 alpha (IL-1 alpha)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IL-1 alpha

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  94. Adult blood sample - Interferon gamma (IFN-γ)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for IFN-γ

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  95. Adult blood sample - Tumor Necrosis Factor alfa (TNF-α)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for TNF-α

    Measured: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child

  96. Adult female blood sample - Humant choriogonadotropin (hCG)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for hCG

    Measured: Collected at GA34-GA36 in both pregnancies

  97. Adult female blood sample - Progesterone

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for Progesterone

    Measured: Collected at GA34-GA36 in both pregnancies

  98. Adult female blood sample - Proinsulin C-peptide

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for Proinsulin C-peptide

    Measured: Collected at GA34-GA36 in both pregnancies

  99. Adult female blood sample - sex hormone binding globulin (SHBG)

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for SHBG

    Measured: Collected at GA34-GA36 in both pregnancies

  100. Adult female blood sample - Prolactin

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for Prolactin

    Measured: Collected at GA34-GA36 in both pregnancies

  101. Adult blood sample -Cortisol

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for Cortisol

    Measured: Collected at GA34-GA36 in both pregnancies

  102. Adult female blood sample -Estradiol

    All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will only be collected from the female participant during pregnancy and be analysed for Estradiol

    Measured: Collected at GA34-GA36 in both pregnancies

  103. Offspring blood sample - glucose

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for glucose

    Measured: Collected 12 months after birth in both offsprings

  104. Offspring blood sample - c-peptide

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for c-peptide

    Measured: Collected 12 months after birth in both offsprings

  105. Offspring blood sample - insulin

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Insulin

    Measured: Collected 12 months after birth in both offsprings

  106. Offspring blood sample - IGF-1

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for IGF-1

    Measured: Collected 12 months after birth in both offsprings

  107. Offspring blood sample - IGFBP-3

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for IGFBP-3

    Measured: Collected 12 months after birth in both offsprings

  108. Offspring blood sample - IGFBP-1

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for IGFBP-1

    Measured: Collected 12 months after birth in both offsprings

  109. Offspring blood sample - CD163

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for CD163

    Measured: Collected 12 months after birth in both offsprings

  110. Offspring blood sample - Ferritin

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Ferritin

    Measured: Collected 12 months after birth in both offsprings

  111. Offspring blood sample - HgbA1c

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for HgbA1c

    Measured: Collected 12 months after birth in both offsprings

  112. Offspring blood sample - Hgb

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Hgb

    Measured: Collected 12 months after birth in both offsprings

  113. Offspring blood sample - CRP

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for CRP

    Measured: Collected 12 months after birth in both offsprings

  114. Offspring blood sample - Triglyceride

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Triglyceride

    Measured: Collected 12 months after birth in both offsprings

  115. Offspring blood sample - Cholesterol HDL

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Cholesterol HDL

    Measured: Collected 12 months after birth in both offsprings

  116. Offspring blood sample - Cholesterol LDL

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Cholesterol LDL

    Measured: Collected 12 months after birth in both offsprings

  117. Offspring blood sample - Total Cholesterol

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Total Cholesterol

    Measured: Collected 12 months after birth in both offsprings

  118. Offspring blood sample - FGF-21

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for FGF-21

    Measured: Collected 12 months after birth in both offsprings

  119. Offspring blood sample - Leptin

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Leptin

    Measured: Collected 12 months after birth in both offsprings

  120. Offspring blood sample - Adiponectin

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Adiponectin

    Measured: Collected 12 months after birth in both offsprings

  121. Offspring blood sample - FFA

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for FFA

    Measured: Collected 12 months after birth in both offsprings

  122. Offspring blood sample - Growth Hormone (GH)

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for GH

    Measured: Collected 12 months after birth in both offsprings

  123. Offspring blood sample - cTroponin I (cTnI)

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for cTnI

    Measured: Collected 12 months after birth in both offsprings

  124. Offspring blood sample - BNP

    A non-fasting venous blood will be drawn. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for BNP

    Measured: Collected 12 months after birth in both offsprings

  125. Cord blood - c-peptide

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for C-peptide

    Measured: Collected at birth of both offspring

  126. Cord blood -Insulin

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Insulin

    Measured: Collected at birth of both offspring

  127. Cord blood -IGFBP-3

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IGFBP-3

    Measured: Collected at birth of both offspring

  128. Cord blood -IGFBP-1

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IGFBP-1

    Measured: Collected at birth of both offspring

  129. Cord blood -IGF-1

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IGF-1

    Measured: Collected at birth of both offspring

  130. Cord blood -Ferritin

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Ferritin

    Measured: Collected at birth of both offspring

  131. Cord blood -cTnI

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for cTnI

    Measured: Collected at birth of both offspring

  132. Cord blood -BNP

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for BNP

    Measured: Collected at birth of both offspring

  133. Cord blood -CRP

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for CRP

    Measured: Collected at birth of both offspring

  134. Cord blood -CD163

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for CD163

    Measured: Collected at birth of both offspring

  135. Cord blood -FGF21

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for FGF21

    Measured: Collected at birth of both offspring

  136. Cord blood -Leptin

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Leptin

    Measured: Collected at birth of both offspring

  137. Cord blood -Adiponectin

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Adiponectin

    Measured: Collected at birth of both offspring

  138. Cord blood -FFA

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for FFA

    Measured: Collected at birth of both offspring

  139. Cord blood - Vitamin D3

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for Vitamin D3

    Measured: Collected at birth of both offspring

  140. Cord blood - HbA1c

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for HbA1c

    Measured: Collected at birth of both offspring

  141. Cord blood - IL-6

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IL-6

    Measured: Collected at birth of both offspring

  142. Cord blood - IL-10

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IL-10

    Measured: Collected at birth of both offspring

  143. Cord blood - IL-1 alpha

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IL-1 alpha

    Measured: Collected at birth of both offspring

  144. Cord blood -TNF- alpha

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for-TNF- alpha

    Measured: Collected at birth of both offspring

  145. Cord blood -IFN- gamma

    Cord blood will be drawn immediately after birth and analysed. Blood will be analyzed for IFN- gamma

    Measured: Collected at birth of both offspring

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start1 Jun 2023
  3. Primary completion11 Apr 2025 (estimated)
  4. Study completion11 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
140 couples will be recruited and randomized to either intervention og control. Participants includes the mother, father and 1st and 2nd child, therefore the total number of participants will be 560.
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05798494
Sponsor's protocol ID
Prepare Child AUH
Acronym
PREPARE CHILD
Status last verified
Jan 2024
First submitted
21 Feb 2023
Last updated
18 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rasmussen L, Knorr S, Antoniussen CS, Bruun JM, Ovesen PG, Fuglsang J, Kampmann U. The Impact of Lifestyle, Diet and Physical Activity on Epigenetic Changes in the Offspring-A Systematic Review. Nutrients. 2021 Aug 17;13(8):2821. doi: 10.3390/nu13082821.

    PubMed 34444981

Questions about this trial

What is this clinical trial studying?

A study testing Weight loss intervention in people with Overweight and Obesity and Weight Loss, run by Ulla Kampmann Opstrup at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ulla K Opstrup, MD, PhD (+4522370857, ullaopst@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neonatal fat mass (time frame: Collected within the first week of birth (strived <48 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05798494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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