Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial

Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity. A Randomized, Parallel Group, Tailored Multifactorial Lifestyle Intervention Trial Among Women With Overweight or Obesity Seeking Pregnancy - the PRE-STORK Trial

Introduction: The prevalence of childhood overweight and obesity has risen from just 4% in 1975 to more than 18% in 2016. Little is known about adiposity of the infant, but it positively associates to the mother's BMI. Globally, the prevalence of overweight has tripled since 1975 and is now affecting one of three Danish women at the time of pregnancy. However, despite increasing awareness of obesity and accumulating evidence of its health consequences limited effect of intervention in childhood obesity exists. Maternal obesity before conception, an excessive increase in body weight during pregnancy and physical inactivity are some of the risk factors suspected of infant adiposity. Lifestyle interventions during pregnancy have shown limited or no effect in the offspring. Therefore, renewed effort to improve the prevention of childhood obesity is warranted.

Methods and analysis: This is a randomized, parallel group, tailored, multifactorial lifestyle intervention trial in women (age 18 to 38 years) with overweight or obesity (BMI 27 to 42 kg/m2) seeking pregnancy. The women are randomized 1:1 to either the lifestyle or standard of care group. The lifestyle intervention is initiated prior to pregnancy. The lifestyle intervention is set off with a low-calorie diet for 8 weeks and throughout the intervention period (prior to and during pregnancy) participants follow an intervention containing exercise according to the World Health Organization guidelines, healthy diet and mentorship to maintain healthy weight before and during pregnancy.The primary outcome is the difference in neonatal adiposity measured at birth. Finally, a child and family cohort will be established to follow the children throughout childhood for healthy weight development. The study will provide evidence of effects from pre-conception-initiated intervention and have the potential to improve health and quality of life for children.

Ethics and dissemination: The trial has been approved by the ethical committee of the Capital Region of Denmark (H-22011403) The trial will be conducted in agreement with the Declaration of Helsinki and monitored to follow the guidelines for good clinical practice. Results will be submitted for publication in international peer-reviewed scientific journals.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Overweight and Obesity
• Intervention / Treatment: Behavioral: Diet; Behavioral: Exercise; Behavioral: Mentorship

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Steno Diabetes Center Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Having overweight or obesity (BMI 25-44 kg/m2)
• Age 18-34 years (no previous pregnancy) or 18-40 years (previous pregnant >16 weeks)
• Planning a pregnancy within the next year
• Willingness to lose at least 10% of initial body weight before pregnancy and be physically able to adhere to WHO physical activity recommendations when entering the study
• Willing to postpone pregnancy until at least 6 months after randomization
• Planning antenatal care and delivery at either Herlev Hospital or Odense University Hospital
• Danish or English speaking

Exclusion Criteria:

• Diabetes (fasting plasma glucose (FPG) >7 mmol/l and HbA1c ≥48 mmol/mol)
• Previous gestational diabetes mellitus (GDM) treated with insulin during pregnancy
• Polycystic ovary syndrome (PCOS) treated with metformin
• Treatment with medication which significantly affect glucose metabolism, appetite, or energy balance
• The use of medications that cause clinically significant weight gain or loss
• Habitual abortion (more than 3 abortions in a row)
• Known infertility (defined as fertility treatment and/or no obtained conception with the same partner after trying >12 months)
• Previous bariatric surgery
• Significant psychiatric disorders
• Uncontrolled/severe medical issues including cardiovascular, pulmonary, rheumatologic, hematologic, oncologic, infectious, or endocrine disease
• Regular exercise training at high intensity (e.g., spinning) >3 hours per week
• Known eating disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle group; A tailored multifactorial lifestyle intervention consisting of diet, exercise and mentorship in women with overweight or obesity to obtain a healthy lifestyle before and during pregnancy.	Behavioral: Diet; An initial 8 weeks of low-calorie diet including meal replacements (total of 800 kcal/day) will be initiated with the objective to lose at least 10% of initial body weight. From week 8 until week 12, an individual food-reintroduction plan will take place with partial meal product substitution. At week 12 and until pregnancy dieticians will ensure sustained compliance with diet aligned with the general recommendations for women seeking pregnancy (low-fat diet, rich in protein and carbohydrates and in some individuals slightly carbohydrate-reduced diet (prediabetes or family disposition to diabetes) with focus on carbohydrate quality (more fiber and whole grain). Consultations with a dietician for mapping diet and eating patterns and regular follow-up with a dietitian to maintain diet changes and modify diets if needed.; Behavioral: Exercise; After an initial 8-week ramp-up phase (during the initial low-calorie diet), the women will be encouraged to attend supervised exercise sessions on the study location (combination of vigorous-intensity, interval-based indoor cycling, and circuit training) twice weekly and to perform additional moderate-to vigorous-intensity exercise to obtain at least 150 min per week of moderate-intensity or 75 min per week of vigorous-intensity physical activity or a combination. The plan will include individual exercise and/or group exercise. Exercise watches with heart-rate monitors will be worn at each exercise session to determine whether the requirement regarding weekly time spent at moderate or vigorous intensity will be met. Regular follow-up with the women to maintain exercise changes and modify the exercise plan if needed.; Behavioral: Mentorship; Women are offered an individualized plan to successfully fulfil the multifactorial lifestyle intervention and the women will be offered both individual and/or group sessions with a mentor. After 8 weeks of the intervention, the women will be invited to another meeting where the choice of mentor will be evaluated, and the women will be offered to join a "pre-parents-group". Group sessions will include conversational sessions, cooking classes and exercise classes with focus on changing lifestyle and maintaining a healthy lifestyle change. At the time of pregnancy groups will be reconsidered and the women will be offered participation in "pregnancy-groups".
No Intervention: Standard of care group; The standard of care group will receive no active intervention but are encouraged to seek any possible guidance from the general practitioner for management of pre-pregnancy obesity according to current guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal adiposity	Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).	Assessed at birth or up to 72 hours postpartum.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placenta function (during pregnancy)	Measured by the represented amount of amniotic fluid, cerebral media and umbilical artery doppler flow of the foetus.	Assessed during pregnancy (week 34).
Neonatal body mass index (BMI) z-score	Body mass index (BMI) is body weight relative to height (kg/m^2) and BMI z-score is called BMI standard deviation (s.d.) scores and is a measure of relative weight adjusted for child age and sex.	Assessed at birth.
Neonatal body composition (fat percent)	Measured by air displacement plethysmography (PEA POD).	Assessed at birth.
Neonatal body composition (fat free mass)	Measured by air displacement plethysmography (PEA POD) and lean mass is also based on this assessment.	Assessed at birth.
Gestational age	The gestational age is registered when giving birth.	Assessed at birth.
Weight for gestational age	Measured as percent of normal weight related to gestational age.	Assessed at birth.
Large for gestational age (LGA)	Assessed as the proportions of infants being born LGA	Assessed at birth.
Small for gestational age (SGA)	Assessed as the proportions of infants being born SGA.	Assessed at birth.
Apgar score	Assessed as the proportions of infants born with Apgar score <7.	Assessed at birth.
Placenta function (birth)	Assessed by the weight of the placenta (in gram).	Assessed at birth.
Weight loss (women)	Assessed as the proportion of women who achieve a weight loss of ≥10% at time of pregnancy (or two years after randomisation without achieving pregnancy)	Assessed up to 2 years.
Pregnancy (women)	Assessed as the proportion of women without obtaining pregnancy or live-born offspring within a period of two years.	Assessed up to 2 years.
Insulin resistance (fasting insulin)	Fasting insulin concentration is assessed prior to a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Insulin resistance (OGTT)	Area under the insulin concentration time curve (0-60 min), area under the insulin concentration time curve (0-120 min), maximum observed insulin concentration, time to maximum observed insulin concentration, baseline-subtracted area under the insulin concentration time curve (0-60 min) and baseline-subtracted area under the insulin concentration time curve (0-120 min), Matsuda index and homeostasis model assessment-insulin resistance (HOMA-IR) are assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Hormonal response - glucagon (OGTT)	Glucagon assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Hormonal response - GLP-1 (OGTT)	Glucagon-like peptide-1 (GLP-1) assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Hormonal response - PYY (OGTT)	Peptide tyrosine tyrosine (PYY) assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Hormonal response - GIP (OGTT)	Gastric inhibitory peptide (GIP) assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Hormonal response - ghrelin (OGTT)	Ghrelin assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Glycaemic variability (CGM and OGTT)	Measured by 10-day coefficient of variance (CV) of glucose levels measured by continous glucose monitoring (CGM) and during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28).
Height (women)	Measured to the nearest 0.5 cm.	Assessed prior to pregnancy (baseline).
Prediabetes (women)	Assessed as the proportion of women with prediabetes.	Assessed prior to pregnancy (6 months from baseline)
Foetal and infant body weight	During pregnancy foetal body weight is determined by ultrasonographic method and infant body weight is measured on a scale.	Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant abdominal circumference	During pregnancy abdominal circumference is determined by ultrasonographic method and infants are measured to the nearest 1.0 cm.	Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant femur length	During pregnancy femur length is determined by ultrasonographic method and infants are measured to the nearest 1.0 cm.	Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant head circumference	During pregnancy head circumference is calculated by biparietal diameter and occiput-frontal diameter by ultrasonographic method and infants are measured to the nearest 1.0 cm.	Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Faeces (infant)	Changes in faecal microbiota composition.	Assessed at birth and 3 months after birth.
Infant body composition (fat mass, fat free mass) PEA POD	Body composition (fat mass (g), and fat free mass (g)) is assessed by air displacement plethysmography (PEA POD).	Assessed 3 months after birth
Infant body composition (fat percent) PEA POD	Body composition (fat percent (%) ) is assessed by air displacement plethysmography (PEA POD).	Assessed 3 months after birth
Infant body composition (fat mass, fat free mass) dual energy x-ray absorptiometry.	Body composition (fat mass (g) and fat free mass (g)) is assessed by dual energy x-ray absorptiometry scans.	Assessed 3 months after birth.
Infant body composition (fat percent) dual energy x-ray absorptiometry.	Body composition (fat percent (%)) is assessed by dual energy x-ray absorptiometry scans.	Assessed 3 months after birth.
Infant BMI z-score	Body mass index (BMI) is body weight relative to height (kg/m^2) and BMI z-score is called BMI standard deviation (s.d.) scores and is a measure of relative weight adjusted for child age and sex.	Assessed 3 months after birth.
Glucose tolerance (OGTT)	Maximum observed glucose concentration, time to maximum observed glucose concentration and baseline-subtracted area under the plasma glucose concentration time curve (0-120 min), and two-hour plasma glucose concentration are assessed during a 75 gram oral glucose tolerance test.	Assessed during pregnancy (week 24-28)
BMI (women)	Calculated as weight (kg) divided by height(m)^2.	Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and 3 months after giving birth.
Body weight (women)	Measured by scale to nearest 0.1 kg	Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28, 34, 38 and at delivery) and 3 months after giving birth.
Body composition (fat percent and muscle mass percent) (women)	Body composition measured by Dual-energy X-ray absorptiometry scans prior to and after pregnancy. During pregnancy measured by bioelectrical impedance analysis.	Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and 3 months after giving birth.
Bone density (T-score) (women)	Bone density is measured by Dual-energy X-ray absorptiometry scans prior to and after pregnancy. During pregnancy measured by bioelectrical impedance analysis.	Assessed prior to pregnancy (baseline, 6 months, 12 months) and 3 months after giving birth.
Resting heart rate (women)	After resting for a minimum of 10 minutes heart rate measured 3 times with 2 min in between each measurement.	Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and 3 months after giving birth.
Blood pressure (women)	After resting for a minimum of 10 minutes systolic and diastolic blood pressure is measured 3 times with 2 min in between each measurement.	Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and 3 months after giving birth.
Fasting plasma glucose (women)	Fasting plasma glucose is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
HbA1c (women)	HbA1c is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - cholesterol (women)	Cholesterol is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - HDL (women)	High-density lipoprotein (HDL) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - LDL (women)	Low-density lipoprotein (LDL) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - VLDL (women)	Very-low-density lipoprotein (VLDL) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - TG (women)	Triglycerides is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Lipid profile - ApoA/ApoB ratio (women)	Apolipoprotein B/apolipoprotein A1 ratio assessed by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Liver function - liver fat (women)	Liver function by Fibro-Scan (a proxy for liver fibrosis) measured by Fibro-Scan (UL-based elastography) and liver fat is measured by the controlled attenuation parameter score in decibel per meter.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Liver function - liver stiffness (women)	Liver function by Fibro-Scan (a proxy for liver fibrosis) is measured by Fibro-Scan (UL-based elastography) and liver stiffness is measured by shear wave velocity in kilopascal.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Food preference (women)	Food preference is measured using the Steno Biometric Food Preference Task after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Bone homeostasis - CTX (women)	Pharmacodynamic endpoints for bone homeostasis derived from bone turnover markers carboxy-terminal collagen crosslinks (CTX) as a marker for bone resorption after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Bone homeostasis - P1NP (women)	Pharmacodynamic endpoints for bone homeostasis derived from bone turnover markers type 1 amino-terminal pro-peptide (P1NP) as a marker for bone formation after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Bone homeostasis - OC (women)	Pharmacodynamic endpoints for bone homeostasis derived from bone turnover markers osteocalcin (OC) as a marker of bone formation after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Inflammatory markers - hs-CRP (women)	High-sensitivity C-reactive protein (hs-CRP) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28), at delivery and 3 months after giving birth.
Inflammatory markers - TNFa (women)	Tumour necrosis factor-α (TNF-α) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Inflammatory markers - IL-6 (women)	Interleukin-6 (IL-6) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Inflammatory markers - LBP (women)	Lipopolysaccharide-binding protein (LBP) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Waist and hip circumference (women)	Waist and hip circumference is measured to the nearest 0.1 cm.	Assessed prior to pregnancy (baseline, 8 weeks, 6 months, 12 months and 18 months) and 3 months after giving birth.
Resting energy expenditure (women)	Resting energy expenditure is meaured using indirect calorimetry.	Assessed prior to pregnancy (baseline, 6 months, and three months after giving birth)
Exercise capacity (women)	Exercise capacity is measured by maximal exercise test with direct measurement of maximal oxygen consumption.	Assessed prior to pregnancy (baseline, 6 months, and three months after giving birth)
Gestational diabetes (women)	Assessed as the proportion of women diagnosed with gestational diabetes according to the Danish guidelines	Assessed during pregnancy (week 10 to 40)
Exercise capacity (women)	Exercise capacity is measured indirectly with the decive Seismofit® which estimates the maximal oxygen consumption by a 3-minute test during rest using seismocardiography.	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 24-28), and three months after giving birth)
Daily physical activity, sedentary time and sleep (women)	Daily physical activity, sedentary time and sleep are measured with an 3-axis accelerometer (AX3, Axivity) for seven consecutive days. Two devices are placed on lower back and the thigh, respectively.	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 24-28), and 3 months after giving birth)
Duration and intensity of physical exercise (women in the intervention group)	Physical exercise duration and intensity, daily physical and sleep are measured in the intervention group by a activity watch.	The women in the intervention group will be wearing the watch 24 hour/day from baseline to 3 months after giving birth.
Hypertensive disorders in pregnancy	Defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHG	Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum
Pre-eclampsia	If hypertension occurs during pregnancy, information on the findings below will be obtained: i. proteinuria > 0,3 gram/liter ii. Thrombocytopenia (< 100x109/l) iii. Renal insufficiency (serum creatinine > 100 mmol/l) iv. Impaired liver function (elevated transaminases to twice the normal concentration) v. Pulmonary edema vi. Cerebral or visual symptoms vii. Utero-placental dysfunction (SGA corresponding to an ultrasound-estimated weight below -15 %)	Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum
Essential hypertension	Defined as diagnosed hypertension before gestional week 20	Will be obtained from electronical medical records prior to pregnancy until gestational week 20.
Mode of delivery	Destinction between; Non-instrumental vaginal delivery; Instrumental vaginal delivery; Elective caesarean section; Emergency caesarean section (grade 1,2 or 3)	Assessed at birth
Breastfeeding practice	Successful breastfeeding 12 weeks after delivery, defined as exclusive breastfeeding (using formula supplements less than once a week)	Assessed by individual questionnaire 4 months after giving birth
Brest milk composition	Analyses will consist of analysing macronutrient content (protein, fat, carbohydrates, and calories), vitamins and minerals	Samples will be collected within 72 hours post partum, and at week 12 after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility treatment (women)	Assessed as the proportion of women who initiate fertility treatment during the trial period	Assessed up to 2 years.
Height (partner)	Height is measured to the nearest 0.5 cm.	Assessed prior to pregnancy of the woman (baseline)
Body composition - fat percent (partner)	Fat percent (%) is measured by bioelectrical impedance analysis after standardized conditions.	Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
Semen quality (partner)	Quality of semen from the father (meassured as number of sperm cells).	Assessed prior to pregnancy of the woman (baseline) and during pregnancy (week 11-14).
Semen epigenetics (partner)	Epigenetic profile of sperm cells	Assessed prior to pregnancy of the woman (baseline) and during pregnancy (week 11-14).
Umbilical cord	Epigenetic profile from umbilical cord blood	Assessed at birth.
Placenta	Epigenetic profile from placenta biopsies	Assessed at birth.
Epigenetic (women, partner and child)	Epigenetic profile in peripheral blood mononuclear cells	Assessed at birth.
Obesity related-phenotypes	Associations between parent and child genetics and obesity-related phenotypes.	Assessed at the end of the trial intervention period.
Neonatal complications (delivery)	Proportion of children with neonatal complications including (simple and complex) asphyxia (represented by potential of Hydrogen (pH)-values from umbilical cord), hypoglycaemia, jaundice, and admittance to neonatal intensive care	Assessed at birth.
Body weight (partner)	Body weight is measured using a scale to the nearest 0.1 kg.	Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 3 months after birth.
BMI (partner)	BMI is calculated as weight (kg) divided by height(m)^2.	Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 3 months after birth.
Body composition - fat mass and fat free mass (partner)	Fat mass (g) and fat free mass (g) are measured by bioelectrical impedance analysis after standardized conditions.	Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 3 months after birth.
Blood pressure (partner)	After resting for a minimum of 10 minutes systolic and diastolic blood pressure is measured 3 times with 2 min in between each measurement.	Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 3 months after birth.
Appetite, physical activity and wellbeing (women and partner)	Appetite sensation, daily physical activity level and wellbeing based on questionnaires.	Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 3 months after birth
Sleep (women and partner)	Sleep patterns based on questionnaires.	Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 3 months after birth.
Self perception of body weight, self-esteem and partner support (women and partner)	Perception of weight-related stigma and self-esteem, social/partner support on eating habits and exercise based on questionnaires.	Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 3 months after birth.
Faeces (women)	Changes in faecal microbiota composition,: (what species are present and how many different types of species are present with a sample) using Shannon index.	Assessed prior to pregnancy (baseline) and 3 months after birth.
Complications (delivery)	Proportion of women who experience complications during delivery (premature delivery, labour induction, vacuum extraction, shoulder dystocia, planned and emergency caesarean section, postpartum haemorrhage and stillbirth).	Assessed at birth.
Thrombelastography (TEG) (women)	TEG is measured by blood sampling after an overnight of fasting	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 11-14 and 24-28), at birth and 3 months after giving birth.
Complications during pregnancy (gestational week 24 - 40)	Proportion of women who experience complications during pregnancy (gestational week 24 - 40) and post-partum (3 months post partum) (deep vein thrombosis, pulmonary embolism, gestational hypertension, preeclampsia, abortion)	Assessed during pregnancy (week 24-40) and 3 months post-partum
International Normalized Ratio in umbillical cord (child)	International Normalized Ratio (combined measure for coagulation factor II, VII, and X). Blood sampled from umbillical cord at birth.	Assessed at birth
Haemoglobin (child)	Concentration of haemoglobin is measured by blood sampling from umbillical cord at birth	Assessed at birth
High-sensitivity C-reactive protein (child)	Concentration of high-sensitivity CRP (hsCRP). Blood sampled from umbillical cord at birth	Assessed at birth
Liver marker alanine transaminase (child)	Concentration of alanine transaminase. Blood sampled from umbillical cord at birth	Assessed at birth
Thrombelastography (TEG) (child)	TEG is measured by blood sampled from umbillical cord at birth and from vein puncture three months after birth	Assessed at birth and 3 months after birth
Concentration of endothelial marker thrombomodulin (women)	Concentration of the endothelial marker thrombomodulin, is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 11-14 and 24-28), at delivery and three months after giving birth.
Coagulation function (Child)	Activated partial thromboplastin time (seconds)(APTT). Blood sampled from umbillical cord at birth.	Measured at birth.
Coagulation ratio (Child)	International normalised ratio (INR) of time (seconds). Blood sampled from umbillical cord at birth.	Measured at birth.
Liver marker bilirubin (Child)	Concentration of bilirubin. Blood sampled from umbillical cord at birth	Measured at birth
Liver marker albumin (Child)	Concentration of albumin. Blood sampled from umbillical cord at birth	Measured at birth
Endothelial marker Syndecan-1 (women)	Concentration of syndecan-1 is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 11-14 and 24-28), at delivery and three months after giving birth.
Endothelial marker PECAM-1 (women)	Concentration of platelet endothelial cell adhesion molecule 1 (PECAM-1) is measured by blood sampling after an overnight of fasting.	Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 11-14 and 24-28), at delivery and three months after giving birth.
Self-perception of the severity of pregnancy-related nausea and vomiting (women)	The severity of pregnancy-related nausea and vomiting is meas-ured based on the questionnaire Pregnancy-Unique Quantification of Emesis and Nausea (PUQE)	Assessed once weekly from registration of pregnancy (week 5-10) until delivery (week 40).
Planned obstetric consultations	Number of planned obstetric consultations after gestational week 20	Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum
Obstetric emergency consultations	Number of obstetric emergency consultations after gestational week 20	Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum
Urinary tract infections during pregnancy	Number of diagnosed urinary tract infections during pregnancy	Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum
Vaginal bleeding in pregnancy	Number of admissions with vaginal bleeding episodes after gestational week 20	Will be obtained from electronical medical records from gestational week 20 until birth
Premature contractions	Admissions with premature contractions before gestational week 34	Will be obtained from electronical medical records from gestational week 20 until birth
Shortened cervix	Admissions with shortened cervix less than 20 mm before gestational week 34	Will be obtained from electronical medical records from gestational week 20 until birth
Preterm delivery	Defined as delivery before gestational week 34	Will be obtained from electronical medical records from gestational week 20 until birth
Induction of labour	Induction (mechanical or medical) of labour before spontaneous onset of labour	Will be obtained from electronical medical records from gestational week 20 until birth
Epidural analgesia	Use of epidural analgesia during birth	Will be obtained from electronical medical records from admission to the labour ward until birth
Scalp pH sampling	Use of scalp pH sampling during birth	Will be obtained from electronical medical records from admission to the labour ward until birth
Oxytocin stimulation	Use of Oxytocin stimulation in active labour	Will be obtained from electronical medical records from admission to the labour ward until birth
Perineal lacerations	Perineal lacerations, destinction between 1st, 2nd, 3rd, and 4th degree	Will be obtained from electronical medical records from the time of birth until 48 hours post partum
Post-partum haemorrhage	Post-partum haemorrhage in mL	Will be obtained from electronical medical records from the time of birth until 48 hours post partum
Admission and re-submission after delivery	Length of admission and re-submission after delivery	Will be obtained from electronical medical records from the time of birth until 12 weeks post partum
Anaemia during and after pregnancy	Defined as haemoglobin less than 5.0 mmol/l	Will be obtained from electronical medical records from gestational week 20 until 12 weeks post partum
Mastitis	Diagnosed mastitis	Will be obtained from electronical medical records from the time of birth until 12 weeks post partum
Endometritis	Diagnosed Endometritis	Will be obtained from electronical medical records from the time of birth until 12 weeks post partum
Hospital admissions	Number of and total length of hospital admissions	Will be obtained from electronical medical records from gestational week 20 until 12 weeks post partum
Mood and depressions	Mood and depressions Edinburgh Postnatal Depression Scale 16 weeks after delivery	Will be assessed by individual questionnaire 4 months after giving birth
Quality of life (SF-36)	Quality of life (SF-36) 16 weeks after delivery	Will be assessed by individual questionnaire 4 months after giving birth

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Tina Vilsbøll, Professor, Steno Diabetes Center Copenhagen; Principal Investigator: Louise G. Grunnet, PhD, Steno Diabetes Center Copenhagen; Principal Investigator: Signe Torekov, Professor, University of Copenhagen

Publications and helpful links

General Publications

• Kornerup N, Danielsen JH, Sahl RE, Pico ML, Johansen MY, Knop FK, Bonnelykke K, Bergholt T, Kelstrup L, Foghsgaard S, Ghauri N, Gronlund E, Lund L, Vinter CA, Lyng Forman J, Barres R, Kragelund Nielsen K, Andersen A, Torekov SS, Groth Grunnet L, Vilsboll T. Healthy lifestyle before and during pregnancy to prevent childhood obesity: study protocol for a parallel group randomised trial - the PRE-STORK trial. BMJ Open. 2025 Jan 25;15(1):e087895. doi: 10.1136/bmjopen-2024-087895.

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2022
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Diet; Mentors
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Exercise; Diet
• Other Study ID Numbers: H-22011403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request. The dataset contains protected health information and will not be available online. Study results will be available by contacting the corresponding author. A proposal must be submitted to the PRE-STORK steering committee. If approved, data will be available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No