Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial
- Conditions
- Pregnancy RelatedOverweight and Obesity
- Interventions
- Behavioral: DietBehavioral: ExerciseBehavioral: Mentorship
- Registration Number
- NCT05578690
- Lead Sponsor
- Steno Diabetes Center Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 360
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lifestyle group Diet 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. Lifestyle group Exercise 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. Lifestyle group Mentorship 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.
- Primary Outcome Measures
Name Time Method Neonatal adiposity Assessed at birth or up to 72 hours postpartum. Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).
- Secondary Outcome Measures
Name Time Method Apgar score Assessed at birth. Assessed as the proportions of infants born with Apgar score \<7.
Foetal and infant body weight Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth. During pregnancy foetal body weight is determined by ultrasonographic method and infant body weight is measured on a scale.
Foetal and infant abdominal circumference Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth. During pregnancy abdominal circumference is determined by ultrasonographic method and infants are measured to the nearest 1.0 cm.
Foetal and infant femur length Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth. During pregnancy femur length is determined by ultrasonographic method and infants are measured to the nearest 1.0 cm.
Foetal and infant head circumference Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth. 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.
Placenta function (during pregnancy) Assessed during pregnancy (week 34). Measured by the represented amount of amniotic fluid, cerebral media and umbilical artery doppler flow of the foetus.
Neonatal body mass index (BMI) z-score Assessed at birth. 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.
Neonatal body composition (fat percent) Assessed at birth. Measured by air displacement plethysmography (PEA POD).
Neonatal body composition (fat free mass) Assessed at birth. Measured by air displacement plethysmography (PEA POD) and lean mass is also based on this assessment.
Gestational age Assessed at birth. The gestational age is registered when giving birth.
Weight for gestational age Assessed at birth. Measured as percent of normal weight related to gestational age.
Large for gestational age (LGA) Assessed at birth. Assessed as the proportions of infants being born LGA
Small for gestational age (SGA) Assessed at birth. Assessed as the proportions of infants being born SGA.
Placenta function (birth) Assessed at birth. Assessed by the weight of the placenta (in gram).
Faeces (infant) Assessed at birth and 4 months after birth. Changes in faecal microbiota composition.
Infant body composition (fat mass, fat free mass) PEA POD Assessed 4 months after birth Body composition (fat mass (g), and fat free mass (g)) is assessed by air displacement plethysmography (PEA POD).
Infant body composition (fat percent) PEA POD Assessed 4 months after birth Body composition (fat percent (%) ) is assessed by air displacement plethysmography (PEA POD).
Infant body composition (fat mass, fat free mass) dual energy x-ray absorptiometry. Assessed 4 months after birth. Body composition (fat mass (g) and fat free mass (g)) is assessed by dual energy x-ray absorptiometry scans.
Infant body composition (fat percent) dual energy x-ray absorptiometry. Assessed 4 months after birth. Body composition (fat percent (%)) is assessed by dual energy x-ray absorptiometry scans.
Infant BMI z-score Assessed 4 months after birth. 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.
Weight loss (women) Assessed up to 2 years. 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)
Pregnancy (women) Assessed up to 2 years. Assessed as the proportion of women without obtaining pregnancy or live-born offspring within a period of two years.
Glucose tolerance (OGTT) Assessed during pregnancy (week 24-28) Maximum observed glucose concentration, time to maximum observed glucose concentration and baseline-subtracted area under the plasma glucose concentration time curve (0-120 min) are assessed during a 75 gram oral glucose tolerance test.
Insulin resistance (fasting insulin) Assessed during pregnancy (week 24-28). Fasting insulin concentration is assessed prior to a 75 gram oral glucose tolerance test.
Insulin resistance (OGTT) Assessed during pregnancy (week 24-28). 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.
Hormonal response - glucagon (OGTT) Assessed during pregnancy (week 24-28). Glucagon assessed during a 75 gram oral glucose tolerance test.
Hormonal response - GLP-1 (OGTT) Assessed during pregnancy (week 24-28). Glucagon-like peptide-1 (GLP-1) assessed during a 75 gram oral glucose tolerance test.
Hormonal response - PYY (OGTT) Assessed during pregnancy (week 24-28). Peptide tyrosine tyrosine (PYY) assessed during a 75 gram oral glucose tolerance test.
Hormonal response - GIP (OGTT) Assessed during pregnancy (week 24-28). Gastric inhibitory peptide (GIP) assessed during a 75 gram oral glucose tolerance test.
Hormonal response - ghrelin (OGTT) Assessed during pregnancy (week 24-28). Ghrelin assessed during a 75 gram oral glucose tolerance test.
Glycaemic variability (CGM and OGTT) Assessed during pregnancy (week 24-28). 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.
BMI (women) Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and four months after giving birth. Calculated as weight (kg) divided by height(m)\^2.
Body weight (women) Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and four months after giving birth. Measured by scale to nearest 0.1 kg
Height (women) Assessed prior to pregnancy (baseline). Measured to the nearest 0.5 cm.
Body composition (fat percent and muscle mass percent) (women) Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and four months after giving birth. Body composition measured by Dual-energy X-ray absorptiometry scans prior to and after pregnancy. During pregnancy measured by bioelectrical impedance analysis.
Bone density (T-score) (women) Assessed prior to pregnancy (baseline, 6 months, 12 months) and four months after giving birth. Bone density is measured by Dual-energy X-ray absorptiometry scans prior to and after pregnancy. During pregnancy measured by bioelectrical impedance analysis.
Blood pressure (women) Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and four months after giving birth. After resting for a minimum of 10 minutes systolic and diastolic blood pressure is measured 3 times with 2 min in between each measurement.
Resting heart rate (women) Assessed prior to pregnancy (baseline, 6 months, 12 months), during pregnancy (week 11-14, 18-21, 24-28 and 34) and four months after giving birth. After resting for a minimum of 10 minutes heart rate measured 3 times with 2 min in between each measurement.
Fasting plasma glucose (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Fasting plasma glucose is measured by blood sampling after an overnight of fasting.
Inflammatory markers - TNFa (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Tumour necrosis factor-α (TNF-α) is measured by blood sampling after an overnight of fasting.
HbA1c (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. HbA1c is measured by blood sampling after an overnight of fasting.
Inflammatory markers - IL-6 (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Interleukin-6 (IL-6) is measured by blood sampling after an overnight of fasting.
Lipid profile - cholesterol (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Cholesterol is measured by blood sampling after an overnight of fasting.
Lipid profile - HDL (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. High-density lipoprotein (HDL) is measured by blood sampling after an overnight of fasting.
Lipid profile - LDL (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Low-density lipoprotein (LDL) is measured by blood sampling after an overnight of fasting.
Lipid profile - VLDL (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Very-low-density lipoprotein (VLDL) is measured by blood sampling after an overnight of fasting.
Lipid profile - TG (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Triglycerides is measured by blood sampling after an overnight of fasting.
Lipid profile - ApoA/ApoB ratio (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Apolipoprotein B/apolipoprotein A1 ratio assessed by blood sampling after an overnight of fasting.
Liver function - liver fat (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. 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.
Liver function - liver stiffness (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. 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.
Food preference (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Food preference is measured using the Steno Biometric Food Preference Task after an overnight of fasting.
Bone homeostasis - CTX (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. 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.
Bone homeostasis - P1NP (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. 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.
Bone homeostasis - OC (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Pharmacodynamic endpoints for bone homeostasis derived from bone turnover markers osteocalcin (OC) as a marker of bone formation after an overnight of fasting.
Inflammatory markers - hs-CRP (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. High-sensitivity C-reactive protein (hs-CRP) is measured by blood sampling after an overnight of fasting.
Inflammatory markers - LBP (women) Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth. Lipopolysaccharide-binding protein (LBP) is measured by blood sampling after an overnight of fasting.
Waist and hip circumference (women) Assessed prior to pregnancy (baseline, 8 weeks, 6 months, 12 months and 18 months) and 4 months after giving birth. Waist and hip circumference is measured to the nearest 0.1 cm.
Resting energy expenditure (women) Assessed prior to pregnancy (baseline and 6 months) Resting energy expenditure is meaured using indirect calorimetry.
Exercise capacity (women) Assessed prior to pregnancy (baseline and 6 months) Exercise capacity is measured by maximal exercise test with direct measurement of maximal oxygen consumption.
Prediabetes (women) Assessed prior to pregnancy (6 months from baseline) Assessed as the proportion of women with prediabetes.
Trial Locations
- Locations (1)
Steno Diabetes Center Copenhagen
🇩🇰Herlev, Denmark