Overweight and ObesityNCT05578690
Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial
A study testing Diet, Exercise and Mentorship in people with Overweight and Obesity and Pregnancy Related, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Pregnancy Related
- What is being tested?
- Diet, Exercise and Mentorship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Oct 2022to Jul 2029
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overweight and Obesity, Pregnancy Related
- Being tested
- Diet, Exercise, Mentorship
- Keywords
- Diet, Exercise, Mentors
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
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.
ExerciseBehavioural
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.
MentorshipBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle group | Experimental | 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. Receives: Behavioral: Diet; Behavioral: Exercise; Behavioral: Mentorship |
| Standard of care group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Neonatal adiposity
Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).
Measured: Assessed at birth or up to 72 hours postpartum.
Secondary outcomes (70)
Foetal and infant body weight
During pregnancy foetal body weight is determined by ultrasonographic method and infant body weight is measured on a scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Placenta function (during pregnancy)
Measured by the represented amount of amniotic fluid, cerebral media and umbilical artery doppler flow of the foetus.
Measured: 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.
Measured: Assessed at birth.
Neonatal body composition (fat percent)
Measured by air displacement plethysmography (PEA POD).
Measured: 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.
Measured: Assessed at birth.
Gestational age
The gestational age is registered when giving birth.
Measured: Assessed at birth.
Weight for gestational age
Measured as percent of normal weight related to gestational age.
Measured: Assessed at birth.
Large for gestational age (LGA)
Assessed as the proportions of infants being born LGA
Measured: Assessed at birth.
Small for gestational age (SGA)
Assessed as the proportions of infants being born SGA.
Measured: Assessed at birth.
Apgar score
Assessed as the proportions of infants born with Apgar score <7.
Measured: Assessed at birth.
Placenta function (birth)
Assessed by the weight of the placenta (in gram).
Measured: Assessed at birth.
Faeces (infant)
Changes in faecal microbiota composition.
Measured: 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).
Measured: Assessed 3 months after birth
Infant body composition (fat percent) PEA POD
Body composition (fat percent (%) ) is assessed by air displacement plethysmography (PEA POD).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed 3 months after 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)
Measured: 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.
Measured: Assessed up to 2 years.
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.
Measured: Assessed during pregnancy (week 24-28)
Insulin resistance (fasting insulin)
Fasting insulin concentration is assessed prior to a 75 gram oral glucose tolerance test.
Measured: 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.
Measured: Assessed during pregnancy (week 24-28).
Hormonal response - glucagon (OGTT)
Glucagon assessed during a 75 gram oral glucose tolerance test.
Measured: 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.
Measured: Assessed during pregnancy (week 24-28).
Hormonal response - PYY (OGTT)
Peptide tyrosine tyrosine (PYY) assessed during a 75 gram oral glucose tolerance test.
Measured: Assessed during pregnancy (week 24-28).
Hormonal response - GIP (OGTT)
Gastric inhibitory peptide (GIP) assessed during a 75 gram oral glucose tolerance test.
Measured: Assessed during pregnancy (week 24-28).
Hormonal response - ghrelin (OGTT)
Ghrelin assessed during a 75 gram oral glucose tolerance test.
Measured: 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.
Measured: Assessed during pregnancy (week 24-28).
BMI (women)
Calculated as weight (kg) divided by height(m)^2.
Measured: 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
Measured: 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.
Height (women)
Measured to the nearest 0.5 cm.
Measured: Assessed prior to pregnancy (baseline).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed prior to pregnancy (baseline, 6 months, and three months after giving birth)
Prediabetes (women)
Assessed as the proportion of women with prediabetes.
Measured: Assessed prior to pregnancy (6 months from baseline)
Gestational diabetes (women)
Assessed as the proportion of women diagnosed with gestational diabetes according to the Danish guidelines
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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:
- 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 %)
Measured: 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
Measured: 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)
Measured: Assessed at birth
Breastfeeding practice
Successful breastfeeding 12 weeks after delivery, defined as exclusive breastfeeding (using formula supplements less than once a week)
Measured: 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
Measured: Samples will be collected within 72 hours post partum, and at week 12 after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start26 Oct 2022
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- The trial is a randomised, parallel-group, intervention study comparing a tailored, intensive, multifactorial lifestyle intervention before and during pregnancy in women with overweight or obesity with standard of care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Tina Vilsbøll, Professor, Principal investigator, Steno Diabetes Center CopenhagenLouise G. Grunnet, PhD, Principal investigator, Steno Diabetes Center CopenhagenSigne Torekov, Professor, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578690
- Sponsor's protocol ID
- H-22011403
- Status last verified
- Feb 2026
- First submitted
- 5 Oct 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 39863406
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05578690
- Acronym / sponsor ID
- H-22011403
- Conditions
- Overweight and Obesity, Pregnancy Related
- Keywords
- Diet, Exercise, Mentors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The trial is a randomised, parallel-group, intervention study comparing a tailored, intensive, multifactorial lifestyle intervention before and during pregnancy in women with overweight or obesity with standard of care.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle group | Experimental | Behavioral: Diet, Behavioral: Exercise, Behavioral: MentorshipA 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. |
| Standard of care group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietAn 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. | Behavioural | Lifestyle group |
| ExerciseAfter 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. | Behavioural | Lifestyle group |
| MentorshipWomen 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". | Behavioural | Lifestyle group |
Primary outcome
Neonatal adiposity
Time frame: Assessed at birth or up to 72 hours postpartum.
Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).
70 secondary outcomes
Foetal and infant body weight
Time frame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant abdominal circumference
Time frame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant femur length
Time frame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Foetal and infant head circumference
Time frame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.
Placenta function (during pregnancy)
Time frame: Assessed during pregnancy (week 34).
Neonatal body mass index (BMI) z-score
Time frame: Assessed at birth.
Neonatal body composition (fat percent)
Time frame: Assessed at birth.
Neonatal body composition (fat free mass)
Time frame: Assessed at birth.
Gestational age
Time frame: Assessed at birth.
Weight for gestational age
Time frame: Assessed at birth.
Large for gestational age (LGA)
Time frame: Assessed at birth.
Small for gestational age (SGA)
Time frame: Assessed at birth.
Apgar score
Time frame: Assessed at birth.
Placenta function (birth)
Time frame: Assessed at birth.
Faeces (infant)
Time frame: Assessed at birth and 3 months after birth.
Infant body composition (fat mass, fat free mass) PEA POD
Time frame: Assessed 3 months after birth
Infant body composition (fat percent) PEA POD
Time frame: Assessed 3 months after birth
Infant body composition (fat mass, fat free mass) dual energy x-ray absorptiometry.
Time frame: Assessed 3 months after birth.
Infant body composition (fat percent) dual energy x-ray absorptiometry.
Time frame: Assessed 3 months after birth.
Infant BMI z-score
Time frame: Assessed 3 months after birth.
Weight loss (women)
Time frame: Assessed up to 2 years.
Pregnancy (women)
Time frame: Assessed up to 2 years.
Glucose tolerance (OGTT)
Time frame: Assessed during pregnancy (week 24-28)
Insulin resistance (fasting insulin)
Time frame: Assessed during pregnancy (week 24-28).
Insulin resistance (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Hormonal response - glucagon (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Hormonal response - GLP-1 (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Hormonal response - PYY (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Hormonal response - GIP (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Hormonal response - ghrelin (OGTT)
Time frame: Assessed during pregnancy (week 24-28).
Glycaemic variability (CGM and OGTT)
Time frame: Assessed during pregnancy (week 24-28).
BMI (women)
Time frame: 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)
Time frame: 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.
Height (women)
Time frame: Assessed prior to pregnancy (baseline).
Body composition (fat percent and muscle mass percent) (women)
Time frame: 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)
Time frame: Assessed prior to pregnancy (baseline, 6 months, 12 months) and 3 months after giving birth.
Resting heart rate (women)
Time frame: 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)
Time frame: 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)
Time frame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
HbA1c (women)
Time frame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 39863406Kornerup 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Vilsbøll, Professor principal investigator
Steno Diabetes Center Copenhagen
Louise G. Grunnet, PhD principal investigator
Steno Diabetes Center Copenhagen
Signe Torekov, Professor principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Exercise and Mentorship in people with Overweight and Obesity and Pregnancy Related, run by Steno Diabetes Center Copenhagen 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?
The sponsor lists 7 inclusion and 12 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal adiposity (time frame: Assessed at birth or up to 72 hours postpartum.). 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 NCT05578690, 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 16 Apr 2026.