Clinical trial NCT05578690: Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Pregnancy Related
Keywords: Diet
Exercise
Mentors
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2022-10-13
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Neonatal adiposity
timeFrame: Assessed at birth or up to 72 hours postpartum.
Secondary outcomes:
measure: Foetal and infant body weight
timeFrame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth.
measure: Foetal and infant abdominal circumference
timeFrame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth.
measure: Foetal and infant femur length
timeFrame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth.
measure: Foetal and infant head circumference
timeFrame: Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 4 months after birth.
measure: Placenta function (during pregnancy)
timeFrame: Assessed during pregnancy (week 34).
measure: Neonatal body mass index (BMI) z-score
timeFrame: Assessed at birth.
measure: Neonatal body composition (fat percent)
timeFrame: Assessed at birth.
measure: Neonatal body composition (fat free mass)
timeFrame: Assessed at birth.
measure: Gestational age
timeFrame: Assessed at birth.
measure: Weight for gestational age
timeFrame: Assessed at birth.
measure: Large for gestational age (LGA)
timeFrame: Assessed at birth.
measure: Small for gestational age (SGA)
timeFrame: Assessed at birth.
measure: Apgar score
timeFrame: Assessed at birth.
measure: Placenta function (birth)
timeFrame: Assessed at birth.
measure: Faeces (infant)
timeFrame: Assessed at birth and 4 months after birth.
measure: Infant body composition (fat mass, fat free mass) PEA POD
timeFrame: Assessed 4 months after birth
measure: Infant body composition (fat percent) PEA POD
timeFrame: Assessed 4 months after birth
measure: Infant body composition (fat mass, fat free mass) dual energy x-ray absorptiometry.
timeFrame: Assessed 4 months after birth.
measure: Infant body composition (fat percent) dual energy x-ray absorptiometry.
timeFrame: Assessed 4 months after birth.
measure: Infant BMI z-score
timeFrame: Assessed 4 months after birth.
measure: Weight loss (women)
timeFrame: Assessed up to 2 years.
measure: Pregnancy (women)
timeFrame: Assessed up to 2 years.
measure: Glucose tolerance (OGTT)
timeFrame: Assessed during pregnancy (week 24-28)
measure: Insulin resistance (fasting insulin)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Insulin resistance (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Hormonal response - glucagon (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Hormonal response - GLP-1 (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Hormonal response - PYY (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Hormonal response - GIP (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Hormonal response - ghrelin (OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: Glycaemic variability (CGM and OGTT)
timeFrame: Assessed during pregnancy (week 24-28).
measure: BMI (women)
timeFrame: 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.
measure: Body weight (women)
timeFrame: 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.
measure: Height (women)
timeFrame: Assessed prior to pregnancy (baseline).
measure: Body composition (fat percent and muscle mass percent) (women)
timeFrame: 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.
measure: Bone density (T-score) (women)
timeFrame: Assessed prior to pregnancy (baseline, 6 months, 12 months) and four months after giving birth.
measure: Blood pressure (women)
timeFrame: 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.
measure: Resting heart rate (women)
timeFrame: 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.
measure: Fasting plasma glucose (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: HbA1c (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - cholesterol (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - HDL (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - LDL (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - VLDL (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - TG (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Lipid profile - ApoA/ApoB ratio (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Liver function - liver fat (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Liver function - liver stiffness (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Food preference (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Bone homeostasis - CTX (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Bone homeostasis - P1NP (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Bone homeostasis - OC (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Inflammatory markers - hs-CRP (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Inflammatory markers - TNFa (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Inflammatory markers - IL-6 (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Inflammatory markers - LBP (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 4 months after giving birth.
measure: Waist and hip circumference (women)
timeFrame: Assessed prior to pregnancy (baseline, 8 weeks, 6 months, 12 months and 18 months) and 4 months after giving birth.
measure: Resting energy expenditure (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months)
measure: Exercise capacity (women)
timeFrame: Assessed prior to pregnancy (baseline and 6 months)
measure: Prediabetes (women)
timeFrame: Assessed prior to pregnancy (6 months from baseline)
Other outcomes:
measure: Fertility treatment (women)
timeFrame: Assessed up to 2 years.
measure: Body weight (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
measure: Height (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline)
measure: BMI (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
measure: Body composition - fat mass and fat free mass (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
measure: Body composition - fat percent (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
measure: Blood pressure (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline and 6 months), during pregnancy (week 11-14) and 4 months after birth.
measure: Appetite, physical activity and wellbeing (women and partner)
timeFrame: Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 4 months after birth
measure: Sleep (women and partner)
timeFrame: Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 4 months after birth.
measure: Self perception of body weight, self-esteem and partner support (women and partner)
timeFrame: Assessed prior to pregnancy (baseline and 6 months), during pregnancy (week 24-28) and 4 months after birth.
measure: Semen quality (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline) and during pregnancy (week 11-14).
measure: Semen epigenetics (partner)
timeFrame: Assessed prior to pregnancy of the woman (baseline) and during pregnancy (week 11-14).
measure: Umbilical cord
timeFrame: Assessed at birth.
measure: Placenta
timeFrame: Assessed at birth.
measure: Epigenetic (women, partner and child)
timeFrame: Assessed at birth.
measure: Faeces (women)
timeFrame: Assessed prior to pregnancy (baseline) and 4 months after birth.
measure: Obesity related-phenotypes
timeFrame: Assessed at the end of the trial intervention period.
measure: Complications (delivery)
timeFrame: Assessed at birth.
measure: Neonatal complications (delivery)
timeFrame: Assessed at birth.
Locations:
city: Herlev
country: Denmark
facility: Steno Diabetes Center Copenhagen
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Tina Vilsbøll, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Steno Diabetes Center Copenhagen
name: Louise G. Grunnet, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Signe Torekov, Professor
role: PRINCIPAL_INVESTIGATOR
References: