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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Neonatal adiposity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistical analysis of the primary outcome will be blinded to the assessors.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mentorship (Behavioral)
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.
干预措施: Diet (Behavioral)
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.
干预措施: Exercise (Behavioral)
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.
结局指标
主要结局
Neonatal adiposity
时间窗: Assessed at birth or up to 72 hours postpartum.
Total fat mass (in gram) assessed by air displacement plethysmography (PEA POD).
次要结局
- Weight for gestational age(Assessed at birth.)
- Large for gestational age (LGA)(Assessed at birth.)
- Small for gestational age (SGA)(Assessed at birth.)
- Apgar score(Assessed at birth.)
- Placenta function (birth)(Assessed at birth.)
- Weight loss (women)(Assessed up to 2 years.)
- Placenta function (during pregnancy)(Assessed during pregnancy (week 34).)
- Neonatal body mass index (BMI) z-score(Assessed at birth.)
- Neonatal body composition (fat percent)(Assessed at birth.)
- Neonatal body composition (fat free mass)(Assessed at birth.)
- Gestational age(Assessed at birth.)
- Pregnancy (women)(Assessed up to 2 years.)
- Glucose tolerance (OGTT)(Assessed during pregnancy (week 24-28))
- Insulin resistance (fasting insulin)(Assessed during pregnancy (week 24-28).)
- Insulin resistance (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - glucagon (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - GLP-1 (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - PYY (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - GIP (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - ghrelin (OGTT)(Assessed during pregnancy (week 24-28).)
- Glycaemic variability (CGM and OGTT)(Assessed during pregnancy (week 24-28).)
- Height (women)(Assessed prior to pregnancy (baseline).)
- Prediabetes (women)(Assessed prior to pregnancy (6 months from baseline))
- Exercise capacity (women)(Assessed prior to pregnancy (baseline, 6 months, and three months after giving birth))
- Foetal and infant body weight(Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.)
- Foetal and infant abdominal circumference(Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.)
- Foetal and infant femur length(Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.)
- Foetal and infant head circumference(Assessed during pregnancy (week 18-21, 24-28 and 34), at birth and 3 months after birth.)
- Placenta function (during pregnancy)(Assessed during pregnancy (week 34).)
- Neonatal body mass index (BMI) z-score(Assessed at birth.)
- Neonatal body composition (fat percent)(Assessed at birth.)
- Neonatal body composition (fat free mass)(Assessed at birth.)
- Gestational age(Assessed at birth.)
- Weight for gestational age(Assessed at birth.)
- Large for gestational age (LGA)(Assessed at birth.)
- Small for gestational age (SGA)(Assessed at birth.)
- Apgar score(Assessed at birth.)
- Placenta function (birth)(Assessed at birth.)
- Faeces (infant)(Assessed at birth and 3 months after birth.)
- Infant body composition (fat mass, fat free mass) PEA POD(Assessed 3 months after birth)
- Infant body composition (fat percent) PEA POD(Assessed 3 months after birth)
- Infant body composition (fat mass, fat free mass) dual energy x-ray absorptiometry.(Assessed 3 months after birth.)
- Infant body composition (fat percent) dual energy x-ray absorptiometry.(Assessed 3 months after birth.)
- Infant BMI z-score(Assessed 3 months after birth.)
- Weight loss (women)(Assessed up to 2 years.)
- Pregnancy (women)(Assessed up to 2 years.)
- Glucose tolerance (OGTT)(Assessed during pregnancy (week 24-28))
- Insulin resistance (fasting insulin)(Assessed during pregnancy (week 24-28).)
- Insulin resistance (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - glucagon (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - GLP-1 (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - PYY (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - GIP (OGTT)(Assessed during pregnancy (week 24-28).)
- Hormonal response - ghrelin (OGTT)(Assessed during pregnancy (week 24-28).)
- Glycaemic variability (CGM and OGTT)(Assessed during pregnancy (week 24-28).)
- BMI (women)(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)(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)(Assessed prior to pregnancy (baseline).)
- 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 3 months after giving birth.)
- Bone density (T-score) (women)(Assessed prior to pregnancy (baseline, 6 months, 12 months) and 3 months after giving birth.)
- 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 3 months after giving birth.)
- Blood pressure (women)(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)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- HbA1c (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Lipid profile - cholesterol (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Lipid profile - HDL (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Lipid profile - LDL (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Lipid profile - VLDL (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Lipid profile - TG (women)(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)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Liver function - liver fat (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Liver function - liver stiffness (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Food preference (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Bone homeostasis - CTX (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Bone homeostasis - P1NP (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Bone homeostasis - OC (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Inflammatory markers - hs-CRP (women)(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)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Inflammatory markers - IL-6 (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Inflammatory markers - LBP (women)(Assessed prior to pregnancy (baseline and 6 months) during pregnancy (week 24-28) and 3 months after giving birth.)
- Waist and hip circumference (women)(Assessed prior to pregnancy (baseline, 8 weeks, 6 months, 12 months and 18 months) and 3 months after giving birth.)
- Resting energy expenditure (women)(Assessed prior to pregnancy (baseline, 6 months, and three months after giving birth))
- Exercise capacity (women)(Assessed prior to pregnancy (baseline, 6 months), during pregnancy (week 24-28), and three months after giving birth))
- Prediabetes (women)(Assessed prior to pregnancy (6 months from baseline))
- Gestational diabetes (women)(Assessed during pregnancy (week 10 to 40))
- Daily physical activity, sedentary time and sleep (women)(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)(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(Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum)
- Pre-eclampsia(Will be obtained from electronical medical records from gestational week 20 until 48 hours post partum)
- Essential hypertension(Will be obtained from electronical medical records prior to pregnancy until gestational week 20.)
- Mode of delivery(Assessed at birth)
- Breastfeeding practice(Assessed by individual questionnaire 4 months after giving birth)
- Brest milk composition(Samples will be collected within 72 hours post partum, and at week 12 after delivery)