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

Launched by STENO DIABETES CENTER COPENHAGEN · Oct 10, 2022

Keywords

ClinConnect Summary

The PRE-STORK trial is studying how a healthy lifestyle before and during pregnancy can help prevent childhood obesity. Researchers are focusing on women aged 18 to 38 who are overweight or obese and planning to get pregnant within the next year. To be eligible, women should have a body mass index (BMI) between 27 and 42, be willing to lose at least 10% of their starting weight, and agree to follow a healthy diet and exercise plan. Participants will be randomly assigned to either a lifestyle intervention group, where they’ll receive guidance on diet and exercise, or a standard care group.

During the trial, women in the lifestyle group will start with an 8-week low-calorie diet followed by ongoing support to maintain healthy habits throughout their pregnancy. The main goal is to see if these changes can reduce the amount of fat in newborns at birth. Additionally, the study will track the children over time to monitor their growth and weight development. This research aims to provide valuable insights that could help improve the health of future generations. If you’re considering joining the trial, it’s important to know that it has ethical approval and is being conducted safely according to established guidelines.

Gender

FEMALE

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