Healthy lifestyle changes before and during pregnancy to prevent childhood obesity
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
This study is testing whether helping women who are overweight or obese make healthy lifestyle changes before and during pregnancy can lower the chances of their children becoming obese.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT05578690 on ClinicalTrials.gov |
What this trial studies
This trial aims to investigate the effects of a tailored lifestyle intervention focusing on diet, exercise, and mentorship for women who are overweight or obese and planning a pregnancy. Participants will be randomized into groups to receive support in making healthy lifestyle changes before and during pregnancy. The study seeks to address the rising prevalence of childhood obesity by targeting maternal health and weight management. By improving maternal lifestyle, the trial hopes to reduce the risk of obesity in their children.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with a BMI of 25-44 who are planning a pregnancy within the next year.
Not a fit: Patients with diabetes, previous gestational diabetes treated with insulin, or other significant metabolic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce the incidence of childhood obesity by promoting healthier maternal behaviors.
How similar studies have performed: While lifestyle interventions during pregnancy have shown limited effects in the past, this study's tailored approach may offer a novel strategy to combat childhood obesity.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Tina Vilsbøll, Professor — Steno Diabetes Center Copenhagen
- Study coordinator: Ronni E. Sahl, PhD
- Email: ronni.eg.sahl@regionh.dk
- Phone: 0045 40387586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.