NCT05578690Active, not recruiting
Healthy Lifestyle Before and During Pregnancy to Prevent Childhood Obesity - the PRE-STORK-trial
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 5 Oct 2022
- Start date
- 26 Oct 2022
- Primary completion date
- Jul 2029
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Obesity
- NCT number
- NCT05578690
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 26 Oct 2022 to the primary completion date, Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous gestational diabetes mellitus (GDM) treated with insulin during pregnancy
- Polycystic ovary syndrome (PCOS) treated with metformin
- The use of medications that cause clinically significant weight gain or loss
- Previous bariatric surgery
Other illness
- Significant psychiatric disorders
- Uncontrolled/severe medical issues including cardiovascular, pulmonary, rheumatologic, hematologic, oncologic, infectious, or endocrine disease
- Known eating disorder
Lab values
- Diabetes (fasting plasma glucose (FPG) \>7 mmol/l and HbA1c ≥48 mmol/mol)
- Treatment with medication which significantly affect glucose metabolism, appetite, or energy balance
Other
- 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)
- Regular exercise training at high intensity (e.g., spinning) \>3 hours per week
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.