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Starting before pregnancy: new hope to stop childhood obesity

NCT ID NCT05578690

Prevention Sponsor: Steno Diabetes Center Copenhagen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether helping women with overweight or obesity adopt a healthy lifestyle before and during pregnancy can reduce the risk of their children developing obesity. About 360 women planning pregnancy will either receive a tailored program including a low-calorie diet, exercise, and mentorship, or standard care. The goal is to see if this early intervention leads to healthier body fat levels in newborns and supports healthy weight throughout childhood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Motor Activity Obesity obesity disorder Overweight pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Overweight and obesity Pregnancy related

Contacts and locations

Locations

  • Steno Diabetes Center Copenhagen

    Herlev, 2730, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.