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Pre-Pregnancy diet may shield kids from obesity

NCT ID NCT05621109

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a weight loss program for overweight or obese women (and their partners) before pregnancy can reduce the risk of their child becoming overweight. 240 couples are randomly assigned to either a very low-calorie diet and counseling or no intervention. The main goal is to see if the baby has less body fat at birth and a healthier weight at 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
very low-calorie diet and dietary counseling
What this could lead to
If it works, this could show that helping parents lose weight before pregnancy lowers the child's risk of becoming overweight.
What could go wrong
This is a single-site study with 240 participants, so results may not apply to everyone. The intervention is intensive and may be hard to follow long-term.

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 240 people

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

Started

Dec 2022

Expected to finish

Jun 2033

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 38 years

Sex

Anyone

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.

Maternal inclusion Criteria: * Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2 * Maternal age range 18-38 years * Not pregnant or breastfeeding Paternal Inclusion Criteria - full protocol (optional participation): * Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2 * Paternal age range 18-55 years * Biological father Parental Inclusion Criteria: * Planning pregnancy within 1 year * Provided voluntary informed consent * Danish or English speaking * Intention to permit the planned offspring to participate in the follow-up study * Able to store biological samples from the offspring at home in the freezer in a box given by the study personnel Parental Exclusion Criteria: * Diabetes mellitus (Type 1 or 2) * Previous or present eating disorder * Allergy towards ingredients in the very low calorie diet products * Severe heart, liver or kidney disease * Conception by in vitro fertilization (intrauterine insemination allowed) * ≥4 consecutive spontaneous pregnancy loss (female) * Having tried to conceive or prior time to pregnancy of more than 12 months * Any medical condition or concomitant medication as judged by the medical responsible * Adherence to vegan diets or other diets interfering with the dietary guidelines in the study * Participation in other clinical trial * Engagement in elite sports or similar strenuous exercise ≥5 h/week * Blood donation or transfusion within the past month before baseline * Blood donation during the study * Inability or unwillingness to follow the study protocol and instructions given by the study personnel * Pregnancy registered between baseline visit and 4 weeks after the baseline visit (urinary analysis with dipstick) A detailed description of the exclusion criteria is given below: Medical conditions as known by the participant: * Diabetes mellitus (type 1 and 2) * History or diagnosis of eating disorder (e.g. restrained eating, disinhibition, emotional eating) * Any significant medical condition as assessed by the investigator (e.g. dysregulated thyroid disease or reproductive diseases) * Any significant psychiatric disorder (i.e. schizophrenia, bipolar disease or depression) as assessed by the investigator * Severe chronic heart, liver and kidney disease * Polycystic ovary syndrome with irregular cycle * Amenorrhea * Severely reduced semen quality incl. azoospermia Medication: \- Current use of medication or use within the previous three months with a potential to affect body weight or pregnancy as judged by the investigator (e.g. systemic corticoids) Personal/other: * Having tried to conceive or prior time to pregnancy of more than 12 months * Weight changes ± 5% three months prior to inclusion * Severe food allergies, food intolerances or dislike expected to interfere with the study, including allergy towards ingredients in the VLCD products * Engagement in elite sports or similar strenuous exercise ≥5 h/week * Blood donation or transfusion within the past month before baseline * Planned blood donation for other purpose than this study during participation * Alcohol abuse, as judged by the investigator, within the previous 12 months * Drug abuse, as judged by the investigator, within the previous 12 months * Psychological or behavioral problems which, in the judgement of the investigator, would lead to difficulty in complying with the study protocol * Participation in other clinical trials within the past three months or intention to do so during the study, which are judged by the investigator to affect the present study * Unable to consume the interventional product for religious reasons, swallowing disorders, other physiological reasons or any other reasons for not being able to follow the recommended diet * Inability or unwillingness to give written informed consent or communicate with study personnel * Inability or unwillingness to follow the study protocol and instructions given by the study personnel * Illiteracy or inadequate understanding of Danish or English language. * Any other condition that judged by the investigator may interfere with the adherence to the study protocol

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight pregnancy disorder Weight Loss

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of Copenhagen

    Frederiksberg, DK, 1958, Denmark

More trials for these conditions

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