RecruitingNot Applicable

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus

Denmark140 participantsStarted 2023-06-01

Plain-language summary

The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m\^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. The overall objective is to test whether a comprehensive pre-conceptional parental weight loss intervention effectively reduces the risk of offspring overweight, and adiposity and its complications compared to a control group.

Who can participate

Age range

18 Years – 38 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Maternal inclusion Criteria: * Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2 * Maternal age range 18-38 years * Connected to Aarhus University Hospital as place of birth * Pregnant Paternal Inclusion Criteria: * Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2 * Paternal age range 18-55 years Parental Inclusion Criteria: * Couples (male and female) * Planning pregnancy within 3 years * 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 * 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 that can affect the results of the current study * Engagement in elite sports or similar strenuous exercise ≥5 h/week at inclusion * Blood donation or transfusion within the past month before screening * Blood donation during the study * Inability or unwillingness to follow the study protocol and instructions given by the study personnel A detailed description of the exclus…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neonatal fat mass

Timeframe: Collected within the first week of birth (strived <48 hours)

Difference in epigenetic changes in child 1 and 2

Timeframe: Assessed at birth

Trial details

NCT IDNCT05798494

SponsorUlla Kampmann Opstrup

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-11

Contact for this trial

Ulla K Opstrup, MD, PhD

+4522370857 ullaopst@rm.dk

View on ClinicalTrials.gov More Overweight and Obesity trials