PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen (NCT05621109) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen
Denmark240 participantsStarted 2022-12-15
Plain-language summary
The study is a single site parallel randomized controlled study.
The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m\^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI.
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. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 12 months.
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
* 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 st…
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
1
Neonatal fat mass
Timeframe: Assessed at birth (strived <24 hours, but allow <48 hours)