Weight loss before pregnancy to reduce childhood obesity risk

PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen

This study tests if losing weight before pregnancy can help couples with an overweight mother reduce the risk of their child becoming overweight later on.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 18 Years to 38 Years
• Sex: All
• Sponsor: University of Copenhagen (other)
• Locations: 1 site (Frederiksberg, DK)
• Trial ID: NCT05621109 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of a pre-conception weight loss intervention on healthy females and couples where the prospective mother is overweight or obese. Participants will be randomized into either a weight loss intervention group or a control group, with the aim of achieving approximately 10% weight loss. The study will assess whether this intervention can lower the risk of childhood overweight and related complications by improving parental health metrics such as insulin resistance and inflammation. A total of 240 participants will be recruited for this single-site study at Hvidovre Hospital in Denmark.

Who should consider this trial

Good fit: Ideal candidates are healthy females aged 18-38 with a pre-pregnancy BMI between 27-44.9 kg/m² who are planning to conceive within the next year.

Not a fit: Patients with diabetes, eating disorders, or severe chronic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the risk of childhood obesity and its associated health complications.

How similar studies have performed: Other studies have shown promising results with pre-conception weight loss interventions, indicating potential for success in this approach.

Eligibility criteria

Maternal inclusion Criteria:

* Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2
* Maternal age range 18-38 years
* Connected to Hvidovre Hospital as place of birth or willing to change from other Hospitals in Region H to Hvidovre Hospital
* 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

Where this trial is running

Frederiksberg, DK

• University of Copenhagen — Frederiksberg, DK, Denmark (RECRUITING)

Study contacts

• Principal investigator: Christian Mølgaard, MD — University of Copenhagen
• Study coordinator: Faidon Magkos, PhD

Conditions: Overweight and Obesity, Weight Loss, Pregnancy Related