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

Criteria the registry did not label

• 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