Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Christian Mølgaard
With
Hvidovre University Hospital
Copenhagen University Hospital, Rigshospitalet
University of Copenhagen
Centre for Childhood Health, Denmark
Age
18–38
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Maternal pre-pregnancy BMI 27.0-44.9 kg/m\^2
Maternal age range 18-38 years
Not pregnant or breastfeeding
Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2
Paternal age range 18-55 years
Biological father
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
You may not be if
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)
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
Clareo Health | PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen
