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

Launched by ULLA KAMPMANN OPSTRUP · Mar 23, 2023

Keywords

ClinConnect Summary

The PRE-Pregnancy Weight Loss trial is studying how losing weight before conception can help reduce the risk of childhood obesity in the future. The researchers are looking for couples where the woman is pregnant and has a body mass index (BMI) between 27 and 44.9, which means she is considered overweight or obese. Participants will be divided into two groups: one group will receive support from dietitians and participate in exercise sessions to help them lose 10% of their weight, while the other group will not receive this intervention. The goal is to see if this weight loss program can lead to healthier outcomes for their future children.

To be eligible for this trial, mothers must be between 18 and 38 years old, pregnant, and have a BMI in the specified range. Fathers should also be in good health and have a BMI between 18.5 and 44.9. Couples need to be planning to have a baby within the next three years and be willing to participate in follow-up studies for their child. Participants can expect guidance on diet and exercise to help them achieve their weight loss goals, along with support throughout the trial. It’s important to note that individuals with certain medical conditions or who are taking specific medications may not be able to join the study.

Gender

ALL

Eligibility criteria

• 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 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
• 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:
• • 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 screening
• • 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