PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Key facts
- Where
- Aarhus, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 38 years old?
Where in Denmark
- Aarhus University HospitalAarhus, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ulla Kampmann Opstrup
- Trial code
- NCT05798494
- Record updated
- 18 January 2024
- Original description
The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m\^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. 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.Read full original descriptionShow less
The study is a single site parallel randomized controlled study. The study will be assessing the effect of a 10% pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant and overweight or obese (BMI 27-44.9 kg/m\^2). The couples in intervention group will receive dietitian counseling and participate in physical activity sessions to attain the 10% weight loss. 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.
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.