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New treatment option for Overweight and Obesity
Official title PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
ClinicalTrials.gov ID: NCT05798494
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 38. Healthy volunteers may be eligible.
You may be able to join if
- Maternal
- 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
You likely can't join 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
- Any medical condition or concomitant medication as judged by the medical responsible
See the full eligibility criteria
- Maternal
- 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
- Paternal pre-pregnancy BMI 18.5-44.9 kg/m\^2
- Paternal age range 18-55 years Parental
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 38 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.