NCT05798494 PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
| NCT ID | NCT05798494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ulla Kampmann Opstrup |
| Condition | Overweight and Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-04-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-06-01 with a primary completion date of 2025-04-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Ulla K Opstrup, Assoc
PRINCIPAL INVESTIGATOR
Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT05798494 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 38 Years, studying Overweight and Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05798494 currently recruiting?
Yes, NCT05798494 is actively recruiting participants. Contact the research team at ullaopst@rm.dk for enrollment information.
Where is the NCT05798494 trial being conducted?
This trial is being conducted at Aarhus, Denmark.
Who is sponsoring the NCT05798494 clinical trial?
NCT05798494 is sponsored by Ulla Kampmann Opstrup. The principal investigator is Ulla K Opstrup, Assoc at Aarhus University Hospital. The trial plans to enroll 140 participants.
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