PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Ulla Kampmann Opstrup
140 participants
Jun 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria12
- 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 pre-pregnancy BMI 18.5-44.9 kg/m\^2
- Paternal age range 18-55 years
- 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
Exclusion Criteria35
- 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
- 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
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Interventions
Subjects will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The mother (and father if overweight, BMI ≥25 kg/m\^2) will receive advice to provide a moderate caloric restriction (-500 to 1000 kcal/d) and power walk 2-4 times a week for a half an hour and attend physical activity sessions every 2nd week to attain a minimum weight loss of approximately 0,5-1,0 kg/week. The weight loss will last until a 10% weight loss (according to pre-pregnancy weight) has been achieved or until 1-year post-partum. If the subject has not achieved a weight loss of 10%, she or he will receive Very low-calorie diet (VLCD) until target weight loss is reached, though no longer than 8 weeks. After weight loss subjects will receive counseling to maintain weight loss and healthy weight gain during pregnancy until birth of the 2nd child.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05798494