Recruiting nowNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 38 Years
SexAll
Healthy volunteersAccepted
ConditionOverweight and Obesity, Weight Loss, Pregnancy Related, Child Nutrition Sciences, Body Composition
Full registry 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
Treatments and study arms
Weight loss intervention
Behavioral
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.
Primary outcomes
Neonatal fat massCollected within the first week of birth (strived <48 hours)Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)
Difference in epigenetic changes in child 1 and 2Assessed at birthCord blood from offspring will be collected at birth and stored at -80 °C until use. At the Department of Molecular Medicine AUH genomic DNA will be extracted from peripheral blood using standard methods e.g., QIAmp® Mini Kit (Qiagen, Germany). 1 μg of genomic DNA will be bisulfide converted using Illumina iScan (platform). The methylation level will be measured using Infinium MethylationEPIC DNA Analysis BeadChip (Array type) at Eurofins Genomics AS (Denmark) or similar methods. The stated required sample size (140 couples) is calculated based on the neonatal fat mass. As no other studies have performed methylation analysis using WGBS in similar cohorts, precise power calculations on epigenetic changes are impractical. However, since the EPICOM study found differentially methylated regions in only 20 cases and 20 controls using Illumina's 450K methylation assay, the power to elucidate…
