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| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
| Rigshospitalet, Denmark | OTHER |
| University of Copenhagen | OTHER |
| Centre for Childhood Health, Denmark |
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The study is a single site parallel randomized controlled study.
The study will be assessing the effect of approximately 10% weight loss intervention vs a control group among healthy females/couples where the prospective mother is overweight or obese (BMI 27-45 kg/m^2) and between 18-38 years. The investigators will recruit a total of 240 healthy females/couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI.
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. The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a reduction in offspring neonatal adiposity, reduced risk of being born large for gestational age (LGA) and with lower BMI z-score at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Rapid moderate weight loss (approximately 10% of body weight at baseline over 8-10 weeks or BMI 23 kg/m^2 is achieved) by very low-calorie diet (VLCD), reintroduction (4 weeks), weight loss maintenance until pregnancy (up to 12 months), and a high protein, high fiber diet during pregnancy (n=120 females/couples). |
|
| Standard of care | No Intervention | The control group will not receive any dietary advice prior to pregnancy. During pregnancy control subjects will receive dietary advice similar to the intervention group, i.e. a high protein, high fiber diet (n=120 females/couples). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight loss intervention | Behavioral | Subjects will receive very low-calorie diet for 8-10 weeks to introduce a rapid weight loss of approximately 10%. Once target weight is achieved, participants will be reintroduced to foods to introduce weight stability. The male will follow the maternal randomization, i.e. weight loss if BMI ≥25 until a BMI of 23 or a weight loss of approximately 10% is obtained. During weight loss maintenance, subjects will receive dietary counseling to follow a diet high in protein (corresponding to 22-25E%), high fiber and wholegrain while fulfilling the requirements for essential fatty acids, micronutrients and trace elements in accordance with Nordic Nutrition Recommendations (NNR) 2012. Throughout the study period participants will be encouraged to follow the official recommendations for physical activity as recommended by the Danish health authorities 2022. |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal fat mass | Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD) | Assessed at birth (strived <24 hours, but allow <48 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Obstetrics outcome - length of gestational age | Length of gestational age. | Assessed at birth of offspring. |
| Obstetric - medication use | Medication use during labor |
| Measure | Description | Time Frame |
|---|---|---|
| Cord blood - epigenetics | Cord blood will be drawn immediately after birth and analysed for epigenetic profile. | Collected at birth |
| Cord blood - pH | Cord blood will be drawn immediately after birth. pH will be assessed. |
Maternal inclusion Criteria:
Paternal Inclusion Criteria - full protocol (optional participation):
Parental Inclusion Criteria:
Parental Exclusion Criteria:
A detailed description of the exclusion criteria is given below:
Medical conditions as known by the participant:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Mølgaard, MD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen | Frederiksberg | DK | 1958 | Denmark |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| UNKNOWN |
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| Collected from initiation of labor until completed birth of offspring. |
| Obstetric - delivery mode | Delivery mode (rupture of membranes or premature contractions, vaginal, cesarean section, instrumental delivery, miscarriage and stillbirth). | Collected at birth of offspring. |
| Obstetric - pregnancy complications | Pregnancy complications e.g. miscarriage, abortion (induced and indication for abortion), hydramnios, gestational hypertension, preeclampsia, need for maternal corticosteroid treatment for fetal lung maturation, urinary tract infection). | Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39). |
| Obstetric - Neonatal unit admissions | Neonatal unit admissions. | Collected at birth and until 6 months after birth of offspring. |
| Obstetric - obstetrics complications | Obstetrics complications (e.g. preterm prelabour rupture of the membranes, shoulder dystocia, birth trauma (perinatal rupture), postpartum hemorrhage, maternal infections, maternal hospitalization). | Collected at birth of offspring |
| Obstetrics - birth defects/abnormalities | Birth defects/abnormalities | Collected at birth of offspring |
| Neonatal morbidities | Neonatal morbidity (e.g. major congenital malformations (ICD10 Q00-Q99 or requiring medical or surgical treatment), birth injury, respiratory distress, transient tachypnoea, neonatal hypoglycemia, systemic infections, admission to neonatal intensive care unit, number of admission days, hyperbilirubinemia), deaths. | Collected at birth of offspring |
| Fetal and offspring growth - body weight | Fetal body weight will be measured with ultrasound during pregnancy and offspring body weight will be measured using an electronic scale. | Collected in gestational age (GA)11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth. |
| Fetal and offspring growth - length | Fetal length will be measured with ultrasound during pregnancy and offspring length will be measured using using an infantometer as appropriate for measuring infant, baby and toddler length. | Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth. |
| Fetal and offspring growth - abdominal circumference | Abdominal circumference will be measured with ultrasound during pregnancy and offspring abdominal circumference will be measured three times to the nearest 0.1 cm using a stretch-resistant measuring tape | Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth. |
| Fetal and offspring growth - crown circumference | Crown circumference will be measured with ultrasound during pregnancy and offspring crown circumference will be measured three times to the nearest 0.1 cm using a stretch-resistant measuring tape | Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth. |
| Fetal and offspring growth - femur length | Femur length will be measured with ultrasound during pregnancy and offspring thigh will be measured three times to the nearest 0.1 cm using a stretch-resistant measuring tape. | Collected in gestational age (GA) 11-13, GA19-21 and GA28, at birth and 3, 6 and 12 months after birth. |
| Fetal growth - fractional limb volume | Fractional limb volume will be measured with ultrasound during pregnancy. | Collected in gestational age 28. |
| Offspring growth - BMI z-score | Offspring body mass index (BMI) z-score (BMI adjusted for age and sex). | Collected at birth and 3, 6 and 12 months after birth of offspring. |
| Offspring growth - weight for gestational age | Weight for gestational age. Measured as percent of normal weight related to gestational age. | Collected at birth and 3, 6 and 12 months after birth of offspring. |
| Offspring growth - large for gestational age | Large for gestational age. Prevalence of infants being LGA. | Collected at birth and 3, 6 and 12 months after birth of offspring. |
| Offspring growth - small for gestational age | Small for gestational age. Prevalence of offspring being small for gestational age (SGA). | Collected at birth and 3, 6 and 12 months after birth of offspring. |
| Offspring growth - apgar score | Apgar score (0-10). The higher the score, the better health condition of the offspring) | Collected at birth of offspring |
| Offspring growth | Offspring circumference (upper arm and hip) and 5 points skinfold (bi- and triceps, subscapularis, belly and waist). Circumferences will be measured to the nearest 0.1 cm using a stretch-resistant measuring tape and skinfolds are measured to the nearest 0.02 cm using a caliper to lightly pinch the skin and the underlying fat | Collected at birth and 3, 6 and 12 months after birth of offspring. |
| Offspring growth - body composition by the POD system | Offspring fat free mass (g) and fat mass (g) will be assessed by air displacement plethysmography using the POD system (either the Pea POD or the Bod POD system depending on the most appropriate for age) | Collected at birth (strived <24 hours, but allow <48 hours) and 3 months after birth of offspring. |
| Offspring blood pressure | Offspring blood pressure (diastolic and systolic blood pressure) will be measured three times after 5-10 minutes rest using an automated device placed on the arm and in direct contact with the skin. | Collected 12 months after birth of offspring |
| Offspring heart rate | Offspring heart rate will be measured three times after 5-10 minutes rest using an automated device placed on the arm and in direct contact with the skin. | Collected 12 months after birth of offspring |
| Offspring growth - self-reported body weight | Self-reported body weight | The study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 14 of age. |
| Offspring growth - self-reported height | Self-reported height | The study staff will make an annual follow-up phone call to the parents to collect information about the offspring's self-reported body weight until the offspring is 14 of age. |
| Adult weight | Adult body weight is measured to the nearest 0.1 kg using a calibrated scale | The intervention: each visit(V) throughout the study (baseline to 12mo. after birth). The control: before pregnancy (baseline, V11 and V14), all visits during pregnancy, at birth, at V27≤6days after birth and 3, 6 and 12 mo. after birth |
| Adult self-reported body weight (control group) | The control group will be instructed to self-report their body weight in a fasting state (no food or drink besides a maximum of 500 mL of water from 10 pm the night before) by using their own personal weight scale at home after having emptied their bladder at time point 9 and approximately monthly from time point 9 until registration of pregnancy. | From baseline to registration of pregnancy (4, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 52 weeks after baseline) |
| Adult Height | Adult height will be measured to the nearest 0.5 cm using a wall-mounted stadiometer. | Collected at baseline (V0). |
| Adult BMI | Calculated ad weight (kg)/height(m)^2 | Collected baseline, visit (V)1-19, registration of pregnancy, in gestational age (GA)8, GA13, GA20, GA28, GA36, GA39, when giving birth and at 3, 6 and 12 months after birth. |
| Adult anthropometric | Waist- and hip circumference will be measured to the nearest 0.5 cm. During pregnancy and at birth the waist of the female will not be measured. | Collected prior to pregnancy (at baseline, visit(V)5, V6, V7, V8, V12, and V16 (V5-V16 only the intervention)), during pregnancy (at registration of pregnancy, in gestational age(GA)13 and GA36), and at 3, 6 and 12 months after birth of offspring. |
| Adult body composition by DEXA scan | Lean mass (g), fat mass (g), abdominal fat (g), visceral fat (g) assessed by a Dual-energy X-ray absorptiometry-scan. | Collected at baseline (visit (V)0), at registration of pregnancy (only male) and after birth (≤6 days after birth of offspring). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult bone markers by DEXA scan | Bone area (cm^2), bone mineral density (g/cm^2) and bone mineral content (g) assessed by a Dual-energy X-ray absorptiometry-scan. | Collected at baseline (visit (V)0), at registration of pregnancy (only male) and after birth (≤6 days after birth of offspring). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult blood pressure | Blood pressure (diastolic and systolic blood pressure) will be measured three times with two minutes apart after 5-10 minutes rest using a validated automatic device. | Collected at baseline (visit (V)0) and in gestational age (GA)36. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult heart rate | Heart rate will be measured three times with two minutes apart after 5-10 minutes rest using a validated automatic device. | Collected at baseline (visit (V)0) and in gestational age (GA)36. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult resting metabolic rate | Resting metabolic rate (calories/24-h) and respiratory quotient will be measured by indirect calorimetry using a ventilated hood system. Participants will lie in the supine position and rest for at least 5 min before measurements commence. The measurement will be performed twice and last for 25 min with 5 min between measurements. | Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult resting respiratory quotient | Resting respiratory quotient will be measured by indirect calorimetry using a ventilated hood system. Participants will lie in the supine position and rest for at least 5 min before measurements commence. The measurement will be performed twice and last for 25 min with 5 min between measurements. | Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult medication use | Use of medication will be collected throughout the study. | Use of medication will be collected at all visits. |
| Offspring medication use | Use of medication will be collected throughout the study. | Birth, after 3, 6 and 12 months after birth of offspring. |
| Adult reproduction - Time to pregnancy | Duration of time to conception defined from time point allowed to conceive to registration of pregnancy. | Registration of pregnancy |
| Adult reproduction - Success rate | Success rate of pregnancy defined as number of achieved pregnancies. | Registration of pregnancy |
| Reproduction (male) - Sperm motility | Sperm motility (%). | Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Reproduction (male) - Sperm concentration | Concentration (in million sperm cells/ml). | Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Reproduction (male) - Sperm morphology | Morphology (%). | Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Reproduction (male) - Sperm acrosomal status | Acrosomal status (%). | Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Reproduction (male) - Sperm DNA fragmentation | DNA fragmentation (%) | Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult glucose metabolism (OGTT, only female) | 2-h oral glucose tolerance test (OGTT) will be performed at gestational age~20 and ~28 or only ~28. | Collected at gestational age (GA)20 and 28 or only 28 (only female) |
| Adult glucose metabolism (CGM, only female) | A continuous glucose monitoring system will be attached to the designated area on the upper body as stated by the manufacture. | Collected at gestational age (GA)28+GA29 |
| Adult glucose metabolism | All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for fasting glucose, insulin, C-peptide and HbA1c | Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult lipid profile | All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for triglycerides, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very-low-density lipoprotein VLDL and total cholesterol | Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult inflammation markers | All blood samples will be collected by venous puncture in the antecubital vein after an overnight fast from at least 10 pm the night before. Samples will be analysed for hsCRP, Tumor necrosis factor alpha (TNF-α) and interleukin (IL6). | Collected at baseline (visit(V)0) and during pregnancy in gestational age (GA)36 (only female). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Offspring glucose metabolism | Total amount of venous blood will be drawn at 12-months follow-up visit. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for glucose, insulin, C-peptide and HbA1c | Collected at 12 months after birth |
| Offspring lipid profile | Total amount of venous blood will be drawn at 12-months follow-up visit. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for triglycerides, LDL, HDL, VLDL and total cholesterol. | Collected at 12 months after birth |
| Offspring inflammation markers | Total amount of venous blood will be drawn at 12-months follow-up visit. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for hsCRP, TNF-α and IL6. | Collected at 12 months after birth |
| Offspring growth factors and hormones | Total amount of venous blood will be drawn at 12-months follow-up visit. Parents will be instructed that the offspring should not have eaten two hours prior to the assessment. Samples will be analysed for Insulin-like Growth Factor 1 (IGF-1) and growth hormone (GH). | Collected at 12 months after birth |
| Collected at birth |
| Cord tissue | A sample of cord tissue will be collected immediately after birth and analysed for epigenetic profile. | Collected at birth |
| Placenta | Placenta weight (gram). | Collected at birth |
| Placenta - biopsies | Eight biopsies will be collected, four on the maternal site and four on the fetal side - one in each quadrant. The samples will be analyzed for protein expression patterns, placental markers, metabolomics, proteomics, markers of inflammation, immune markers and exosomes. | Collected at birth |
| Vaginal swab (female) - Microbiome | The females will be instructed how to perform the vaginal swab at the study site. Changes in microbiome will be assessed from vaginal swab samples. | Collected at baseline, at gestional age(GA) 13 and GA36. Additionally, the intervention group will collect a sample at visit (V)8 during the intervention period. |
| Vaginal swab (female) - pH | The females will be instructed how to perform the vaginal swab at the study site. Changes in pH will be assessed from vaginal swab samples. | Collected at baseline, at gestional age(GA) 13 and GA36. Additionally, the intervention group will collect a sample at visit (V)8 during the intervention period. |
| Offspring feces - Microbiom | Will be analysed for microbiome. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - Short chain fatty acids | Will be analysed for short chain fatty acids. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - Metabolomics | Will be analysed for metabolomics. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - Proteomics | Will be analysed for proteomics. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - pH | Will be assessed for pH. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - Inflammation markers | Will be analysed for inflammation markers. | Collected at birth (the 4 th day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring feces - consistency and frequency | Whenever a fecal sample is collected stool consistency of the collected sample, and an estimate of stool frequency will be collected with a questionnaire. | Collected at birth (the 4 the day after birth or as soon as possible thereafter) and at 1, 3, 6 and 12 months after birth. |
| Offspring urine | Parents will be instructed to collect offspring's urine samples. Offspring urine will be analyzed for metabolomics. | Collected at birth and at 1, 3, 6 and 12 months of age. |
| Adult feces - Microbiome | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be analysed for microbiome. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - Short chain fatty acids | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be analysed for short chain fatty acids. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - Metabolomics | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be analysed for metabolomics | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - Proteomics | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be analysed for proteomics. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - Inflammation markers | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be analysed for inflammation markers. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - pH | Participants will collect a fecal spot sample at home maximum 24 hours before the planned visit. Will be assessed for pH. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult feces - consistency and frequency | Whenever a fecal sample is collected stool consistency of the collected sample, and an estimate of stool frequency will be collected with a questionnaire. | Collected at baseline (visit(V)0), during pregnancy (gestational age (GA)36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult urine | Participants will collect a urine spot sample at the study site. Adult urine will be analyzed for metabolomics. | Collected at baseline (visitV)0), during pregnancy (GA36, only female) and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult dietary intake | 24-h dietary recall performed by trained personnel. | Collected at baseline (visit(V)0), during pregnancy (GA13 and GA36) and 6 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Offspring dietary intake | At birth (< 48 hours after birth) and at 3 months after offspring birth of offspring we will collect information on offspring dietary intake including breast feeding, use of formula and type as well as use of antibiotics. The offspring's dietary intake will be registered (either as 24-h dietary recall performed by trained personnel or by electronic software) at each follow-up visit (6 and months). | Collected at birth, after 3, 6 and 12 months after offspring birth. |
| Semen epigenetics marks | Epigenetic profile based on array-measurements. Analysed for methylation changes. | Collected at baseline (visit(V)0) and at V11. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Cognitive development of offspring | Offspring cognitive development will be assessed by a Habituation and Free Play Test. | Collected at 6 and 12 months after birth. |
| Offspring development | Diet, physical activity and sleep will be assessed by validated questionnaires. | 3, 6 and 12 months after offspring birth. |
| Offspring language development | Offspring language development will be assessed by validated questionnaires. | Collected 12 months after offspring birth. |
| Epigenetics | Epigenetics analyses from whole blood. Will be analysed for methylation changes. | Collected at baseline (visit(V)0) and at V8 (only intervention group) and in gestational age (GA)36 - only female). Collected at birth for offspring. |
| Adult physical activity | Physical activity and sleep will be assessed by an accelerometer and the females and males will wear the accelerometer for 7 days and 8 nights. | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 (only females during pregnancy). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult physical activity | Physical activity will be assessed by the International Physical Activity Questionnaire (IPAQ). | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 and 3, 6 and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult background | Demographic information. | Collected prior baseline V0 |
| Adult wellbeing - Depression | Depression will be assessed by Major depression questionnaire (ICD-10). | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 and 3, 6 and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult wellbeing - Quality of life | Quality of life will be assessed by the validated tool, Short form-36 (SF-36). | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 and 3, 6 and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult wellbeing - Stress | Stress will be assessed by validated tool, Perceived Stress Scale. | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 and 3, 6 and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult sleep | Sleep will be assessed by the validated tool, Pittsburgh sleep quality index questionnaire (PSQI). | Collected at baseline (visit(V)0), at gestational age (GA)13 and GA36 and 3, 6 and 12 months after birth of offspring. Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adult sexual score | Sexual score assessed by questionnaire. | Collected at baseline (visit(V)0). Additionally, at V8 (prior to pregnancy) for the intervention group. |
| Adults liver steatosis and stiffness by Liver ultrasound elastography (FibroScan) | Measured by Liver ultrasound elastography (FibroScan) | Collected at baseline (Visit(v)0), prior to pregnancy for the intervention group (v8), week 52 in the pre-pregnancy period if pregnancy is not achieved (v19), at gestational age (GA)20 (v23), and 3 months after birth of offspring (v28). |
| Breast milk from mother - establishment of lactation | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for sodium:potasium ratio | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| Breast milk from mother - establishment of lactation - inflammatory markers | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for inflammatory markers | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| Breast milk from mother - establishment of lactation - immune markers | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for immune markers | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| Breast milk from mother - establishment of lactation - growth factors | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for growth factors | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| Breast milk from mother - establishment of lactation - appetite regulation hormones | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for appetite regulation hormones | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| Breast milk from mother - establishment of lactation - microbiome | Non-fasting breast milk. Mothers will empty one full breast at each time point with an electric pump. Breast milk will be analysed for microbiome | Collected at visit 27 (6 days after birth), visit 28 (3 months after birth), visit 29 (6 months after birth) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |