Clinical trial NCT05798494: PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Official title: PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Aarhus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Weight Loss
Pregnancy Related
Child Nutrition Sciences
Body Composition
Keywords: Overweight
Pregnancy
Weight loss
Diet, Reducing
Epigenetics
Healthy Lifestyle
DNA Methylation
Exercise
Offspring's neonatal fat mass
Pea Pod
Infant, Large for Gestational Age
Body Fat Distribution
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Per Ovesen, Professor Dept. of Obsteterics, Aarhus University Hospital
name: Jens Meldgaard Bruun, Professor Steno Diabetes Center Aarhus, Aarhus University Hospital
name: Sine Knorr, PhD Steno Diabetes Center Aarhus, Aarhus University Hospital
First posted: 2023-04-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 140 couples will be recruited and randomized to either intervention og control. Participants includes the mother, father and 1st and 2nd child, therefore the total number of participants will be 560.
Primary purpose: PREVENTION

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.

Detailed description: The study is a single site parallel randomized controlled study. The study will be assessing the effect of a pre-conceptional weight loss intervention vs a control group among healthy couples where the prospective mother is pregnant (recruited at gestational age 18-36), overweight or obese (BMI 27-44.9 kg/m\^2), between 18-38 years and planning an additional pregnancy within the following 3 years.

The investigators will recruit a total of 140 healthy pregnant couples who will be randomized 1:1 to either intervention or control, stratified according to maternal pre-pregnancy BMI and previous or present diagnosis of gestational diabetes.

The couples in intervention group will receive dietary counseling by a dietitian from 3 months post-partum of the 1st child until birth of the 2nd child. The goal is to achieve a healthy lifestyle and a moderate weight loss of 10% according to pre-pregnancy weight during the first year. Hereafter, the couples will be guided in weight maintenance until pregnancy of the second child. During pregnancy the goal is to achieve a healthy weight gain. Couples in intervention group will also participate in physical activity sessions every 2nd week and advised to walk with moderate intensity at least 2-4 times a week for at least half an hour.

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 1st baby born before intervention is started will be the "index child" and the metabolic and anthropometric parameters of the 1st child will be compared to parameters of the second child to assess the effect of the parent's healthy lifestyle between the two pregnancies.

The investigators hypothesize that parental weight loss intervention, initiated before conception, will facilitate lower parental insulin resistance, inflammation, body weight and adiposity, incretin responses and energy expenditure compared to usual care. For the offspring the investigators hypothesize that the intervention will reduce adverse pregnancy outcomes with a short-term reduction in the risk of being born large for gestational age with excessive fat mass and a long-term reduction in the risk of developing overweight or obesity as a consequence of both social (family approach) and biological (epigenetic modifications) pathways.

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

Primary outcomes:
measure: Neonatal fat mass
timeFrame: Collected within the first week of birth (strived <48 hours)
measure: Difference in epigenetic changes in child 1 and 2
timeFrame: Assessed at birth
Secondary outcomes:
measure: Obstetrics outcome - length of gestational age
timeFrame: Assessed at birth of both offsprings
measure: Obstetric - medication use
timeFrame: Collected from initiation of labor until completed birth of both offsprings
measure: Obstetric - delivery mode
timeFrame: Collected at birth of both offsprings
measure: Obstetric - pregnancy complications
timeFrame: Collected at gestational age (GA) 34-36 and after birth of both offsprings
measure: Obstetric - Neonatal unit admissions
timeFrame: Collected at birth and until 12 months after birth of both offsprings
measure: Obstetric - obstetrics complications
timeFrame: Collected at birth of both offsprings
measure: Obstetrics - birth defects/abnormalities
timeFrame: Collected at birth of both offsprings
measure: Neonatal morbidities
timeFrame: Collected at birth of both offsprings
measure: Fetal and offspring growth - body weight
timeFrame: Collected from medical record during pregnancy, measured in gestational age (GA) GA34-GA36 via ultrasound in both pregnancies, at birth and 3, 12 and 18 months after birth of both offsprings
measure: Fetal and offspring growth - length
timeFrame: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings
measure: Fetal and offspring growth - abdominal circumference
timeFrame: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies, and measured at birth and 3, 12 and 18 months after birth of both offsprings
measure: Fetal and offspring growth - crown circumference
timeFrame: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies
measure: Fetal and offspring growth - femur length
timeFrame: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,
measure: Fetal growth - fractional limb volume
timeFrame: Collected from medical record during pregnancy, measured in GA34-GA36 via ultrasound in both pregnancies,
measure: Offspring growth - BMI z-score
timeFrame: Collected at birth and 3, 12 and 18 months after birth of both offsprings
measure: Offspring growth - weight for gestational age
timeFrame: Collected at birth and 3, 12 and 18 months after birth of both offsprings
measure: Offspring growth - large for gestational age
timeFrame: Collected at birth of both offsprings
measure: Offspring growth - small for gestational age
timeFrame: Collected at birth of both offsprings
measure: Offspring growth - apgar score
timeFrame: Collected at birth of offspring of both offsprings
measure: Offspring growth
timeFrame: Collected at birth and 3, 12 and 18 months after birth of offspring.
measure: Offspring growth - body composition by the POD system
timeFrame: Collected within the first week of birth and 3 months post partum in both offsprings
measure: Offspring blood pressure
timeFrame: Collected 12 and 18 months after birth of both offsprings
measure: Offspring heart rate
timeFrame: Collected 12 and 18 months after birth of both offsprings
measure: Offspring growth - self-reported body weight
timeFrame: 18 months after birth 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 18 of age
measure: Offspring growth - self-reported height
timeFrame: 18 months after birth 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 18 of age
measure: Adult weight
timeFrame: Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child)
measure: Adult Height
timeFrame: Collected in GA34-GA36 in index pregnancy
measure: Adult BMI
timeFrame: Collected in GA34-36 in 1st pregnancy, study visits 3, 12 and 24mo. pp after 1st child, GA34-36 in 2nd pregnancy and at follow up vist (3, 12 and 18mo. pp of 2nd child).
measure: Adult anthropometric
timeFrame: Intervention: each visit throughout study (GA34-36 of 1st child to 18mo. after birth of 2nd child). Control: In GA34-36 in both pregnancies, at study visits (3, 12 and 24mo. pp) and follow up visits (3, 12 and 18 months pp of 2nd child)
measure: Adult blood pressure
timeFrame: Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child
measure: Adult heart rate
timeFrame: Collected at GA34-36 in 1st pregnancy, study visits 3, 12 and 24 months pp. of 1st child, GA34-36 in 2nd pregnancy and 3 months pp after 2nd child
measure: Adult resting metabolic rate
timeFrame: Collected at study visit 3, 12, and 24 months pp after 1st child.
measure: Adult resting respiratory quotient + substrate
timeFrame: Collected at study visit 3, 12, and 24 months pp after 1st child.
measure: Adult medication use
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st. child
measure: Offspring medication use
timeFrame: Birth, after 3, 12, and 18 months after birth of both offsprings
measure: Adult reproduction - Time to pregnancy
timeFrame: Registration of 2nd. pregnancy (up to tree years from birth of 1.st. child)
measure: Adult glucose metabolism (OGTT)
timeFrame: Performed at study visits 3, 12 and 24 months pp of 1st. child
measure: Adult Oral Glucose Tolerance Test (OGTT) during pregnancy (only female)
timeFrame: Collected in GA28 of 1st and 2nd pregnancy (performed after risk score at gestational age~20 and ~28 or only ~28)
measure: Placenta - weight (gram)
timeFrame: Collected at birth of both offsprings
measure: VO2-max adult - cardiorespiratory fitness
timeFrame: Collected at study visit 3, 12 and 24 months pp after birth of 1st child
measure: Cardiac function offspring - Left ventricular and right ventricular morphology
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - left centricular ejection fraction
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - fractional shortening
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Systolic function, strain
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Systolic function, strain rate
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - TAPSE and RV fractional area change
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Diastolic function, left ventricular E/A-ratio
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Diastolic function, tissue velocities (E', A', S')
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Diastolic function, strain
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Overall cardiac function
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Pulmonary artery acceleration time
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Pulmonary artery pressure
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cardiac function offspring - Persistent ductus arteriosus (PDA)
timeFrame: Collected at birth and at 12 months follow up visit after birth of each child
measure: Cord blood - Telomore length
timeFrame: Collected at birth of both offsprings
measure: Cord blood - pH
timeFrame: Collected at birth
measure: Cord blood - Epigenetics
timeFrame: Collected at birth of both offsprings
measure: Adult body composition by DEXA scan
timeFrame: Collected at study visits 3, 12 and 24 months pp. of 1st child
measure: Adult bone markers by DEXA scan - bone mineral content
timeFrame: Collected at study visits 3, 12 and 24 months pp. of 1st child
measure: Adult bone markers by DEXA scan - bone area
timeFrame: Collected at study visits 3, 12 and 24 months pp. of 1st child
measure: Adult bone markers by DEXA scan - bone mineral density
timeFrame: Collected at study visits 3, 12 and 24 months pp. of 1st child
measure: Adult blood sample - glucose
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - CD163
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - HbA1c
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Kreatinin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - eGFR
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - C-reaktivt protein (CRP)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Alanintransaminase (ALAT)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Gamma-GT (GGT)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Basisk fosfatase (BASP)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Bilirubin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Ferritin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Hemoglobin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Leukocytter
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - platelets
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Triglyceride
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Cholesterol HDL
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Cholesterol LDL
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Total Cholesterol
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - vitamin B12
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - vitamin D3
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - c-peptide
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Insulin-like Growth Factor-1 (IGF-1)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Insulin-like growth factor-binding protein-1 (IGFBP-1)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Insulin-like growth factor-binding protein-3 (IGFBP-3)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Fibroblast growth factor 21 (FGF-21)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Leptin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Adiponectin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Ghrelin
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Growth Hormone (GH)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Free fatty Acids (FFA)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Interleukin 6 (IL-6)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Interleukin 6 (IL-10)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Interleukin-1 alpha (IL-1 alpha)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Interferon gamma (IFN-γ)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult blood sample - Tumor Necrosis Factor alfa (TNF-α)
timeFrame: Collected at GA34-GA36 in 1st pregnancy, study visit 3, 12 and 24 months pp of 1st child, at GA34 in 2nd pregnancy and at follow visit 3 months pp after 2nd child
measure: Adult female blood sample - Humant choriogonadotropin (hCG)
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult female blood sample - Progesterone
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult female blood sample - Proinsulin C-peptide
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult female blood sample - sex hormone binding globulin (SHBG)
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult female blood sample - Prolactin
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult blood sample -Cortisol
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Adult female blood sample -Estradiol
timeFrame: Collected at GA34-GA36 in both pregnancies
measure: Offspring blood sample - glucose
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - c-peptide
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - insulin
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - IGF-1
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - IGFBP-3
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - IGFBP-1
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - CD163
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Ferritin
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - HgbA1c
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Hgb
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - CRP
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Triglyceride
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Cholesterol HDL
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Cholesterol LDL
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Total Cholesterol
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - FGF-21
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Leptin
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Adiponectin
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - FFA
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - Growth Hormone (GH)
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - cTroponin I (cTnI)
timeFrame: Collected 12 months after birth in both offsprings
measure: Offspring blood sample - BNP
timeFrame: Collected 12 months after birth in both offsprings
measure: Cord blood - c-peptide
timeFrame: Collected at birth of both offspring
measure: Cord blood -Insulin
timeFrame: Collected at birth of both offspring
measure: Cord blood -IGFBP-3
timeFrame: Collected at birth of both offspring
measure: Cord blood -IGFBP-1
timeFrame: Collected at birth of both offspring
measure: Cord blood -IGF-1
timeFrame: Collected at birth of both offspring
measure: Cord blood -Ferritin
timeFrame: Collected at birth of both offspring
measure: Cord blood -cTnI
timeFrame: Collected at birth of both offspring
measure: Cord blood -BNP
timeFrame: Collected at birth of both offspring
measure: Cord blood -CRP
timeFrame: Collected at birth of both offspring
measure: Cord blood -CD163
timeFrame: Collected at birth of both offspring
measure: Cord blood -FGF21
timeFrame: Collected at birth of both offspring
measure: Cord blood -Leptin
timeFrame: Collected at birth of both offspring
measure: Cord blood -Adiponectin
timeFrame: Collected at birth of both offspring
measure: Cord blood -FFA
timeFrame: Collected at birth of both offspring
measure: Cord blood - Vitamin D3
timeFrame: Collected at birth of both offspring
measure: Cord blood - HbA1c
timeFrame: Collected at birth of both offspring
measure: Cord blood - IL-6
timeFrame: Collected at birth of both offspring
measure: Cord blood - IL-10
timeFrame: Collected at birth of both offspring
measure: Cord blood - IL-1 alpha
timeFrame: Collected at birth of both offspring
measure: Cord blood -TNF- alpha
timeFrame: Collected at birth of both offspring
measure: Cord blood -IFN- gamma
timeFrame: Collected at birth of both offspring
Other outcomes:
measure: Offspring feces - Microbiome
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - Short chain fatty acids
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - Metabolomics
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - Proteomics
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - pH
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - Inflammation markers
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - consistency
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - frequency
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring feces - gastrointestinal symptoms
timeFrame: Collected within the first week after birth (but should avoid to collect the first fecal excretion after birth (meconium)), at study visit 3 and 12 months after birth of each offspring
measure: Offspring urine
timeFrame: Collected within the first week of birth and at 3 and 12 months follow up of each offspring
measure: Adult feces - Microbiome
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - Short chain fatty acids
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - Metabolomics
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - Proteomics
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - Inflammation markers
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - pH
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - consistency
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - frequency
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult feces - gastrointestinal symptoms
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Adult urine
timeFrame: Collected at GA34-GA36 in each pregnancy and at study visit 3, 12 and 24 months pp of 1st child
measure: Offspring nutritional milestones
timeFrame: Collected at 12 and 18 months after offspring birth
measure: Offspring development, WHO milestones
timeFrame: Collected at 12 and 18 months after offspring birth
measure: Adult physical activity
timeFrame: Collected at study visit 3, 12 and 24 months pp of 1st child
measure: Adult physical activity - Physical Activity Questionnaire (IPAQ)
timeFrame: Collected at GA34-GA36 in each pregnancy, study visit at 3, 12 and 24 months pp of 1st child and 3 months pp visit after 2nd child
measure: Adult background quistionnaire, ethnicity,
timeFrame: Collected after screening in GA34-GA36 of 1st child
measure: Adult background quistionnaire, education
timeFrame: Collected after screening in GA34-GA36 of 1st child
measure: Adult background quistionnaire, parity
timeFrame: Collected after screening in GA34-GA36 of 1st child
measure: Adult background quistionnaire, pre-pregnancy weight
timeFrame: Collected after screening in GA34-GA36 of 1st child
measure: Adult background quistionnaire, demographic information
timeFrame: Collected after screening in GA34-GA36 of 1st child
measure: Adult wellbeing - Depression, Major depression questionnaire (ICD-10)
timeFrame: Collected at GA34-GA36 in each pregnancy, study visit at 3, 12 and 24 months pp of 1st child and 3 months pp visit after 2nd child
measure: Adult wellbeing - Quality of life, Short form-36 (SF-36)
timeFrame: Collected at GA34-GA36 in each pregnancy, study visit at 3, 12 and 24 months pp of 1st child and 3 months pp visit after 2nd child
measure: Adult wellbeing - Stress, Perceived Stress Scale
timeFrame: Collected at GA34-GA36 in each pregnancy, study visit at 3, 12 and 24 months pp of 1st child and 3 months pp visit after 2nd child
measure: Adult sleep
timeFrame: Collected at GA34-GA36 in each pregnancy, study visit at 3, 12 and 24 months pp of 1st child and 3 months pp visit after 2nd child
measure: Adult dietary intake, 24-h recall
timeFrame: Collected at GA34-GA36 in each pregnancy, at visit 3, 12 and 24 months pp of the 1st child and 3 months visit after 2nd child. Further collected at 6, 18, 30 and 36 months pp and in GA12 and GA20 of 2nd pregnancy in intervention group
measure: Adult dietary intake, FFQ
timeFrame: Collected at GA34-GA36 in each pregnancy, at study visit 3, 12 and 24 months pp of the 1st child and 3 month follow up vist after 2nd child
measure: Offspring dietary intake
timeFrame: Collected within the first week of birth and 3, 12 and 18 months after birth off each offspring
measure: Breast milk - nutrients biomarkers
timeFrame: Collected within the first week of birth and 3 months pp after each birth
measure: Breast milk - Hormonal and inflammatory markers
timeFrame: Collected within the first week of birth and 3 months pp after each birth
measure: Breast milk - Metabolomics
timeFrame: Collected within the first week of birth and 3 months pp after each birth
measure: Breast milk - Proteomics
timeFrame: Collected within the first week of birth and 3 months pp after each birth
measure: Breast milk - Short chain fatty acids and related metabolites
timeFrame: Collected within the first week of birth and 3 months pp after each birth
measure: Adult participation - dietitian guidance
timeFrame: Every 1-2 month from 3 months pp of 1st child to birth of 2nd child
measure: Adult participation - physical session and power walk
timeFrame: Every 2nd week from 3 months pp of 1st child to birth of 2nd child
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Ulla K Opstrup, Assoc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen L, Knorr S, Antoniussen CS, Bruun JM, Ovesen PG, Fuglsang J, Kampmann U. The Impact of Lifestyle, Diet and Physical Activity on Epigenetic Changes in the Offspring-A Systematic Review. Nutrients. 2021 Aug 17;13(8):2821. doi: 10.3390/nu13082821.