Overweight and ObesityPREPARE CHILDNCT05621109
PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - Copenhagen
A study testing Weight loss intervention in people with Overweight and Obesity and Weight Loss, run by Christian Mølgaard at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Weight Loss, Pregnancy Related
- What is being tested?
- Weight loss intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2022to 30 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Maternal inclusion Criteria:
- Maternal pre-pregnancy BMI 27.0-44.9 kg/m^2
- Maternal age range 18-38 years
- Not pregnant or breastfeeding
Paternal Inclusion Criteria - full protocol (optional participation):
- Paternal pre-pregnancy BMI 18.5-44.9 kg/m^2
- Paternal age range 18-55 years
- Biological father
Parental Inclusion Criteria:
- Planning pregnancy within 1 year
- 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 (intrauterine insemination allowed)
- ≥4 consecutive spontaneous pregnancy loss (female)
- Having tried to conceive or prior time to pregnancy of more than 12 months
- 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
- Engagement in elite sports or similar strenuous exercise ≥5 h/week
- Blood donation or transfusion within the past month before baseline
- Blood donation during the study
- Inability or unwillingness to follow the study protocol and instructions given by the study personnel
- Pregnancy registered between baseline visit and 4 weeks after the baseline visit (urinary analysis with dipstick)
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
- Amenorrhea
- Severely reduced semen quality incl. azoospermia
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:
- Having tried to conceive or prior time to pregnancy of more than 12 months
- Weight changes ± 5% three months prior to inclusion
- 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 baseline
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen
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.
- Conditions
- Overweight and Obesity, Weight Loss, Pregnancy Related
- Being tested
- Weight loss intervention
- Medical subject headings
- Overweight, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Weight loss intervention |
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal fat mass
Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)
Measured: Assessed at birth (strived <24 hours, but allow <48 hours)
Secondary outcomes (54)
Obstetrics outcome - length of gestational age
Length of gestational age.
Measured: Assessed at birth of offspring.
Obstetric - medication use
Medication use during labor
Measured: 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).
Measured: 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).
Measured: Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39).
Obstetric - Neonatal unit admissions
Neonatal unit admissions.
Measured: 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).
Measured: Collected at birth of offspring
Obstetrics - birth defects/abnormalities
Birth defects/abnormalities
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Collected in gestational age 28.
Offspring growth - BMI z-score
Offspring body mass index (BMI) z-score (BMI adjusted for age and sex).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Collected 12 months after birth of offspring
Offspring growth - self-reported body weight
Self-reported body weight
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Collected at baseline (V0).
Adult BMI
Calculated ad weight (kg)/height(m)^2
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Use of medication will be collected at all visits.
Offspring medication use
Use of medication will be collected throughout the study.
Measured: 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.
Measured: Registration of pregnancy
Adult reproduction - Success rate
Success rate of pregnancy defined as number of achieved pregnancies.
Measured: Registration of pregnancy
Reproduction (male) - Sperm motility
Sperm motility (%).
Measured: 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).
Measured: Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.
Reproduction (male) - Sperm morphology
Morphology (%).
Measured: Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.
Reproduction (male) - Sperm acrosomal status
Acrosomal status (%).
Measured: Collected baseline and at visit (V) 11. Additionally, at V8 (prior to pregnancy) for the intervention group.
Reproduction (male) - Sperm DNA fragmentation
DNA fragmentation (%)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Collected at 12 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start15 Dec 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Mølgaard
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, University of Copenhagen, Centre for Childhood Health, Denmark
- Responsible party
- Sponsor-investigator, Christian Mølgaard, University of Copenhagen
- Investigators
- Christian Mølgaard, MD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621109
- Sponsor's protocol ID
- L101
- Acronym
- PREPARE CHILD
- Status last verified
- May 2026
- First submitted
- 3 Nov 2022
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRE-Pregnancy Weight Loss And the Reducing Effect on CHILDhood Overweight - a Randomized Controlled Study in Copenhagen
- ClinicalTrials.gov ID
- NCT05621109
- Acronym / sponsor ID
- PREPARE CHILD / L101
- Conditions
- Overweight and Obesity, Weight Loss, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Christian MølgaardUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital, Copenhagen University Hospital, Rigshospitalet, University of Copenhagen, Centre for Childhood Health, Denmark
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Weight loss interventionRapid 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). |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss interventionSubjects 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. | Behavioural | Intervention |
Primary outcome
Neonatal fat mass
Time frame: Assessed at birth (strived <24 hours, but allow <48 hours)
Offspring's neonatal fat mass (grams) assessed by air displacement plethysmography (Pea POD)
54 secondary outcomes
Obstetrics outcome - length of gestational age
Time frame: Assessed at birth of offspring.
Obstetric - medication use
Time frame: Collected from initiation of labor until completed birth of offspring.
Obstetric - delivery mode
Time frame: Collected at birth of offspring.
Obstetric - pregnancy complications
Time frame: Collected at registration of pregnancy, in gestational age (GA) 8, GA13, GA20, GA28, GA36 and GA39).
Obstetric - Neonatal unit admissions
Time frame: Collected at birth and until 6 months after birth of offspring.
Obstetric - obstetrics complications
Time frame: Collected at birth of offspring
Obstetrics - birth defects/abnormalities
Time frame: Collected at birth of offspring
Neonatal morbidities
Time frame: Collected at birth of offspring
Fetal and offspring growth - body weight
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Collected in gestational age 28.
Offspring growth - BMI z-score
Time frame: Collected at birth and 3, 6 and 12 months after birth of offspring.
Offspring growth - weight for gestational age
Time frame: Collected at birth and 3, 6 and 12 months after birth of offspring.
Offspring growth - large for gestational age
Time frame: Collected at birth and 3, 6 and 12 months after birth of offspring.
Offspring growth - small for gestational age
Time frame: Collected at birth and 3, 6 and 12 months after birth of offspring.
Offspring growth - apgar score
Time frame: Collected at birth of offspring
Offspring growth
Time frame: Collected at birth and 3, 6 and 12 months after birth of offspring.
Offspring growth - body composition by the POD system
Time frame: Collected at birth (strived <24 hours, but allow <48 hours) and 3 months after birth of offspring.
Offspring blood pressure
Time frame: Collected 12 months after birth of offspring
Offspring heart rate
Time frame: Collected 12 months after birth of offspring
Offspring growth - self-reported body weight
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: From baseline to registration of pregnancy (4, 8, 12, 16, 20, 24, 30, 36, 42, 48, and 52 weeks after baseline)
Adult Height
Time frame: Collected at baseline (V0).
Adult BMI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group.
Adult resting respiratory quotient
Time frame: Collected at baseline visit (V)0. Additionally, at V8 (prior to pregnancy) for the intervention group.
Adult medication use
Time frame: Use of medication will be collected at all visits.
Offspring medication use
Time frame: Birth, after 3, 6 and 12 months after birth of offspring.
Adult reproduction - Time to pregnancy
Time frame: Registration of pregnancy
Adult reproduction - Success rate
Time frame: Registration of pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Mølgaard, MD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight loss intervention in people with Overweight and Obesity and Weight Loss, run by Christian Mølgaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal fat mass (time frame: Assessed at birth (strived <24 hours, but allow <48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.