Weight loss before pregnancy and the effect on child health

Woman
As a coming mother you can participate in the project if you

• Are between 18-38 years old
• Have a BMI of 27.0-44.9 kg/m²
• Are planning pregnancy within 1 year
• Are affiliated with Hvidovre Hospital or are willing to seek permission to give birth at Hvidovre Hospital
• Do not have diabetes
• Are in good health

Men
As a coming farther you can participate in the entire project (full participation) if you

• Are between 18-55 years old
• Have a BMI of 18.5-44.9 kg/m²
• Do not have diabetes
• Are in good health

Or you can participate partly, where you provide information about yourself via a questionnaire, but do not participate in examinations and consultations which are related to parents/males.

There are no criteria related to age, BMI etc. if you participate partly.

Child
The future child will automatically participate in the project by participating in child examinations from the child´s birth until the child is 18 months old; as well as in the subsequent telephone follow-up until the child is 14 years old.

Further, it requires

• That you have signed informed consent to participate
• That you speak and understand Danish or English, as all written and oral information and questionnaires will be in Danish or English
• That you intend to let the future child participate in the project
• Are willing to store the child's urine and feces in a small closed container in the home freezer until subsequent visits which can be up to 2 months after sample collection.

Other inclusion and exclusion criteria will be reviewed at a screening visit after participation in an information meeting.

What coming parents get from participating

• All female participants will receive dietitian counselling in healthy diet during pregnancy
• Male participants will with full participation receive dietitian guidance in weight loss diet-/weight maintenance diet during the pregnancy period depending on individual aims
• As participants, you will receive thorough health examinations of your planned child's growth and development from the time it is in the womb until it is 18 months old.
• The woman will be given the vitamins and minerals recommended when planning pregnancy or pregnancy (folate from start to second trimester as well as iron and vitamin D from start to birth of the offspring).
• Men with full participation will be given vitamin D from the start until pregnancy is registered and confirmed.
• Participants in the intervention group will receive dietitian counselling in weight loss and weight loss maintenance before pregnancy.
• It is expected that people in the intervention group will improve their overall health due to weight loss

What children get from participating

• All children will receive extra measurements and examinations at child investigation days from birth of the child until the child is 18 months old.
• After completion of the study, the child will receive a gift to less than 200 d.kr. after the 18-month examination.

Participant information
Read more about the project and what it entails in the participant information.

Interested?

If you want to hear more about the project, please contact us. Please note that this is only an indication of interest in participating in the study and not a binding registration for project participation.

Measurements and examinations

Most visits will take place at the Department of Nutrition, Exercise and Sports, Frederiksberg, while up to five examinations of the prospective parents will take place at Hvidovre Hospital and up to three examinations of the prospective father (by full participation) will take place at Rigshospitalet. In addition, examinations after birth of the child will take place at the Institute at Frederiksberg and Hvidovre Hospital.

Overview of the measurements throughout the study

• We measure the prospective parents' weight, height, waist and hip circumference
• We measure the prospective parents' body composition using a DEXA scanner
• We measure the child's weight, length, circumference and skin fold thickness
• We measure the child's body composition using a PEA Pod, Bod POD and/or DEXA scan
• We measure prospective parents and the child's blood pressure and heart rate.
• We measure blood sugar metabolism using a continuous blood sugar monitor which is carried for up to 16 days
• We measure resting metabolic rate using indirect calorimetry
• We measure the baby's growth by an ultrasound scan in gestational week 28
• We collect information about the parents' and children's dietary intake
• We collect stool samples, urine and blood samples from future parents and children
• We collect sperm samples from the man
• We collect vaginal swabs from the woman
• We collect samples from the placenta, umbilical cord blood and tissues (at birth)
• We collect breast milk
• We measure physical activity and sleep using an activity tracker worn for 7 days and 8 nights
• We collect questionnaires about depression, quality of life, stress, sleep quality, physical activity, and sexual score.
• We collect questionnaires about the child's physical activity, sleep, illnesses, medication use and development.
• During the trial, we will have access to your patient record for the purpose of obtaining information relevant to the project. This could be information such as the baby's growth, blood tests, any complications and method of birth. 

See also the participant information for more information and description of the individual measurements.

Women with overweight have a higher risk of complications throughout pregnancy and during birth compared to women with normal weight. Further, women with overweight tend to gain excess weight during pregnancy and give birth to larger babies.

These two factors are suggested to contribute to increased risk of overweight and e.g. diabetes for the children later in life. Recent research has shown that the paternal weight and health plays a role in the growth and development of the foetus and later health of the child. It is suggested that it might be the ’programming’ of the child. 

Studies of people with overweight have shown that weight loss benefits the body’s metabolism, which can positively impact the sperm and the environment of which the egg grows in. It is important that the diet which the woman consumes during pregnancy, contribute everything necessary to both mother and child.

We know, that by following the recommended guidelines, the pregnant woman and the foetus will get all the necessary nutrients and the weight gain will be limited. New research suggests that diets with extra protein and many fibres can help regulate appetite and therefore prevents excess weight gain during pregnancy.

Approximately half of all adults are overweight, and so it comes with good reason to investigate whether weight loss in the prospective parents prior to conception can contribute to the reduction in obesity and co-morbidities in the child.

The research project PREPARE CHILD – CPH will follow 240 women/couples and their planned child over a period of approximately 3 years; from the time they plan pregnancy until the offspring is 18 months old. The women/couples who would like to participate and meet the criteria (decided at a screening visit) will be randomized to two groups.

The first, the intervention group will lose approximately 10% using a formula diet (very low-calorie diet) the first 3 months, before trying to conceive. Hereafter the weight loss should be maintained using dietician counselling and a diet rich in protein and dietary fibers.

The second group, the control group, will live as usual until pregnancy is achieved; and are allowed to conceive after the first investigation day.

As a male, it is not a requirement to participate in the project, which means that a woman can participate alone with the future child as long as both holders of parental custody provide consent to this.

The control group prior to pregnancy

Women/couples in the control group, will live as usual and until pregnancy is achieved; and are allowed to conceive after the first investigation day.

The intervention group prior to pregnancy

The woman and perhaps her partner (only partners having a BMI≥25 kg/m²) in the intervention group will lose approximately 10% using a formula diet during the first 8-10 weeks, followed by a reintroduction period before they are allowed to try to conceive. Hereafter the weight loss should be maintained using dietician counselling and a diet rich in protein and dietary fibers.

During pregnancy (both the intervention and control group)

During pregnancy the control group as well as the intervention group will be advised to follow a diet high in protein and dietary fibres. During pregnancy women/couples will receive dietetic counseling and will undergo investigations and measurements.

Investigation days during the trial

All interested in the trial must attend an information meeting at the Department of Nutrition, Exercise and Sports (NEXS), Frederiksberg. Those women/couples who would like to participate and meet the criteria (to be decided at a screening visit) participate in initial investigation day (baseline visit).

The trial period for each adult participant extends over a maximum of about 3 years.

Women/couples in the control group must attend up to 2 visits before pregnancy.

During the weight loss period, women/couples in the intervention group should participate in dietitian counselling approximately every two weeks for the first 3 months and during the weight loss maintenance period, they should participate in dietitian counselling approximately every 4-6 weeks.

During pregnancy, women/couples in both groups must attend 7 visits with dietitian counseling and measurements approximately every 6-8 weeks after registry of pregnancy.

There will be a total of 5 child investigation days. The visits take place at birth of the child and when the child is 3, 6, 12 and 18 months old. After the 18-month investigation visit, a telephone call will be made annually until the child is 14 years old to collect information about the child's height and weight.

The study is registered on www.clinicaltrials.gov, which is a database of human clinical studies.

The results of the study, whether positive, negative or inconclusive, will be published in professional international journals or at scientific meetings.

When publishing the results, it will not be possible to identify each individual participant in any way.

PREPARE CHILD - CPH is initiated by Associate Professor Nina Rica Wium Geiker, Professor Henriette Svarre Nielsen and Senior scientist Kristian Almstrup and is funded by the Novo Nordisk Foundation (DKK 16.000.000).

Professor Christian Mølgaard and Associate Professor Camilla Trab Damsgaard will lead the child examinations of the planned child.

The amount for the project is deposited in an independent research account, which is subject to public audit. The funding includes salaries for project staff as well as the expenses associated with the execution of the study.

The funders have no influence on the execution, interpretation or publication of the project.

Pharmovital ApS, Søborg, is donating iron supplements (AminoJern®) to the female participants in the project and PharmaNord, Vejle, is donating folic acid to the women and vitamin D to both the women and the man.

Lego Charity has donated small LEGO® Duplo packages to the children after completion of the last visit.

None of the project staff have a personal connection to the funders or the donating companies.

The PREPARE CHILD - CPH project has been developed in collaboration with researchers from the University of Copenhagen, Hvidovre Hospital and Rigshospitalet.

Collaborators

The overall project PREPARE CHILD – Denmark consists of two projects, the PREPARE CHILD - CPH and the PREPARE CHILD – AUH.

The overall research project is a collaboration between the University of Copenhagen, Region H (Hvidovre Hospital and Rigshospitalet), Aarhus University, Steno Diabetes Center Aarhus and Region Midt.