PreBabe

Conducted by the University of Sydney

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Struggling to conceive? You are not alone.

Did you know 1 in 2 women are above a healthy weight range when trying for a baby and 1 in 7 couples have trouble falling pregnant?

PreBabe is a world-first clinical trial exploring how losing weight prior to pregnancy can improve the long-term health of mothers and babies.

Q1: What is the PreBabe study?

PreBabe is a world-first clinical trial exploring how losing weight prior to pregnancy can improve the long-term health of mothers and babies.

One in two women in Australia are currently above a healthy weight when starting their pregnancy journey.

Losing weight before falling pregnant may make it easier to conceive.

It’s also safer for women and their baby to lose weight prior to becoming pregnant, rather than during pregnancy, which is not recommended.

The aim is to assist women to lose weight and build healthier lifestyles in a supportive environment within a clinical setting, this will provide health benefits and women may be more likely to fall pregnant.

It is possible that babies and children may also be healthier, as research has shown that mothers having a BMI (body mass index) over 25 doubles the risk of having a bigger baby (4kg+), which increases the risk of obesity in childhood.

Leading the PreBabe research team, Professor Adrienne Gordon is a senior staff specialist Neonatologist for newborn care and a Clinical Professor of Obstetrics, Gynaecology, Neonatology, within the Faculty of Medicine and Health at the University of Sydney. Since the filming of the video John Hunter Hospital in Newcastle has been added as a PreBabe Study Site.

Q2: What will the study achieve?

The study will generate new knowledge for researchers and health care providers to better understand which weight loss approach can best help women with overweight who want to become pregnant.

The results will provide better information for women when making decisions about how to have a safe, healthy pregnancy and birth, and which type of weight loss has the best short and long-term results.

Q3: Who is the study aimed at and where is the study located?

Women with overweight or obesity (BMI>25), aged 18-40 who are considering a pregnancy in the next few years. Calculate your BMI online HERE.

This study is being run across five maternity hospitals in Sydney and Hunter New England Region.

Royal Prince Alfred Hospital, Camperdown

Royal Hospital for Women, Randwick

Nepean Hospital, Kingswood

Westmead Hospital, Westmead

John Hunter Hospital, Newcastle

As such, participants need to be living close to one of these five hospitals.

About 750 women are required each year over the next three years.

Q4: What is involved for those wanting to take part in the PreBabe study?

For women who agree to be involved, there will be a screening process to check eligibility and they will then be referred to the closest study hospital clinic and given an appointment with the study team.

Study participants will then be allocated to one of the two weight loss programs, each of which runs for 10 weeks.

Women in both programs will have two in person visits and one telehealth appointment over the 10 week period at their allocated PreBabe Hospital Clinic.

Every woman will then be contacted monthly over the next 12 months to ask if they have become pregnant.

Blood will be collected for routine pre-pregnancy testing at the beginning and end of the weight-loss period.

After the weight-loss phase there will be two short ten minute telehealth appointments at six and twelve months with online questionnaires.

Participants will not receive any payment for taking part, but will have the opportunity to take part in a free 10 week weight loss program.

Q5: Which weight loss program will the women be on?

While there are many ways to safely lose weight, this study is testing two different weight loss programs to see which has the best long-term results for women and babies:

1) A combination of meal replacements and conventional healthy meals supported by a trial website
OR

2) Conventional healthy meals supported by telephone coaching calls.

Both approaches are safe and designed for use prior to becoming pregnant. If women become pregnant while on the study, we will help them move safely to a healthy pregnancy eating plan.

Did you know 1 in 2 women are above healthy weight when trying for a baby?

Q6: Why is overweight or obesity a problem in pregnancy and for the baby?

Although you may be healthy, carrying extra weight at the start of a pregnancy can be associated with complications such as high blood pressure, diabetes, miscarriage and caesarean delivery. Some babies need to be admitted to the special care nursery.

Losing weight prior to pregnancy reduces the risk of these complications and may help you to conceive naturally and may be safer for you and your baby.

Q7: What is a randomised control trial?

A randomised control trial (RCT) is a trial where the participants are randomly assigned to one of the two treatment groups. Neither the researcher nor the participant decides which of the diets you will follow. This is the best way to test which diet works.

Q8: Will my medical records be accessed and how is my privacy protected?

All the data and information you provide to the study is treated with confidentiality and will be stored electronically on a research database which is a secure, web-based, non-commercial data management tool hosted and securely maintained on the Sydney Local Health District Servers.

At your first clinic visit you will be asked to give consent for the PreBabe researchers to access your de-identified Medicare and Pharmaceutical Benefits Scheme data.

Q9: What are the risks and benefits of participating in the study?

Both of the diets being tested in the study are known to be safe. The only risk is some discomfort due to the blood collection on visits one and three.

There may be no direct benefit to you however you will receive a preconception consultation and speak to expert health professionals who will support you through the weight-loss phase of the study. You will contribute to the body of research which will ultimately aim to improve pregnancy outcomes for mothers and babies.

Q10: Can I withdraw from the study at any time?

Participation in the study is voluntary and you can withdraw at any time without any impact on your medical treatment or relationship with the health professionals caring for you. We ask that you notify the PreBabe Team.

Disclaimer: Thank you for considering the PreBabe Study. Due to previous research the outcome for mothers and babies has never been better. Whilst this study is aiming to improve your health, participation does not guarantee weight loss and/or a pregnancy. If you have any questions please do not hesitate to contact us cpc.prebabe.study@sydney.edu.au or your midwife or your Doctor.