Author: annette-briley

What are the benefits of taking part?
You may not benefit personally from
taking part, but you may help plan an effective antenatal programme that
improves the outcome of pregnancy for many women in the future, and influence the health of their children for the whole of their life.
What are the side-effects of taking part?
The main side-effect is that we will need your time. We will want to stay in touch with you throughout your pregnancy & we appreciate how busy pregnant women are.
What happens if anything goes wrong?
In the unlikely event that you are harmed by taking part in this study no special insurance applies. However if you are harmed due to negligence normal NHS indemnity may apply, but you may have to pay for this action. Regardless of this, should you wish to complain about any aspect of the way you have been approached or treated during the course of this study the normal NHS complaints mechanism is available to you.
What drug is being tested?
There is no drug being tested.
What will happen to the results of the study?
The results will be published in medical journals. No individual information will be available. We will use the results to plan a large study where we will test

diet and activity programmes on a lot of pregnant women to make sure they work.
What if new information
becomes available?
Should new information become
available the researchers will discuss this with you and you can decide if you want to continue in the study. It may be that the doctors and midwives
decide it would be better for you to stop being part of the study. If this happens they will discuss this with you.
Who is paying for this research?
The National Institute for Health Research (NIHR) have funded this study. The
midwife and health trainer working on this project have their salaries paid by this
organisation. The hospital and other
midwives and doctors do not receive any payment if you help with this research.
Who has reviewed this study?
St Thomas’ research ethics committee reviewed and agreed this study.
What do I do if I have further questions or want to take part?
For further information please contact:
Claire Singh
Research Midwife
Tel: 020 7188 3641 (answerphone)
Or, Annette Briley,
Clinical Trials Manager
Tel: 020 7188 3643
Thank you for taking time to read this leaflet and consider taking part in this study

UK Pregnancies:
Better Eating and
Activity Trial
Phase 2
You are being invited to take part in a research study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends and relatives if you wish. Please ask if anything is not clear or if you would like more information. Take time to decide whether or not you wish to take part.

Patient Information Sheet Phase 2 Version 3 Jan 2010

Background:
You can’t open a paper or watch TV
today without hearing that people are heavier than previous generations, and that this increase in weight leads to health
problems.
Many women who are heavy when they
become pregnant have no problems in pregnancy and deliver a healthy baby. At the moment no one can predict those women at greatest risk.
But we do know that heavier women are more at risk of pregnancy complications than women who are thinner. These
complications include miscarriage,
gestational diabetes & high blood
pressure in pregnancy for the mother. At the same time the baby can grow excessively & be larger than expected, sometimes the baby can grow more slowly and therefore be smaller than expected, both can cause problems during delivery for the mother & the baby. We also know that being born too large or too small can have health consequences that last well into childhood and beyond.
We want to see if we can develop an antenatal programme that improves the outcomes for women and their babies. This will need to include advice about what you eat and the physical activities you feel able to do, and enjoy, in pregnancy. The dietary advice will be about food we believe will be better for you to eat rather than a “diet” in the usual meaning, as weight loss in pregnancy has not been linked to better outcomes. The exercise advice will be tailored to your fitness level.
There are many “experts” involved in this project, including nutritionists, psychologists, activity experts, service evaluators, midwives and health trainers.
In order to work out what works best, in terms of what pregnant women should eat and how much & what type of activity works for them, we have talked to women but now need to ask a group of women to try this out for us. This will involve talking to the study midwife or health trainer every week, and putting the dietary and activity advice we think will work

into practice. We want to know if our ideas work for real women with busy lives. You will be asked how following the plan fits in with your life, so we will therefore be very interested in how it works for you. You will therefore be asked to complete questionnaires about this. Once we have worked out what works best for women & could become part of routine antenatal care we test this in a large clinical trial.
What we want you to think about is whether you would be prepared to help us in this first testing of the advice.
Why have I been chosen?
You have been asked to take part because you are pregnant and had a body mass index (BMI) of 30 or more when you first saw your midwife or doctor.
What do I have to do if I take part?
You will be seen by a research midwife who will answer any questions you may have. Once you have agreed to take part you will be asked to sign a consent form and be given a copy of this to keep. The midwife will ask you about your past medical & obstetric history. You will also be asked about your current eating & physical activity. You will be asked to wear a monitor that measures your activity for 7 days. This will be repeated on two more occasions during your pregnancy. You will be asked to take part in the study & will be asked what you think about it.
The midwife will also take a blood sample from you when you first take part , at 28 weeks (6 months) and again at around 34 weeks (about 6 weeks before your baby is due). You will also have a glucose tolerance test at 28 weeks. This is often done on pregnant women to see how their bodies are handling the blood sugar levels
When you return the monitor, about a week after the first appointment, you will be put into one of two groups. Group 1 will have routine antenatal care and see the midwife two more times, group 2 will see a health trainer and meet other women in the study weekly for 8 weeks, at these sessions advice and information about healthy lifestyle choices will be

discussed. At all these appointments information will be collected bout what you are eating and the activities you are doing. You may be asked to wear a monitor for some of the time to measure your activity level.
All of this will be in addition to your normal antenatal care, although wherever possible we will arrange visits to suit you, and they may take place in the hospital, at your GP surgery, in another venue close to your home or may even be in your home.
We would also like to speak to your partner and take a blood sample from him, although you can still take part even if he does not want to.
When you have had your baby we would like to record details about your pregnancy and delivery, including measurements from your baby and a blood sample from the umbilical cord, or the baby’s saliva sample. We will also ask you if you agree to your baby having a special scan to help us work out how new babies store their body fat. This scan is called a PeaPod. We would also like to see you and your baby when he/she is 6 months old. At this appointment we will measure & weigh your baby & ask about feeding since birth. At this time we would also like to weigh and measure you and ask you questions about food and activity.
Will my taking part be kept confidential?
All information stored about you will have your name, address and other identifying details removed. No one will be able to identify you from anything we record. All computers used will be password protected.
Only people directly involved in the study will have access to the information.
Do I have to take part?
Whether you decide to take part or not is entirely up to you. Your decision will not affect the care you receive in any way. If you agree to take part, you are free to withdraw at a later stage, without giving a reason, although you
may be asked if you mind us collecting details about your delivery from your medical notes. Again it is entirely up to you if you agree to this.