Author: annette-briley

What happens if anything goes wrong? In the unlikely event that you are harmed by taking part in this study no special insurance applies. 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 pregnancy 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.
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: 07850320507
Or, Annette Briley,
Clinical Trial Manager
Tel: 020 7188 3643

UK Pregnancies:
Better Eating and
Activity Trial
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.

Partner Information Sheet : version 1 Dec 2008

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, midwives and health trainers. In order to see what works best, in terms of what pregnant women should eat and how much and what type of

activity works for them, we need to talk to women and get a group of women to try this out for us. Once we have worked out what works best for women & could become part of routine antenatal care, we will then go on to test this in a large clinical trial. What we want you to think about is whether you would be prepared to help us in the first part of this process.
Why have I been chosen? You have been asked to take part because your partner has agreed to help with this research. Your child’s health is influenced by genes from his/her mother & father and therefore it is important for us to know about your health and how that could affect your baby.
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 & given a copy of this to keep. The midwife will talk to you about your family & medical history. You will be weighed and measured and may be asked about your lifestyle. The midwife will take a blood sample from you at this stage, one of the tests we will do will be looking at your DNA. Blood is the best way for us to do this but it is possible to use a saliva test. You may also be asked to answer questions about food and exercise, this could be a questionnaire or an interview, either with the researcher or a group of other men. All interviews will be taped to make sure your views are correctly heard.

After the birth of your baby we would like to record details about the delivery, including measurements from your baby and a blood sample from the umbilical cord, or a saliva sample.
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 bale 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 your partner receives in any way. If you agree to take part, you are free to withdraw at a later stage, without giving a reason. Your partner can still take part even if you choose not too.
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 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 we need your time! Your details and sample can be taken at any time so can be when you come to the hospital with your partner or following the birth of your baby.