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The IIH Weight trial

Invitation to join a research study
What is this trial for?

Most people with IIH are overweight. We think losing weight is the best treatment. The IIH Weight trial is trying to find out if weight loss surgery and diet can help treat IIH.

Why am I being asked to take part?

You are being asked to take part because your doctor has diagnosed you with IIH and you are fit enough to be able to have surgery.

Do I have to take part?

No. Taking part is your choice. No one will think badly of you if you don’t take part. You can withdraw at any time if you choose to take part.

What are the possible risks?

If you join the trial you will have a lumbar puncture at 4 or 5 of the visits. There is a risk of headache after a lumbar puncture.

You have a 50:50 chance of being referred for weight loss surgery. This involves general anaesthetic (being put to sleep). All surgery involves some risk, and complications can be serious. However, weight loss surgery is generally very safe and you can discuss the safety of different operations with your surgeon.
Will I be paid for taking part?

We will help with travel and parking costs, and we will offer compensation for your time at the repeat visits.

What will happen to me if I take part?

First visit

First you will have an assessment day. This will involve eye tests, a lumbar puncture, and some blood tests.
If these tests show you are suitable, you can enter the trial. You will be put in a treatment group.

Treatment groups

In this trial there are two groups of patients. One group is referred to a year of free Weight Watchers. The other is referred to weight loss surgery.
People are put in one these groups at random – like tossing a coin.

Follow up visits

After, you will have further clinic visits. There are quick check-ups after 3 and 6 months. Then there are assessment days after 1, 2 and 5 years, just like at your first visit.

Final visit

Your final visit will be in 5 years. It will be the same as the first visit. We want to follow you up for a long time to see if your method of weight loss is a long term treatment for IIH.

Where can I get more information?

The rest of this leaflet has the full details. Please read on if you are interested!

For questions about the study please contact:

A randomised controlled trial of bariatric surgery versus a community weight loss programme for the sustained treatment of Idiopathic Intracranial Hypertension: the IIH:WT Trial

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