RecruitingInterventional

Dietary optimisation as a defence against gestational diabetes

This study aims to understand if changing your diet early in pregnancy can help prevent gestational diabetes, a type of high blood sugar that starts during pregnancy. Gestational diabetes can affect both mum and baby. Researchers will invite 75 pregnant women at higher risk to take part. They will be split into three groups, each following a different eating plan provided in 'diet boxes' for several weeks. The goal is to see if these diets can improve how the body controls sugar levels. Participants will receive free food and extra health checks, hoping to find new ways to keep mothers and babies healthy during and after pregnancy.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

Start

01 May 2026

Estimated completion

30 Apr 2028

Gestational diabetes

What is this study about?

Each year, around 100,000 pregnant women in the UK develop gestational diabetes. This is when blood sugar levels become too high during pregnancy. It can pose health risks for both the mother and the baby, not just during pregnancy but also later in life. When you're pregnant, your body works hard to provide everything your baby needs. Hormones from the placenta can make it harder for your body to use insulin effectively, which is the hormone that controls blood sugar.

Most women's bodies naturally make more insulin to keep their blood sugar stable. However, some women can't produce enough extra insulin, leading to high blood sugar levels and, therefore, gestational diabetes. We don't fully understand why some bodies adapt better than others. While some reasons are genetic, meaning they're inherited, there must also be other factors at play, because not all women who have gestational diabetes in one pregnancy get it again in a future pregnancy. By understanding these non-inherited causes, we hope to find new ways to prevent or manage gestational diabetes.

This study will explore whether changing your diet and how your body stores fat early in pregnancy can improve how your body handles sugar. We plan to invite 75 pregnant women who have a higher chance of developing gestational diabetes. They will be divided into three groups: one group will follow a diet designed to reduce body fat, another will follow a diet focused on changing where the body stores fat, and the third group will stick to a standard diet. The aim is to see if any of these dietary changes can help mothers-to-be maintain healthy blood sugar levels.

Key takeaways

This study aims to prevent gestational diabetes through diet.
Food boxes with specific diets will be provided free of charge.
Participants will receive extra health checks and scans.
The study involves follow-up appointments until 2 years after birth.
The risks are considered low, with potential benefits for mum and baby.
You can withdraw from the study at any time.

Who may be eligible?

You might be able to join this study if you are at least 18 years old and are up to 16 weeks pregnant. You also need to have a body mass index (BMI) over 25, and at least one risk factor for gestational diabetes. Examples of risk factors include having a family history of diabetes, having had gestational diabetes before, or having a history of polycystic ovary syndrome.

It's important that you plan to receive all your antenatal care at the study centre and are happy to give your consent to take part. If you need support with language, an interpreter can help you understand everything.

However, you won't be able to join if you are pregnant with more than one baby (e.g., twins), or if you have certain health conditions like severe kidney, liver, or heart problems, or psychiatric conditions that need hospital care. You also can't take part if you are taking certain medications like high-dose steroids, have severe anaemia, or if you already have type 1 or type 2 diabetes. People with very specific dietary needs, such as being vegan or having severe allergies, also won't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Are you 16 weeks pregnant or less?
Do you have a BMI over 25?
Do you have at least one risk factor for gestational diabetes (e.g., family history)?
Are you planning to receive all your pregnancy care at the study hospital?
Do you not have type 1 or type 2 diabetes already?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll first have some measurements taken, including your body make-up, what you usually eat, and how active you are. Then, you'll be placed into one of three diet groups: a control group, a reduced-calorie group, or a reduced-carbohydrate group. For several weeks, starting between 12-16 weeks of pregnancy and lasting until 24-28 weeks, nutritious 'diet boxes' with your meals will be delivered to your home every week. You'll have follow-up appointments that will fit in with your usual check-ups at 20, 24-28, and 36 weeks of pregnancy. After your baby is born, you'll also have follow-up visits at 3, 12, and 24 months. While taking part in the study, you will wear a sensor to track your blood sugar levels. Overall, the study will last from when you join early in your pregnancy until 24 months after your baby is born.

Potential risks and benefits

Taking part offers several potential benefits. You'll receive free, healthy food boxes designed to give you and your baby all the nutrients needed. You'll also be checked for gestational diabetes earlier in your pregnancy, meaning if you do develop it, treatment can start sooner, which can lead to better outcomes. Additionally, you'll have extra ultrasound and MRI scans, giving you more chances to see your baby's development. Studies show that people who participate in research often benefit from the extra attention from healthcare professionals. If this study is successful, the diets tested could lead to better health for mums and babies in the long run. The risks are considered low; the small amount of extra blood needed for tests won't harm you or your baby. The diets are designed to be safe and meet health guidelines. Wearing a blood sugar sensor might be a minor inconvenience for some, but most people don't find it bothersome. You always have the right to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals of Leicester NHS Trust
City only
Leicester, England

Common questions

What is gestational diabetes?

It's a type of high blood sugar that starts during pregnancy and usually goes away after the baby is born.

Will I have to pay for the special diet food?

No, the food for your diet group will be provided free of charge and delivered to your home.

How long will I need to be in the study?

You'll be involved from early pregnancy until 24 months after your baby is born, with regular check-ups.

What if I change my mind about taking part?

You are free to leave the study at any time, for any reason, without it affecting your usual care.

Is the food safe for me and my baby?

Yes, the diets are carefully planned to be safe, healthy, and provide all the necessary nutrients for a healthy pregnancy.

How to find out more

Sylvia Brooks

uhl-tr.dodgediabetes@nhs.net +44 (0)116 258 4023 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.