Active not recruitingNAINTERVENTIONAL

Best Start - Weight Management During Pregnancy

The 'Best Start' study wants to help pregnant women who are overweight (with a BMI of 30 or more) manage their weight gain during pregnancy. We know that gaining too much or too little weight can affect both the mother and baby's health. This study will test a program called 'Foodwise in Pregnancy', which offers advice on healthy eating and lifestyle. Around 500 women will take part. Half will join the 'Foodwise' program, and the other half will receive their usual pregnancy care. We will then compare how much weight gain occurs in each group and look at health information for both mums and babies. The aim is to find effective ways to support healthy pregnancies.

At a glance

Status

Active not recruiting

Phase

Sponsor

Cwm Taf University Health Board (NHS)

Enrolment target

526

Start

01 Jul 2017

Estimated completion

01 May 2027

Obesity in Pregnancy

What is this study about?

When you're pregnant, how much weight you gain can be important for your health and your baby's health. If you are overweight before pregnancy, it can sometimes lead to extra challenges for both mum and baby. Doctors and scientists are always looking for the best ways to support women during this time.

This study, called 'Best Start', is testing a new program named 'Foodwise in Pregnancy'. This program is designed to give pregnant women who are overweight helpful advice on eating well and staying active. The main goal is to see if this support can help women gain a healthy amount of weight during their pregnancy, which is usually between 5kg and 9.1kg for those who are overweight.

To find out if 'Foodwise in Pregnancy' works, we need to compare it with the usual care women receive. So, about 500 women will join this study. Half of them will take part in the 'Foodwise' program, and the other half will continue with their standard antenatal care without the program. By comparing these two groups, we can see if the special program makes a difference to how much weight women gain and what effects it has on their and their baby's health. We will look at information like antenatal and postnatal check-ups for both mum and baby, including things like whether the baby was born early or any complications occurred.

Key takeaways

The study aims to help pregnant women with a BMI of 30 or more manage weight gain.
It tests a program called 'Foodwise in Pregnancy' with healthy eating and lifestyle advice.
Around 500 women will take part, with half getting the program and half getting usual care.
Researchers will look at health data for mums and babies to see the program's effects.
Participation includes weekly group sessions for one group, or continuing with standard care for the other.
Your health information from routine visits will be used, with your permission.

Who may be eligible?

You might be able to join the 'Best Start' study if you are pregnant and are 16 years old or older. At your first scan (usually around 12 weeks, but up to 16 weeks), if your Body Mass Index (BMI) is 30 or more, and you live in the Cwm Taf University Health Board area, you could be eligible.

However, you wouldn't be able to join if your BMI is less than 30, or if you are under 16 years old. Also, if you have diabetes (either before pregnancy or developing it during pregnancy), or if your doctor or midwife thinks it wouldn't be safe for you to take part due to another health condition, then this study might not be right for you.

This study is open to women carrying one baby or more.

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 pregnant?
Are you 16 years old or older?
Is your BMI 30 or more at your early pregnancy scan?
Do you live in the Cwm Taf University Health Board area?
Do you *not* have diabetes or another condition that would prevent participation?
Can you provide informed consent to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the 'Best Start' study, your involvement will last throughout your pregnancy and after your baby is born. You'll be randomly placed into one of two groups. Half the participants will be in the 'Foodwise in Pregnancy' group. This means you would attend seven weekly group sessions, each lasting two hours. These sessions, held in community locations, cover healthy eating, practical cooking, and easy exercise like walking. You'll also receive a pedometer to help track your steps and encourage activity. The other half of participants will continue to receive their usual pregnancy care from their midwife.

Regardless of which group you are in, we will ask for your permission to look at information already collected during your routine prenatal and postnatal appointments. This includes details about your weight gain, how your baby was born, and any health information for you or your baby. There are no additional medications or extra medical procedures involved in this study.

Potential risks and benefits

Taking part in the 'Best Start' study might offer you the benefit of receiving structured advice on healthy eating and lifestyle during pregnancy, which could help you manage your weight and potentially improve outcomes for you and your baby. However, there's no guarantee of specific benefits, as we are still learning if this program is more effective than standard care. Being in a study involves attending sessions or allowing access to your medical records, which means giving some of your time. There are no known physical risks associated with the healthy eating and lifestyle advice given. Remember, you have the right to withdraw from the study at any time without it affecting the care you receive.

Locations (4)

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

Royal Glamorgan Hospital
Verified postcode
Llantrisant, United Kingdom
Prince Charles Hospital
Verified postcode
Merthyr Tydfil, United Kingdom
Ysbyty Cwm Cynon Hospital
Verified postcode
Mountain Ash, United Kingdom
Ysbyty Cwm Rhondda Hospital
Verified postcode
Tonypandy, United Kingdom

Common questions

What is a 'BMI'?

BMI stands for Body Mass Index. It's a way health professionals estimate if your weight is healthy for your height.

Will I have to pay to join this program?

No, if you are selected for the 'Foodwise in Pregnancy' group, all sessions and materials are provided free of charge.

What if I get into the group that doesn't do the special program?

If you're in the control group, you'll still receive all your usual excellent antenatal care from your healthcare team, just as you would normally.

How will my personal information be kept safe?

All information collected will be kept private and all details that could identify you will be removed before any results are shared.

Can my partner come to the sessions with me?

The information provided suggests the sessions are for participants, but you could ask the study team if it's possible for a partner to attend.