Before you enrol in the study, your blood sugar level will be tested by our research midwife, using a finger-prick blood test. You do not have to go without food for this test. If your blood sugar levels are high, you cannot take part in this study but we will make sure that you are referred to receive appropriate care for your pregnancy. If your sugar levels are normal, we would like to enrol you in our study.

 

On the day you join this study

You will be asked to have the following done:

• A finger-prick blood test to measure ‘blood fat’ (such as cholesterol)
• Measure your blood pressure, weight and height, and arm circumference (using a tape measure)
• You will be allocated (by computer) to one of the following four groups:

1. Probiotic capsule plus routine dietary advice
2. Probiotic capsule plus dietary education
3. Placebo (a harmless dummy capsule) plus dietary education
4. Placebo capsule plus routine dietary advice

• Complete questionnaires/surveys about your health, lifestyle and well-being, which will take approximately 30 minutes
• Provide a blood and urine sample. These samples will be used to see if we can predict development of later pregnancy problems such as diabetes and high blood pressure and whether some women respond better to the HUMBA study interventions than others. You can still participate in this study even if you decline to provide these samples.

 

Daily (for all women)

All women who agree to participate will be asked to take one probiotic or placebo (dummy) capsule every day from study entry until the baby is born. You will not be able to know which one you are taking until the end of the study.

Dietary education (for half of the women)

Women who are allocated to the dietary education groups will:

• Receive detailed advice on healthy diet and physical activity in pregnancy. This will consist of 4 one-to-one sessions with a community health worker in a location that best suits the woman. The sessions will begin soon after joining the study and end by 26-28 weeks of pregnancy. Each education session will last about 30 minutes to 1 hour.
• Receive text messages 3 times per week about healthy diet and physical activity in pregnancy (if you have a mobile phone)

Routine dietary advice (for half of the women)

Women who are allocated to routine dietary advice will:

Receive best practice information in a pamphlet produced by the NZ Ministry of Health (Eating for Healthy Pregnant Women). This contains dietary advice that follows current New Zealand guidelines. These women will also receive a pamphlet with information from the NZ Ministry of Health about healthy physical activity and weight gain in pregnancy.

Note- the HUMBA study team does not provide any routine pregnancy care- this is provided by your lead maternity caregiver as usual.

 

Around 26-28 weeks of pregnancy (for all women)

• You will have an oral glucose tolerance test, at the laboratory. This is a standard test to check for diabetes in pregnancy.

 

Around 28-30 weeks of pregnancy (for all women)

You will be asked to have the following done at a meeting with our research midwife:

• A finger-prick blood test to check your average blood sugar level and to measure ‘blood fat’ (such as cholesterol)
• Measure your blood pressure and weight
• Complete questionnaires about your health, lifestyle and well-being, which will take about 20 minutes

 

At 30–38 weeks of pregnancy (for all women)

It is common for overweight women to have ultrasound scans during pregnancy to check the baby’s growth. Your LMCs will arrange scans to check the growth of your baby at late pregnancy as per usual practice. HUMBA study will provide a petrol voucher to assist one late pregnancy scan. 

 

Around 36 weeks of pregnancy (for all women)

You will be asked to have the following done at a meeting with our research midwife:

• A finger-prick blood test to check your average blood sugar level and to measure blood fats
• Measurements of your blood pressure, weight and arm circumference
• Complete questionnaires about your health, lifestyle and well-being, which will take about 20 minutes
• Provide a sample of your blood, urine, stool (poo) and hair (a few strands). These samples will be used to work out how the different HUMBA interventions work in different women. You can still participate in this study if you decline to provide these samples.

 

Around 1-2 days after your baby is born (for all women and babies)

You will be asked if the researchers can visit you to:

• Collect information about the birth
• Measure your baby’s weight and length
• Measure your baby’s body fat (by measuring how thick the fat is under the baby’s skin – this is a test that involves pinching the skin gently)
• Perform a simple scan for your baby called a Pea Pod test at Middlemore Hospital. You can still participate in this study if you decline to have the Pea Pod test. The Pea Pod test measures your baby’s fat and muscle tissue, is safe and painless and takes less than 10 minutes.
  

 

Around 6 weeks after having your baby (for all women)

A researcher will contact you by phone to see how you and your baby are doing.

 

Around 4-6 months after having your baby (for all women and babies)

An appointment will be made with one of the researchers and you will be asked to do the following:

• A finger-prick blood test to check your average blood sugar level and measure your ‘blood fat’ (such as cholesterol)
• Measurements of your blood pressure, weight, arm circumference and body composition
• Complete questionnaires about your health, lifestyle and well-being, which will take approximately 20 minutes

For your baby, a paediatrician will:

• Measure your baby’s weight and length
• Estimate your baby’s body fat by measuring how thick the fat is under the baby’s skin (this is a test that involves pinching the skin gently) and also in the Pea Pod
• Ask you to complete questionnaires about your baby’s feeding, health and well-being, which will take approximately 20 minutes.