UK Pregnancies Better Eating and Activity Trial
| ISRCTN | ISRCTN89971375 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89971375 |
| Secondary identifying numbers | 1 |
- Submission date
- 23/07/2008
- Registration date
- 28/11/2008
- Last edited
- 29/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
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 and high blood pressure in pregnancy for the mother. At the same time the baby can grow excessively and be larger than expected, sometimes the baby can grow more slowly and therefore be smaller than expected, and both can cause problems during delivery for the mother and 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. In order to work out what works best, in terms of what pregnant women should eat and how much and what type of activity works for them, we have talked to women but now need to ask a group of women to try this out for us. This will involve talking to the study midwife or health trainer every week, and putting the dietary and activity advice we think will work into practice. We want to know if our ideas work for real women with busy lives. You will be asked how following the plan fits in with your life, so we will therefore be very interested in how it works for you. You will therefore be asked to complete questionnaires about this. Once we have worked out what works best for women and could become part of routine antenatal care we will test this in a large clinical trial. What we want you to think about is whether you would be prepared to help us in this first testing of the advice.
Who can participate?
You have been asked to take part because you are pregnant and had a body mass index (BMI) of 30 or more when you first saw your midwife or doctor.
What does the study involve?
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 and be given a copy of this to keep. The midwife will ask you about your past medical and obstetric history. You will also be asked about your current eating and physical activity. You will be asked to wear a monitor that measures your activity for 7 days. This will be repeated on two more occasions during your pregnancy. You will be asked to take part in the study and will be asked what you think about it. The midwife will also take a blood sample from you when you first take part, at 28 weeks (6 months) and again at around 34 weeks (about 6 weeks before your baby is due). You will also have a glucose tolerance test at 28 weeks. This is often done on pregnant women to see how their bodies are handling the blood sugar levels. When you return the monitor, about a week after the first appointment, you will be put into one of two groups. Group 1 will have routine antenatal care and see the midwife two more times, and group 2 will see a health trainer and meet other women in the study weekly for 8 weeks. At these sessions advice and information about healthy lifestyle choices will be discussed. At all of these appointments information will be collected about what you are eating and the activities you are doing. You may be asked to wear a monitor for some of the time to measure your activity level. All of this will be in addition to your normal antenatal care, although wherever possible we will arrange visits to suit you, and they may take place in the hospital, at your GP surgery, in another venue close to your home or may even be in your home. We would also like to speak to your partner and take a blood sample from him, although you can still take part even if he does not want to. When you have had your baby we would like to record details about your pregnancy and delivery, including measurements from your baby and a blood sample from the umbilical cord, or the baby's saliva sample. We will also ask you if you agree to your baby having a special scan to help us work out how new babies store their body fat. This scan is called a PeaPod. We would also like to see you and your baby when he/she is 6 months old. At this appointment we will measure and weigh your baby and ask about feeding since birth. At this time we would also like to weigh and measure you and ask you questions about food and activity.
What are the possible benefits and risks of participating?
You may not benefit personally from taking part, but your participation may help with the planning of an effective antenatal programme that improves the outcome of pregnancy for many women in the future, and influence the health of their children for the whole of their life. The main side-effect is that we will need your time. We will want to stay in touch with you throughout your pregnancy and we appreciate how busy pregnant women are.
Where is the study run from?
St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
November 2008 to March 2017
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Claire Singh
Research Midwife
Tel: 020 7188 3641 (answerphone)
Annette Briley
Clinical Trials Manager
Tel: 020 7188 3643
Contact information
Scientific
Maternal and Foetal Research Unit
10th Floor North Wing
St Thomas' Hospital
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 3639 |
|---|---|
| lucilla.poston@kcl.ac.uk |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Improving pregnancy outcome in obese women; a multicentre randomised controlled trial |
| Study acronym | UPBEAT |
| Study objectives | Current study hypothesis as of 06/06/2012: This study hypothesises that a complex intervention focussing on dietary glycemic load and physical activity delivered over a period of 8 weeks during pregnancy in obese women will lead to a reduction in Gestational Diabetes Mellitus, (GDM) and a lower incidence of macrosomia. Previous study hypothesis: This study will aim to develop a complex intervention that will lead to the improvement of pregnancy outcome in obese pregnant women. Through individualised dietary and physical activity regimes we aim to improve maternal glucose sensitivity in obese pregnant women and thereby reduce the incidence of maternal, foetal and neonatal complications. |
| Ethics approval(s) | NRES Committee London - Westminster, 03/02/2009, ref: 09/HO802/5 |
| Health condition(s) or problem(s) studied | Obesity during pregnancy |
| Intervention | Current interventions as of 0/06/2012: The intervention is delivered by a health trainer in weekly sessions between 20 and 28 weeks' gestation and focusses on changing the diet (lowering the glycemic load, free sugars and saturated fat intake) with advice on increasing mild to moderate physical activity. Each session comprises a targetted dietary and physical activity change with individualised SMART goals. Women in the control arm will receive standard antenatal care. All women have an OGTT at 28 weeks. Previous interventions: The intervention consists of an individualised activity and diet plan. Women will be recruited between 10 - 16 weeks gestation and the interventions will continue until delivery. Therefore maximum duration for any one woman would be 32 weeks (allowing for her to deliver at 2 weeks post-estimated date of delivery). Women in the control arm will have blood taken at recruitment and again in late pregnancy. Other than this they will receive usual pregnancy care and advice in accordance with local and national antenatal care guidelines. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure(s): 1. Maternal: GDM by HAPO criteria. 2. Infant: macrosomia (>90th customised birthweight centile). Previous primary outcome measure(s): Improved maternal glucose sensitivity, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks). |
| Secondary outcome measures | Current secondary outcome measure(s): 1. Maternal: complications in pregnancy (inc GDM, pre-eclampsia, depression, quality of life), physical activity, diet, gestational weight gain, maternal body composition (skin folds), mode of delivery, hospital admissions. Health economic assessment. 2. Infant: adverse outcomes, neonatal unit admissions, SGA, LGA, body composition (skin folds). 3. At 6 months post partum: maternal and child diet and physical activity. Maternal general health (inc depression, quality of life). Maternal and child body composition. Childhood modifiers/modulators of obesity. 4. 3 years: To be confirmed; measures of maternal and child body composition, diet, physical activity. Childhood mental health, cardiovascular function. Previous secondary outcome measure(s): Reduction in foetal, maternal and pregnancy complications, assessed at recruitment (10 - 16 weeks), and again in the third trimester (32 - 36 weeks). |
| Overall study start date | 01/11/2008 |
| Completion date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 1546 patients |
| Total final enrolment | 1158 |
| Key inclusion criteria | 1. Willing and able to give informed consent 2. Pregnant women with booking body mass index (BMI) greater than or equal to 30 kg/m^2 3. Singleton pregnancy |
| Key exclusion criteria | Current exclusion criteria as of 06/06/2012: 1. Unwilling or unable to give informed consent 2. Pregnant women with booking BMI less than 30 kg/m^2 3. Multiple pregnancy 4. Pre-existing diabetes mellitus 5. Pre-existing hypertension requiring treatment, pre-existing thyroid and renal disease, current psychosis, sickle cell disease, thalassemia, coeliac disease Previous exclusion criteria: 1. Unwilling or unable to give informed consent 2. Pregnant women with booking BMI less than 30 kg/m^2 3. Multiple pregnancy 4. Pre-existing diabetes mellitus |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
University/education
Capital House
Guys Campus
St Thomas' Street
London
SE1
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Programme Grants for Applied Research, PGfAR
- Location
- United Kingdom
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
- Location
- United Kingdom
Government organisation / Local government
- Alternative name(s)
- CSO
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programm, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, EU 7th Framework Programme, European Union 7th Framework Programme, Siebten Rahmenprogramm, Séptimo Programa Marco, Septième programme-cadre, Settimo programma quadro, 7th Framework Programme, Seventh EU Framework Programme, FP7
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/07/2013 | Yes | No | ||
| Results article | pilot study results | 01/02/2014 | Yes | No | |
| Protocol article | 18/02/2014 | Yes | No | ||
| Results article | 01/08/2014 | Yes | No | ||
| Results article | 01/10/2015 | Yes | No | ||
| Results article | 29/11/2016 | Yes | No | ||
| Results article | 01/01/2018 | Yes | No | ||
| Results article | 21/01/2019 | Yes | No | ||
| Results article | maternal altered lipid metabolism and associations with offspring adiposity | 31/03/2022 | 01/04/2022 | Yes | No |
| Results article | 12/10/2022 | 13/10/2022 | Yes | No | |
| Results article | Secondary analysis of clinical history and clinical/anthropometric measures | 30/12/2022 | 03/01/2023 | Yes | No |
| Results article | subgroup assessment | 23/03/2023 | 24/03/2023 | Yes | No |
| Other publications | Secondary analysis | 24/07/2024 | 29/07/2024 | Yes | No |
Editorial Notes
29/07/2024: Publication reference added.
24/03/2023: Publication reference added.
03/01/2023: Publication reference added.
13/10/2022: Publication reference added.
01/04/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the 2019 reference.
23/01/2019: Publication reference added.
27/06/2018: Publication reference added.
01/12/2016: Publication reference added.
13/05/2014: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/10/2013 to 01/03/2017.
2. The target number of participants was changed from 1564 to 1546.
06/06/2012: The following changes were made to the trial record:
1. Previous scientific title: Improving pregnancy outcome in obese women: a feasibility study.
2. Previous study design: Feasibility trial.
3. Previous target number of participants: 100 patients.
