Healthy Eating and Lifestyle in Pregnancy

Lead Research Organisation: Cardiff University
Department Name: School of Medicine

Abstract

Obesity in pregnancy is linked to poorer outcomes for both mother and child. It is also linked to complications during the pregnancy and at birth such as increased risk of caesarean section or diabetes that develops during the pregnancy. Retaining weight gain following pregnancy can lead to longer term obesity. We have developed an intervention for obese pregnant women based around the Slimming World approach combined with input from midwives which targets diet and physical activity. A scientific evaluation is now needed to determine whether or not this is effective. We plan to do this by recruiting 20 antenatal units across the UK. We will train midwives from half the units in how to deliver the intervention. Women attending intervention units will attend groups run by ?Slimming World? and a midwife. These women will be encouraged to eat more healthily and increase their levels of exercise using a walking programme. Women attending control units will receive usual care and a leaflet giving advice on diet and exercise. The main outcome we will look at is the difference in Body Mass Index (BMI), 12 months from giving birth, between the women in intervention and control groups. We will also measure changes in diet and exercise levels, mental health, quality of life, child?s weight, self confidence, social support and self regulation. Pregnancy and birth outcomes will be assessed as well as the cost effectiveness of the intervention. Women will be followed up at the 36th week of pregnancy, then at 6 weeks, 6 months and one year after giving birth. Some of these women will be invited to take part in an interview which will ask them about their experiences of the intervention. This intervention could reduce complications during pregnancy and childbirth as well as influence women?s health behaviours in the longer term which could impact not only on the woman?s health but that of her family as well. If the study is successful we will develop a training package for midwives which could be rolled out across the UK. We will develop a study website which is accessible to everyone which will describe the study results. We will also offer to send all participants a summary of the results and we will look for creative ways to publicise the results via the media. We will use our links with Slimming World to publicise the results, including on their website.

Technical Summary

Around 1 in 5 pregnant women in the UK are obese. Obesity is linked generally to poor health and also pregnancy complications. Retaining weight gain following pregnancy can lead to long-term obesity. There is evidence that excess maternal weight gain during pregnancy is associated with obesity in the child at 3 years and in adolescence, which suggests there is potential for influencing not only the mother?s lifestyle but the new child?s weight and the family?s health behaviour. Intervening with pregnant obese women and equipping them with the skills, knowledge and support necessary to manage their weight effectively during pregnancy and after childbirth is an important step in tackling overweight and obesity among women of child bearing age. This study is a cluster randomised controlled trial which will examine whether a weight management intervention for obese pregnant women, which targets physical activity and healthy eating, is effective in reducing women?s BMI at 12 months from giving birth and at what cost. Secondary outcomes include; pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity, pregnancy and birth complications, social support, self regulation and self efficacy. Twenty maternity units will be recruited and midwives will be trained in recruitment and the intervention. These units will be randomised, ten to the intervention group and ten to the control group. We will recruit women over 18 with a BMI of =30 between 12 and 20 weeks gestation, 570 women will be recruited allowing for a drop out of 30%. Those women attending the maternity units randomised to the intervention group will attend a weekly, 1.5 hour specialist weight management and physical activity support group run jointly by ?Slimming World? and midwives. At each session weight will be monitored and advice given regarding diet, lifestyle and pregnancy. Slimming World advice is similar to that advised for pregnancy and for breastfeeding mothers and offers a balanced unrestricted diet. Additional exercise recommendations will encourage graded, supervised increases in daily physical activity through a walking programme. Women attending control units will receive usual care and a leaflet giving advice on diet and physical activity. Women will be followed up at 36 weeks gestation, 6 weeks post birth, six months and one year after birth. Positive results are likely to lead to refinement and roll-out of the intervention.
 
Description Member of the Cross Party Group on Improving Scotlands Health (Sharon Simpson)
Geographic Reach National 
Policy Influence Type Participation in a advisory committee
 
Description A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC
Amount £197,000 (GBP)
Funding ID NIHR127551 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2019 
End 06/2022
 
Description Arthritis Research UK Clinical Studies
Amount £202,752 (GBP)
Funding ID 21395 
Organisation Versus Arthritis 
Sector Charity/Non Profit
Country United Kingdom
Start 04/2017 
End 03/2019
 
Description Chief Scientist Office (Sharon Simpson)
Amount £34,091 (GBP)
Organisation Chief Scientist Office 
Sector Public
Country United Kingdom
Start 09/2017 
End 08/2018
 
Description GW4 Initiator Fund
Amount £2,815 (GBP)
Organisation GW4 
Sector Academic/University
Country United Kingdom
Start 05/2014 
End 07/2014
 
Description Physical Activity Monitors in an Exercise Referral Setting
Amount £245,994 (GBP)
Organisation Health and Care Research Wales 
Sector Public
Country United Kingdom
Start 10/2015 
End 09/2017
 
Description Slimming World Research Funding
Amount £72,000 (GBP)
Organisation Slimming World 
Sector Private
Country United Kingdom
Start 07/2013 
End 06/2016
 
Title HELP trial dataset 
Description This dataset includes data from pregnant women and women in the postpartum period. Data were collected at baseline and at 36 weeks gestation and at 6 weeks, 6 months and 12 months postpartum. Body Mass Index at 12 months postpartum was the primary outcome. Secondary outcomes include pregnancy weight gain, quality of life, mental health, waist-hip ratio, child weight centile, admission to neonatal unit, diet, physical activity levels, pregnancy and birth complications, social support, self-regulation and self-efficacy. Data on cost effectiveness and process evaluation data were also collected. 
Type Of Material Database/Collection of data 
Year Produced 2014 
Provided To Others? No  
Impact None as yet 
 
Description Behavioural weight management: components of effectiveness 
Organisation Imperial College Healthcare NHS Trust
Country United Kingdom 
Sector Hospitals 
PI Contribution We have been working with lead site to put together a funding application to NIHR HTA.
Collaborator Contribution They have led the submission of the appliication.
Impact None as yet.
Start Year 2019
 
Description Behavioural weight management: components of effectiveness 
Organisation Teesside University
Country United Kingdom 
Sector Academic/University 
PI Contribution We have been working with lead site to put together a funding application to NIHR HTA.
Collaborator Contribution They have led the submission of the appliication.
Impact None as yet.
Start Year 2019
 
Description Behavioural weight management: components of effectiveness 
Organisation University of Aberdeen
Country United Kingdom 
Sector Academic/University 
PI Contribution We have been working with lead site to put together a funding application to NIHR HTA.
Collaborator Contribution They have led the submission of the appliication.
Impact None as yet.
Start Year 2019
 
Description Collaboration with Slimming World 
Organisation Slimming World
Country United Kingdom 
Sector Private 
PI Contribution We negotiated with Slimming World to pay for half the cost of delivering the intervention to study participants. We have also been awarded funding from Slimming World to for a PhD, this will allow us to complete a longer term follow-up of participants in the study, as well as complete additional qualitative work and exploration of maintenance of weight as well as issues around the impact on the other family members particularly the child.
Collaborator Contribution Slimming World have helped deliver the intervention to study participants as well as recruiting staff to deliver it. They also assisted with training intervention midwives and a member of Slimming World is a collaborator on the Trial Management Group and has had intellectual input into the study.
Impact At present we have not published anything from the study which is still ongoing. The collaboration is muti-disciplinary involving dietetics, psychology, statistics, health economics and medicine.
Start Year 2009
 
Description Physical activity of young children 
Organisation University of Strathclyde
Country United Kingdom 
Sector Academic/University 
PI Contribution We collaborated on submitting two funding applications one to Wellcoma and the other to CSO.
Collaborator Contribution They led the funding application bids.
Impact None as yet.
Start Year 2019
 
Description Process Evaluation Group 
Organisation University of Cambridge
Country United Kingdom 
Sector Academic/University 
PI Contribution In collaboration with colleagues from Exeter, Norwich and Cambridge won funding from the British Psychological Society to run a seminar series on using process evaluation to understand and improve the psychological underpinnings of health-related behaviour change interventions. Where we brought together a group of researchers with an interest in this topic. We have run three seminars on this topic and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014.
Collaborator Contribution In collaboration with colleagues from Exeter, Norwich and Cambridge won funding from the British Psychological Society to run a seminar series on using process evaluation to understand and improve the psychological underpinnings of health-related behaviour change interventions. Where we brought together a group of researchers with an interest in this topic. We have run three seminars on this topic and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014.
Impact We have produced a report as a result of the seminar series and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014. We also bid for and won some money (£2814) from the GW4 (collaboration of Bristol, Bath, Cardiff and Exeter universities) to carry on this work.
Start Year 2012
 
Description Process Evaluation Group 
Organisation University of Exeter
Department Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution In collaboration with colleagues from Exeter, Norwich and Cambridge won funding from the British Psychological Society to run a seminar series on using process evaluation to understand and improve the psychological underpinnings of health-related behaviour change interventions. Where we brought together a group of researchers with an interest in this topic. We have run three seminars on this topic and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014.
Collaborator Contribution In collaboration with colleagues from Exeter, Norwich and Cambridge won funding from the British Psychological Society to run a seminar series on using process evaluation to understand and improve the psychological underpinnings of health-related behaviour change interventions. Where we brought together a group of researchers with an interest in this topic. We have run three seminars on this topic and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014.
Impact We have produced a report as a result of the seminar series and are running a symposium at the UK Society of Behavioural Medicine Conference in December 2014. We also bid for and won some money (£2814) from the GW4 (collaboration of Bristol, Bath, Cardiff and Exeter universities) to carry on this work.
Start Year 2012
 
Description Weight loss maintenance researchers 
Organisation Newcastle University
Country United Kingdom 
Sector Academic/University 
PI Contribution We have set up a group of researchers who are interested in weight loss maintenance research. We have collaborated to write a paper and also to run a symposium at the ASO Obesity conference where we all spoke about our research on this topic.
Collaborator Contribution We have set up a group of researchers who are interested in weight loss maintenance research. We have collaborated to write a paper and also to run a symposium at the ASO Obesity conference where we all spoke about our research on this topic.
Impact A paper in the British Journal of Health Psychology. A symposium at the ASO UK Congress of Obesity.
Start Year 2012
 
Description Weight loss maintenance researchers 
Organisation University of Exeter
Department Medical School
Country United Kingdom 
Sector Academic/University 
PI Contribution We have set up a group of researchers who are interested in weight loss maintenance research. We have collaborated to write a paper and also to run a symposium at the ASO Obesity conference where we all spoke about our research on this topic.
Collaborator Contribution We have set up a group of researchers who are interested in weight loss maintenance research. We have collaborated to write a paper and also to run a symposium at the ASO Obesity conference where we all spoke about our research on this topic.
Impact A paper in the British Journal of Health Psychology. A symposium at the ASO UK Congress of Obesity.
Start Year 2012
 
Description i-WIP collaboration (Sharon Simpson) 
Organisation Queen Mary University of London
Department Queen Mary Innovation
Country United Kingdom 
Sector Private 
PI Contribution SS is currently part of a network called the International Weight Management in Pregnancy (i-WIP) collaborative group. This is an international group with colleagues from 16 countries including the USA, Brazil, Australia, Spain, Croatia and Norway. I have shared my expertise and experience on this topic and we have shared (or will share) data from trials/studies on interventions for maternal obesity to enable IPD meta analyses yet to be completed.
Collaborator Contribution The partners have shared their experience and expertise on this topic. We have also shared (or will share) data from trials/studies on interventions for maternal obesity to enable IPD meta analyses yet to be completed.
Impact We have submitted a funding application entitled - Diet and physical activity in pregnancy to prevent gestational diabetes: Individual Participant Data (IPD) meta-analysis on the differential effects of interventions. This was submitted to National Institute for Health Research Health Technology Assessment Programme for funding in 2019.
Start Year 2018
 
Title HELP Group Intervention 
Description The HELP group based intervention has been developed and refined and we have trained the individuals who are delivering the intervention. It is now being delivered to the participants in the HELP trial. The initial funding for development came from Cardiff and Vale NHS Trust and funding for this refinement came as part of the NPRI funding. 
Type Therapeutic Intervention - Psychological/Behavioural
Current Stage Of Development Late clinical evaluation
Year Development Stage Completed 2010
Development Status On hold
Clinical Trial? Yes
Impact The pilot study using the unrefined version of the intervention was delivered to 23 women and is or has been delivered to the women in the intervention arm trial. 
URL http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7742
 
Description Association for the Study of Obesity Maternal Obesity Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact This presentation led to much discussion about useing process evaluation in trials.

This work has led to developing collaborations with other researchers with an interest in this area.
Year(s) Of Engagement Activity 2014
 
Description Association for the Study of Obesity UK Congress on Obesity 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Two talks were delivered on the results of the study which sparked questions and discussion afterwards.

This work has led to developing collaborations with other researchers with an interest in this area in the UK and abroad. This year we have submitted an international symposium to next years ISBNPA conference as a result of connections made at this conference from presentation of the study results.
Year(s) Of Engagement Activity 2014
 
Description British Dietetic Association Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Health professionals
Results and Impact Author: Karen Jewell. 40 people attended the British Dietetic Association Conference in London and there was good discussion of the issues presented. The title was the HELP Study pilot results.

Participants said they would go back to their unit to link up with maternity services.
Year(s) Of Engagement Activity 2011
 
Description British Psychological Society Research Seminar 21st September Manchester 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact British Psychological Society Research Seminar 21st September Manchester. Title: Weight is the new challenge': how can health psychology help professionals who provide maternity care to support women to have a healthy weight and lifestyle in pregnancy? Author: Sharon Simpson. Sharon Simpson presented the design of the HELP study intervention and methods for the trial to a group of around 150 health professionals and researchers interested in this topic area.

There were many questions asked and in depth discussion following the presentation. An email network of interested parties was developed.
The main impact was that a network of researchers interested in obesity in pregnancy was been set up. Expressions of interest in collaborating on future funding applications is being put together.
Year(s) Of Engagement Activity 2012
 
Description Delivered a 4 day course at the University of Bergen entitled "Design, management, conduct and reporting of empirical research studies" 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact The aim was to deliver a course on the "Design, management, conduct and reporting of empirical research studies" to postgraduate students at the University of Bergen to increase their knowledge and understanding of the above and give them some useful tools relevant to their PhD as well as to prepare them for their future research careers. Seven students attended. There were a lot of discussions and questions and students have taken some of the tools and knowledge and applied this in their PhDs. The course received excellent feedback.
Year(s) Of Engagement Activity 2016
 
Description Delivered a 4 day course at the University of Bergen entitled "Interdisciplinary perspectives on modifiable social influences on behaviour" 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact The aim was to deliver a course on the "Interdisciplinary perspectives on modifiable social influences on behaviour" to postgraduate students at the University of Bergen to increase their knowledge and understanding of the above, to get them to think about the importance of social influences on behaviour and to help equip them for their future research careers. Seven students attended. There were a lot of discussions and questions and students have taken some of the tools and knowledge and applied this in their PhDs. The course received excellent feedback.
Year(s) Of Engagement Activity 2016
 
Description ECO conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Sharon Simpson presented "The Healthy Eating and Lifestyle in Pregnancy (HELP) Study: Design and Baseline Data" at the European Congress of Obesity conference to attended by over 3000 researchers. The conference was held in Liverpool in May 2013. Other authors were Elinor John, Dunla Cassidy and the HELP team.This presentation sparked questions and discussion with others interested in this topic

This presentation sparked questions and discussion with others interested in this topic
Year(s) Of Engagement Activity 2013
 
Description HELP study dissemination day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact We presented the results of the HELP study to practitioners. This stimulated much discussion and questions.

Health practitioners asked for a copy of the slides so they could share with their colleagues.
Year(s) Of Engagement Activity 2014
 
Description NISCHR CRC symposium 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Rebecca Holland presented the HELP study at the National Institute for Social Care and Health Research symposium in November 2012 to policy makers and staff of NISCHR.

This presentation sparked questions and discussion.
Year(s) Of Engagement Activity 2012
 
Description National Midwifery Conferences (BJM, RCM and RCOG) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Health professionals
Results and Impact National Midwifery Conferences (BJM, RCM and RCOG). Author: Karen Jewell. Midwives and obstetricians attended a talk and there was much discussion afterwards.

A number of people contacted the speaker afterwards for further information about the pilot study as well as details on how they might implement something similar locally.
Year(s) Of Engagement Activity 2009,2010,2011
 
Description Poster (Welsh Branch of the Doctoral Midwifery Research Society Conference) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact A poster presentation at the Welsh Branch of the Doctoral Midwifery Research Society Conference, Friday 23rd November 2012.

None
Year(s) Of Engagement Activity 2012
 
Description Poster at UKCRC conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Sharon Simpson presented "The Healthy Eating and Lifestyle in Pregnancy (HELP) Study: Design and Baseline Data" at the UKCRC Public Health Research Centres of Excellence annual conference to over 100 researchers. The conference was held in Cardiff in July 2013. Other authors were Elinor John, Dunla Cassidy and the HELP team.

This presentation sparked questions and discussion with others interested in this topic working across the UKCRC Centres of Excellence.
Year(s) Of Engagement Activity 2013
 
Description Presentation 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Presentation of the HELP Study design and baseline data at the Cardiff University Postgraduate Day to around 50 students. Authors Elinor John, Sharon A Simpson, Karen Jewell, Dunla Cassidy and the HELP study team.

This presentation sparked questions and discussion.
Year(s) Of Engagement Activity 2012
 
Description Presentation at UKSBM 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Sharon Simpson presented to a group of about 60 academics from mixed disciplines. This presentation sparked questions and discussion and further emails with others interested in this topic. The conference was United Kingdom Society of Behavioural Medicine and was held in Manchester December 2012. The title was "If I knew then what I know now!" Developing complex interventions for trials from idea to protocol and beyond." Authors: Sharon A Simpson


This presentation sparked questions and discussion and further emails with others interested in this topic.
Year(s) Of Engagement Activity 2012
 
Description Presentation at UKSBM 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Elinor John presented "The Healthy Eating and Lifestyle in Pregnancy (HELP) Study: Design and Baseline Data" at the United Kingdom Society of Behavioural Medicine in Manchester 2012. Authors Elinor John, Sharon A Simpson, Dunla Cassidy, Karen Jewell and the HELP study team. There were questions asked and in depth discussion following the presentation.

There were questions asked and in depth discussion following the presentation.
Year(s) Of Engagement Activity 2012
 
Description Presentation at annual meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach Regional
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact This was the DECIPHer a UKCRC Public Health Research Centre of Excellence annual meeting where around 50 researchers met to share the work they were doing. This presentation sparked questions and discussion with others interested in this topic working across DECIPHer. The conference was in Bristol 4th October and the other authors were Sharon Simpson, Dunla Cassidy, Rebecca Cannings-John and Elinor John.

Sparked questions and discussion with others interested in this topic working across DECIPHer.
Year(s) Of Engagement Activity 2013
 
Description Presentation at the MRC Public Health Sciences Research Network Symposium on Self efficacy 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact MRC Public Health Sciences Research Network Symposium on Self Efficacy, 24th October 2012 Southampton. Author: Sharon Simpson. Dr Sharon Simpson presented the intervention design and theoretical model for the HELP study intervention to a group of 25 researchers.

There were many questions asked and in depth discussion following the presentation. An email network of interested parties was developed.
The main impact was that the group will produce a report and recommendations from the day on using self efficacy in the design of behaviour change interventions
Year(s) Of Engagement Activity 2012
 
Description Public Health Agency Conference 2014 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Health professionals
Results and Impact The talk on the HELP trial qualitative results led to questions and much discussion.

This work has led to developing collaborations with other researchers with an interest in this area.
Year(s) Of Engagement Activity 2014
 
Description Westminster Policy Advisory Panel 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? Yes
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Policymakers/politicians
Results and Impact Full debate on issues of obesity on pregnancy.

Unknown.
Year(s) Of Engagement Activity 2011