Establishing a healthy growth trajectory from birth: The Baby Milk Trial

Lead Research Organisation: MRC Epidemiology Unit

Abstract

The prevalence of childhood obesity has increased rapidly over the past two decades. Excess weight in childhood tracks into adult life and causes problems both in the short term and in the long term. National surveys show that more than one in five children are already overweight (13%) or obese (10%) when they start school. Hence any efforts to prevent obesity must start early. The Foresight Report and the Healthy Weight Healthy Lives strategy have highlighted the importance of preventing childhood obesity by focussing on the early years. However, to date there is little evidence on which to develop effective preventive strategies. Infancy is a period of rapid growth and weight gain and obesity prevention during this period may be effective. Nutrition and growth during infancy may also have long term effects by altering eating behaviours and risks of obesity and obesity-related disorders in later life.

UK Infant Feeding Surveys show that at birth one in three (35%) of babies receive formula-milk and this number increases to almost all babies (92%) at 6 months of age. Hence, in addition to promoting breastfeeding, it important to optimise the growth of formula-milk fed babies. Our previous research shows that parents who give their babies formula-milk as part of their everyday diet need more information and support. Researchers at the Centre for Diet and Activity Research (CEDAR) and MRC Epidemiology Unit in Cambridge have been working with mothers and healthcare professionals to develop a feeding programme which aims to avoid excess weight gain in formula-milk fed babies. The programme we have developed aims to support parents who feed their babies formula-milk to achieve a healthy pattern of growth and weight gain.

The infant feeding programme will be tested in a randomised controlled trial involving 700 mothers and their babies. Half the mothers will be given advice and support to follow the new feeding programme. The other half will be given routine advice about formula-milk feeding and weaning. The growth of babies in the two groups will be compared. This comparison is important to test whether our new feeding programme is effective in preventing excess weight gain and subsequent obesity.

The results of the study will help to inform infant feeding guidelines and will also help us understand the links between infant feeding, behaviour, appetite and growth.

Technical Summary

Data from the National Child Measurement Programme show that in England, by the time children start school, 13% are overweight and a further 10% are obese. Infancy is a period of rapid growth, developmental plasticity and habit formation; hence could be a critical period when obesity prevention may be most effective.

Current UK formula-milk feeding instructions are based on 1985 World Health Organisation (WHO) recommendations. In 2004, based on new data on energy expenditure in infants, the WHO suggested that 1985 recommendations overestimated infant energy requirements. The WHO 2004 recommendations have been endorsed by the UK Scientific Committee for Nutrition in their Draft Energy Report. Since the instructions on the formula-milk tins are based on the old 1985 recommendations for energy requirements, this may contribute to excess weight gain in formula-milk fed infants.

We aim to evaluate the cost-effectiveness and acceptability of a theory-based behavioural intervention to avoid excess formula-milk intake and to prevent rapid weight gain during infancy. Guided by the MRC framework for complex interventions, our multi-disciplinary group have used an iterative process to optimise the proposed intervention and its evaluation.

We will recruit 700 mothers who introduce formula-milk feeds within six weeks of their baby's birth into a randomised controlled trial. The intervention group will receive the behavioural intervention delivered by trained and quality-assured facilitators over six months through 3 face-to-face contacts, 2 telephone contacts and written materials. The control group will have the same number of contacts with facilitators and general issues about feeding will be discussed. The primary outcome is change in weight standard deviation score from birth to 1 year. Secondary objectives are to quantify the effects of the intervention on infant energy intake and diet at age 8 months and changes in infant adiposity during the first year of life.

Planned Impact

The rising prevalence of childhood obesity is a major public health challenge for the 21st century. Being obese increases the risk of diabetes, hypertension, cardiovascular disease and cancer. It can also impair a person's well-being, quality of life and ability to earn. The Foresight Report predicted that if previous trends continued, nearly 60% of the UK population could be obese by 2050. The economic implications would be substantial. By 2050 there would be a seven fold increase in direct healthcare costs of overweight and obesity, with wider costs to society and business reaching £45.5 billion per year (at 2004 prices). If the Baby Milk trial shows that targeting infancy weight gain is effective in reducing the burden of obesity, it has the potential to benefit the whole of society. Changing the recommendations on formula-milk tins has the potential to be a low-cost universal intervention leading to population level changes in dietary behaviour and subsequent obesity risk.

Policy makers will benefit in setting future recommendations for infant feeding guidelines. For example the current recommendation is to feed a baby on demand and many parents take this to mean that the baby should be fed every time she/he cries. This could result in overfeeding. Printed instructions on formula-milk packaging recommend 6 feeds per day of 90mls per feed from birth, while breastfed babies get only 8mls per feed in the first few days of life and more frequent feeds. These differences could potentially programme formula-milk fed babies to expect larger portion sizes and calorie loads.
Future parents will benefit as the study could inform consistent, practical and acceptable infant feeding guidelines. The information generated could inform health visitor training and information booklets on infant feeding.

The trial will address the key question of ability to promote healthy growth in infancy and the cohort is also highly suitable for follow up, to improve understanding of the causal mechanisms of childhood obesity. The detailed diet and phenotypic data available in this cohort will be complementary to the UK 2012 Birth Cohort. There are very few research teams working on this important area. This will give the UK a lead in research into childhood obesity by focussing on formula-milk intake. We are not aware of any other studies with such detailed measures of infant diet, maternal correlates of infant feeding and infant growth throughout the first year of life.

The immediate beneficiaries will be the 700 parent-infant dyads recruited to the study. In our questionnaire validation study, 44% of the mothers tightly packed the formula-milk scoops which could lead to over concentrated feeds and excess weight gain. Parents will be given support and advice regarding formula-milk feeding, weaning and growth monitoring so that the babies do not become overweight or obese. This could have long term consequences for better health.

The trial will also promote a greater awareness of the importance and conduct of community-based child health research in primary care. We have presented and discussed the trial to local health visitors, midwives and the primary care research network team who will actively promote the study to eligible participants. This has improved their knowledge and understanding of good clinical practice with regard to clinical research. As the study progresses we will keep them informed of the emerging findings through regular contacts at their team meetings and through updates in their newsletters.

Staff employed on the study will benefit from the training they will receive. All investigators will benefit due to the novel nature of the intervention and its evaluation.

Publications

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Lakshman R (2012) Childhood obesity. in Circulation

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Mazarello Paes V (2015) Determinants of sugar-sweetened beverage consumption in young children: a systematic review. in Obesity reviews : an official journal of the International Association for the Study of Obesity

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Pennant ME (2017) Premenopausal abnormal uterine bleeding and risk of endometrial cancer. in BJOG : an international journal of obstetrics and gynaecology

 
Description Caroline Walker Trust Publication on Infant Milks in the UK
Geographic Reach National 
Policy Influence Type Citation in other policy documents
URL http://www.cwt.org.uk/publications.html#milk2
 
Description Nutrition for Healthy Term Infants: Recommendations from Birth to Six Months A joint statement of Health Canada, Canadian Paediatric Society, Dietitians of Canada, and Breastfeeding Committee for Canada
Geographic Reach National 
Policy Influence Type Citation in other policy documents
URL http://www.hc-sc.gc.ca/fn-an/nutrition/infant-nourisson/recom/index-eng.php
 
Description Scientific Recommendations for a National Infant Feeding Policy, 2nd Edition (2011). Food Safety Authority of Ireland, Dublin. ISBN 1-904465-78-1
Geographic Reach National 
Policy Influence Type Citation in other policy documents
 
Description The evidence and rationale for the UNICEF UK Baby Friendly Initiative standards
Geographic Reach National 
Policy Influence Type Citation in other policy documents
 
Description NIHR School for Public Health Research
Amount £165,250 (GBP)
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 04/2012 
End 03/2014
 
Title Intervention leaflets, protocols, training manual, presentation 
Description We have developed two leaflets as part of the intervention and refined them after discussions with psychologists, nutritionists, mothers, health visitors and midwives. We have also produced a training manual and presentations for health visitors. 
Type Of Material Biological samples 
Year Produced 2012 
Provided To Others? Yes  
Impact The materials have been made available collaborators in Australia where we plan to set up a similar trial. These materials will be made available on the trial website at the end of the study. They have been shared with a group in Australia who are applying for a grant to conduct a similar trial. 
 
Title Questionnaires to assess milk intake and maternal attitudes 
Description We have developed and validated a questionnaire to evaluate the trial. We have also developed a training manual for health visitors. 
Type Of Material Physiological assessment or outcome measure 
Provided To Others? No  
Impact Validation paper published in open access peer reviewed journal and have had requests for use of the questionnaire. Will be used in the trial and if successful will be used in the wider community. 
 
Description Anglia Ruskin University 
Organisation Anglia Ruskin University
Country United Kingdom 
Sector Academic/University 
PI Contribution Collaboration with Professor Sarah Redsell at Anglia Ruskin University. Collaboration is still under development.
Collaborator Contribution Collaboration is still under development.
Impact Collaboration is still under development.
Start Year 2017
 
Description Growing Healthy App 
Organisation Deakin University
Country Australia 
Sector Academic/University 
PI Contribution Input to content of App
Collaborator Contribution Development and Testing of app
Impact Development of app in process
Start Year 2014
 
Description Healthcare Public Health Advice Service- Lead for Prioritisation and Pathways 
Organisation Cambridgeshire and Peterborough Clinical Commissioning Group
Department Commissioning, Finance and Senior Management Team
Country United Kingdom 
Sector Public 
PI Contribution Robust evaluation of the evidence and benchmarking to develop clinical policies, pathways, surgical thresholds, assess business cases and individual and exceptional funding requests.
Collaborator Contribution GPs and Consultants- clinical input Commissioners- contractual input Lay Members- public opinion
Impact Clinical policies available on the website http://www.cambsphn.nhs.uk/CCPF.aspx
Start Year 2013
 
Description Healthy feeding, healthy growth in formula fed infants 
Organisation Queensland University of Technology (QUT)
Department Institute of Health & Biomedical Innovation
Country Australia 
Sector Academic/University 
PI Contribution Provided intervention materials from Baby Milk Trial
Collaborator Contribution Conducted a pilot in Australia using a combined 'Baby Milk and Nourish' intervention and in the process of applying for a grant to NHMRC Australia
Impact Completed pilot successfully and applying for a grant to do the definitive trial
Start Year 2012
 
Description Influence of maternal education on growth of contemporary 4-6 year old children in UK, Sweden and China 
Organisation Karolinska Institute
Department Department of Clinical Science, Intervention and Technology
Country Sweden 
Sector Academic/University 
PI Contribution Obtained UK data from the Millenium cohort study, performed all the analyses and wrote the paper submited for publication. JDZ extracted and cleaned the China data, RL and KO performed the analyses. JL is the founder and project leader of All Babies in South East Sweden Study (ABIS) and JZ of National Children's Growth Standard Survey (NCGSS). TS co-ordinated compiling the data from Sweden and China and writing the paper. All authors contributed to the critical revision of the manuscript and approved the final version.
Collaborator Contribution Obtained, cleaned and shared data from China (National Children Growth Standard Survey) and Sweden (All babies in Southeast Sweden study )
Impact Paper titled 'Higher maternal education is associated with favourable growth of young children in different countries' under review with International Journal of Epidemiology and Community Health Authors Rajalakshmi Lakshman, *Jianduan Zhang, Felix S Koch, Jing Zhang, Claude Marcus, Johnny Ludvigsson, Ken K Ong,Tanja Sobko
Start Year 2009
 
Description Influence of maternal education on growth of contemporary 4-6 year old children in UK, Sweden and China 
Organisation Linkoping University
Department Division of Paediatrics
Country Sweden 
Sector Academic/University 
PI Contribution Obtained UK data from the Millenium cohort study, performed all the analyses and wrote the paper submited for publication. JDZ extracted and cleaned the China data, RL and KO performed the analyses. JL is the founder and project leader of All Babies in South East Sweden Study (ABIS) and JZ of National Children's Growth Standard Survey (NCGSS). TS co-ordinated compiling the data from Sweden and China and writing the paper. All authors contributed to the critical revision of the manuscript and approved the final version.
Collaborator Contribution Obtained, cleaned and shared data from China (National Children Growth Standard Survey) and Sweden (All babies in Southeast Sweden study )
Impact Paper titled 'Higher maternal education is associated with favourable growth of young children in different countries' under review with International Journal of Epidemiology and Community Health Authors Rajalakshmi Lakshman, *Jianduan Zhang, Felix S Koch, Jing Zhang, Claude Marcus, Johnny Ludvigsson, Ken K Ong,Tanja Sobko
Start Year 2009
 
Description ProAsk-Development and feasibility testing of an interactive, educational programme to facilitate Proactive Assessment of Obesity Risk during Infancy 
Organisation Anglia Ruskin University
Country United Kingdom 
Sector Academic/University 
PI Contribution Provide input to protocol, grant application, ethics application, intervention development, outcome measures etc. Co-applicant on MRC PHIND grant application £150,000
Collaborator Contribution Leading this research
Impact Successful grant application to MRC PHIND scheme
Start Year 2013
 
Description Public Health England 
Organisation Public Health England
Country United Kingdom 
Sector Public 
PI Contribution Dr Rajalakshmi Lakshman has collaborated with Public Health England as part of their regional and national teams.
Collaborator Contribution To be confirmed.
Impact Still to be confirmed.
Start Year 2017
 
Description Service Public Health 
Organisation Cambridgeshire County Council
Department Public Health Service; Cambridgeshire County Council
Country United Kingdom 
Sector Public 
PI Contribution -Presented work at the Healthy Child Programme Board and Countywide Obesity Group. - Liaised with Director of Public Health and Consultant in Public Health (Health Improvement) to approve funding 'in principle' of intervention costs for Go-Active trial (PI Kirsten Corder)
Collaborator Contribution -Help with recruitment to Baby Milk trial through Children's Centres. -Agreed funding of intervention costs for the Go-Active trial (PI Kirsten Corder)
Impact Mult-disciplinary- councillors, health, social care,
Start Year 2013
 
Description Systematic Reviews of Determinants of Obesity Related Dietary & Physical Activity Behaviours 
Organisation Durham University
Department Wolfson Research Institute
Country United Kingdom 
Sector Academic/University 
PI Contribution Obtained funding from the NIHR School for Public Health Research, wrote the protocol paper
Collaborator Contribution Systematic Review and literature searching expertise
Impact Protocol published on PROSPERO, further publications in preparation.
Start Year 2012
 
Description 1st Internation Conference on Early Nutrition and Growth 
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 Oral Presentation at 1st Internation Conference on Early Nutrition and Growth. Approximately 40 researchers/policy makers/industry representatives attended. Spaked many questions about healthy growth patterns

Not noted
Year(s) Of Engagement Activity 2012
 
Description Baby Milk Cambridgeshire News 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact Submitted draft article on Baby Milk study for publication in health section of Cambridge News. Raj Lakshman, Fiona Whittle, Paul Browne
Year(s) Of Engagement Activity 2015
 
Description Baby-Milk Study press Release - Regional 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact Baby-Milk Study press Release - Regional
Year(s) Of Engagement Activity 2015
 
Description Cambridge News - Walking Routes 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact Quoted in new Cambridge News article on new map of walking routes in Cambridge
Year(s) Of Engagement Activity 2015
URL http://www.cambridge-news.co.uk/New-walking-map-set-launch-Addenbrooke-8217-s/story-26523253-detail/...
 
Description Institute of Metabolic Science Research Day 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Institute of Metabolic Science Research Day, November 2012. 50-60 postgraduate students, early career researchers and seniour scientists attended. Title of talk- Can we prgramme human infants againist obesity 1st November 2012

Many questions and discussion
Year(s) Of Engagement Activity 2012
 
Description Interviews with newspaper journalists and magazine editors 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact The journal did a press release for the paper- Systematic review of parents experiences of bottle feeding. This was picked up by 191 press articles and I did interviews for journalists.

Greater awareness among health professionals and the public about issues related to bottle feeding.
Year(s) Of Engagement Activity 2009
 
Description Leyden Academy phD students visit 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Leyden Academy phd students visited the unit and I spoke about development and evalaution of complex public health interventions

Positive feedback on evaluation forms
Year(s) Of Engagement Activity 2012
 
Description Local Baby Milk Press Release 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Media (as a channel to the public)
Results and Impact Press release for Baby Milk Study issued to 11 local newspapers in Cambridgeshire and Hertfordshire, to encourage bottle feeding mothers to join in orrder to meet recruitment target. Raj Lakshman, Fiona Whittle.
Year(s) Of Engagement Activity 2015
 
Description Medical Student teaching on Globesity a Public Health Challenge 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Undergraduate students
Results and Impact 75 medical students attended the teaching session during Phase 3 public health teaching.

Positive feedback on evaluation forms.
Year(s) Of Engagement Activity 2011,2012
 
Description NIHR School for Public Health Research 1st Annual Scientific Meeting 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact NIHR School for Public Health Research 1st Annual Scientific Meeting Sept 2012. The audience included researchers, policy makers (including Chief Executive of Public Health England) and public health professionals (including the President of the Faculty of Public Health). Date 10th October 2012

Presented a paper and poster on the protocol for Systematic Reviews of Determinants of obesity related dietary and physical activity behaviours.
Year(s) Of Engagement Activity 2012
 
Description Oral Presentation and Royal College of Paediatric and Child Health Annual Conference 
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 Royal College of Paediatrics and Child Health Annual Conference. 24/5/2012

Not noted
Year(s) Of Engagement Activity 2012
 
Description Population Health Methods Conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach National
Primary Audience Other academic audiences (collaborators, peers etc.)
Results and Impact Oral presentation at Population Health Methods Conference, Birmingham 24-26 April 2012.

Not noted.
Year(s) Of Engagement Activity 2012
 
Description Presentation at Healthy Child Programme Board Cambridgeshire County Council 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Health professionals
Results and Impact 20 people attended including Clinical Commissioning Group, Acute Trusts and County Council staff involved in delivering the Healthy Child Programme.

Chrildren's Centres agreed to display recrutiment leaflets.
Year(s) Of Engagement Activity 2013
 
Description Publication in South Cambs and Cambridgeshire City magazines 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Public/other audiences
Results and Impact Information about the study was adversited in the Local Authoritiy magazines in the Autumn 2011 editions.

Recruitment of participants into the trial. Enquiries from Mother and Baby magazine and public.
Year(s) Of Engagement Activity 2011
 
Description Service evaluation of a weight managment programme for overweight 17-13 year olds 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Wrote a report and presented the findings to the County-wide Obesity Group. This was a service evalution of a programme for overweight 7-13 year olds.

Informed future adaptation, commissiong and implementation of the programme
Year(s) Of Engagement Activity 2013
 
Description Study to discover babies 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Media (as a channel to the public)
Results and Impact "APU and University of Nottingham press release on ProAsk online resource ""Study to discover babies' risk of becoming overweight: New computer programme allows health visitors to talk to parents and intervene""
//
Reported on AM BBC Look East (19/05/15), and PM ITV Anglia News , and article on MedicalXpress http://medicalxpress.com/news/2015-05-baby-healthy.html. Also reported in Cambridge Evening News and on Heart FM, Capital Radio, Smooth Radio and on the Mark Forrest show 18 May (20.40) which goes out across 39 different local Radio Stations .
//
http://www.itv.com/news/anglia/update/2015-05-19/could-a-new-computer-programme-tell-us-if-babies-will-grow-up-obese/"
Year(s) Of Engagement Activity 2015
URL http://www.itv.com/news/anglia/update/2015-05-19/could-a-new-computer-programme-tell-us-if-babies-wi...
 
Description Talks to Regional Infant feeding coordinators, Community Midwives, Health Visitors 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Discussion of early childhood obesity prevention.

Greater awarness of issues with formula-milk feeding and childhood obesity, help with recruitment to the study
Year(s) Of Engagement Activity 2011
 
Description Visited 15 GP Practices in the area to promote the Baby Milk Study 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Health professionals
Results and Impact At each of the Practices between 4 to 15 GPs and Practices nurses attended and issues relating to early childhood obesity prevention were discussed including new growth charts, common symptoms like vomiting and constipation, mistakes in formula-milk feeds preparation.

GPs have started recruiting babies to the trial. Have greater awareness of issues relating to formula-feeding.
Year(s) Of Engagement Activity 2011,2012
 
Description Workshop on applying for Grants and Fellowships 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach National
Primary Audience Postgraduate students
Results and Impact UKCRC Centres of Excellence Conference, 5-6 July 2012, Durham, 50 Early Career Researchers attended

Many Early Career Researchers said they were inspired to apply for fellowships.
Year(s) Of Engagement Activity 2012