Development and testing of a multi-component intervention to reduce infant formula-milk intake and excess weight gain.

Lead Research Organisation: MRC Epidemiology Unit

Abstract

Excess weight in childhood causes problems both in the short term and in the long term. The number of people who are overweight or obese has been increasing and this is now even seen in preschool children. Research suggests that gaining a lot of weight in the first year of life may lead to obesity in childhood and adulthood. Research also suggests that the amount of milk currently recommended for infants is 15-20% more than what they actually need. This may be the reason why formula-fed babies are more likely to gain excess weight. We want to see if we can help parents feed their infants appropriately so that they do not consume more than they need and therefore put on excess weight. A group of doctors and psychologists will develop a programme after reviewing the literature and consulting with mothers, midwives and health visitors. Mothers on the programme will be given a new feeding schedule and educated on how to monitor the growth of their babies. Monitoring growth is an important way of picking up early if there is excessive weight gain and to prevent obesity. We will test this programme in a trial and if successful, develop this approach further for future use in the wider community.

Technical Summary

Background Recent systematic reviews describe a consistent positive association between infant weight gain and obesity risk in children and adults. Those observational studies are supported by randomised trials of early nutrition in preterm infants indicating long-term adverse consequences of rapid weight gain on adult metabolic disease risk.

In 2004, based on new scientific data the FAO/WHO/UNU reduced their recommended energy requirements for infants by 15-20%. Furthermore, by placing growth of the breast-fed infant as the norm, the 2006 WHO International Growth Standard recommends a lower plane of infant weight gain compared to current UK infants. Neither recommendation has yet been adopted in the UK.

Aim To develop and test a multi-component intervention to reduce infant formula-milk intake and weight gain between birth to age 6 months.

Design and Methods

Stage I: To understand the factors associated with variation in energy intake of bottle-fed babies, I will conduct a systematic literature review of determinants of quantity of formula milk that mothers give their infants. I will also carry out a qualitative study using focus groups and individual semi-structured interviews with mothers of formula milk fed infants to explore their attitudes, beliefs and sources of advice on this topic.

Stage II: Development of the multi-component intervention: I will develop the intervention and pilot it to test acceptability and to further refine it prior to the main trial. Parents participating in the pilot study will be contacted regularly and interviewed in order to identify factors affecting delivery of the intervention. Various aspects of the trial protocol will also be piloted.

Stage III: Within an ongoing prospective birth cohort study, I will test the efficacy of a multi-component intervention (involving parental education on optimal infancy energy intake and weight gain, lowered recommendations on quantities of formula milk at different ages and feedback on infant weight gain using the WHO 2006 growth charts) using a single blind explanatory randomised control trial [design] to reduce energy intakes and infancy weight gain between 0-6 months [outcomes].

Outcomes: The main outcome is weight gain between 0-6 months. Secondary outcomes include parental attitudes, beliefs and knowledge regarding infant weight gain and intakes.

Scientific and medical opportunities: This study will improve understanding of why some infants are fed more than others and will help in the development of a pragmatic intervention for future testing in the broader community setting with longer-term follow-up to assess its impact on childhood obesity risk.

Publications

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Lakshman R (2009) Early age at menarche associated with cardiovascular disease and mortality. in The Journal of clinical endocrinology and metabolism

 
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 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 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
 
Description National Prevention Research Initiative Phase 4
Amount £770,114 (GBP)
Funding ID MR/J000361/1 
Organisation Medical Research Council (MRC) 
Department National Prevention Research Initiative (NPRI)
Sector Charity/Non Profit
Country United Kingdom
Start 04/2012 
End 09/2015
 
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 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 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 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 Biomedical Campus Development Group 
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 This was a workshop regarding the development of the Cambridge Biomedical Campus and I was invited to deputise for the Director of Public Health- Cambridgeshire County Council. My suggestion was to create opportunities for promoting health through the campus:
· Design encouraging healthy lifestyles: exercise, smoking cessation.
· Health and wellbeing of populations: embedding research into practice.
· Developing the CBC as an exemplar worksite promoting health and wellbeing of staff.



Recommendation included in development plan.
Year(s) Of Engagement Activity 2013
 
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 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