Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Pediatrics

A core outcome set for trials of infant-feeding interventions to prevent childhood obesity

Abstract

Background

Standardisation of outcomes measured and reported in trials of infant-feeding interventions to prevent childhood obesity is essential to evaluate and synthesise intervention effects. The aim of this study is to develop an infant-feeding core outcome set for use in randomised trials of infant-feeding interventions, with children ≤1 year old, to prevent childhood obesity.

Methods

Core outcome set development followed four stages: (1) systematic review of outcomes reported in the extant literature; (2) meeting with national and international stakeholders to discuss and clarify identified outcomes; (3) e-Delphi study with national and international stakeholders to prioritise outcomes; (4) meeting with national and international stakeholders to reach consensus on outcomes. Stakeholders in stages 2–4 were paediatricians, general practitioners, nurses, midwives, non-clinician researchers, parents, dieticians, nutritionists, and childcare providers.

Results

Twenty-six outcomes were identified for inclusion in the core outcome set. These were grouped in nine outcome domains: ‘breastfeeding and formula feeding’, ‘introduction of solids’, ‘parent feeding practices and styles’, ‘parent knowledge and beliefs’, ‘practical feeding’, ‘food environment’, ‘dietary intake’, ‘perceptions of infant behaviour and preferences’, and ‘child weight’.

Conclusions

The core outcome set identified in this study is the minimum that should be measured and reported in trials of infant-feeding interventions to prevent childhood obesity. This standardisation of outcomes will enable more comprehensive examination and synthesis of the effects of infant-feeding interventions to prevent childhood obesity.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

Fig. 1

Similar content being viewed by others

References

  1. Ng M, Fleming T, Robinson M. Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2014;384:746.

    Google Scholar 

  2. Kim J, Lee I, Lim S. Overweight or obesity in children aged 0 to 6 and the risk of adult metabolic syndrome: a systematic review and meta-analysis. J Clin Nurs. 2017;26:3869–80.

    PubMed  Google Scholar 

  3. Biro FM, Wien M. Childhood obesity and adult morbidities. Am J Clin Nutr. 2010;91:1499S–1505S.

    PubMed  PubMed Central  Google Scholar 

  4. Bacha F, Gidding SS. Cardiac abnormalities in youth with obesity and type 2 diabetes. Curr Diabetes Rep. 2016;16:62.

  5. Mohanan S, Tapp H, McWilliams A, Dulin M. Obesity and asthma: pathophysiology and implications for diagnosis and management in primary care. Exp Biol Med. 2014;239:1531–40.

    Google Scholar 

  6. Maffeis C, Tato L. Long-term effects of childhood obesity on morbidity and mortality. Horm Res. 2001;55(Suppl 1):42–45.

    CAS  PubMed  Google Scholar 

  7. Blake-Lamb TL, Locks LM, Perkins ME, Woo Baidal JA, Cheng ER, Taveras EM. Interventions for childhood obesity in the first 1,000 days; a systematic review. Am J Prev Med. 2016;50:780–9.

    PubMed  PubMed Central  Google Scholar 

  8. Taylor BJ, Gray AR, Galland BC, Heath AM, Lawrence J, Sayers R, et al. Targeting sleep, food, and activity in infants for obesity prevention: an RCT. Pediatrics. 2017;139:e20162037.

    PubMed  Google Scholar 

  9. Brown A, Lee M. Maternal child-feeding style during the weaning period: association with infant weight and maternal eating style. Eat Behav. 2011;12:108–11.

    PubMed  Google Scholar 

  10. Fewtrell M, Bronsky J, Campoy C, Domellöf M, Embelton N, Fidler Mis N, et al. Complementary feeding: a position paper by the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) committee on nutrition. J Pediatr Gastroenterol Nutr. 2017;64:119–32.

    CAS  PubMed  Google Scholar 

  11. Papoutsou S, Savva SC, Hunsberger M, Jilani H, Miochels N, Ahrens W, et al. Timing of solid food introduction and association with later childhood overweight and obesity: the IDEFICS study. Matern Child Nutr. 2018;14. https://doi.org/10.1111/mcn.12471.

  12. Pearce J, Langley-Evans SC. The types of food introduced during complementary feeding and risk of childhood obesity: a systematic review. Int J Obes. 2013;37:477–85.

    CAS  Google Scholar 

  13. Hurley KM, Cross MB, Hughes SO. A systematic review of responsive feeding and child obesity in high-income countries. J Nutr. 2011;141:495–501.

    CAS  PubMed  PubMed Central  Google Scholar 

  14. Matvienko-Sikar K, Toomey E, Delaney L, Harrington J, Byrne M, Kearnery P, et al. Effects of healthcare professional delivered early feeding interventions on feeding practices and dietary intake: a systematic review. Appetite. 2017;123:56–71.

    PubMed  Google Scholar 

  15. Redsell SAE B, Swift JA, Siriwardena AN, Weng S, Nathan D, Glazebrook C. Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood. Matern Child Nutr. 2016;12:24–38.

    Google Scholar 

  16. Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST, et al. The COMET handbook: version 1.0. Trials. 2017;18:280.

    PubMed  PubMed Central  Google Scholar 

  17. Clarke M. Standardising outcomes for clinical trials and systematic reviews. Trials. 2007;8:39.

  18. Potter S, Holcombe C, Ward JA, Blazeby JM, Group BS. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg. 2015;102:1360–71.

    CAS  PubMed  PubMed Central  Google Scholar 

  19. Webbe J, Brunton G, Ali S, Duffy JM, Modi N, Gale C. Developing, implementing and disseminating a core outcome set for neonatal medicine. BMJ Paediatr Open. 2017;1:e000048.

    PubMed  PubMed Central  Google Scholar 

  20. Gardner W, Kelleher KJ. Core quality and outcome measures for pediatric health. JAMA Pediatrics. 2017;171:827–8.

    PubMed  Google Scholar 

  21. Webbe J, Modi N, Gale C. Core quality and outcome measures for pediatric health RESPONSE. JAMA Pediatrics. 2018;172:299–300.

    PubMed  Google Scholar 

  22. Whitford H, Hoddinott P, Amir LH, Chamberlain C, East CE, Jones L, et al. Routinely collected infant feeding data: time for global action. Matern Child Nutr. 2018;14:e12616.

    PubMed  PubMed Central  Google Scholar 

  23. Matvienko-Sikar K, Byrne M, Kelly C, Toomey E, Hennessy M, Devane D, et al. Development of an infant feeding core outcome set for childhood obesity interventions: study protocol. Trials. 2017;18:463.

    PubMed  PubMed Central  Google Scholar 

  24. Kirkham JJ, Gorst S, Altman DG, Blazeby J, Clarke M, Devane D, et al. Core outcome Set-STAndards for reporting: the COS-STAR statement. PLoS Med. 2016;13:e1002148.

    PubMed  PubMed Central  Google Scholar 

  25. Matvienko-Sikar K, Griffin C, McGrath N, Toomey E, Byrne M, Kelly C, et al. Developing a core outcome set for childhood obesity prevention: a systematic review. Matern Child Nutr. 2018;15:e12680.

    PubMed  PubMed Central  Google Scholar 

  26. Matvienko-Sikar K, Kelly C, Sinnott C, McSharry J, Houghton C, Heary C, et al. Parental experiences and perceptions of infant complementary feeding: a qualitative evidence synthesis. Obes Rev. 2018;19:501–17.

    CAS  PubMed  Google Scholar 

  27. Toomey E, Byrne M, Houghton C, Kelly C, Matvienko-Sikar K, McSHarry J, et al. Health-care professional and parental views and experiences of implementing infant feeding interventions: a qualitative evidence synthesis. Lancet. 2018;392:S87.

  28. COMET. Plain Language Summary. http://www.comet-initiative.org/resources/PlainLanguageSummary.

  29. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:1–8.

    Google Scholar 

  30. COMET. Delphi Manager Software. http://www.comet-initiative.org/delphimanager/.

  31. Pagnini D, King L, Booth S, Wilkenfeld R, Booth M. The weight of opinion on childhood obesity: recognizing complexity and supporting collaborative action. Int J Pediatr Obes. 2009;4:233–41.

    PubMed  Google Scholar 

  32. Ben-Sefer E, Ben-Natan M, Ehrenfeld M. Childhood obesity: current literature, policy and implications for practice. Int Nurs Rev. 2009;56:166–73.

    CAS  PubMed  Google Scholar 

  33. Modrek S, Basu S, Harding M, White JS, Bartick MC, Rodriguez E, et al. Does breastfeeding duration decrease child obesity? An instrumental variables analysis. Pediatr Obes. 2017;12:304–11.

    CAS  PubMed  Google Scholar 

  34. Koletzko B, von Kries R, Closa R, Escribano J, Scaglioni S, Giovannini M, et al. Lower protein in infant formula is associated with lower weight up to age 2 y: a randomized clinical trial. Am J Clin Nutr. 2009;89:1836–45.

    CAS  PubMed  Google Scholar 

  35. Weber M, Grote V, Closa-Monasterolo R, Escribano J, Langhendries JP, Dain E, et al. Lower protein content in infant formula reduces BMI and obesity risk at school age: follow-up of a randomized trial. Am J Clin Nutr. 2014;99:1041–51.

    CAS  PubMed  Google Scholar 

  36. Weng SF, Redsell SA, Swift JA, Yang M, Glazebrook CP. Systematic review and meta-analyses of risk factors for childhood overweight identifiable during infancy. Arch Dis Child. 2012;97:1019–26.

    PubMed  PubMed Central  Google Scholar 

  37. O’Malley C, Mazarello Paes V, Hesketh K, Moore HJ, Ong K, Van Sluijs, et al. Systematic review on the determinants of fruit and vegetable consumption in young children (aged 0-6). Obes Facts. 2015;8:70

    Google Scholar 

  38. DiSantis KI, Hodges EA, Johnson SL, Fisher JO. The role of responsive feeding in overweight during infancy and toddlerhood: a systematic review. Int J Obes. 2011;35:480–92.

    CAS  Google Scholar 

  39. Schrempft S, van Jaarsveld CHM, Fisher A, Wardle J. The obesogenic quality of the home environment: associations with diet, physical activity, TV viewing, and BMI in preschool children. PLoS ONE. 2015;10:e0134490.

    PubMed  PubMed Central  Google Scholar 

  40. Birch LL, Anzman-Frasca S. Promoting children’s healthy eating in obesogenic environments: lessons learned from the rat. Physiol Behav. 2011;104:641–5.

    CAS  PubMed  PubMed Central  Google Scholar 

  41. Sinha IP, Smyth RL, Williamson PR. Using the delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8:e1000393.

    PubMed  PubMed Central  Google Scholar 

  42. Khandpur N, Charles J, Davison KK. Fathers’ perspectives on coparenting in the context of child feeding. Child Obes. 2016;12:455–62.

    PubMed  PubMed Central  Google Scholar 

  43. Earle S, Hadley R. Men’s views and experiences of infant feeding: a qualitative systematic review. Matern Child Nutr. 2018;14:e12586.

    PubMed  PubMed Central  Google Scholar 

  44. Davison KK, Kitos N, Aftosmes-Tobio A, Ash T, Agarnov A, Sepulveda M, et al. The forgotten parent: fathers’ representation in family interventions to prevent childhood obesity. Prev Med. 2018;111:170–6.

    CAS  PubMed  Google Scholar 

  45. Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS ONE. 2015;10:e0129514.

    PubMed  PubMed Central  Google Scholar 

  46. Dos Santos F, Drymiotou S, Martin AA, Mol BW, Gale C, Devane D, et al. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018;125:1673–80.

    PubMed  Google Scholar 

  47. McGrattan M, Barry HE, Ryan C, Cooper JA, Passmore AP, Robinson AL, et al. The development of a core outcome set for medicines management interventions for people with dementia in primary care. Age Ageing. 2018;48:260–6.

    Google Scholar 

  48. Bergmeier H, Paxton SJ, Milgrom J, Anderson SE, Baur L, Hill B, et al. Early mother-child dyadic pathways to childhood obesity risk: a conceptual model. Appetite. 2019;144:104459.

    PubMed  PubMed Central  Google Scholar 

  49. Prinsen CA, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Ver HCW, et al. COSMIN guideline for systematic reviews of outcome measurement instruments. Qual Life Res. 2016;25:21.

    Google Scholar 

Download references

Acknowledgements

The authors would like to thank all participants of e-Delphi, and participants of the stakeholder and consensus meetings: AnneMarie Bennett, Brendan O Shea, Carol Ni Chaoimh, Eilish Whelan, Elizabeth O Sullivan, Ide NicDhonncha, Joanne O Halloran, Karen Roche, Kathy McSharry, Marian O Reilly, Mary Flynn, Oonagh Meade, Patricia Leahy-Warren, Rachel Laws, Sarah Redsell, Shalini Ojha, and Tony Heffernan. The authors would also like to thank the COMET Initiative for advice and support in developing the COS.

Funding

This research was supported by a Health Research Board Interdisciplinary Capacity Enhancement Award (ICE-2015-1026) and an Irish Research Council New Foundations Award (2015). CG was in receipt of a Health Research Board-Trials Methodology Research Network (HRB-TMRN) summer studentship to support this research.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Karen Matvienko-Sikar.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Matvienko-Sikar, K., Griffin, C., Kelly, C. et al. A core outcome set for trials of infant-feeding interventions to prevent childhood obesity. Int J Obes 44, 2035–2043 (2020). https://doi.org/10.1038/s41366-020-0538-2

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41366-020-0538-2

This article is cited by

Search

Quick links