The Role of Incentives in Long-Term Nutritional and Growth Studies in Children

Objectives: Available published advice on use of incentives is limited and generally refers to short term studies without longer follow-up, predominantly conducted in developed countries. We aim to summarise published information related to the use of incentives in long-term nutrition studies involving infants, children and adolescents and the views of researchers in the field, in order to provide guidance on acceptable incentives. Methods: We conducted a literature review and a short online survey of researchers regarding their opinions on the use of incentives in paediatric long-term (follow-up) clinical studies. Results: Responses from 38 researchers from 14 different countries indicated that 41% had used incentives to increase participation and 29% to 73%, depending on child age and type of procedure, thought incentives may be used to increase compliance with follow-up visits. A small number of respondents thought incentives would not be approved by national ethics boards. Conclusions: Based on the literature review and the survey results, and ESPGHAN working group concluded that incentives for children and adolescents up to the value of 30 euros, based on average EU income levels, may be offered as cash, vouchers or age appropriate gifts or toys, in addition to reimbursing expenses. Additional incentives may be offered if a study includes more burdening procedures, techniques that may appear frightening for younger children, or requires sustained participation (e.g. dietary diaries or activity monitoring). There was agreement that it is preferable to give toys or gifts rather than money to younger children. Address correspondence and reprint requests to Berthold Koletzko, MD PhD Dres.h.c, Professor of Paediatrics, LMU - Ludwig-Maximilians-Universität München, Dr. von Hauner Children's Hospital, Lindwurmstr. 4, 80337 München, Germany (e-mail: office.koletzko@med.lmu.de). Received 17 June, 2018 Accepted 27 August, 2018 Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal's Web site (www.jpgn.org). The conflicts of interest disclosure and funding declaration: NFM, KK, MF and BK – none related to the topic. NFM acknowledges support of the Slovenian Research Agency (P3-0395: Nutrition and Public Health; L3-8213, L3-7538), European Food Safety Authority (EU Menu) and University Medical Centre Ljubljana, Slovenia. The work of CC is financially supported in part by the Commission of the European Communities Projects Early Nutrition (FP7-289346), MyNewGut (FP7 613979), DynaHEALTH (H2020-633595). Additional support has been received from Spanish Ministry of Economy and Competitiveness SFA2015-69265-C2-1-R and BFU2012-40254-C03-01. MF is supported by the Great Ormond Street Hospital Children's Charity. The work of BK is financially supported in part by the Commission of the European Communities, Projects Early Nutrition (FP7-289346), DYNAHEALTH (H2020-633595) and LIFECYCLE (H2020-SC1-2016-RTD), the European Research Council Advanced Grant META-GROWTH (ERC-2012-AdG 322605), the Erasmus Plus programmes "Early Nutrition eAcademy Southeast Asia - 573651-EPP-1-2016-1-DE-EPPKA2-CBHE-JP" and "Early Nutrition eAcademy Southeast Asia - 573651-EPP-1-2016-1-DE-EPPKA2-CBHE-JP" and " Capacity Building to Improve Early Nutrition and Health in South Africa - 598488-EPP-1-2018-1-DE-EPPKA2-CBHE-JP", and the EU Interreg Programme "Focus in CD - CE111". Additional support has been received from the German Ministry of Education and Research, Berlin (Grant Nr. 01 GI 0825), the German Research Council (Ko912/12-1) and the University of Munich Innovation Initiative. © 2018 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology,

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