Advertising of Human Milk Substitutes in United Kingdom Healthcare Professional Publications: An Observational Study.

BACKGROUND: Inappropriate marketing of human milk substitutes negatively influences efforts to protect breastfeeding. Although healthcare professionals can positively influence infant feeding decisions, government regulations permit manufacturers to communicate messages to them through advertising. RESEARCH AIMS: (1) To identify the extent of human milk substitute advertising in publications aimed at United Kingdom healthcare professionals and (2) to describe compliance with the International Code of Marketing of Breast-Milk Substitutes and United Kingdom Formula and Follow-on Formula Regulations. METHODS: This was a cross-sectional observational study. We reviewed publications targeting healthcare professionals working with families in the United Kingdom (N = 19). Quantity and type of human milk substitute advertisements, as a proportion of all advertising, in each publication were recorded. All unique advertisements were double assessed for compliance. RESULTS: Human milk substitute advertising was found in nine (47%) of the 19 publications (four affiliated with professional associations), making up 10.3% (n = 196) of these publications' total advertising. Of human milk substitute advertisements found, 65.4% (n = 110) were for products used to manage cows' milk protein allergy. Of the 32 unique human milk substitute advertisements found, none complied with the International Code of Marketing of Breast Milk Substitutes or United Kingdom Formula and Follow-on Formula Regulations. CONCLUSIONS: Many healthcare professionals' publications had non-compliant human milk substitute advertisements. There is an urgent need to ensure full compliance with international and local regulation in future advertisements and to consider whether advertisements are justified at all.

Guidance for the Conduct and Reporting of Clinical Trials of Breast Milk Substitutes.

Importance: Breast milk substitutes (BMS) are important nutritional products evaluated in clinical trials. Concerns have been raised about the risk of bias in BMS trials, the reliability of claims that arise from such trials, and the potential for BMS trials to undermine breastfeeding in trial participants. Existing clinical trial guidance does not fully address issues specific to BMS trials. Objectives: To establish new methodological criteria to guide the design, conduct, analysis, and reporting of BMS trials and to support clinical trialists designing and undertaking BMS trials, editors and peer reviewers assessing trial reports for publication, and regulators evaluating the safety, nutritional adequacy, and efficacy of BMS products. Design, Setting, and Participants: A modified Delphi method was conducted, involving 3 rounds of anonymous questionnaires and a face-to-face consensus meeting between January 1 and October 24, 2018. Participants were 23 experts in BMS trials, BMS regulation, trial methods, breastfeeding support, infant feeding research, and medical publishing, and were affiliated with institutions across Europe, North America, and Australasia. Guidance development was supported by an industry consultation, analysis of methodological issues in a sample of published BMS trials, and consultations with BMS trial participants and a research ethics committee. Results: An initial 73 criteria, derived from the literature, were sent to the experts. The final consensus guidance contains 54 essential criteria and 4 recommended criteria. An 18-point checklist summarizes the criteria that are specific to BMS trials. Key themes emphasized in the guidance are research integrity and transparency of reporting, supporting breastfeeding in trial participants, accurate description of trial interventions, and use of valid and meaningful outcome measures. Conclusions and Relevance: Implementation of this guidance should enhance the quality and validity of BMS trials, protect BMS trial participants, and better inform the infant nutrition community about BMS products.

Methodological development of an exploratory randomised controlled trial of an early years' nutrition intervention: the CHERRY programme (Choosing Healthy Eating when Really Young).

Good nutrition in the early years of life is vitally important for a child's development, growth and health. Children's diets in the United Kingdom are known to be poor, particularly among socially disadvantaged groups, and there is a need for timely and appropriate interventions that support parents to improve the diets of young children. The Medical Research Council has highlighted the importance of conducting developmental and exploratory research prior to undertaking full-scale trials to evaluate complex interventions, but have provided very limited detailed guidance on the conduct of these initial phases of research. This paper describes the initial developmental stage and the conduct of an exploratory randomised controlled trial undertaken to determine the feasibility and acceptability of a family-centred early years' nutrition intervention. Choosing Healthy Eating when Really Young (CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban (Islington) and one rural (Cornwall) location in the United Kingdom. In the development stage, a mixed-methods approach was used to investigate the nature of the problem and options for support. A detailed review of the evidence informed the theoretical basis of the study and the creation of a logic model. In the feasibility and pilot testing stage of the exploratory trial, 16 children's centres, with a sample of 394 families were recruited onto the study. We hope that the methodology, which we present in this paper, will inform and assist other researchers in conducting community-based, exploratory nutrition research in early years settings.

Considerations and lessons learned from designing a motivational interviewing obesity intervention for young people attending dental practices: a study protocol paper.

BACKGROUND: With the prevalence of child obesity increasing worldwide, and the consumption of sugar-sweetened beverages identified as a major contributor to obesity in adolescents, there is a need for effective interventions aimed at dietary behaviour change in this group. Primary dental care settings are in an ideal position to influence adolescents' dietary behaviours, yet have been under-utilised for this purpose. Motivational Interviewing (MI) has shown promise in influencing other health behaviours. However, there is lack of published methodologies on which to base the design of such interventions, and limited evidence on its effectiveness in influencing dietary change. We undertook a study to test the feasibility of a MI intervention aimed at reducing soft drink consumption in adolescents attending dental surgeries. We present the study design for the development and evaluation of the intervention. METHOD: Ten dental practices in north London were randomised into control or intervention. Adolescent participants in control settings received routine advice and intervention participants received a brief MI intervention. The intervention was designed using comprehensive stakeholder engagement and consisted of 3-4 short MI sessions and a maintenance phase delivered by trained researchers through the use of age-specific resources. Process evaluation was carried out using qualitative and quantitative methods to assess intervention feasibility in a primary dental care setting. DISCUSSION: By focussing on the development and evaluation of the intervention, this paper contributes to the limited available knowledge and identifies methodological considerations for undertaking a MI intervention for dietary change in adolescents in primary dental care settings.

A systematic review of the effect of dietary exposure that could be achieved through normal dietary intake on learning and performance of school-aged children of relevance to UK schools.

The aim of the present review was to perform a systematic in-depth review of the best evidence from controlled trial studies that have investigated the effects of nutrition, diet and dietary change on learning, education and performance in school-aged children (4-18 years) from the UK and other developed countries. The twenty-nine studies identified for the review examined the effects of breakfast consumption, sugar intake, fish oil and vitamin supplementation and 'good diets'. In summary, the studies included in the present review suggest there is insufficient evidence to identify any effect of nutrition, diet and dietary change on learning, education or performance of school-aged children from the developed world. However, there is emerging evidence for the effects of certain fatty acids which appear to be a function of dose and time. Further research is required in settings of relevance to the UK and must be of high quality, representative of all populations, undertaken for longer durations and use universal validated measures of educational attainment. However, challenges in terms of interpreting the results of such studies within the context of factors such as family and community context, poverty, disease and the rate of individual maturation and neurodevelopment will remain. Whilst the importance of diet in educational attainment remains under investigation, the evidence for promotion of lower-fat, -salt and -sugar diets, high in fruits, vegetables and complex carbohydrates, as well as promotion of physical activity remains unequivocal in terms of health outcomes for all schoolchildren.