Constructing validated clinical tools to enable the development of a new evidence base for personalised nutrition practice in obesity management

This project focused on evaluating, constructing and integrating standardised clinical data-collection tools for obesity management in personalised nutrition practice. A mixed methods research design including surveys and interviews was used. A collaborative Delphi survey method was undertaken with purposefully selected stakeholder participants, who then contributed to the construction of four new tools.
The project comprised of two research questions:
1. Is it possible and ethical to standardise a personalised approach to nutrition practice?
2. If so, what tools can be constructed and validated to help individual health history data collection, clinical decision making and clinical outcome analysis to enable the development of a case-by-case evidence base for personalised nutrition practice in the management of obesity?
Theoretical frameworks that influenced the project include: the functional medicine approach, clinical psychoneuroimmunology (cPNI), the interdisciplinary approach of systems science, pathophysiological mechanistic reasoning and translational bioinformatics. The project focused on personalised nutrition practice, which is primarily centred on nutritional therapy but also draws on the practice of dietitians, nutritionists, functional medicine and cPNI practitioners.
The research project had five stages included in the overall design. The first was a literature review undertaken to inform the project approach and tool development. The second stage involved gathering, categorising and evaluating existing tools. Surveys and interviews assessed practitioner experiences of using tools, while interviews with statisticians and academics evaluated their experiences and views on tool development to inform the development of new tools. The third stage was the Delphi method: a multi-staged, collaborative survey resulting in the development of four new clinical tools. The fourth stage was a pilot trial which aimed to achieve face validity and measure feasibility and utility for each of the four tools. The final stage included a survey and interviews which aimed to evaluate ways standardised tools could be successfully embedded into personalised nutrition practice.
The findings showed that there were few ethical concerns with utilising standardised data-collection tools in nutrition practice, but there were numerous ethical considerations in relation to the development of a case-by-case evidence base for personalised nutrition practice. It was possible to construct new tools aimed at standardising individual health history data collection and clinical outcome analysis in order to support clinical decision making, but it was not possible to validate these tools.
This project has been the first of its kind: a synthesis of different nutritional practice approaches to support the development of robust translational bioinformatics tools using pathophysiological reasoning. The results have created new knowledge in terms of understanding, defining and developing an evidence-based personalised nutrition practice approach. This could lead to major change initiatives and enhance and strengthen the nutrition profession.