Developing dietary advice guides for food-based clinical trials

Randomised controlled trials provide the highest level of evidence for the effects of foods and food components on health. Study designs require detailed dietary modelling to control for food and nutrient variables which should parallel with easy to follow dietary education materials to assist in meeting nutrient targets. The aim of this project was to develop dietary advice guides for a clinical trial examining the effects of omega-3 fatty acids on weight loss over a 12 month period. Initially, food-based models for the dietary targets were developed for different energy levels. The research team then identified issues relating to categories of food information to be provided to participants. Visual representations of the information were trialled within the team. Dietary models and advice were based on six food categories. The advice models focussed on the number of servings per day. The protein category needed individual sub-categories to be formed and number of serves prescribed per week. The issues identified included the determination of serving size, sub-categories of foods within each group, qualifying information and using motivational messages to encourage consumption from each category. Consistency in the visual representations were considered of value to ensure pattern recognition of information on each new category of food. The development of dietary advice guides for use in clinical trials requires effective control of dietary variables presented and poses a number of design challenges which may be overcome by drawing on a range of dietetic skills from within the research team. Funding Source: NHMRC Project Grant #514631 Contact Details: Rebecca Thorne, (02) 4221 5992, beck@uow.edu.a