Grant: Catalyst Grant: SPOR Innovative Clinical Trials (iCT)

Obesity prevention in children is one of the top 5 research priorities identified by Canadian parents and doctors. Although cow milk has been a dietary staple for children in Canada for over a century, industry has touted soy milk as the 'perfect balance between good nutrition and good taste' and many parents now consider soy milk to be a healthier choice for children than cow milk. However, it is not known whether soy milk offers nutritional advantages, such as healthier weights, or whether it increases the risk of inadequate nutrient intake. To answer this question, a randomized clinical trial is needed. We will use a Trials Within Cohorts design which enables researchers to use the strengths of a large children's cohort study to enroll large numbers of participants while lowering costs, improving feasibility and enhancing real world impact. Vanguard trials provide crucial information on how to perform a definitive clinical trial. We will conduct a Vanguard trial that compares two groups of 2-year-old children, one group recommended to drink soy milk, and the other recommended to drink cow milk. We will evaluate parents' willingness to having their child randomized to consume soy milk, whether parents follow this recommendation, and whether families return for follow-up measurements. Parents and physicians may have strong milk preferences, concerns about inconvenience, ambivalence about health benefits, and lack of familiarity with soy milk. Through information from in-depth interviews with parents and physicians, we will tailor this innovative trial to their needs. The results of this research will help us to develop a definitive soy milk trial for children, which holds the potential to reduce childhood obesity in Canada. These results will help policy makers, clinicians and families make informed decisions about soy milk for children based on industry independent, high quality, randomized trial evidence generated from routine clinical settings.