Feasibility and Acceptability of a Proposed Infant Feeding Intervention Trial for the Prevention of Type I Diabetes

OBJECTIVE: To determine the feasibility of a randomized double-blind controlled trial of an infant formula without intact cow's-milk protein for preventing type I diabetes in high-risk children. RESEARCH DESIGN AND METHODS: We surveyed 83 people who either were parents of a child with type I diabetes or were pregnant women with type I diabetes in the ambulatory diabetes and obstetrics clinics in a university hospital. After a written and verbal description of the cow's milk-diabetes hypothesis, participants were asked to sign a sham consent form. A questionnaire designed to explore factors affecting their decision to either sign or not sign the consent form, as well as infant-feeding patterns, was subsequently administered. RESULTS: Overall, 69.9% (95% confidence interval, 60.0-79.8%) consented to participation in the proposed randomized trial. The decision to consent was not affected by the degree of belief in the cow's milk-diabetes hypothesis, the child's risk of diabetes, the respondent's demographic data, or infant feeding habits. CONCLUSIONS: A randomized feeding intervention study is an acceptable and feasible way to determine whether avoidance of cow's-milk protein during the first 6 months of life prevents type I diabetes in North American children.