Diabetes Care, Vol 18, Issue 7 940-942, Copyright © 1995 by American Diabetes Association

ARTICLES

Feasibility and acceptability of a proposed infant feeding intervention trial for the prevention of type I diabetes

HC Gerstein, JR Simpson, S Atkinson, DW Taylor and J VanderMeulen
McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.

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.
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