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- Title
Feasibility and acceptability of a proposed infant feeding intervention trial for the prevention of type I diabetes.
- Authors
Gerstein, Hertzel C.; Simpson, Janis Randall; Atkinson, Stephanie; Taylor, D. Wayne; VanderMeulen, John; Gerstein, H C; Simpson, J R; Atkinson, S; Taylor, D W; VanderMeulen, J
- Abstract
<bold>Objective: </bold>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.<bold>Research Design and Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Publication
Diabetes Care, 1995, Vol 18, Issue 7, p940
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/diacare.18.7.940