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.


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.
Gerstein
H C
HC
McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada.
Simpson
J R
JR
Atkinson
S
S
Taylor
D W
DW
VanderMeulen
J
J
D000818:Animals; D001942:Breast Feeding; D002417:Cattle; D016001:Confidence Intervals; D003922:Diabetes Mellitus, Type 1 / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007223:Infant; D007225:Infant Food; D007231:Infant, Newborn; D007258:Informed Consent; D010349:Patient Compliance; D018579:Patient Selection; D011247:Pregnancy; D011254:Pregnancy in Diabetics; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016312:Treatment Refusal