PC32 DIETARY COMPLIANCE IN DIABETES PREVENTION PROJECT IN FINLAND

Abstract

Introduction: Diabetes Prevention Project is an international, randomised, double-blinded trial. The hypothesis to be tested is whether hydrolysed infant formula compared to cow’s milk based formula decreases the risk of developing type 1 diabetes in children with increased genetic disease susceptibility. Eligible children have to have a family member affected by type 1 diabetes and a HLA class II genotype predisposing to type 1 diabetes. The outcome measures are emergence of type 1 diabetes associated autoantibodies and clinical type 1 diabetes. The children are followed for 10 years. Methods: During the first 6–8 months of life the infant will be given Study Formula if additional milk is needed. According to the protocol the infant should use Study Formula daily for at least 2 months before the age of 8 months, when the intervention will end at the latest. During the intervention period cow’s milk, beef and foods containing these have to be avoided. Dietary compliance is monitored with dietary interviews every month of intervention, which comprises questions on breastfeeding and use of Study Formula, allowed foods and those foods to be avoided. For the present study we used the data collected in Finland by the end of November 2003 (altogether 149 children at different stages of the intervention). Results: At 2 weeks of age 96% of the infants were breastfed and 39% were exclusively breastfed, and at the 3-month interview 83% and 29%, respectively. At the 6-month interview 60% of the children were breastfed, but only 2% were exclusively breast-fed. At 9 months of age 48% of the children were still breastfed. During the first 2 weeks of life 33% of the infants received Study Formula daily. Between 2 and 3 months of age 38% of the infants received Study Formula daily, and between 5 and 6 months of age 62%. Among the first 76 children to reach the end of the intervention 60 (79%) had received Study Formula for at least 2 months, 10 (13%) less than 2 months and 6 (8%) not at all. Of the children 22% had used food not recommended during the intervention (on average 1.2 deviations/child). The most common deviations were use of hydrolysed formula other than the Study Formula (9%), milk-based formula (8%) and milk acid bacteria that may contain trace amounts of milk protein (5%). Conclusion: These results show that a majority of the children were breastfed over the first 6 months. Exclusive breastfeeding was less common and decreased rapidly with age. The dietary compliance was good with 79% of the children receiving Study Formula for at least 2 months. A proportion of the children showed deviations from the dietary restrictions during the intervention.