Intensive Dietary and Activity Counselling (IDAC) study: a randomised trial following infants genetically susceptible to type 1 diabetes to prevent {beta}-cell dysfunction and islet autoimmunity - a study protocol

Introduction Type 1 diabetes is a chronic autoimmune disease, preceded by the presence of islet autoantibodies, a preclinical state defined as islet autoimmunity. Several environmental exposures have been associated with the initiation of islet autoimmunity but the triggers remain largely unknown.

Rapid growth and weight gain during childhood are some of the exposures that have been proposed to promote islet autoimmunity. A high intake of protein and animal milks in early childhood is consistently associated with increased later obesity.

Growth during early childhood is directly related to dietary intake and especially protein intake and this association has been linked to increased risk of islet autoimmunity and type 1 diabetes. The Intensive Dietary and Activity Counselling (IDAC) study aims to determine whether a healthy lifestyle counselling from age 3 months to age 2 years improves β-cell health in children with increased risk for islet autoimmunity.

Methods and analysis The IDAC study is a randomised trial (1:1 allocation) with two parallel groups, aiming to enrol 1244 children at increased genetic risk of type 1 diabetes before the age of 4 months.