PaRent InterventiOn to pRevent dIsordered eating in children with TYpe 1 diabetes (PRIORITY): Study protocol for a feasibility randomised controlled trial.

Abstract

Increasing evidence suggests that children and young people with type 1 diabetes (T1D) are at greater risk of disordered eating compared to children without T1D. Disordered eating in T1D has been linked to impaired wellbeing, increased health service use and early mortality. To address this problem, we will co-develop a psycho-education intervention for parents of children and young people with T1D, informed by the Information Motivation Behavioural Skills model. The objective of this study is to assess the feasibility and acceptability of the intervention compared to a waitlist control group using a feasibility randomised controlled trial (RCT) design. We aim to recruit 70 parents of children and young people with T1D (11-14years), 35 in each arm. Those assigned to the intervention will be invited to participate in two workshops of 2h each. Parents will be asked to complete outcome measures regarding eating habits, diabetes management, as well as a questionnaire based on the Information Motivation Behavioural Skills model which provides a theoretical foundation for the intervention. These will be completed at baseline, 1- and 3-month post-intervention. Children and young people will be asked to complete questionnaires on their eating behaviours at the same time intervals. Parents randomised to receive the intervention will be invited to take part in interviews to feedback on the intervention and research protocol acceptability. It is anticipated that the psycho-education intervention aimed at parents will help prevent the development of disordered eating in children and young people with T1D and improve parental wellbeing. The results of this feasibility trial will determine whether this intervention approach is acceptable to families living with T1D, and whether a definitive RCT of intervention effectiveness is justified. Qualitative findings will be used to refine the intervention and study protocols. This protocol has been registered with ClinicalTrials.gov [Identifier: NCT04741568].