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

Abstract

Aims 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. Methods 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 (11–14 years), 35 in each arm. Those assigned to the intervention will be invited to participate in two workshops of 2 h 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. Conclusion 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. Trial registration This protocol has been registered with ClinicalTrials.gov [Identifier: NCT04741568].

Integrating conversations about disordered eating in children and young people into routine type 1 diabetes care: a practical guide

“…9 Full recruitment, interven tion and procedure details can be found in the study protocol. 9 Ethical approval was sought from the Health Research Authority and Health and Care Research Wales and granted by the South Birmingham Research Ethics Committee (reference 20/ WM/0242). Within the interview schedule, questions explored par ents' attitudes to T1D teams discuss ing and screening for T1DE within routine clinical appointments.…”

“…The PRIORITY randomised control trial recruited and randomised 89 parents with a child aged 11-14 with T1D to receive a parenting interven tion immediately (n=44) or be in a waitlist control condition (n=45). 9,10 The 25 intervention condition par ents who had completed three month followup questionnaire measures by December 2022 were invited to be interviewed at a three month followup about their experi ence of the study (as data collection for the PRIORITY trial continued until January 2023, four additional parents completed followup meas ures who are not captured in this paper due to time constraints). Of these 25, 10 accepted.…”

“…It is important to acknowledge to parents that the internet and media now provide CYP with access to infor mation about ways to lose weight, including insulin restriction within T1D. 9 Age of their child with type 1 diabetes 11.9…”

Development and Theoretical Underpinnings of the PRIORITY Intervention: A Parenting Intervention to Prevent Disordered Eating in Children and Young People With Type 1 Diabetes

“…Specifically, the PRIORITY intervention drew on psychological theories of behaviour change, namely the Information-Motivation-Behaviour Skills (IMB) framework ( 26 ). Future work will assess whether this intervention improves parent and child outcomes, as well as the level of therapist skills to deliver the intervention in routine clinical settings ( 27 ).…”

“…A feasibility randomised controlled trial of the PRIORITY intervention is being completed with 70 parents recruited from NHS settings and third sector organisation to determine acceptability and feasibility of the approach ( 27 ). Alongside analyses of outcomes, qualitative interviews will be conducted with participants to ensure a definitive trial is acceptable and reflective of the needs of the population of parents of CYP with T1D.…”