STEADY I
Research type
Research Study
Full title
Safe management of people with Type 1 diabetes and EAting Disorders studY (STEADY)- Stage 1
IRAS ID
243046
Contact name
Marietta Anna Stadler
Contact email
Duration of Study in the UK
4 years, 10 months, 26 days
Research summary
People with T1DM must adhere to multiple self-care roles and tasks (multiple daily insulin injections, regular blood glucose monitoring, adjustment of insulin dose according to physical activity, stress and food intake) in order to achieve optimal glucose control to avoid acute and late complications.
Eating disorders (such as bulimia nervosa and anorexia nervosa) are amongst the most common mental health problems in T1DM and are 2-fold more common in young adults with T1DM than in people without diabetes. The omission of insulin injections with the intention of losing weight is a behaviour unique to T1DM with ED and leads to acute and chronic complications and therefore 3-fold higher mortality rates. To date, no effective intervention has been described for this vulnerable patient group.
This protocol describes the first (of two) stages of the development of a complex intervention that integrates diabetes cognitive behavioural therapy (CBT) with diabetes self-management education for people with type 1 diabetes (T1DM) and eating disorders (ED).Overall aims of STEADY Stage 1:
Develop a complex intervention that integrates diabetes cognitive behavioural therapy (CBT) with diabetes self-management education for people with type 1 diabetes (T1DM) and eating disorders (ED) to improve their glycaemic control and to reduce psychological distress in a steady graded approach (STEADY)[Overall aims of Stage 2: not part of this protocol: Assess the feasibility of comparing STEADY with usual care in a future definitive randomised controlled trial (RCT)]
Specific aims of STEADY Stage 1
Stage I: Design a complex intervention – outlined in this protocol:
1. Qualitative methods (focus groups) to:
a) understand the barriers and facilitators that patients with T1DM and ED experience in their efforts to recover;
b) describe the challenges and therapeutic strategies of health care professionals (HCP) when treating people with T1DM and ED
c) production of a trigger film using BBC material and filmed patient interviews
2. Experience-based co-design (EBCD) to:
d) develop the modules for the diabetes CBT intervention for T1DM with ED- specific components focusing on safe graded insulin titration while addressing fear of insulin and fear of weight gain;
e) adapt and expand an evidence based CBT manual for T1DM for ED.(Stage II: Conduct a feasibility study using a randomised controlled trial (RCT))- this will be the next step after completion of Stage I
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0812
Date of REC Opinion
29 May 2018
REC opinion
Further Information Favourable Opinion