Abstract THE IMPACT OF TOTAL DIET REPLACEMENT FOR REMISSION OF TYPE 2 DIABETES ON DISORDERED EATING; A PROTOCOL FOR A NON-INFERIORITY RANDOMISED CONTROL TRIAL
Elena Tsompanaki1, Dimitrios A Koutoukidis1, Paul Aveyard1, Rebecca J Park2
1Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom/2Department of Psychiatry, University of Oxford, Oxford, United Kingdom

Introduction The National Health System in England is currently piloting a weight loss programme for type 2 diabetes (T2D) remission, where participants replace all food with low-energy nutritionally complete formula products for 12 weeks (total diet replacement, TDR) and receive behavioural support. This programme has shown evidence of effectiveness in achieving T2D remission. However, it could also worsen disordered eating and may prompt eating disorders in susceptible people. We aim to investigate if the TDR programme is non-inferior to standard care for scores of disordered eating in susceptible individuals. Methods Fifty six people with recently diagnosed T2D, BMI>27kg/m2, and clinically medium to high scores of disordered eating based on the eating disorders examination questionnaire will be randomised 1:1 to TDR or standard care. Participants will be re-assessed at 1, 3, and 6 months. The primary outcome will be the between-group difference in the score of the eating disorders examination questionnaire. Weight, HbA1c, impairment, and quality of life will be secondary outcomes. Using the recorded consultations, we will evaluate the process in observed changes in eating behaviour and disordered eating.  Conclusions If TDR for T2D remission is deemed non-inferior to standard care, more people may enrol and benefit from T2D remission. If TDR leads to exacerbation of disordered eating, this may lead to screening people with T2D for eating disorders to ensure no unintended harm.

Category
Treatment/Prevention