ARIADNE 2: A study of weight loss for diabetes treatment and wellbeing
Research type
Research Study
Full title
The impact of low-energy totAl diet Replacement with behavioural support for remIssion of type 2 DIAbetes on disordEred eatiNg: the ARIADNE randomised non-inferiority controlled trial
IRAS ID
330766
Contact name
Paul Aveyard
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance team
Duration of Study in the UK
1 years, 5 months, 16 days
Research summary
The NHS has started a trial-run of a weight loss programme replacing food with around 860-calorie shakes and soups for 3 months, offered to people with newly diagnosed type 2 diabetes (T2D) to lose weight and reverse their diabetes. Some healthcare professionals and charities are sceptical about the programme’s effect on people’s mental health, as they fear it may trigger people to have a negative relationship with their body image and food (disordered eating). Some studies show indirectly that these programmes are somewhat safe, however we do not know for sure if it could affect people’s relationship with food for the worse. We plan to investigate these concerns by inviting 154 people with T2D and disordered eating (picked up by questionnaires they will fill in) to participate in a trial. Of these people, 77 will get TDR and the rest will get their standard care. We will measure how their scores of disordered eating change at 1, 3, 4, 6 and 12 months. We also plan to explore and understand their experiences using TDR and their thoughts about eating and body image. This study will help shed light on how safe this type of diet is for people with disordered eating in a context where people are being closely monitored and could be given help, should eating disorders or other psychological problems emerge.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
23/LO/0633
Date of REC Opinion
22 Sep 2023
REC opinion
Further Information Favourable Opinion