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The NHS has started a trial-run of a weight loss programme replacing food with 800-calorie shakes and soups for 3 months, offered to people with newly diagnosed type 2 diabetes (T2D) to lose weight and put their diabetes into remission. Some healthcare professionals and charities are sceptical about the programme's effect on people's mental health. They fear it may trigger people to have a negative relationship with food (disordered eating). Some studies show indirectly that these programmes are somewhat safe; however it is not known for sure if it could affect people's relationship with food for the worse. Investigators will invite 56 people with T2D and disordered eating (picked up by questionnaires they will fill in) to participate in a trial. Of these participants, 28 will get TDR and the rest will get their standard care. Investigators will then measure how their scores of disordered eating change at 1, 3, 4, 6, 12 and 24 months. Investigators also plan to analyse the recorded sessions to better understand participants' 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. It may lead to screening for eating disorders if TDR becomes standard care. If concerns are unfounded, it can reassure people with type 2 diabetes and healthcare professionals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention- Low calorie diet/ Total diet replacement | Experimental | Participants in the intervention group will be offered a dietitian-delivered intervention over 6 months, similar to the NHS pilot of low calorie diets for type 2 diabetes remission. The intervention starts with 12 weeks of low-energy total diet replacement (approx. 860 kcal/day) in a nutritionally replete package of soups, shakes, and bars. It continues with stepped food reintroduction (maximum 6 weeks) as a low-calorie, nutrient-rich diet personalised to the individual participant circumstances and preferences, and weight maintenance (6 weeks). |
|
| Control- usual care | Other | Participants allocated to the control group will be offered and continue benefiting from standard care. Participants will not be stopped from pursuing any behavioural weight management programme but if they do, this will be recorded. Participants will be offered an invitation to a 30-45' 1:1 session with the research dietitian at the end of the study to provide help and signposting as required for the management of their diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low calorie total diet replacement | Behavioral | Summary
|
| Measure | Description | Time Frame |
|---|---|---|
| Global score of disordered eating psychopathology | Between group difference in scores of disordered eating psychopathology, as measured by the global score of the self-administered Eating Disorders Examination questionnaire (EDE-Q). Scores range from 0 to 6, with higher scores indicating more severe eating disorders psychopathology. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Global score of disordered eating psychopathology | Between group difference in scores of disordered eating psychopathology, as measured by the global score of the self-administered Eating Disorders Examination questionnaire (EDE-Q). Scores range from 0 to 6, with higher scores indicating more severe eating disorders psychopathology. | 4, 12, 16, 52 and 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in medication | Changes in diabetes medication between TDR and control | 12, 24, 52 and 104 weeks |
| Changes in quality of life | Between group difference in quality of life, measured by the Problem Areas In Diabetes (PAID) Scale. PAID is used to measure distress related to emotions, treatment, food and social support in living with diabetes. Scores range from 0 to 100, with higher scores indicating higher diabetes distress. |
Inclusion Criteria:
Exclusion Criteria:
The participant must not enter the study if ANY of the following apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuffield Department of Primary Care Health Sciences | Oxford | Oxford | OX26GG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40506207 | Derived | Tsompanaki E, Aveyard P, Park RJ, Jebb SA, Koutoukidis DA. An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial. Lancet Psychiatry. 2025 Jul;12(7):483-492. doi: 10.1016/S2215-0366(25)00126-9. | |
| 38685400 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D005247 | Feeding Behavior |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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An independent member of the research team, who will not be delivering the intervention or conducting baseline or follow-up assessments, will do the randomisation by inputting the data onto the software. The research team will then notify the participant of their allocation group and further steps.
Due to the nature of the intervention and the control group, blinding of the participants and the researchers to the intervention is not possible. However, the assessment of the primary outcome will be blinded, as questionnaires will be self-administered online. The PIS will present the study to participants in a more general context, focusing on the impact of total diet replacement on well-being, without mentioning disordered eating, as this could predispose participants in their questionnaire answers and heavily affect the outcomes of this study, introducing measurement bias and weakening the conclusions drawn.
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| Usual care | Other | Participants allocated to the control group will be offered and continue benefiting from standard care. Participants will not be stopped from pursuing any behavioural weight management programme but if they do, this will be recorded. |
|
| Subscales of disordered eating psychopathology | Between group difference in sub-scale scores of disordered eating, assessed by the subscale scores of Eating Disorders Examination questionnaire (EDE-Q): Restraint, Eating concern, Shape concern, Weight concern. Subscale scores reflect the severity of the specific characteristics of disordered eating. Higher scores in each subgroup indicate more severe psychopathology. | 4, 12, 16, 24, 52 and 104 weeks |
| Psychosocial impairment | Between group difference in psychosocial impairment, assessed by the self-administered clinical impairment assessment (CIA) questionnaire. The CIA measures the severity of psychosocial impairment due to eating disorder features, and scores range from o to 48, with higher scores indicating more severe impairment. | 4, 12, 16, 24, 52 and 104 weeks |
| Weight | Changes between group, assessed by self-weighing | 4, 12, 16, 24, 52 and 104 weeks |
| 12, 24, 52 and 104 weeks |
| Process evaluation of significant changes in disorder eating psychopathology during the intervention | Qualitative analysis of transcribed sessions with the dietitian in people with significant EDE-Q changes (more than 1 SD) | Through study completion, an average of 2 years |
| Safety/ New cases needing referral to specialist services | To examine the safety signals of TDR in people with disordered eating, by collecting the incidence of cases of high suspicion of a new eating disorder, measured by referral of participant to see their GP for further referral to specialist services | Through study completion, an average of 1 year |
| Tsompanaki E, Aveyard P, Park RJ, Koutoukidis DA. The impact of low-energy total diet replacement with behavioural support for remission of type 2 diabetes on disordered eating (ARIADNE): Protocol for a non-inferiority randomised controlled trial. Contemp Clin Trials. 2024 Jul;142:107542. doi: 10.1016/j.cct.2024.107542. Epub 2024 Apr 27. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001522 | Behavior, Animal |
| D001519 | Behavior |