ARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing

NCT05744232 | Active Not Recruiting DMC

• 1 other identifier: R82152/RE004
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2diabetes; Disordered Eating; Obesity; Overweight and Obesity; Diet Habit

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Global score of disordered eating psychopathology

  4, 12, 16, 52 and 104 weeks

• Subscales of disordered eating psychopathology

  4, 12, 16, 24, 52 and 104 weeks

• Psychosocial impairment

  4, 12, 16, 24, 52 and 104 weeks

• Weight

  4, 12, 16, 24, 52 and 104 weeks

Other Outcomes (4)

• Changes in medication

  12, 24, 52 and 104 weeks

• Changes in quality of life

  12, 24, 52 and 104 weeks

• Process evaluation of significant changes in disorder eating psychopathology during the intervention

  Through study completion, an average of 2 years

Study Arms (2)

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).

Behavioral: Low calorie total diet replacement

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.

Other: Usual care

Interventions

Low calorie total diet replacement BEHAVIORAL

Summary 1. Weeks 1-12: TDR phase 2. Weeks 13-14: Food reintroduction phase I 3. Weeks 15-16: Food reintroduction phase II 4. Weeks 17 till 20: Food reintroduction phase III 5. Weeks 21 till 24: Maintenance phase

Intervention- Low calorie diet/ Total diet replacement

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.

Control- usual care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give informed consent, can communicate in English
• Age between 18 and 65 years inclusive
• Live in England
• BMI ≥27 kg/m2 or higher (adjusted to ≥25 kg/m2 for people of Black, Asian and minority ethnic origin)
• Diagnosed with T2D within 6 years prior to the day of screening
• Global EDE-Q scores ≥2.67
• To have an HbA1c taken in the last 12 months
• Latest HbA1c ≥43 mmol/mol (6.1%) and ≤87 mmol/mol (10%) if on diabetes medication OR latest hbA1c ≥ 48 mmol/mol (6.5%) and ≤87 mmol/mol (10%), if not on diabetes medication.
• If diagnosed with type 2 diabetes more than 1 year since day of screening, the participant must have attended their GP surgery for monitoring/ diabetes review when last offered
• Commit to continue annual reviews with their GP, even if T2D remission is achieved

You may not qualify if:

• The participant must not enter the study if ANY of the following apply:
• Current or previous clinical diagnosis of an eating disorder
• Combination of EDE-Q ≥4 AND a CIA score ≥16 at screening
• Currently participating in a structured weight loss programme or self-reporting that they have lost \>10% of their body weight in the last 3 months
• Insulin use
• Known kidney disease of stage 3/4/5 or eGFR \<60 mls/min/1.73 m2 within the last 12 months
• Active substance use disorder
• Active cancer other than skin cancer
• Known proliferative retinopathy that has not been treated
• Porphyria
• Undergone or is awaiting bariatric surgery
• Myocardial infarction or stroke within previous 6 months
• Severe heart failure defined as equivalent to the New York Heart Association (NYHA) grade 3 or 4
• Active liver disease (not including non-alcoholic fatty liver disease)
• Pregnant, breastfeeding, or planning to become pregnant during the course of the study

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Nuffield Department of Primary Care Health Sciences

Oxford, Oxford, OX26GG, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40506207 DERIVED

• 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.

  PMID: 38685400 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Feeding Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 24, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-08

Locations

GB (1)