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

Sponsor

University of Oxford (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05744232

Collaborator

(none)

Enrollment

Arms

21.1

Anticipated Duration (Months)

Study Details

Study Description

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 and 12 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.

Condition or Disease	Intervention/Treatment	Phase
Type2diabetes Disordered Eating Obesity Overweight and Obesity Diet Habit	Behavioral: Low calorie total diet replacement Other: Usual care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official 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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention- Low calorie diet/ Total diet replacement 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 Summary Weeks 1-12: TDR phase Weeks 13-14: Food reintroduction phase I Weeks 15-16: Food reintroduction phase II Weeks 17 till 20: Food reintroduction phase III Weeks 21 till 24: Maintenance phase
Other: Control- usual care 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 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.

Arm

Intervention/Treatment

Experimental: Intervention- Low calorie diet/ Total diet replacement

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

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

Other: Control- usual care

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

Outcome Measures

Primary Outcome Measures

Global score of disordered eating psychopathology [24 weeks]
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.

Secondary Outcome Measures

Global score of disordered eating psychopathology [4, 12, 16, and 52 weeks]
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.
Subscales of disordered eating psychopathology [4, 12, 16, 24 and 52 weeks]
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.
Psychosocial impairment [4, 12, 16, 24 and 52 weeks]
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.
Weight [12, 24 and 52 weeks]
Changes between group, assessed by self-weighing

Other Outcome Measures

Changes in medication [12, 24 and 52 weeks]
Changes in diabetes medication between TDR and control
Changes in quality of life [12, 24 and 52 weeks]
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.
Process evaluation of significant changes in disorder eating psychopathology during the intervention [Through study completion, an average of 1 year]
Qualitative analysis of transcribed sessions with the dietitian in people with significant EDE-Q changes (more than 1 SD)
Safety/ New cases needing referral to specialist services [Through study completion, an average of 1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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
Soy or milk or fish allergy, lactose intolerance, or following a vegan diet
People currently participating in another study or clinical trial of a CTIMP/non-CTIMP

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Oxford

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Oxford

ClinicalTrials.gov Identifier:

NCT05744232

Other Study ID Numbers:

R82152/RE001

First Posted:

Feb 24, 2023

Last Update Posted:

Feb 24, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Obesity

Diabetes Mellitus, Type 2

Overweight

Study Results

No Results Posted as of Feb 24, 2023