Back to resultsARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing
Primary Purpose
Type2diabetes, Disordered Eating, Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Low calorie total diet replacement
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Type2diabetes
Eligibility Criteria
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
Sites / Locations
- Nuffield Department of Primary Care Health SciencesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention- Low calorie diet/ Total diet replacement
Control- usual care
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Weight
Changes between group, assessed by self-weighing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05744232
Brief Title
ARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Disordered Eating, Obesity, Overweight and Obesity, Diet Habit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention- Low calorie diet/ Total diet replacement
Arm Type
Experimental
Arm Description
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).
Arm Title
Control- usual care
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low calorie total diet replacement
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Global score of disordered eating psychopathology
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Global score of disordered eating psychopathology
Description
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.
Time Frame
4, 12, 16, and 52 weeks
Title
Subscales of disordered eating psychopathology
Description
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.
Time Frame
4, 12, 16, 24 and 52 weeks
Title
Psychosocial impairment
Description
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.
Time Frame
4, 12, 16, 24 and 52 weeks
Title
Weight
Description
Changes between group, assessed by self-weighing
Time Frame
12, 24 and 52 weeks
Other Pre-specified Outcome Measures:
Title
Changes in medication
Description
Changes in diabetes medication between TDR and control
Time Frame
12, 24 and 52 weeks
Title
Changes in quality of life
Description
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.
Time Frame
12, 24 and 52 weeks
Title
Process evaluation of significant changes in disorder eating psychopathology during the intervention
Description
Qualitative analysis of transcribed sessions with the dietitian in people with significant EDE-Q changes (more than 1 SD)
Time Frame
Through study completion, an average of 1 year
Title
Safety/ New cases needing referral to specialist services
Description
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
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Tsompanaki, MSc
Phone
+ 44 (0)1865289669
Email
elena.tsompanaki@phc.ox.ac.uk
Facility Information:
Facility Name
Nuffield Department of Primary Care Health Sciences
City
Oxford
ZIP/Postal Code
OX26GG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Tsompanaki, MSc
Phone
01865289669
Email
elena.tsompanaki@phc.ox.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
ARIADNE: A Study of Weight Loss for Diabetes Treatment and Wellbeing
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