Investigating the feasibility and acceptability of providing online guided self-help for binge eating in adults with type 2 Diabetes
| ISRCTN | ISRCTN12377526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12377526 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 296694 |
| Protocol serial number | IRAS 296694 |
| Sponsor | University of Leeds |
| Funder | Diabetes UK |
- Submission date
- 19/11/2021
- Registration date
- 25/11/2021
- Last edited
- 14/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Binge eating has been identified as a significant problem in people living with type 2 diabetes. People who binge eat are more likely to have obesity, raised blood sugar, find losing weight harder, and experience poorer mental health. Early intervention is crucial for eating disorders. The National Institute for Health and Care Excellence (NICE) recommends Guided Self-Help (GSH) as the first line of treatment for adults with binge eating disorder. Members of the current research team have developed and provided evidence for a brief psychological treatment for disordered eating called guided self-help. The POSE-D study has adapted this so that it is suitable specifically to address binge eating in people living with type 2 diabetes.
The current study aims to test whether it is possible to recruit to and deliver the adapted brief psychological treatment to people with T2 diabetes and binge eating and to see whether the treatment is acceptable to both patients and Guides.
Who can participate?
We will invite adults from selected NHS sites across England (including GP practices, weight management, and diabetes services) to participate. Participants will be those living with type 2 diabetes, with experience of binge eating, and who speak English. People will not be able to take part if they are currently receiving psychological therapy, have had recent weight loss surgery, are low weight, or live with a learning disability, severe mental illness, or have hearing or sight difficulties.
What does the study involve?
Participants will be invited to take part in an online brief psychological treatment for binge eating. The treatment comprises 7 online sessions, delivered over 3- months with tasks to complete between sessions which will be supported remotely by a trained Guide. Participants will complete questionnaires asking them about their eating, mood, and quality of life on three occasions: before, immediately after, and at 3 months after the treatment. Participants will also be asked to visit their GP at the same time points for a blood sugar test (HbA1c) and to measure their height and weight. Both participants and Guides may be invited to be interviewed to talk about their experiences of the adapted treatment.
What are the possible benefits and risks of participating?
Taking part may help people living with type 2 diabetes gain better control over their eating. They may also experience improvements in mood, weight, and blood sugar control. Participant feedback will help to refine the Guided Self-Help treatment and so it will benefit others who are living with Type 2 diabetes and have difficulties controlling their eating.
However, the topic is sensitive, so there is a small chance that participants might feel uncomfortable talking about some of the issues relating to eating and mood.
Where is the study run from?
University of Leeds (UK)
When is the study starting and how long is it expected to run for?
December 2020 to October 2023
Who is funding the study?
Diabetes UK (UK)
Who is the main contact?
Dr Gemma Traviss-Turner
G.Traviss@leeds.ac.uk
Contact information
Scientific
Leeds Institute of Health Sciences
Level 10 Worlsey Building
Leeds
LS2 9LJ
United Kingdom
 ORCID ID |
0000-0002-1770-6216 |
|---|---|
| Phone | +447786857747 |
| g.traviss@leeds.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Case series |
| Secondary study design | Non randomised study |
| Participant information sheet | 40697_PIS_v2_10Nov21.pdf |
| Scientific title | Providing Online guided Self-help for Eating disorders in adults with type 2 Diabetes (POSE-D): a pilot study |
| Study acronym | POSE-D |
| Study objectives | 1. To test the feasibility of recruiting and delivering an online guided self-help intervention for people with T2 diabetes and binge eating 2. To determine the acceptability of the intervention from both a participant and Guide perspective |
| Ethics approval(s) | Approved 18/02/2022, Yorkshire & Humber Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048170; leedseast.rec@hra.nhs.uk), ref: 22/YH/0016 |
| Health condition(s) or problem(s) studied | Management of binge eating in adults with Type 2 diabetes |
| Intervention | All participants will be offered the intervention. It comprises a 7 session guided self-help intervention completed over 3 months, accessed online, and supported in 7 x 1 h sessions via Zoom (or similar), phone or email by Guides (dieticians or other health professionals). Participants will complete the interactive materials for each section prior to seeing their Guide. Guides will receive mandatory training prior to supporting the intervention, by the research team and regular supervision during the intervention |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Binge eating measured using the Gormally Binge Eating Scale (BES) at 3 months |
| Key secondary outcome measure(s) |
1. Binge cessation measured using the Eating Disorder Examination Questionnaire (EDEQ v6) at baseline, 3, and 6 months. |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. T2 diabetes diagnosis 2. Experience of binge eating within last 6 months 3. Aged ≥18 years 4. English literate |
| Key exclusion criteria | 1. Current treatment for eating disorder 2. Current psychological therapy 3. Bariatric surgery in last 6 months 4. BMI <18 kg/m² 5. Identify as living with a learning disability 6. Severe mental illness 7. Hearing or visual impairment 8. Unable to speak English |
| Date of first enrolment | 13/06/2022 |
| Date of final enrolment | 04/04/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
8 Victoria Road
Leeds
LS6 1PF
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Victoria Road
Shipley
Bradford
BD18 3LD
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
West Park Hospital
Edward Pease Way
Darlington
DL2 2TS
United Kingdom
Sheffield
S10 2SB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the Chief Investigator Dr Gemma Traviss-Turner (G.Traviss@leeds.ac.uk). Both quantitative data from questionnaires and qualitative data from interviews will be anonymised. Data will only be shared for research purposes for further analysis, at aggregated level for reviews or related studies as outlined in the informed consent form. All files will be encrypted. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/11/2024 | 14/11/2024 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | Adapting the existing evidence-based guided self-help intervention to online remote delivery to address binge eating in adults with T2D | 03/04/2023 | 14/11/2024 | Yes | No |
| Participant information sheet | version 2 | 10/11/2021 | 22/11/2021 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 2 | 10/11/2021 | 22/11/2021 | No | No |
Additional files
- 40697_Protocol_V2_10Nov21.pdf
- Protocol file
- 40697_PIS_v2_10Nov21.pdf
- Participant information sheet
Editorial Notes
14/11/2024: Publication references added.
09/01/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2023 to 31/10/2023.
2. The intention to publish date was changed from 31/01/2024 to 30/04/2024.
3. The plain English summary was updated to reflect these changes.
16/08/2023: The contact confirmed the record is up to date.
15/05/2023: Total final enrolment added.
12/05/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2022 to 04/04/2023.
2. The overall study end date was changed from 31/03/2023 to 31/08/2023.
3. Leeds Teaching Hospitals NHS Trust, Southern Health NHS Foundation NHS Trust, Royal Devon and Exeter NHS Foundation Trust, and Portsmouth Hospitals University NHS Trust were removed from the study participating centres.
24/05/2022: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/01/2022 to 13/06/2022.
2. The recruitment end date was changed from 31/10/2022 to 31/12/2022.
3. The overall study end date was changed from 31/01/2023 to 31/03/2023.
4. The plain English summary was updated to reflect these changes.
5. The ethics approval was added.
26/11/2021: Internal review.
22/11/2021: Trial’s existence confirmed by Diabetes UK.
