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 |
| IRAS number | 296694 |
| Secondary identifying numbers | IRAS 296694 |
- 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
| Study design | Case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| 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 | Binge eating measured using the Gormally Binge Eating Scale (BES) at 3 months |
| Secondary outcome measures | 1. Binge cessation measured using the Eating Disorder Examination Questionnaire (EDEQ v6) at baseline, 3, and 6 months. 2. Eating disorder behaviours and psychopathology measured using the 28-item Eating Disorder Examination Questionnaire EDE-Q (v6) at baseline, 3, and 6 months 3. Mood measured using the Patient Health Questionnaire -9 (PHQ-9) and Generalized Anxiety Disorder -7 (GAD-7) at baseline, 3, and 6 months 4. Health related quality of life measured using the EQ5D-5L at baseline, 3, and 6 months 5. Physiological markers of diabetes measured using weight, height, and HbA1c from blood samples at baseline, 3, and 6 months, unless they have had a recent test within the past 4 weeks. 6. Engagement and drop-out measured using documentation of participant uptake, drop-out, and withdrawal and digital usage data collected between baseline and 6 months. The study will utilise advanced interaction and tracking technology will be used to identify detailed interactions of the participants with the online self-help materials. This will include (but is not limited to) access times, progress markers, repeat access of specific materials, frequency of access and progress throughout the guided sessions. The data will be used to derive usage patterns, a detailed understanding of engagement with the material, and to help understand where further help and support may be needed within the guided self-help programme. The data collection is automated with the triggers embedded within the learning content which will provide a good standard for data coherence. |
| Overall study start date | 01/12/2020 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
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
Sponsor information
University/education
Worsley Building
Clarendon Way
Leeds
LS2 9LJ
England
United Kingdom
| Phone | +44 (0)113-34-37587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The Chief Investigator is required to submit an annual study report to Diabetes UK which will include results from this first phase of our research (adaptation of the GSH intervention through co-design). This will be within 2 weeks of the anniversary of commencement of the grant period (including the 8 week pause - Due February 2022). A final report will then be produced within 6 weeks of the end of the grant period which will include results of phase 2 (the pilot trial) (Due February 2023). We propose to publish the results of our pilot trial in a peer-reviewed journal, along with a professionally produced YouTube animation summarising the results and easy-to-read summaries to disseminate to study participants. No participant-level data will be made available to participants. However, the full study report and protocol will be available on request from the Chief Investigator or Diabetes UK. We will use our PPI advisory group to inform dissemination activities. Diabetes UK recognises the benefits of making the results of research available as broadly as possible, including to people living with diabetes and their supporters. They therefore require grant holders to publish articles as open access within six months of their first publication. This will be done using the Green route i.e. the manuscript will be deposited in the White Rose Repository (available to members of Universities of Leeds, York, and Sheffield) and Europe PubMed Central. Diabetes UK will be acknowledged as a funder in all publications and presentations. The University of Leeds and grant holder (GTT) will give advanced notice of any press/media statement connected to the results of the grant and provide copies of all articles published. |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version 2 | 10/11/2021 | 22/11/2021 | No | Yes |
| Protocol file | version 2 | 10/11/2021 | 22/11/2021 | No | 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 |
| Results article | 11/11/2024 | 14/11/2024 | Yes | No |
Additional files
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.
