Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000810718
Ethics application status
Approved
Date submitted
20/05/2022
Date registered
9/06/2022
Date last updated
9/06/2022
Date data sharing statement initially provided
9/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of addressing binge eating on weight management in people with obesity: A pilot service-evaluation of group-based guided self-help (GSH) for binge eating disorder in a specialist hospital-based obesity service
Scientific title
The impact of addressing binge eating on weight management in people with obesity: A pilot service-evaluation of group-based guided self-help (GSH) for binge eating disorder in a specialist hospital-based obesity service
Secondary ID [1] 307062 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 326205 0
Binge eating 326206 0
Condition category
Condition code
Diet and Nutrition 323513 323513 0 0
Obesity
Mental Health 323514 323514 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Guided self-help

Participants who screen positive for binge eating symptomology will be sent a patient information sheet inviting them to take part in the guided self-help group program to address binge eating. Those who decline this invitation and those who screen negative for binge eating symptomology will be offered appointments for the group weight management clinics (usual care).

We will utilise ‘Working to Overcome Eating Difficulties’. This is the name of the manual. It was designed specifically for this study. The authors of the manual are Dr Suzanne Heywood-Everett, Prof Andrew Hill and Ms Ursula Philpot from the University of Leeds. A printed hardcopy of the manual which includes a food diary as part of its content is provided to each participant. The program consists of seven 1 hour long group Zoom sessions, spread over 12 weeks. The first four sessions occur weekly, the next two fortnightly and the last session is 4 weeks later.

Group numbers are between six and eight participants. Attendance is recorded at each session. The strategy used to monitor adherence is the name of the participant is recorded.

The seven guide-facilitated group sessions reflect the seven sections in the manual. It starts with an introductory session that familiarises the participant with the program and establishes engagement. The following sessions address the following: eating disorders and this treatment approach; physical and psychological health; food and health, and unwanted behaviours; thoughts; learning to feel good about yourself and planning for the future.

The program is participant-led and the content based on the principles of cognitive behavioural therapy. Participants are requested to read and complete multiple exercises/tasks in the relevant sections prior to each session. The amount of time spent is up to the participant. It is anticipated to take no more than 1 hour to complete. Their guide (a dietitian) reviews the completions with the participants, discusses these, and helps troubleshoot any difficulties encountered in completing each section.

Participants then begin a weight loss program at the Metabolism & Obesity Service. The Metabolism & Obesity Service offers a lifestyle intervention program with a focus on diet, activity and lifestyle modification. This is a six 1 hour long group Zoom program that is conducted over 8 weeks. The first four sessions occur weekly, the next two fortnightly. These commence no longer than 1 month after the completion of the guided self-help program. They can wait and commence the next Metabolism & Obesity Service lifestyle intervention program if they choose to. This will mean waiting up to 3 months. The Metabolism & Obesity Service provides patient centred care. We are flexible and understanding to patients needs.

Attendance is recorded at each session. The strategy used to monitor adherence is the name of the participant is recorded. The program is presented by nursing and allied health therapists at the Metabolism & Obesity Service. They present upon the following topics: diet modifications for weight loss, lifestyle modifications for weight loss and activity. The activity content of the program is also presented via Zoom. Activity suggestions are presented on PowerPoint slides. It includes understanding the importance of exercise, the benefits of exercise, the role of exercise in weight loss and management, energy expenditure, types of exercise, exercise apparel, exertion scales, warming up and cooling down, apps and exercise to do at home.

After the group program, each patient is seen individually or in a group setting run by a therapist (dietitian, physiotherapist or nurse). This occurs around 3 months after starting the Metabolism & Obesity Service lifestyle intervention program. This means 12 weeks after they start the Metabolism & Obesity Service lifestyle intervention program. The Metabolism & Obesity Service takes patient centred care approach. Individual appointments are therefore at the discretion of the patient. The duration of individual appointments is dependent upon the clinical needs of the patient. Typically, the duration is 20 minutes to 1 hour. Patients are then followed up monthly for 2 years as or clinically appropriate.
Intervention code [1] 323516 0
Behaviour
Intervention code [2] 323703 0
Lifestyle
Comparator / control treatment
Usual care.

Patients begin a weight loss program at the Metabolism & Obesity Service. They do not complete the guided self-help program.

To recap, the Metabolism & Obesity Service offers a lifestyle intervention program with a focus on diet, exercise and lifestyle modification. This is a six 1 hour long group Zoom program that is conducted over 8 weeks. The first four sessions occur weekly, the next two fortnightly. Attendance is recorded at each session. The program is presented by nursing and allied health therapists at the Metabolism & Obesity Service. They present upon the following topics: diet modifications for weight loss, lifestyle modifications for weight loss and exercise. The exercise content of the program is also presented via Zoom. Exercise suggestions are presented on PowerPoint slides. After the group program, each patient is seen individually or in a group setting run by a therapist (dietitian, physiotherapist or nurse). This occurs around 3 months after starting the group program. The Metabolism & Obesity Service takes patient centred care approach. Individual appointments are therefore at the discretion of the patient. The duration of individual appointments is dependent upon the clinical needs of the patient. Typically, the duration is 20 minutes to 1 hour. Patients are then followed up monthly for 2 years as or clinically appropriate.
Control group
Active

Outcomes
Primary outcome [1] 331266 0
Weight change

This will be assessed from comparing the weight recorded from using electronic standing scales at the different timepoints and comparing it with the baseline weight. This comparison will also provide a percentage of weight change.
Timepoint [1] 331266 0
Baseline; this means before the Metabolism & Obesity Service weight management program begins. This does not mean prior to the guided self-help program.

At 3 months after the commencement of Metabolism & Obesity Service weight management program; this means at 12 weeks after the Metabolism & Obesity Service weight management program begins.

At 6 months after the commencement of Metabolism & Obesity Service weight management program; this means at 24 weeks after the Metabolism & Obesity Service weight management program begins.
Secondary outcome [1] 409361 0
Change in quality of life assessed by World Health Organization Quality of Life questionnaire (WHOQOL)
Timepoint [1] 409361 0
Baseline; this means before the Metabolism & Obesity Service weight management program begins. This does not mean prior to the guided self-help program.

At 3 months after the commencement of Metabolism & Obesity Service weight management program; this means at 12 weeks after the Metabolism & Obesity Service weight management program begins.

At 6 months after the commencement of Metabolism & Obesity Service weight management program; this means at 24 weeks after the Metabolism & Obesity Service weight management program begins.
Secondary outcome [2] 410124 0
Change in binge eating behaviours as assessed by the Binge Eating Disorder Screener (BEDS-7)
Timepoint [2] 410124 0
Baseline; this means before the Metabolism & Obesity Service weight management program begins. This does not mean prior to the guided self-help program.

At 3 months after the commencement of Metabolism & Obesity Service weight management program; this means at 12 weeks after the Metabolism & Obesity Service weight management program begins.

At 6 months after the commencement of Metabolism & Obesity Service weight management program; this means at 24 weeks after the Metabolism & Obesity Service weight management program begins.
Secondary outcome [3] 410125 0
Retention rates of the Metabolism & Obesity Service weight management program. Retention rates will be assesed by the attendance rates are recorded for each of the Metabolism & Obesity Service weight management program sessions.
Timepoint [3] 410125 0
The attendance rates for each of the Metabolism & Obesity Service weight management program sessions.

Eligibility
Key inclusion criteria
Participant inclusion criteria are: aged greater or equal to 18 years and a body mass index greater or equal to 30 kg/m2.

Participant inclusion criteria for the guided self-help group are: aged greater or equal to 18 years and a body mass index greater or equal to 30 kg/m2 and a positive screen for binge eating symptomology. The questionnaire used to confirm a positive screen is the Binge Eating Disorder Screener (BEDS-7). It is a 7-item measure designed to screen for binge eating disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions are: concurrent treatment for eating or weight problems; previous bariatric surgery; pregnancy; severe current psychiatric or medical conditions that would preclude full participation in the treatment (e.g. major depression, psychosis); insufficient English language skills to engage with the guided self-help program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be analysed for normality using the Shapiro-Wilk test. For within group changes, repeated measures ANOVA will be used. As well as an analysis of completers (those who attend the final guided self-help session), an intention to treat (ITT) analysis will also be included. For the ITT analysis, dropouts will be treated using a variety of sensitivity analyses. Longitudinal data analysis to examine the change of key outcomes over the study period and the impact of patient characteristics on key variables (such as adherence to guided self-help program, clinic treatment) will be conducted using the STATA statistical program.

We will also compare weight outcomes from the guided self-help group with those of patients who: (i) screened positive for binge eating symptomology but decline to participate and (ii) screened negative for binge eating symptomology at the time of study recruitment. For analysis of differences between these cohorts, an ANCOVA or the non-parametric equivalent will be used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/12/2021
Date of last participant enrolment
Anticipated
17/10/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
50
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22318 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 37479 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311366 0
Hospital
Name [1] 311366 0
Royal Price Alfred Hospital
Country [1] 311366 0
Australia
Primary sponsor type
Hospital
Name
Royal Price Alfred Hospital
Address
50 Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 312758 0
None
Name [1] 312758 0
Address [1] 312758 0
Country [1] 312758 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310859 0
Sydney Local Health District (SLHD) - RPA Zone
Ethics committee address [1] 310859 0
Ethics committee country [1] 310859 0
Australia
Date submitted for ethics approval [1] 310859 0
07/03/2019
Approval date [1] 310859 0
03/09/2019
Ethics approval number [1] 310859 0
STE00633

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119122 0
Prof Ian Caterson
Address 119122 0
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown
NSW 2050
Country 119122 0
Australia
Phone 119122 0
+61 2 9562 5607
Fax 119122 0
Email 119122 0
[email protected]
Contact person for public queries
Name 119123 0
Janet Franklin
Address 119123 0
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown
NSW 2050
Country 119123 0
Australia
Phone 119123 0
+61 2 9515 4220
Fax 119123 0
Email 119123 0
[email protected]
Contact person for scientific queries
Name 119124 0
Janet Franklin
Address 119124 0
Royal Prince Alfred Hospital
50 Missenden Road
Camperdown
NSW 2050
Country 119124 0
Australia
Phone 119124 0
+61 2 9515 4220
Fax 119124 0
Email 119124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval has not been sought to provide individual participant data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.