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Trial registered on ANZCTR


Registration number
ACTRN12615000807550
Ethics application status
Approved
Date submitted
19/07/2015
Date registered
4/08/2015
Date last updated
4/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the efficacy of cognitive-behavioral guided self-help and health at every size guided self-help for disordered eating.
Scientific title
A randomized controlled trial of the effects of cognitive-behavioural vs. health at every size guided self-help on symptoms of subclinical disordered eating in Australian adults.
Secondary ID [1] 287104 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered eating 295627 0
Condition category
Condition code
Mental Health 295906 295906 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a randomised controlled trial (RCT) of two psychological interventions for disordered eating. The proposed study targets both males and females aged between 18 and 65 years.
The interventions include:
Cognitive-behavioural guided self-help (CBT G-SH) is one intervention based on the self-help manual, Overcoming Binge Eating (Fairburn, 2013), which has received considerable empirical support for reducing eating disorder behaviours and cognitions. It is a program designed to target the cognitive, behavioural and emotional processes that maintain the core symptoms of eating disorders. There are 8 serial steps in this program that are designed to modify dysfunctional eating disorder cognitions (e.g. extreme concerns about weight and shape) and behaviours (e.g. restrictive dieting and binge eating). For this program, there will be 8 sessions that run over 10 weeks. The first 2 weeks of the program will enable participants to read the first half of the book – a psychoeducation section that teaches people about the nature of dieting and binge eating. The remaining 8 weeks will be devoted to the treatment program. Participants will meet face to face weekly with a provisional clinical psychologist who will guide them through the program. Sessions will take between 35-50 minutes, and participants will get a chance to review their progress, discuss any obstacles to change, and discuss any challenges they are having with the program. To monitor adherence to the program, a visual analogue scale will be used to ask participants to indicate their level adherence over the preceding week. Lack of adherence to the program will allow the facilitator to discuss any potential barriers to adherence while also allowing for discussion of strategies that might facilitate adherence in successive sessions.
Intervention code [1] 292348 0
Behaviour
Intervention code [2] 292440 0
Treatment: Other
Comparator / control treatment
The comparative treatment includes a non-dieting Health at Every Size (HAES) guided self-help intervention, based on the book ‘If not dieting, then what?” by Dr Rick Kausman. This book contains psychoeducation chapters that explains the nature and link between body image and self-evaluation, dieting, reasons for ‘non-hungry eating’, and the evidence for the long-term success of current weight-loss methods. In addition several interrelated techniques are provided in this book that help participants (1) reduce their disinhibited/binge eating by helping people eat mindfully, (2) reduce the negative body image people have by teaching people to appreciate the diversity of body shape (3) to eliminate restrictive dieting and food avoidance by helping people develop a positive relationship with food. There will be 8 face to face sessions of this program, run by a provisional clinical psychologist, that last a total of 10 weeks. The first two weeks participants will get a chance to read the entire book before they start implementing the techniques. The following 8 weeks will allow both facilitator and participant to go through individual modules outlined in the chapters. During sessions, which lasts between 35-50 minutes, participants will be educated about nutrition principles and importance of regular (enjoyable) physical activity, the importance of disentangling feelings of self-worth from their weight and shape and getting in touch with their physiological hunger and satiety cues. Opportunities to discuss barriers to change and challenges to the intervention will also be discussed in session. This is consistent with other HAES interventions on weight-preoccupied individual (e.g. Bacon Stern, Van Loan, & Keim, 2005). To monitor adherence to the program, a visual analogue scale will be used to ask participants to indicate their level adherence. Lack of adherence to the program will allow the facilitator to discuss any potential barriers to adherence while also allowing for discussion of strategies that might facilitate adherence in successive sessions.
Control group
Active

Outcomes
Primary outcome [1] 295593 0
Eating disorder psychopathology, assessed by the Eating Disorder Examination Questionnaire (EDE-Q) Global Score
Timepoint [1] 295593 0
Baseline, post-treatment, 6 month follow-up and 24 month follow-up
Primary outcome [2] 295594 0
Objective Binge Eating abstinence: Assessed by an individual item on the EDE-Q - 'on how many days have you consumed what others would regard as unusually large amount of food, and of these days is there a sense of loss of control"?
Timepoint [2] 295594 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [1] 315932 0
Mean AQoL (Assessment of quality of life) and short-form-36 scores.
Timepoint [1] 315932 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [2] 315933 0
Mean depression and anxiety subscale scores on the depression anxiety stress scale.
Timepoint [2] 315933 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [3] 315934 0
Mean dichotomous thinking in eating disorder scale scores
Timepoint [3] 315934 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [4] 315935 0
Mean disinhibition subscale scores on the three factor eating questionnaire
Timepoint [4] 315935 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [5] 315936 0
Mean clinical impairment questionnaire scores (Clinical Impairment Questionnaire)
Timepoint [5] 315936 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [6] 315937 0
Mean total intuitive eating scores on the Intuitive Eating Scale-2
Timepoint [6] 315937 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [7] 315938 0
Mean body appreciation scores
Timepoint [7] 315938 0
Baseline, post-treatment, 6 month follow up and 24 month follow up
Secondary outcome [8] 316206 0
Change in dietary restraint over preceding 7 days (assessed by a single item on the EDE-Q 'Have you deliberately tried to limit the amount of food you eat to influence your weight or shape'?)
Timepoint [8] 316206 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [9] 316207 0
Change in objective binge eating episodes over the past 7 days (Assessed by single item on the EDE-Q 'on how many days have you consumed what others would regard as unusually large amount of food, and of these days is there a sense of loss of control")
Timepoint [9] 316207 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [10] 316208 0
Change in shape concern over prior 7 days (assessed by single item on the EDE-Q; 'How dissatisfied have you been with your shape'?)
Timepoint [10] 316208 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [11] 316209 0
Change in weight concern over prior 7 days (assessed by single item on the EDE-Q; 'How dissatisfied have you been with your weight?)
Timepoint [11] 316209 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [12] 316212 0
Change in eating behaviour self-efficacy (assessed by single item on the Eating Behaviour Self-efficacy Scale 'how difficult is it to control our overeating')
Timepoint [12] 316212 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [13] 316213 0
Regular eating adherence, assessed by daily recall of number of snacks and meals consumed
Timepoint [13] 316213 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [14] 316214 0
Change in motivation for exercise in past 7 days (assessed by individual item on the Exercise motivation inventory 'I exercise for enjoyment')
Timepoint [14] 316214 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [15] 316215 0
Change in intuitive eating in past 7 days (assessed by single item on the Intuitive Eating Scale-2 'I rely on my hunger and satiety cues to tell me when to eat')
Timepoint [15] 316215 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [16] 316216 0
Change in body appreciation in past 7 days (assessed by single item on the body appreciation scale 'I feel good about my body')
Timepoint [16] 316216 0
Session 1, 2, 3, 4, 5, 6, 7, 8
Secondary outcome [17] 316233 0
Frequency of weight checking in prior 7 days (assessed by participant recall)
Timepoint [17] 316233 0
Session 1, 2, 3, 4, 5, 6, 7, 8

Eligibility
Key inclusion criteria
Inclusion criteria includes: age between 18-65 years, exhibit symptoms of disordered eating that are not of clinical severity (i.e. objective and subjective binge eating occurring less than once per week over prior 3 months; Eating disorder examination questionnaire global score < 4), can meet the requirements for face to face contact.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes: Age <18 years and >65 years, any DSM-5 psychiatric disorder, unable to complete the full duration of treatment, pregnancy, seeking psychological treatment concurrently, BMI<18.5.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/08/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 291672 0
University
Name [1] 291672 0
Australian Catholic University
Country [1] 291672 0
Australia
Primary sponsor type
Individual
Name
Jake Linardon
Address
School of psychology
Australian Catholic University
Level 5,17 Young Street,
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 290349 0
Individual
Name [1] 290349 0
A/Prof Leah Brennan
Address [1] 290349 0
School of psychology
Australian Catholic University
Level 5,17 Young Street,
Fitzroy VIC 3065
Country [1] 290349 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293204 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 293204 0
Ethics committee country [1] 293204 0
Australia
Date submitted for ethics approval [1] 293204 0
Approval date [1] 293204 0
16/07/2015
Ethics approval number [1] 293204 0
2015-58H

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

Contacts
Principal investigator
Name 58846 0
A/Prof Leah Brennan
Address 58846 0
School of psychology
Australian Catholic University
Level 5, The Daniel Mannix Building,
17 Young Street,
Fitzroy, VIC 3065
Country 58846 0
Australia
Phone 58846 0
+613 9953 3662
Fax 58846 0
Email 58846 0
[email protected]
Contact person for public queries
Name 58847 0
Jake Linardon
Address 58847 0
School of psychology
Australian Catholic University
Level 5, The Daniel Mannix Building,
17 Young Street,
Fitzroy, VIC 3065
Country 58847 0
Australia
Phone 58847 0
+613 9230 8073
Fax 58847 0
Email 58847 0
[email protected]
Contact person for scientific queries
Name 58848 0
Leah Brennan
Address 58848 0
School of psychology
Australian Catholic University
Level 5, The Daniel Mannix Building,
17 Young Street,
Fitzroy, VIC 3065
Country 58848 0
Australia
Phone 58848 0
+613 9953 3662
Fax 58848 0
Email 58848 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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