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Trial registered on ANZCTR


Registration number
ACTRN12615001250527
Ethics application status
Approved
Date submitted
9/11/2015
Date registered
16/11/2015
Date last updated
4/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an online prevention and early intervention program for young people at risk for eating disorders: a randomised controlled trial
Scientific title
Examining the effectiveness of ProYouth OZ with and without peer support compared to a wait-list control condition in reducing eating disorder attitudes and behaviours among young people at risk for eating disorders
Secondary ID [1] 287817 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eating disorders 296695 0
Condition category
Condition code
Mental Health 296930 296930 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project involves a three-arm randomised controlled trial that aims to evaluate the effectiveness of the Internet-based prevention and early intervention program ProYouth OZ in reducing weight and shape concerns and/or eating disorder symptoms in young people. An additional aim of this project is to examine whether the addition of synchronous online peer-to-peer support (i.e. Internet-based chat sessions in a group format) increases treatment effectiveness.

Arm 1
Participants will receive access to the ProYouth OZ website for 6 weeks allowing them to read comprehensive information on eating disorders and access the monitoring and feedback system that aims at monitoring eating disorder related symptoms and providing early minimal intervention with supportive feedback. In addition participants will have access to the online peer-to-peer support component, i.e. attending weekly 1hour moderated group chats to interact with peers for a period of 6 weeks. The chats will be delivered by a trained PhD Psychology student who has several years of experience in delivering online group chats.

Self-Monitoring
The participants will have access to the monitoring and feedback system that aims to monitor eating disorder related symptoms, to detect symptom elevation early and to provide early minimal intervention with supportive feedback. Participants can be tracked closely over time and receive supportive feedback on the four dimensions of: 1) body dissatisfaction, 2) body weight and shape concerns 3) balanced diet and nutrition 4) binges and compensatory behaviours. In the case of deterioration, messages are provided that express concern and give advice on how to counteract negative development in their eating behaviour and weight and shape attitudes. Positive feedback reinforces healthy eating behaviours and improvements. If participants report severe deterioration during this monitoring process, they automatically receive an email advising them to seek more intensive face-to-face help.

Arm 2
Participants in this condition will receive ProYouth OZ as described above without the peer-to-peer support component.

Arm 3
The control group will be placed on the waitlist until the intervention period and the first follow-up (3 months) is complete. Then participants in the control condition will be provided with access to the program delivered to Arm 2.

Adherence to the intervention will be measured by monitoring number of logins to the program and number of attended chat sessions.
Intervention code [1] 293208 0
Prevention
Comparator / control treatment
The control group will be placed on the waitlist until the intervention period and the first follow-up (3 months) is complete. Then participants in the control condition will be provided with access to the program delivered to Arm 2.
Control group
Active

Outcomes
Primary outcome [1] 296543 0
Eating disorder attitudes assessed with the total score of the EDE-Q (Eating Disorder Examination Questionnaire)
Timepoint [1] 296543 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [1] 318757 0
Body image assessed using the Body Shape Questionnaire - Short Form
Timepoint [1] 318757 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [2] 318759 0
Weight and shape concerns assessed using the Weight Concern Scale (WCS). This is a composite.
Timepoint [2] 318759 0
Screening, Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [3] 318760 0
Eating disorder behaviours assessed using the Short Evaluation of Eating Disorders (SEED)
Timepoint [3] 318760 0
Screening, baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [4] 318761 0
Stages of change assessed using the Stages of Change Questionnaire for Eating Disorder Symptoms (SOCQ-ED)
Timepoint [4] 318761 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [5] 318762 0
Quality of life assessed using the EURhisQoL-8
Timepoint [5] 318762 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [6] 318763 0
Social support assessed using the MOS-SS Subscale 1 (emotional/informational)
Timepoint [6] 318763 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [7] 318764 0
Loneliness assessed using the UCLA Loneliness Scale
Timepoint [7] 318764 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [8] 318765 0
Self-esteem assessed using the Rosenberg Self-Esteem Scale
Timepoint [8] 318765 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [9] 318766 0
Depression symptoms assessed using the Patient Health Questionnaire (PHQ-4)
Timepoint [9] 318766 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [10] 318767 0
Help-seeking intentions assessed using the General Help Seeking Questionnaire (GHSQ)
Timepoint [10] 318767 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up
Secondary outcome [11] 318791 0
Help-seeking attitudes assessed using the Attitudes towards seeking Professional Psychological Help Questionnaire - Short Form (ATSPPH-SF).
Timepoint [11] 318791 0
Baseline, post intervention (6 weeks), 3-, 6-, 12-months follow up

Eligibility
Key inclusion criteria
Aged between 18 and 25, having a score of score of >57 on the on the Weight Concern Scale (WCS), having subclinical behavioural symptoms of an eating disorder (e.g., binge eating, vomiting, use of laxatives) according to the Short Evaluation of Eating Disorders (SEED), having regular Internet access, comfortable with using the Internet, no vision or reading problems and a willingness to participate in weekly online group chats and provide an email address.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who meet the diagnostic criteria for an eating disorder (according to the self-report screening), or who indicate that they are currently in treatment for an eating disorder will be excluded from the study. Participants who self-report a diagnosis of an eating disorder, a substance-related disorder, post-traumatic stress disorder, schizophrenia, or a personality disorder will also be excluded.


Study design
Purpose of the study
Prevention
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
22/02/2016
Actual
10/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
229
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 292341 0
University
Name [1] 292341 0
The Australian National University
Country [1] 292341 0
Australia
Primary sponsor type
University
Name
The Australian National University
Address
63 Eggleston Road
Canberra ACT 0200
Country
Australia
Secondary sponsor category [1] 291020 0
Other Collaborative groups
Name [1] 291020 0
Young and Well Cooperative Research Center
Address [1] 291020 0
17/71 Victoria Cres
Abbotsford VIC 3067
Country [1] 291020 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293806 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 293806 0
The Australian National University
Canberra ACT 2601
Ethics committee country [1] 293806 0
Australia
Date submitted for ethics approval [1] 293806 0
11/11/2015
Approval date [1] 293806 0
18/01/2016
Ethics approval number [1] 293806 0
2015/742

Summary
Brief summary
This project involves a three-arm randomised controlled trial that aims to evaluate the effectiveness of the Internet-based prevention and early intervention program ProYouth OZ in reducing weight and shape concerns and/or eating disorder symptoms in young people. An additional aim of this project is to examine whether the addition of synchronous online peer-to-peer support (i.e. Internet-based chat sessions in a group format) increases treatment effectiveness.

The project has several aims:

(1) To examine the effectiveness of ProYouth OZ compared to a wait-list control condition on a range of outcomes including eating disorder attitudes and behaviours, barriers towards seeking help, self-esteem, symptoms of depression and anxiety, quality of life, and social support.
(2) To examine the effectiveness of ProYouth OZ with online peer support compared to ProYouth OZ without peer support on a range of outcomes including eating disorder attitudes and behaviours, barriers towards seeking help, self-esteem, symptoms of depression and anxiety, quality of life, and social support.
(3) To explore engagement, adherence and use of the online peer-to-peer support groups.
(4) To examine and compare users satisfaction of ProYouth OZ with and without online peer support.
Trial website
http://cmhr.anu.edu.au/research/projects/proyouth-oz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61386 0
Ms Kathina Ali
Address 61386 0
National Institute for Mental Health Research (NIMHR)
Research School of Population Health
The Australian National University
63 Eggleston Rd
Canberra ACT 2601
Country 61386 0
Australia
Phone 61386 0
+61 2 6125 9155
Fax 61386 0
Email 61386 0
[email protected]
Contact person for public queries
Name 61387 0
Kathina Ali
Address 61387 0
National Institute for Mental Health Research (NIMHR)
Research School of Population Health
The Australian National University
63 Eggleston Rd
Canberra ACT 2601
Country 61387 0
Australia
Phone 61387 0
+61 2 6125 9155
Fax 61387 0
Email 61387 0
[email protected]
Contact person for scientific queries
Name 61388 0
Kathina Ali
Address 61388 0
National Institute for Mental Health Research (NIMHR)
Research School of Population Health
The Australian National University
63 Eggleston Rd
Canberra ACT 2601
Country 61388 0
Australia
Phone 61388 0
+61 2 6125 9155
Fax 61388 0
Email 61388 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

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