Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001258842
Ethics application status
Approved
Date submitted
29/11/2012
Date registered
29/11/2012
Date last updated
29/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bread n' Butter... Gluten Free of Course! An online intervention to improve gluten free diet adherence, coping, and quality of life in coeliac disease
Scientific title
Bread n' Butter... Gluten Free of Course! An online intervention to improve gluten free diet adherence, coping, and quality of life in coeliac disease
Secondary ID [1] 281600 0
Nil
Universal Trial Number (UTN)
U1111-1137-4677
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease 287883 0
Condition category
Condition code
Oral and Gastrointestinal 288253 288253 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 288264 288264 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Six online modules to be completed over six weeks. Each module takes approximately 30 minutes to complete and involves participants engaging with an interactive computer program to apply the target skills to their own examples of target problems. Module 1: label reading skills
Module 2: problem solving skills
Module 3: communication skills
Module 4: cognitive challenging skills
Module 5: goal setting skills
Module 6: summary module
AT the end of each module participants are required to set specific plans for how they will practice the skills prior to completion of the next module. Plans are reviewed at the beginning of each subsequent module and participants asked to identify the factors which either facilitated their performance or acted as barriers to carrying out their plans.
Intervention code [1] 286127 0
Behaviour
Intervention code [2] 286139 0
Treatment: Other
Comparator / control treatment
Waitlist control condition: immediately after completing the post-survey (8 weeks after baseline) participants in the waitlist group will be given access to the intervention materials.
Control group
Active

Outcomes
Primary outcome [1] 288434 0
Gluten free diet adherence: measured using the Coeliac Dietary Adherence Test (Leffler et al., 2009). The CDAT is a seven item questionnaire assessing gluten free diet adherence via questions about gluten avoidance habits, coeliac disease related symptoms and self-efficacy. The CDAT has been validated against more objective measures of adherence including the gold standard dietitian rated assessment of adherence.
Timepoint [1] 288434 0
Baseline, immediate post-intervention, three-month follow-up
Secondary outcome [1] 300150 0
Psychological symptoms: to be assessed using the Depression, Anxiety, Stress Scale (Lovibond & Lovibond, 1995) - a 21 item self-report questionnaire assessing the negative emotional states of depression, anxiety and stress. The Eating Disorders Inventory-3 Eating Disorder Risk Scale (Garner, 2004) - a 25 item questionnaire assessing the risk of an individual developing an eating disorder via questions related to body dissatisfaction, drive for thinness, and bulimic behaviours.
Timepoint [1] 300150 0
Baseline, immediate post-intervention, three-month follow-up
Secondary outcome [2] 300151 0
Gluten free diet knowledge: to be assessed using 14 ingredient lists adapted from educational materials used by the coeliac society of NSW. Requires participants to state whether each product is gluten free or not based on their knowledge of safe and gluten-containing ingredients.
Timepoint [2] 300151 0
Baseline, immediate post-intervention, three-month follow-up
Secondary outcome [3] 300152 0
Theory of planned behaviour variables: Intention, Attitude, Subjective Norm and Perceived Behavioural Control. Assessed using the 17 item Coeliac Disease Theory of Planned Behaviour questionnaire (Sainsbury & Mullan, 2011).
Timepoint [3] 300152 0
Baseline, immediate post-intervention, three-month follow-up
Secondary outcome [4] 300153 0
Quality of life: Overall QOL, psychological and physical QOL to be assessed using the World Health Organisation Quality of Life Instrument BREF (Murphy et al., 2000).
Timepoint [4] 300153 0
Baseline, immediate post-intervention, three-month follow-up

Eligibility
Key inclusion criteria
Biopsy confirmed coeliac disease, aged 16 years and over, gluten free diet duration minimum 3 months
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Does not have biopsy confirmed coeliac disease, aged below 16 years, has been on a gluten free diet for less than 3 months.

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)
Three separate sets of randomised numbers (1 = waitlist, 2 = intervention) were generated using an online random number generator. Following completion of the baseline measures participant's adherence category was determined (excellent, moderate, poor). The main researcher (Kirby Sainsbury) then allocated the participant to the intervention or waitlist group by using the next number within the respective adherence category. After each enrolment in the trial the allocation was crossed off the list.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online random number generator (http://www.random.org) was used to generate 3 sets of 80 integers between one and two. The 3 sets were labeled as "excellent", "moderate," and "poor."
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Waitlist control design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286406 0
University
Name [1] 286406 0
The University of Sydney
Country [1] 286406 0
Australia
Primary sponsor type
Individual
Name
Kirby Sainsbury
Address
The University of Sydney
School of Psychology
Brennan MacCallum room 446
Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 285190 0
None
Name [1] 285190 0
Address [1] 285190 0
Country [1] 285190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288482 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 288482 0
The University of Sydney
Sydney, NSW, 2006
Ethics committee country [1] 288482 0
Australia
Date submitted for ethics approval [1] 288482 0
06/02/2012
Approval date [1] 288482 0
08/03/2012
Ethics approval number [1] 288482 0
14567

Summary
Brief summary
An online intervention to improve gluten free diet adherence, coping, psychological symptoms and quality of life in adults with coeliac disease. The intervention modules are based on the theory of planned behaviour and cognitive behaviour therapy. It was hypothesised that relative to the waitlist control group the intervention group would evidence greater improvements in gluten free diet adherence, psychological symptoms, and quality of life from baseline to immediate post-intervention.
Trial website
http://bread-n-butter-gf.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34994 0
Address 34994 0
Country 34994 0
Phone 34994 0
Fax 34994 0
Email 34994 0
Contact person for public queries
Name 18241 0
Kirby Sainsbury
Address 18241 0
The School of Psychology
Brennan MacCallum room 446
The University of Sydney
Sydney, NSW, 2006
Country 18241 0
Australia
Phone 18241 0
61 414468389
Fax 18241 0
Email 18241 0
[email protected]
Contact person for scientific queries
Name 9169 0
Kirby Sainsbury
Address 9169 0
The School of Psychology
Brennan MacCallum room 446
The University of Sydney
Sydney, NSW, 2006
Country 9169 0
Australia
Phone 9169 0
61 414468389
Fax 9169 0
Email 9169 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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePredicting intention and behaviour following participation in a theory-based intervention to improve gluten free diet adherence in coeliac disease.2015https://dx.doi.org/10.1080/08870446.2015.1022548
N.B. These documents automatically identified may not have been verified by the study sponsor.