Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000432112
Ethics application status
Approved
Date submitted
7/03/2019
Date registered
18/03/2019
Date last updated
26/02/2020
Date data sharing statement initially provided
18/03/2019
Date results information initially provided
26/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Stress Reduction Intervention for Disordered Eating Behaviours
Scientific title
Evaluation of a smartphone-based stress reduction intervention for reducing episodes of disordered eating among women who engage in stress-related eating behaviours.
Secondary ID [1] 297582 0
None
Universal Trial Number (UTN)
U1111-1229-4886
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Disordered Eating 311837 0
Binge Eating 311838 0
Condition category
Condition code
Mental Health 310437 310437 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Stress reduction intervention.

The intervention will involve a series of brief 3-5 minute stress reduction activities that are delivered via a smartphone application ('app'). These activities are audio files which included guided meditations, breathing exercises, thought defusion (letting go of thoughts), body scans, and gratitude exercises.

There will be two intervention groups: guided and self-guided. Once access to the app is provided, participants in both groups will be able to access the stress-reduction activities whenever they choose. However, it is recommended that participants use these activities at times when they are feeling stressed. Participants in the guided intervention group will also receive personalised prompts to remind them to use the app; these are delivered when participants report they are at least moderately stressed. This reporting occurs via periodic surveys prompted through the same app; these are delivered 4 times per day at randomised times between the hours of 9am to 9pm for the four week duration of the study. The survey comprises only one question ("How stressed are you right now?"). Participants in the self-guided intervention group will also complete this monitoring and have access to the stress-reduction activities to use whenever they choose, however they will not receive any personalised reminders.

The intervention phase of the study will last for four weeks.

Participants' use of the intervention will be monitored through the app, in which participants will be asked to respond to a brief one-item survey prior to and after using a stress-reduction activity. As the activities are delivered via the app, it is not possible to directly assess fidelity. Adherence will be promoted through provision of a variety of different exercises to allow participants to engage with those they find most helpful and reduce the likelihood of disinterest due to repetition.
Intervention code [1] 313813 0
Treatment: Other
Intervention code [2] 313814 0
Behaviour
Intervention code [3] 313815 0
Lifestyle
Comparator / control treatment
This study will employ an active/wait-list control group. Participants in the control group will be asked to monitor their mood and eating behaviours via a smartphone app. The app will prompt participants to complete four surveys per day for four weeks. Participants will be prompted to complete these surveys at randomised times between the hours of 9am and 9pm. The surveys are estimated to take less than 1 minute to complete and will ask 5 questions about participants' current mood (e.g., “How stressed do you feel right now?”) and eating behaviours (e.g., “Since the last survey, have you eaten, or had an urge to eat, as a way to cope with, distract from, or soothe distressing feelings?”).

After the four week monitoring period, participants in the control group will receive access to the stress reduction intervention.
Control group
Active

Outcomes
Primary outcome [1] 319306 0
Frequency of disordered eating episodes (i.e., binge eating, overeating, and loss of control eating) as measured by self-report using the Eating Disorder Examination Questionnaire.
Timepoint [1] 319306 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up
Primary outcome [2] 319307 0
Change in negative affect as measured by the Positive and Negative Affect Schedule
Timepoint [2] 319307 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up
Secondary outcome [1] 367664 0
Change in Eating Disorder Examination Questionnaire Total Score
Timepoint [1] 367664 0
Baseline; Immediately post-intervention (primary endpoint); 4-week follow up

Eligibility
Key inclusion criteria
Identify as a woman, aged 18 years and over, own a smartphone, engage in stress-related eating behaviours, this may include eating mindlessly, non-hungry eating, eating foods one may normally choose to avoid, overeating, feeling a sense of loss of control over one’s eating, and binge eating.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The required sample size is 183 (61 in each group). This has been calculated to allow for detection of a standardised group difference post-intervention between intervention and control groups of 0.5, at a power level of .8 and an alpha of .05, with allowance for 20% attrition.

The primary analysis will be multilevel models, with maximum likelihood estimation to account for missing data due to attrition. Further, subsequent exploratory analyses will be conducted to identify patterns of intervention use and whether accumulated use of the intervention has beneficial effects on stress and/or disordered eating episodes beyond that seen for each individual use.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
6/07/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
23/09/2019
Date of last data collection
Anticipated
2/03/2020
Actual
25/11/2019
Sample size
Target
183
Accrual to date
Final
227
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302129 0
University
Name [1] 302129 0
Deakin University
Country [1] 302129 0
Australia
Primary sponsor type
Individual
Name
A/Prof Matthew Fuller-Tyszkiewicz
Address
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 301966 0
Individual
Name [1] 301966 0
Mrs Jodie Mechielsen
Address [1] 301966 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country [1] 301966 0
Australia
Other collaborator category [1] 280581 0
Individual
Name [1] 280581 0
A/Prof Alexander Mussap
Address [1] 280581 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country [1] 280581 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302812 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 302812 0
Deakin Research Integrity
221 Burwood Highway
Burwood, Victoria 3125
Ethics committee country [1] 302812 0
Australia
Date submitted for ethics approval [1] 302812 0
19/01/2019
Approval date [1] 302812 0
24/05/2019
Ethics approval number [1] 302812 0
2019-015

Summary
Brief summary
The proposed study aims to evaluate the efficacy of a stress-reduction intervention for unhealthy and disordered eating behaviours. The study will be conducted as a randomised control trial, with a wait-list control group and two intervention groups; one intervention group will be prompted to use the intervention, whilst the other will not. All groups will complete a baseline survey, followed by four weeks of ecological momentary assessment to obtain data regarding their eating behaviours and affect. During this time, the intervention groups will also be provided with brief stress-reduction activities via smartphone application that they can complete when stressed. Participants in the intervention groups will also complete a four-week follow-up survey. The study will recruit at least 183 women, aged 18 years and over, who report stress-related unhealthy or disordered eating. It is expected that use of the intervention will reduce the momentary and longer-term risk of disordered eating.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91478 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91478 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91478 0
Australia
Phone 91478 0
+61392517344
Fax 91478 0
Email 91478 0
[email protected]
Contact person for public queries
Name 91479 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91479 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91479 0
Australia
Phone 91479 0
+61392517344
Fax 91479 0
Email 91479 0
[email protected]
Contact person for scientific queries
Name 91480 0
A/Prof Matthew Fuller-Tyszkiewicz
Address 91480 0
School of Psychology, Deakin University
221 Burwood Highway
Burwood, Victoria 3125
Country 91480 0
Australia
Phone 91480 0
+61392517344
Fax 91480 0
Email 91480 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
Protection of participant confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7108Informed consent form  [email protected]
7109Ethical approval  [email protected]



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.