Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001662853p
Ethics application status
Submitted, not yet approved
Date submitted
1/10/2021
Date registered
3/12/2021
Date last updated
3/12/2021
Date data sharing statement initially provided
3/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Adaptation of the My Food and Mood app for adults at risk of Posttraumatic Stress Disorder (PTSD): Lived experience feedback, engagement and prototype design ideas
Scientific title
Adaptation of the My Food and Mood app for adults at risk of Posttraumatic Stress Disorder (PTSD): Lived experience feedback, engagement and prototype design ideas
Secondary ID [1] 305452 0
Nil known
Universal Trial Number (UTN)
U1111-1271-5076
Trial acronym
Linked study record
383108

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 323830 0
Condition category
Condition code
Mental Health 321337 321337 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our overall project is comprised of two sub-studies. The first sub-study is outlined in this record and entails Phases 1 and 2 of our project.

This is a single group intervention. We will recruit a minimum of 16 adults (target of 20) at risk of PTSD to undertake Phases 1 and 2. Recruitment and participation for this study are completely online.

PHASE 1
Phase 1 asks participants to review the PLS, provide consent, answer questions for eligibility screening (10 – 15 minutes) and undertake an Initial Consumer Input Survey (10 – 15 minutes). Participants will then be provided with two-week access to trial the My Food & Mood program.

The My Food & Mood program is a modularised educational dietary program designed to support individuals with depression to adopt a Mediterranean style diet. My Food & Mood program is a smartphone application. It contains modularised educational dietary videos and activities about healthy eating for mental health. Participants can use the app to record the overall quality of their meals and snacks (Food), generally how they are feeling each day (Mood), a range of lifestyle activities (Lifestyle), a shopping list and dietary goals. The app will then generate a bar chart of their weekly Food together with goals achieved and lifestyle choices to help them look at these patterns over time. The application will support their knowledge and skill development in shopping, cooking and consuming foods consistent with a Mediterranean style diet. Participants decide how much or how little they use the application.

Anticipated usage times are drawn from the cohort study (Young et al. 2021) which optimised and evaluated the My Food and Mood app version utilised in this study. For an average of 3.6 weeks total engagement, participants had a total usage time of 1 hour 52 minutes, for 30 active sessions for an average of 4 minutes 55 seconds per session. Most participation occurred within the first two weeks. We anticipate similar average times per session in this study and predict approximately 1.5 hours total usage time. The total time for videos is 52 minutes 40 seconds. Participants receive a daily notification at 7 pm that says "Have you recorded your food & mood for today?" Participants are provided with an instructional video and an email with instructions.

Participants are advised in their Plain Language Statement that their usage behaviour will be tracked via data analytics. App data tracked will include (1) weeks engaged, (2) total usage time, (3) total time key activities, (4) number of active sessions, (5) average time per session, (6) per protocol percentage, (7) goals completed and (8) percentage of videos watched. This data will serve as a measure of engagement in the program.

PHASE 2
For Phase 2 participants will take part in an online Consumer Input Group Meeting (1 hour Zoom meeting). Here they participate in tasks such as idea generation (Brainstorming), and reviews/feedback of the My Food & Mood program.

At the end of the My Food and Mood app trial period, participants will receive an automated email advising of zoom meeting Consumer Input Group details to enable participation in Phase 2 of this project. This email includes information about the time and date of the meeting, login instructions, and Consumer Input Group procedures. It is anticipated that the zoom meeting will be booked for 1 week after the 10th and 20th participant completes their two-week app trial period. A reminder email will be sent to participants one day and one hour before each Consumer Input Group meeting. Participants will be requested to have their voice and camera activated during the Consumer Input Group meeting but may elect to have their camera off, or to leave the meeting at any time. The Consumer Input Group meeting will be recorded to ensure accurate data collection. Participants will be asked to consent (via a meeting pop up box) to session recording at the beginning of the video conference.

We will run two consumer input group experiences, with each group containing at least 8-12 participants. These experiences will occur electronically via Zoom video conferencing facilities which allow real-time voice and visual group interactions. Consumer input group experiences will require participants to provide verbal responses and participate in a facilitated group discussion regarding a series of structured questions. Participants will be asked about their experience and use of the My Food & Mood program, factors that helped or hindered their motivation, suggestions for improvements, and changes they would like to see for those who are at risk of PTSD. Consumer input group experiences will be organised and facilitated by student investigator, Gina Howland, who is an experienced and practising Clinical Psychologist.
Intervention code [1] 321851 0
Lifestyle
Intervention code [2] 322174 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329122 0
Engagement Total Usage time (assessed independently):
Participant usage behaviour will be tracked via data analytics.
App data tracked will include total usage time. This data will serve as a measure of engagement in the program.
Timepoint [1] 329122 0
throughout the 2 week prototype trial period (week 1 and week 2)
Primary outcome [2] 329525 0
Engagement Average Intensity score (composite):
Participant usage behaviour will be tracked via data analytics. App data tracked will include (1) number of active sessions - calculated as a percentage (2) goals completed - calculated as a percentage and (3) percentage of videos watched. The average of each participant's percentages in these areas will be calculated. This data will serve as a measure of engagement in the program.
Timepoint [2] 329525 0
throughout the 2 week prototype trial period (week 1 and week 2)
Primary outcome [3] 329777 0
Consumer input group discussion information
We will run two consumer input group experiences, with each group containing at least 8-12 participants. These experiences will occur electronically via Zoom video conferencing facilities. Consumer input group experiences will require participants to provide verbal responses and participate in a facilitated group discussion regarding a series of structured questions. Participants will be asked about their experience and use of the My Food & Mood program, factors that helped or hindered their motivation, suggestions for improvements, and changes they would like to see for those who are at risk of PTSD. Consumer input group experiences will be organised and facilitated by student investigator, Gina Howland, who is an experienced and practising Clinical Psychologist.
Timepoint [3] 329777 0
approximately 1 week after the 10th and 20th participant completes their two-week app trial period.
Secondary outcome [1] 402867 0
nil
Timepoint [1] 402867 0
nil

Eligibility
Key inclusion criteria
Inclusion criteria are:
-18 years or over
-Reside in Australia
-At risk of PTSD (Score 33 or higher on PCL-5)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
-Indicate they have no dietary autonomy
-Indicate they are on a medically prescribed diet
-Low computer literacy
-Low English literacy
-No Internet or smartphone access

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample of 24 participants for Phase 1 and Phase 2 is based on recommended group numbers for focus groups being 6-10 participants [33]. Given it is generally necessary to substantially overrecruit the number of potential participants relative to what is necessary [35], we will recruit 12 participants per consumer input group, with the aim of having at least 8 participants in each consumer input group. We intend to run two parallel online consumer input groups, in case one of the groups is compromised.

We will calculate descriptive statistics of outcome variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/12/2021
Actual
Date of last participant enrolment
Anticipated
10/01/2022
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309808 0
University
Name [1] 309808 0
Deakin University
Country [1] 309808 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Barwon Health -University Hospital Geelong, Ryrie St & Bellerine St, Geelong. Victoria. 3216
Country
Australia
Secondary sponsor category [1] 310844 0
None
Name [1] 310844 0
N/A
Address [1] 310844 0
N/A
Country [1] 310844 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309555 0
Deakin University High Risk Ethics Committee (DUHREC)
Ethics committee address [1] 309555 0
The Human Research Ethics Office,
Deakin University
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 309555 0
Australia
Date submitted for ethics approval [1] 309555 0
09/09/2021
Approval date [1] 309555 0
Ethics approval number [1] 309555 0

Summary
Brief summary
Post-Traumatic Stress Disorder (PTSD) is a debilitating and costly condition. Conventional treatments are insufficient and fail to adequately address comorbid conditions such as coronary heart disease and diabetes. Dietary intervention is a well-established approach in treatment of physical conditions whereas building evidence suggests improving diet quality may address factors that are maintaining and exacerbating PTSD. However, current research in dietary improvement programs for those at risk of PTSD is limited in quantity and quality. We aim to adapt the My Food and Mood app for adults with PTSD symptoms, using a co-design approach with those with lived experience of PTSD.

24 adults at risk of current PTSD (i.e. with an elevated score on a PTSD symptoms measure) will undertake a consumer survey, trial the My Food and Mood app and provide feedback in an online group meeting. This information will be used to develop the Healthy Eating Lifestyle Program (HELP) app to pilot.

This project will provide a solid foundation for the co-development and optimisation of a digital program targeting diet quality improvement for those at risk of PTSD. Given the relatively high prevalence of PTSD and its enormous individual and societal costs, an online self-help approach could provide a pragmatic and effective adjunct treatment strategy. Outcomes of the project will inform funding applications for a large online RCT to establish the comparative efficacy of dietary interventions for PTSD populations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114574 0
Dr Tetyana Rocks
Address 114574 0
Food & Mood Centre, Deakin University Location: Barwon Health -
University Hospital Geelong, Ryrie St & Bellerine St, Geelong VIC
3220
Country 114574 0
Australia
Phone 114574 0
+61 41965 4417
Fax 114574 0
Email 114574 0
[email protected]
Contact person for public queries
Name 114575 0
Ms Gina Howland
Address 114575 0
Food & Mood Centre, Deakin University Location: Barwon Health -
University Hospital Geelong, Ryrie St & Bellerine St, Geelong VIC
3220
Country 114575 0
Australia
Phone 114575 0
+61 427 518 774
Fax 114575 0
Email 114575 0
[email protected]
Contact person for scientific queries
Name 114576 0
Dr Tetyana Rocks
Address 114576 0
Food & Mood Centre, Deakin University Location: Barwon Health -
University Hospital Geelong, Ryrie St & Bellerine St, Geelong VIC
3220
Country 114576 0
Australia
Phone 114576 0
+61 41965 4417
Fax 114576 0
Email 114576 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
To ensure privacy and confidentiality to participants.


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.