Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001733864
Ethics application status
Approved
Date submitted
11/11/2021
Date registered
20/12/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a codesigned online Healthy Eating Lifestyle Program (HELP) for adults at risk of Posttraumatic Stress Disorder (PTSD): A pilot feasibility study
Scientific title
Development of a codesigned online Healthy Eating Lifestyle Program (HELP) for adults at risk of Posttraumatic Stress Disorder (PTSD): A pilot feasibility study
Secondary ID [1] 305772 0
Nil known
Universal Trial Number (UTN)
U1111-1270-0294
Trial acronym
Healthy Eating Lifestyle Program (HELP)
Linked study record
The current study is a linked follow up study to:
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

ACTRN12621001662853p

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder 324276 0
Condition category
Condition code
Mental Health 321770 321770 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 second sub-study is outlined in this record and entails Phases 3 and 4 of our project.

This is a single group intervention. We will recruit 300 adults at risk of PTSD to undertake pilot testing of a HELP prototype. Recruitment and participation for this study are completely online.

PHASE 3
Phase 3 asks 100 participants to review the PLS, provide consent, answer questions for eligibility screening (10 – 15 minutes) and then pilot HELP prototype Version 1.0 (User analytics embedded) for 4 weeks.

The HELP prototype Version 1.0 will be an adapted version of the My Food and Mood app trialled in Phases 1 and 2 of our project. The adaptations will be based on feedback, engagement and prototype design ideas provided from those with lived experience of PTSD in Phases 1 and 2.

We anticipate the HELP prototype will contain modularised educational dietary videos and activities about healthy eating for mental health. Participants will likely 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 may 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 likely also support their knowledge and skill development in shopping, cooking and consuming foods consistent with a Mediterranean style diet. However, these are only anticipated content considerations because actual content will be determined by user feedback, engagement and prototype design ideas in Phases 1 and 2.

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. Again, this is subject to change based on user feedback, engagement and prototype design ideas in Phases 1 and 2.

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.
Our protocol suggests participants watch the videos within the first two weeks and for the remaining 6 weeks daily recording of food, mood, lifestyle, and 1 goal set and completed each week. Participants can opt to use any tracking tools straight away. An instruction video which explains suggested protocol and an email with instructions will be provided to participants. Please note that these recommendations are subject to change, based on feedback from participants as the app is iteratively developed.

PHASE 4
At the end of 4 weeks, participants will be invited to undertake Phase 4 Consumer Input Follow Up Survey (20-25 minutes) completion. The follow-up survey asks questions about the acceptability of HELP, barriers and enablers of HELP (user experience), suggestions for future HELP prototypes and screeners for diet quality and PTSD symptoms.

The survey data and user analytics collected from the prototype pilot will be analysed and then used to modify the HELP prototype to create HELP Version 2.0. Another 100 participants will then be recruited to begin Phase 3 to pilot HELP Version 2.0 and undertake Phase 4. The will enable further adaptions to create HELP Version 3.0 to be piloted by the final 100 participants.
Intervention code [1] 322172 0
Lifestyle
Intervention code [2] 322173 0
Treatment: Devices
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329522 0
change in score for Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Timepoint [1] 329522 0
baseline and week4 (end of intervention)
Primary outcome [2] 329523 0
change in score for The Mediterranean Diet Adherence Screener (MEDAS)
Timepoint [2] 329523 0
baseline and week 4 (end of intervention)
Primary outcome [3] 329524 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 [3] 329524 0
throughout the use of HELP app (weeks 1 to 4)
Secondary outcome [1] 402866 0
Consumer Input Follow Up Survey Questions. This survey was specifically designed for our project.
Participants will be asked about their experience and use of HELP, satisfaction with HELP, perceived appropriateness, factors that helped or hindered their motivation, suggestions for improvements, changes they would like to see for those who are at risk of PTSD and intent to continue use.
Timepoint [1] 402866 0
End of Week 4
Secondary outcome [2] 403746 0
PRIMARY OUTCOME:
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] 403746 0
throughout the use of HELP app (weeks 1 to 4)

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 target sample size of 300 participants for Phase 3 and Phase 4 was selected based on pragmatic considerations of the feasibility of recruitment and available resources and was thought likely to provide reasonable experience with the program. This is consistent with sample size recommendations of minimums between 24 and 50 for pilot studies offered in the literature. It is also consistent with sample size calculations for examining engagement used for the My Food & Mood Study on which our study is modelled. In the My Food & Mood Study, assuming a mean of 90 (SD 25) minutes engagement time, a sample size of 100 participants per cohort, and type I error of 0.5, the study had 80% power to detect 10 minutes or greater improvement in mean engagement time across each version of the program.
A different power calculation is required for measuring the outcome of the variable PCL 5 score (PTSD measure). We have adopted the approach recommended in the literature which suggests that while traditional power calculations are inappropriate for pilot studies (since the primary aim of a pilot study is not to test the superiority of one treatment over the other), a sample size justification is important. They advocate for using a main trial’s target effect size, to estimate the pilot study’s optimum sample size. Accordingly, we calculated power based on a previous RCT on an internet-based self-guided intervention for PTSD. The sample size for the main RCT was calculated with a power of 0.80 to detect a mean 10-point difference on the PCL-5 score between a treatment and control group, at a 5% significance level. Assuming a mean of 36.97 and standard deviation of 21.16, 70 participants in each group would be needed for an RCT. Using this information, we can use stepped rules of thumb for pilot studies based on the target effect size and the size of the RCT to calculate our pilot study sample size. Using a PCL-5 10-point difference, and an SD of 21.6, the standardized effect size is 10/21.6=0.47. Therefore, for an 80% powered RCT, we should use a sample size of 10 per arm for the pilot. Our intended sample of 100 for the final HELP cohort is well above this. This offers security against high drop-out rates or non-use attrition rates and will aid is estimations such as recruitment rate and retention rates useful in estimating RCT duration.

We will calculate descriptive statistics of outcome variables relating to acceptability, engagement and feasibility. We will use one sample binomial exact test of proportions for categorical outcomes (e.g., the proportion of patients with high user engagement or who completed the intervention), and Wilcoxon signed ranks test for ordinal outcomes (e.g., PCL-5 scores, diet quality scores) at baseline and week 4 of the pilot. We will use a p-value of 0.05 as the significance threshold.
We will also estimate the variability in diet and PTSD scores by generating interval estimates of the mean difference for these outcome measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2022
Actual
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
1/09/2022
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310129 0
University
Name [1] 310129 0
Deakin University
Country [1] 310129 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Deakin University Location, Ryrie St & Bellerine St, Geelong. Victoria. 3216
Country
Australia
Secondary sponsor category [1] 311200 0
None
Name [1] 311200 0
N/A
Address [1] 311200 0
N/A
Country [1] 311200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309817 0
Deakin University High Risk Ethics Committee (DUHREC)
Ethics committee address [1] 309817 0
Ethics committee country [1] 309817 0
Australia
Date submitted for ethics approval [1] 309817 0
09/09/2021
Approval date [1] 309817 0
17/12/2021
Ethics approval number [1] 309817 0
2021-356

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

Contacts
Principal investigator
Name 115490 0
Dr Tetyana Rocks
Address 115490 0
Food & Mood Centre, Deakin University Location: Ryrie St & Bellerine St, Geelong VIC
3220
Country 115490 0
Australia
Phone 115490 0
+61 41965 4417
Fax 115490 0
Email 115490 0
[email protected]
Contact person for public queries
Name 115491 0
Gina Howland
Address 115491 0
Food & Mood Centre, Deakin University Location: Ryrie St & Bellerine St, Geelong VIC
3220
Country 115491 0
Australia
Phone 115491 0
+61 427 518 774
Fax 115491 0
Email 115491 0
[email protected]
Contact person for scientific queries
Name 115492 0
Tetyana Rocks
Address 115492 0
Food & Mood Centre, Deakin University Location: Ryrie St & Bellerine St, Geelong VIC
3220
Country 115492 0
Australia
Phone 115492 0
+61 41965 4417
Fax 115492 0
Email 115492 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.