Development of a codesigned online Healthy Eating Lifestyle Program (HELP) for adults at risk of Posttraumatic Stress Disorder (PTSD): A pilot feasibility study

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.