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[DRAFT VERSION]

Project Title: A virtual assistant delivered Mediterranean lifestyle intervention - development and feasibility study

Short Title: Mediterranean lifestyle and physical activity study (MedLiPal)

Trial registration: ANZCTR pending Protocol version: V1 8th Jan 2019

Associate Professor Carol Maher, Chief Investigator, UniSADr Karen Murphy, Chief Investigator, UniSA

Professor Julie Ratcliff, UniSAProfessor Stephen Nicholls, SAHMRI

Dr Camille Short, University of AdelaideDr Ross Smith (UniSA)

Dr Courtney Davis, UniSADr Rachel Curtis (UniSA)

MedLifeVA Protocol V1 8th Jan 2019 Page 1 of 28

Confidential Information

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Synopsis

NAME OF INVESTIGATIONAL PRODUCT

MedLife Virtual Assistant (MVA, chatbot)

TITLE OF STUDY A virtual assistant delivered Mediterranean lifestyle intervention - development and feasibility study

SHORT TITLE Mediterranean lifestyle and physical activity study (MedLiPal)

PROTOCOL NUMBER V1 8th Jan 2018FUNDER NilPROJECT PHASE 12 weeksPRIMARY OBJECTIVES 1. Design and implement a 12-week MedDiet

lifestyle intervention using virtual assistant technology and wireless wearables technology 2. Assess whether a 12-week Mediterranean lifestyle intervention delivered via virtual assistant will result in behaviour change conducive to improved health outcomes

Physical activity level (AAS) Mediterranean dietary adherence (14-

item questionnaire)SECONDARY OBJECTIVES

3. Assess whether behaviour change will result in improved CVD risk factors after 12 weeksOutcome measures:

Blood pressure (SBP and DBP) BMI and waist circumference

STUDY DESIGN Single arm intervention studySTUDY DURATION 12 weeksNUMBER OF PARTICIPANTS

30

NUMBER OF CENTRES 1INCLUSION CRITERIA Free-living men and women

Access to an electronic device with internet connection

Capable of interacting with study technology

Aged between 45-75 years Do not currently meet the Australian

physical activity guidelines and not MedLifeVA Protocol V1 8th Jan 2019 Page 2 of 28

consuming a Mediterranean style diet. EXCLUSION CRITERIA Person considered by the investigator

to be unwilling, unlikely or unable to comprehend or comply with the study protocol

Unable to consume a Mediterranean diet

Significant impairment limiting ability to increase step count

Major/life-threatening disease or condition

Pregnant/lactatingTEST PRODUCT MedLiPal Virtual Assistant (MVA) chatbot

deployed through instant messaging serviceFORMULATION & DOSAGE

The MVA (chatbot) is being supplied by outThought. The outThought Virtual Assistant framework provides the capabilities necessary to deploy an AI chat-based assistant that can have a conversation with a participant. The IBM Watson Assistant conversational engine will be utilised to provide the underlying Natural Language Processing, which is used to interpret the intent of the participants interactions. The MVA will be trained with the assistance of dietitians to be able to administer counselling and information to participants to aid and encourage them to follow a MedDiet and increase daily step count. The MVA will be deployed through the cloud-based instant messaging service (Slack) with other enrolled participants.

STATISTICAL ANALYSES Descriptive statistics will be presented for baseline characteristics. For categorical variables, counts and percentages will be provided. For continuous variables, means and SEMs will be provided (or non-parametric equivalents). We will analyse on an intention to treat basis as the primary analysis. Assuming normal distribution, linear mixed models will be used to compare means for dietary adherence and daily step count at week 0, 6 and 12., as well as secondary outcomes (BMI, BP, waist circumference, lipids). If this is not possible then non-parametric procedures will be considered. Statistical significance will be set at P ≤ 0.05. Statistical analyses will be performed using SPSS for Windows (version 25.0; SPSS,


Chicago, IL).

Abbreviations

MedDiet Mediterranean dietMedLiPal Mediterranean diet lifestyle physical activity studyBMI Body mass indexSBP Systolic blood pressureDBP Diastolic blood pressurePA Physical activityMVA MedDiet Virtual AssistantAAS Active Australia Survey


Table of ContentsSynopsis.............................................................................................................................................2

Abbreviations...................................................................................................................................4

1. Introduction...........................................................................................................................7

Background and rationale.................................................................................................7

Aim:.................................................................................................................................................8

Primary Objectives:...............................................................................................................8

Secondary Objective:...........................................................................................................8

Trial Design................................................................................................................................8

Study Visits:..............................................................................................................................8

2. Methods: Participants, interventions and outcomes...................................10

Study setting...........................................................................................................................10

Eligibility criteria..................................................................................................................10

Intervention.............................................................................................................................10

Mediterranean Diet.............................................................................................................11

Physical Activity Intervention.......................................................................................13

Outcomes..................................................................................................................................15

Participant timeline.............................................................................................................16

Sample size..............................................................................................................................16

Recruitment.............................................................................................................................16

Methods: Data collection, management and analysis....................................16

Data collection methods...............................................................................................16

Methods: Monitoring..........................................................................................................18

Adverse events..................................................................................................................18

Safety......................................................................................................................................18

Medications..........................................................................................................................18

3. Ethics and dissemination.............................................................................................18

Research ethics approval.................................................................................................18

Protocol amendments........................................................................................................19

Consent or assent................................................................................................................19

Confidentiality........................................................................................................................19

Declaration of interests....................................................................................................19

Access to data........................................................................................................................20

Dissemination policy...........................................................................................................20


Other Regulatory requirements...................................................................................20

Insurance...................................................................................................................................20

4. References............................................................................................................................20

5. Appendices...........................................................................................................................23

Appendix 1: 14-item Mediterranean Diet Questionnaire................................................24

Appendix 2: Active Australia Survey......................................................................................26

Appendix 3: MedDiet checklist for weekly check-in with chatbot................................28


1. Introduction

Background and rationale

Research has shown that modifiable risk factors such as smoking, obesity, dyslipidaemia, physical inactivity and inadequate intake of fruits and vegetables account for most incidences of cardiovascular disease (CVD) globally [1]. In Australia, CVD is a leading cause of death and disability adjusted life years, responsible for 13% of male deaths and 11% of female deaths in 2016 [2]. The most recent Australian national nutrition survey revealed only 4% of adults consume the recommended amount of vegetables [3]. Furthermore, 56% of adults in 2014-2015 were not sufficiently physically active, and only 19% of adults aged 18-65 met the guidelines [2]. More than 60% of adults are overweight or obese in Australia [2]. Interventions to modify these risk factors are needed. Changing diet and physical activity (PA) related behaviours are currently the first line treatment for obesity and can improve risk factors for cardiovascular disease as well as other cardiometabolic conditions.The Mediterranean dietary pattern has been extensively studied and shown to modify CVD risk factors and improve outcomes long term [4,5]. Both longitudinal cohort and intervention trials have concluded closer adherence to this dietary pattern results in improved health outcomes and is associated with better weight status [6-11]. The MedDiet is primarily plant based, including vegetables (particularly leafy green vegetables, onions and tomatoes), fruits (citrus, stone fruits, berries and pomaceous fruits), legumes, whole grain cereals and olive oil. Cheese, yoghurt, meats and red wine are consumed moderately, sweets rarely. Recent work amongst Australian populations has shown that healthy older adults at risk of CVD can adhere to the MedDiet, resulting in metabolic health benefits [12-14]. However, delivery of the intervention has been face-to-face, involving dietitians and other health professionals, in a one-on-one or small group setting. Furthermore, follow-up sessions are often undertaken to enhance compliance to the diet. Expensive and time consuming, this method of delivery is inaccessible to many Australians. Few Australians currently access health professionals or programs to modify behaviour. Technology, in the form of handheld devices, wearables and computers have an increasingly important role in the lives of Australians. Roughly 80% of Australians own a smartphone and 93% use the internet [15]. Utilizing this technology to encourage and monitor diet and PA related behaviours may be a more cost-effective and wide-reaching method to address risk factors than face-to-face interviews. Some studies have shown successful smartphone-assisted interventions for weight loss [16] and physical activity [17], although studies tend to be small and involve a component of human-delivered education. We propose to use a 100% technology-based intervention, including website, instant messaging service and wearables, with a virtual assistant (chatbot), capable of administering and supporting a MedDiet and lifestyle intervention. This method is accessible to most Australians. If this method could successfully alter dietary and PA related behaviour, this could lead to a widespread reduction in risk factors for CVD.


Aim:

Examine the feasibility, acceptability and preliminary efficacy of a 12-week Mediterranean lifestyle intervention delivered via virtual assistant, website, instant messaging service, and wireless wearables.

Primary Objectives:

1. Design and implement a 12-week MedDiet lifestyle intervention delivered by virtual assistant, website, instant messaging service and wireless wearables technology 2. Assess whether a 12-week Mediterranean lifestyle intervention delivered by virtual assistant, website, instant messaging service and wearable technologies will result in behaviour change conducive to improved health outcomes

Secondary Objective:

3. Assess whether dietary and PA related behaviour change, resulting from a technology based intervention, will improve BMI, waist circumference and blood pressure after 12 weeks.

Trial Design

The trial will be a single arm, intervention trial to assess whether a lifestyle intervention delivered entirely via technology (website, virtual assistance, wearables) can result in meaningful healthful behaviour change. The study comprises an online screening questionnaire and 12-week intervention period. Participants will complete a screening questionnaire to determine eligibility, and a baseline, week 6 and week 12 visit for assessments, as shown in Table 1. Table 1. Study schedule of assessments*Assessment Screenin

g Week 0 Week 6 Week 12

Height xWeight x x xWaist circumference x x xBlood pressure x x xDietary adherence (14-item questionnaire)

x x x x

Physical activity adherence (AAS)

x x x

Week 6 questionnaire xExit questionnaire xAdverse events x x*Data on use of MVA will collected on an ongoing basis throughout the trial via in-built monitoring systems

Study Visits:


ScreeningIn response to advertisements, participants will be emailed a copy of the information sheet and link to a survey monkey-designed screening questionnaire, to determine if they meet eligibility criteria. The survey will include informed consent, and participants will be required to indicate they have read and understood the information sheet and are willing to commence the study before completing the survey. Participants will supply date of birth, disease status, family history of disease, smoking status, physical activity levels, dietary information to determine adherence to a MedDiet, computer or smart phone access and literacy, and whether they are able to attend a minimum of 4 appointments at the University of South Australia over approximately 4 months via the screening questionnaire. If their answers indicate they are eligible, they will be contacted by staff via phone to book in a baseline visit.BaselineAt baseline, the following measures will be collected: height, body weight, waist circumference and blood pressure. In addition, baseline PA levels will be assessed by the Active Australia Survey, and MedDiet adherence will be assessed using a 14-item questionnaire. Participants will then be instructed in how to access the website, and download and access the hosting platform (Slack) for the MVA. They will then use their phones or a computer to undertake the intervention education. This will be undertaken while at their appointment, to allow staff to assist if there is a problem with the technology. They will be given hard copies of their visit schedule, contact details for the staff and a logbook to record their interactions with the MVA. They will also be given a wearable wristwatch/band to take home (Such as FitBit® Alta™ or Garmin Vívofit® 4). Instructions in the use of this equipment will be given. No direct dietary or PA instruction will be given by staff. This visit is expected to take approximately 1 hour, although times may vary depending on use of the website/technology. Week 6At week 6, the following measures will be collected: body weight, waist circumference and blood pressure, dietary adherence and physical activity levels. Participants will be instructed to complete the week 6 questionnaire. This visit is expected to take approximately 30 minutes. Week 12At week 12 (final visit), the following measures will be collected: body weight, waist circumference and blood pressure. A dietary questionnaire and physical activity questionnaire will be completed to assess adherence for the past 6 weeks. Participants will be instructed to complete the exit questionnaire. This visit is expected to take approximately 30 minutes. Weekly check-in, between visitsIn addition to these clinic visits, participants will engage with the MVA software via Slack once per week in a semi-structured interview. The MVA will host a conversation designed to assess the average daily step count for the past week


participants have completed, and how many servings of key foods participants have consumed in the previous week. This is intended to replace weekly or fortnightly sessions with a health coach, encouraging compliance with the recommendations and preventing participants ‘falling off the wagon’. Additionally, these sessions will provide participants an opportunity to ask questions on any diet or PA related topic, which will test the MVA software.

2. Methods: Participants, interventions and outcomes

Study setting

The study will be a single site study, conducted at the University of South Australia (UniSA) City East Campus, Adelaide, South Australia. All visits will occur at the Clinical Trials Facility, Bonython Jubilee building, ground floor. The Clinical Trials Facility is a state-of-the-art research facility completed in 2013, with a variety of high quality equipment and facilities, including private clinic rooms, laboratory facilities, digital scales, blood pressure monitors, wall-mounted stadiometres, steel measuring tapes and dual x-ray absorptiometry.

Eligibility criteria

Inclusion criteria: Free-living men and women Access to an electronic device with internet connection Capable of interacting with study technology Aged between 45-75 years Not currently meeting the physical activity guidelines (less than 150

minutes of moderate and less than 75 minutes of vigorous activity) Not currently consuming the Mediterranean diet (7 or less out of 14 in

adherence score)

Exclusion criteria Person considered by the investigator to be unwilling, unlikely or unable to

comprehend or comply with the study protocol Unable to consume a Mediterranean diet, due to allergy or other food

aversion Significant impairment limiting ability to increase step count Major/life-threatening disease or condition (Alzheimer’s disease or

dementia, cancer, end stage kidney disease or liver disease) Pregnant/lactating

The MedDiet questionnaire used to assess adherence scores, including scoring criteria, is shown in Appendix 1. PA level will be assessed in the screening survey.

Intervention

MedLife Virtual Assistant


A MedLife Virtual Assistant (MVA) (chatbot) will be provided by outThought to perform the following tasks:

Deliver information required to guide participants to consume a MedDiet and increase step-count, including:

o Definition of terms (related to MedDiet and PA)o Required amounts of key food groups and serving sizeso Goal setting for increasing PA through step counto Health benefits associated with PA and MedDieto Tips and suggestions o Answer frequently asked questions from participantso Links to external resources which support/provide additional

information Monitor usefulness of the MVA throughout study, via collection of data on:

o Frequency of use by participantso Type of questions askedo Whether the response given by MVA was helpful from participant

perspectiveo Ease of access, any technical issues, aesthetics of the website and

delivery platform (Slack) Administer questionnaires/surveys and collect data on adherence to the

MedDiet and step counto Complete series of regular weekly checks on progress, namely step

counts and dietary checklists

The MVA will be implemented using the outThought Virtual Assistant framework and IBM Watson Assistant Service. The outThought Virtual Assistant framework provides the capabilities necessary to deploy an AI chat-based assistant to the cloud-based instant messaging service (Slack) that can have a conversation with a participant, understanding the intent of interactions with participants and respond to those intents intelligently.

The IBM Watson Assistant conversational engine provides the underlying Natural Language Processing, which is used to interpret the intent of the participants interactionsIn addition to these components, a new MedDiet Assistant corpus will be trained to understand specific questions and answers that relate to the Mediterranean diet and lifestyle.In some instances, MVA may direct participants to answers that are contained in external websites.

The virtual assistant will be trained with the assistance of dietitians to be able to converse with participants in a motivational interviewing style, with all necessary information to answer questions, and link to external resources. A group chat ‘room’ is created on Slack where participants can join, which will include the chatbot with whom they can converse. Participants can also have private conversations with the chatbot in separate rooms.

Mediterranean Diet

Administration


The MedDiet intervention will be administered through use of a dietitian-designed website, assisted by the MVA and instant messaging service (Slack). The website will contain information on the history, health benefits and general principles of the diet, recipes, and a set of specific instructions including target number of servings of key food groups and serving sizes. Instructions will be delivered via short videos, filmed by dietitians, and written sections. Links to other web-based sources of information will be provided. Furthermore, a room will be created using Slack which participants will be able to join, where the MVA will be added. Participants will be able to access the chatbot anytime they have internet access. RequirementsThe MedDiet intervention will be modelled on the intervention diet used for the MedLey study [19]. Serving sizes are based loosely on the Australian Dietary Guidelines (2013). The MedDiet is a plant based diet, with moderate consumption of meats, dairy and red wine, and low consumption of added sugars and highly processed foods. Vegetables, fruits, legumes, nuts and wholegrain foods make up the core of the diet, supplemented with extra virgin olive oil. Red wine should be consumed in moderation, with meals. Tomato, onion and garlic should be sautéed in extra virgin olive oil to make Sofrito sauce, at least twice per week. Specific recommendations for each food group are shown in Table 2.Table 2. Specific recommendations for the Mediterranean diet, based on MedLey diet1

Food group RecommendationDaily

1. Olive oil, extra virgin 40-80 ml, 2-4 Tbsp2. Vegetables ≥400 g, approximately 5-6 serves3. Fruit 2-3 serves, 300-450 g fresh fruit, or equivalent

canned/dried fruit4. Breads and cereals 5 serves, choose wholegrain 5. Red wine ≤200 ml, with meals6. Dairy 2 serves, mostly as cheese and yoghurt

Weekly7. Sofrito sauce 2/week, onions, garlic and tomato sautéed in

olive oil (combined with pasta, salad, meat, vegetables, pizza)

8. Legumes 250 g, approximately 2.5 cups or 3-4 serves9. Fish 300-400 g, include at least one serve oily fish10.Red meat ≤100 g 11.Chicken/poultry 100-200 g 12.Smallgoods ≤100 g 13.Nuts ≥5 serves, approximately 30 g or 1 handful14.Eggs ≤6 15.Sweets, processed

foods≤3 times, in small portions (e.g. small slice cake)

1MedLey Protocol Paper, Davis et al. 2015 [19]

MedDiet Adherence Measures


Adherence will be measured using a 14-item questionnaire, modified from the 12-item questionnaire utilised in the PREDIMED study (Appendix 1). This will be administered at screening, baseline, week 6 and week 12. Participants answer 14 questions relating to their intake of foods over the previous few weeks and are scored based on their adherence with MedDiet principles. Higher scores indicate better adherence, maximum score of 14 indicating very close adherence with the MedDiet. In addition, participants will be prompted by the MVA once per week, to complete a brief online monitoring session (Appendix 3). The MVA will collect information on the number of serves participants are consuming for each key food group listed in Table 2, and provide feedback, tips and suggestions as needed in a conversational style. Participants will have a chance to ask questions directly and receive advice from the MVA on any topic. Box 1 shows an example of a conversation to collect weekly food intake data between the chatbot and a participant.

Physical Activity Intervention


The PA intervention will be focused around step count. This was chosen as the best measure incidental activity, which will be encouraged as part of the Mediterranean lifestyle. Participants will be instructed to move in as many ways as possible, and to incorporate physical activity through incidental movement as part of their daily lives, such as through walking more for travel, being more active in their leisure time, getting into their gardens, playing with kids or grandkids etc.

At the baseline visit, one of the instructional videos will include information on the highly active lifestyles led in traditional Mediterranean countries, and how step counts are declining in modern society. The benefits of being active will be discussed. Participants will be instructed by the MVA to set themselves a goal for step count, to be tracked with their fitness band.

These instructions will be present on the website, encoded into the MVA and linked from external sources. Participants will be encouraged to increase their physical activity gradually to meet their step count, and only attempt physical activity well within their capabilities. They will be encouraged to include physical activity in as many ways as they can. No further specific instructions will be provided to participants.

Wearable Technology

Wearable fitness-promoting wrist bands will be provided to each participant. Participants will be required to record total active minutes collected by their wristbands with the MVA, to monitor PA levels. The MVA will prompt participants for this information and request it in a conversational style once per week (Appendix 3).

Physical activity adherence

Physical activity levels will be assessed at screening, baseline, week 6 and week 12. At screening a single question will assess overall activity:

In the past week, on how many days have you done a total of 30 minutes or more of physical activity, which was enough to raise your breathing rate? This may include sport, exercise, heavy gardening and brisk walking or cycling for recreation or to get to and from places but should not include housework or physical activity that may be part of your job

The Active Australia Questionnaire will be used at all other timepoints (Appendix 2). It will be administered as a paper form, in person at each clinic visit.

Weight lossThe MedDiet and PA interventions may result in weight loss for participants, however this will be self-directed. Weight loss is not a targeted outcome and the diet is not designed to be hypocaloric compared to usual intake. Participants will self-regulate their intake according to their hunger/activity needs. For this reason, a recommended range of servings is given for several food groups, to


allow flexibility of food quantity consumed. If there is evidence of weight loss or gain at week 6, participants may discuss this with study staff.

Outcomes

The following outcome measures will be used to answer the first primary objective:

Questionnaires administered at week 6 and week 12 to gather feedback from participants about aspects of the MVA, including

o Usefulness overallo Usefulness for specific purposes, such as answering questions or

directing to resourceso Technical aspects, such as bugs, glitches, lago The relationship between use of the MVA and adherence to the

intervention Data collected from MVA during study

o Number of times accessedo Types of questions askedo Whether questions were answered satisfactorily.

The following outcome measures will be used to assess the second primary objective:

Dietary adherence scores, measured at baseline, week 6 and week 12 visits, from the 14-item checklists. Scores for individuals are obtained, and the average compared across time points.

Physical activity levels, measured at baseline, week 6 and week 12 visits by the Active Australia Survey. From the survey, total minutes spent in walking, gardening, vigorous activities and moderate activities can be calculated. Proportion of people doing sufficient activity and proportion of people who were sedentary can be calculated.

The following outcome measures will be used to assess the secondary objective: Blood pressure (SBP and DBP), measured at baseline, week 6 and week 12

in clinic using digital monitors. BMI, measured from weight taken in clinic at baseline, week 6 and week

12, and height taken at baseline. Waist circumference, measured at baseline, week 6 and week 12.

Participant timeline


Figure 1. Flow chart of participant timeline in study

Sample size

As this is a pilot study, a sample size calculation was not done. A sample size of 30 adults was deemed sufficient to provide meaningful feedback to take forward into larger projects. Data from this study may be used to inform sample size calculations in future studies.

Recruitment

We will use media, such as news programs, and social media, to promote and advertise the study. Participants will be recruited from the greater metropolitan Adelaide area.

Methods: Data collection, management and analysis

Data collection methods

All data will be collected in person with trained staff at the Clinical Trials Facility. Data collection methods for each outcome measure are described in detail below.Weight, height and waist circumferenceBody weight will be measured using an electronic scale in the fasted state, after removing outer layers of clothing, pocket contents and without shoes. Height will be measured using a wall mounted stadiometer (SECA, Hamburg, Germany) with volunteers in stockinged or bare feet. BMI will be calculated thus: BMI= weight (kg)/height (m)2.


Screening

Online survey, consentEligibilty criteria assessedContacted by phone if eligible to schedule a baseline visit

Week 0

Clinic visitInitial introduction to MedDiet Virtual Assistant and inital eductionHeight, weight, waist circumference, blood pressure

Week 6

Clinic visitWeek 6 questionnarie to assess use of MVA at half-way pointWeight, waist circumference, blood pressure

Week 12

Clinic visitWeek 12 exit questionnaire to assess use of MVA and overall studyWeight, waist circumference, blood pressure

Waist circumference (in centimetres) will be measured at either the visual narrow or midpoint, according to the ISAK International Standards for Anthropometric Assessment. A Lufkin 6mmx2m steel measuring tape will be used. Whether visual narrow or midpoint is used will be recorded and used for all future measures.Blood pressureBlood pressure will be assessed using an OMRON Healthcare Co. digital blood pressure monitor (model 1A1B (Hem-7000-CIL). Participants will be seated for at least 10 minutes prior to the measurement. They will be asked to remove outer layers of clothing and/or roll up sleeves, and place feet flat on the ground. The forearm will be rested at table height, palm up, and the cuff will be placed approximately 2–3 cm above the anti-cubital fossa. Three measurements of blood pressure will be taken, each spaced at least one minute apart.Physical activityTo assess physical activity levels, one screening question will assess eligibility (does the participant already complete 30 minutes of PA on at least 5 days). This question will form part of the online screening questionnaire. The Active Australia Survey will be used (Appendix 2) to assess PA levels at baseline, week 6 and week 12 for the outcome measurement. In addition, participants will be asked to track their average step count on a weekly basis, with the chatbot. Dietary adherence To assess dietary adherence, participants will complete a 14-item questionnaire in clinic, under dietetic supervision (Appendix 1). The questionnaire will assess adherence to Mediterranean diet principles; higher scores indicate better adherence, maximum possible score 14.Week 6 and Week 12 QuestionnairesAt week 6 and week 12 participants will be asked to complete a questionnaire to assess usefulness, usability and acceptability of the website, MVA, instant messaging service and wearable technology in delivering the intervention. Data managementData collected from questionnaires will be entered manually into an excel spreadsheet by study staff. All clinically collected data will be initially written into case report forms, then transcribed into an excel spreadsheet. Results from blood tests will be recorded in case report forms and electronically in an excel spreadsheet. Chatbot data will be exported to an excel spreadsheet, which can be imported to SPSS for analysis.Statistical methodsDescriptive statistics will be presented for baseline characteristics. For categorical variables, counts and percentages will be provided. For continuous variables, means and SEMs will be provided (or non-parametric equivalents). We will analyse on an intention to treat basis as the primary analysis. Assuming normal distribution, one-way repeated measures ANOVA will be used to compare


means for adherence and PA at week 0, 6 and 12., as well as secondary outcomes (BMI, BP, waist circumference, lipids). If this is not possible then non-parametric procedures will be considered. Statistical significance will be set at P ≤ 0.05. Statistical analyses will be performed using SPSS for Windows (version 25.0; SPSS, Chicago, IL) and Stata (version 11, Statacorp, College Station, Texas).

Methods: Monitoring

Adverse eventsAll non-serious adverse events will be recorded using the adverse events form in the case report forms, within 24 hours of the staff being made aware of the event. A chief investigator must review and sign each adverse event. Serious adverse events, defined as an event either resulting in hospitalisation, prolonging hospitalisation, that are life threatening, or that result in death, must be recorded on the adverse events form, and must be reported to HREC within 24 hours of staff being made aware of the event.Any adverse event resulting directly from the intervention must be reported to the local HREC within 24 hours of staff being made aware of the event.SafetyParticipants with known health conditions which may interfere with their ability to complete the physical activity requirements or consume a MedDiet, may still meet eligibility criteria. In such cases, the participant may be required to seek approval from their GP to participate in the study. For example, those with type 2 diabetes, known heart conditions, or neurological conditions such as early stage Parkinson’s disease, will be considered on a case by case basis. Medications

Participants will be instructed to continue taking their regular medications/supplements for the duration of the study. At screening, all medications (name, dose, frequency, reason for use) will be recorded including supplements and vitamins. Participants will be asked at each visit whether any medications have changed. We will report any notable symptoms or indication that medication dosage should be altered to the participants nominated GP. If medications are adjusted this will be recorded by the investigators and an updated copy of medications will be requested.

3. Ethics and dissemination

Research ethics approval

Ethics approval will be sought from the University of South Australia Human Research Ethics Committee (UniSA HREC). The protocol, participant information sheet, case report forms and other materials will be approved before study commencement. Protocol amendments


Any changes to protocol will be submitted to the UniSA HREC for approval as an amendment.Consent or assent

Participants will be provided with an information sheet before commencing the study, after initially responding to advertisements. The information sheet will be emailed to them along with the survey to assess eligibility. This information sheet will provide a full description of all study procedures, inclusion/exclusion criteria, potential risks and benefits and other key information. Once participants have read this information sheet, if they are interested in participating in the study, they can then proceed to the online questionnaire. The consent form for the study will be presented as the first page of this online questionnaire. The consent form will make it explicit that participants should have read the information sheet before signing the consent form, and provide contact details for study staff. If participants have questions at this stage they will be encouraged to contact the study staff.There will be a button for participants to select which will replace a signature which will signify their consent. Once consent has been given, the questionnaire can be completed. At the beginning of the baseline appointment, a staff member will run through the study procedures briefly. The participant will have another opportunity to ask questions or clarify the study at this time. If the staff member is satisfied that the participant understands the study, he/she will sign a declaration at the beginning of the case report form. Confidentiality

All hard copy data will be stored in locked filing cabinets, in rooms accessible only by access key card. All participants will be given a coded ID (letter-number combination) when invited to their baseline appointment. All case report forms and other study material (questionnaires, biological samples) will be labelled with this study ID and participant initials. No other identifying information will be included on any study documents. Codes to identify participants, along with contact details, will be kept in an excel spreadsheet accessible only by password. Participants will be given the option to use their names, or their study IDs, when joining Slack for the study. They will be made aware that their names will be visible to other study participants. If participants wish to remain confidential their studyID can be used instead of name.Published results will not include any identifying information unless explicit permission is granted from the individual. All participants will receive a copy of their personal study results within 3 months of completing the trial, and a copy of the overall study results once data analysis has been finalised. Declaration of interests

The authors declare no conflict of interest.


Access to data

Access to study data will be limited to the study team. Personal results will be available to participants at any time, and a copy of all study results (weight, height, waist circumference, BMI, PA levels, dietary information, BP, lipids, fasting glucose) for all time points will be provided to participants upon completion or after early withdrawal from the study.Hard-copy data will be stored in the Clinical Trials Facility data storage facility for the required period of 15 years before being destroyed. Electronic data will be kept on an external hard drive for the same period, after which the external hard drive will be wiped clean. Dissemination policy

Results will be published in appropriate peer-reviewed journals. High-ranking, open-access journals will be targeted for greater dissemination of results. Other Regulatory requirements

This trial will be registered with to the Australian and New Zealand Clinical Trials Registry (ANZCTR).Insurance

This trial qualifies for standard insurance conditions, which are granted upon full ethics approval.

4. References

1. DPhil, SY, Hawken, S, Ounpuu, S, Dans, T, Avezum, A, Lanas, F, McQueen, M, Budaj, A, Pais, P, Varigos, J, Lsheng, L 2004. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. The Lancet;364;9438;937-952.2. Australian Institute of Health and Welfare 2018. Australia’s Health 2018. Australia’s health series no. 16. AUS 221. Canberra, AIHW 3. Australian Bureau of Statistics (ABS) 2016, Australian Health Survey: Consumption of food groups from the Australian Dietary Guidelines, Australia 2011-2012. ABS Catalogue No. 4364.0.55.0124. Estruch, R, Salas-Salvado, RJ, Covas, MI, Corella, CD, Aros, F, Gomez-Gracia, E, Ruiz-Gutierrez, V, Fiol, M, Lapatra, J, Lamuela-Raventos RM, et al. 2018. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. New Eng J of Med;378:e34; doi: 10.1056/NEJMoa18003895. Sofi, F.; Macchi, C.; Abbate, R.; Gensini, G.F.; Casini, A, 2014. Mediterranean diet and health status: An updated meta-analysis and a proposal for a literature-based adherence score. Public Health Nutr;17;2769–2782.6. Panagiotakos, D. Pitsavos, C, Chrysohoou, C, Palliou K, Lentzas, I, Skoumas, I, Stefanadis, C. 2009. Dietary patterns and 5-year incidence of


cardiovascular disease: A multivariate analysis of the ATTICA study. Nutr, Metab and Cardiovasc Dis;19;253-263.7. Kouris-Blazos, A, Gnardellis, C, Wahlqvist, ML, Trichopoulos, D, Lukito, W, Trichopoulou, A. 1999. Are the advantages of the Mediterranean diet transferable to other populations? A cohort study in Melbourne, Australia. Brit J of Nutr;82;57-61.8. Menotti A, Kromhout D, Blackburn H, Fidanza F, Buzina R, Nissinen A. Food Intake patterns and 25-year motality from coronary heart disease: Cross cultural correlations in the Seven Countries Study. Eur J of Epi 1999;15:501-15.9. Bamia C, Trichopoulos D, Ferrari P, Overvad K, Bjerregaard L, Tjønneland A, Halkjær J, Clavel-Chapelon F, Kesse E, Boutron-Ruault M et al. Dietary patterns and survival of older Europeans: The EPIC-elderly study (European Prospective Investigation into Cancer and Nutrition). Public Health Nutr 2007;10;6:590-598.10. Serra-Majem L, Roman B, Estruch R. Scientific evidence of interventions using the Mediterranean diet: a systematic review. Nutr Rev 2006;64(suppl);2:S27-S4711. Buckland, G, Bach, A, Serra-Majem, L. 2008. Obesity and the Mediterranean diet: a systematic review of observational and intervention studies. Obes Rev; 9;582-593.12. Davis, CR, Hodgson JM, Bryan, J, Garg, M, Woodman, R, Murphy, K, 2017. OlderAustralians can achieve high adherence to the Mediterranean diet during a 6 monthrandomised intervention; results from the MedLey study. Nutrients; 9:534,DOI: 10.3390/nu9060534.

13. Davis CR, Hodgson JM, Woodman R, Bryan J, Wilson C, Murphy KJ. AMediterranean diet lowers blood pressure and improves endothelial function: resultsfrom the MedLey randomized intervention trial. Am J Clin Nut 2017; 105:1305-1313; DOI: 10.3945/ajcn.116.146803

14. Davis, CR, Bryan, J, Hodgson, JM, Woodman, R, Murphy, KJ, 2017. A Mediterranean dietreduces F2-isoprostanes and triglycerides among older Australian men and womenafter 6 months. J of Nut;147:1348-1355, DOI: 10.3945/jn.117.248419.

15. Poushter, J 2016. Smartphone ownership and internet usage continues to climb in emerging economies (but advanced economies still have higher rates of technology use). Pew Research Centre Global Technology Report, Feb. 2016. 16. Martin, CK, Miller, AC, Thomas, DM, Champagne, CM, Han, Hongmei, Church, T 2015. Efficacy of SmartLoss, a smartphone-based weight loss intervention: Results from a randomized controlled trial. Obesity; 23; 935-942. Doi: 10.1002/oby.21063. 17. Glynn, LG, Hayes, PS, Casey, M, Glynn, F, Alvarez-Iglesias, A, Newell, J, O’Laighin, G, Heaney, David, O’Donnell, M, Murphy, AW 2014. Effectiveness of a


smartphone application to promote physical activity in primary care: the SMART MOVE randomised controlled trial. British J of General Practice. doi: 10.3399/bjgp14X680461.18. The Australian Institute of Health and Welfare (AIHW), 2003. The Active Australia Survey. A guide and manual for implementation, analysis and reporting. Catalogue no. CVD 22. Canberra: AIHW.

19. Davis CR, Bryan J, Hodgson JM, Wilson, C, Dhillon V, Murphy KJ, 2015. A randomisedcontrolled intervention trial evaluating the efficacy of an AustralianisedMediterranean diet compared to the habitual Australian diet on cognitive function,psychological wellbeing and cardiovascular health in health older adults (MedLeystudy): protocol paper. BMC Nutrition;1:35;DOI: 10.1186/s40795-015-0033-7

20. Australian Government Department of Health. Australia’s Physical activity and sedentary behaviour guidelines 2013. Accessed 19 Sep 2018. http://www.health.gov.au/internet/main/publishing.nsf/content/health-pubhlth-strateg-phys-act-guidelines


5. Appendices

Appendix 1: 14-item Mediterranean diet questionnaireAppendix 2: Active Australia SurveyAppendix 3: MedDiet checklist for weekly check-in with chatbot


Appendix 1: 14-item Mediterranean Diet Questionnaire

Foods and frequency of consumption1. Do you use olive oil as your main culinary fat? (please circle Y

or N) Y / N

2. Do you preferentially consume white meat over red meat? Y / N

3. How much olive oil do you consume per day including oil used for frying, salads, out-of-house meals, etc.? (Please answer in tablespoons (1Tb= approximately 20mL))

4. How many vegetable servings do you consume per day?(1 serving= ½ cup cooked or 1 cup salad or 1 tomato)

5. How many fruit servings (including pieces of fruit and natural 100% fruit juices) do you consume per day?

6. How many servings of butter, margarine or cream to you consume per day?

(1 serving=2 tsp of butter or margarine (12 g) /2 tablespoon (40g) of cream)

7. How many servings of red meat, hamburger, or meat products (ham, sausage etc.) do you consume per week? (1 serving = 100g)

8. How many sweet or carbonated beverages do you consume per week?

9. How many glasses of red wine do you drink per week? (Consider 1 glass as 100 ml)10. How many servings of legumes do you consume per week? (1

serving = 75g)11. How many servings of fish or shellfish do you consume per

week? (1 serving = 150g fish or 4-5 units/200g shellfish)

12. How many times per week do you consume commercial sweets or pastries (not homemade), such as cakes, cookies, biscuits?

13. How many servings of unsalted, plain nuts (including peanuts and nut spreads) do you consume per week?

(1 serving = 30g, or 1.5 Tbsp.)14. How many times per week do you consume Sofrito sauce

(made with onion, tomato and garlic simmered with olive oil) with vegetables, pasta, rice or other dishes?

Score /14


Scoring criteria: Question To score 1

point: 1. Do you use olive oil as your main culinary fat? (please circle Y or N)

YES

2. How much olive oil do you consume in a given day including oil used for frying, salads, out-of-house meals, etc.? (Please answer in tablespoon (1Tb= approximately 20mL))

2 or more

3. How many vegetable servings do you consume per day? (1 serving= ½ cup cooked or 1 cup salad or 1 tomato)

5 or more

4. How many fruit units (including pieces of fruit and natural 100% fruit juices) do you consume per day?

2 or more

5. How many servings of red meat, hamburger, or meat products (ham, sausage etc.) do you consume per day? (1 serving = 100-150g)

less than 1

6. How many servings of butter, margarine or cream to you consume per day? (1 serving = 1 tablespoon (20g) of butter or margarine or 2 tablespoon (40g) of cream)

less than 1

7. How many sweet or carbonated beverages do you drink per day?

less than 1

8. How much wine do you drink per week?(100ml wine is 1 standard drink but for most Australians 1 glass is 200 ml, or 2 standard drinks)

<14 standard drinks per

week9. How many servings of legumes do you consume per week? (1 serving = 150g)

3 or more

10. How many servings of fish or shellfish do you consume per week? (1 serving = 100-150g fish or 4-5 units or 200g shellfish)

3 or more

11. How many times per week do you consume commercial sweets or pastries (not homemade), such as cakes, cookies, biscuits, or custard?

3 or less

12. How many servings of nuts (including peanuts) do you consume per week? (1 serving = 30g)

5 or more

13. Do you preferentially consume chicken, turkey or rabbit meat instead of veal, pork, hamburger/steak or sausage?

Yes

14. How many times per week do you consume vegetables, pasta, rice or other dishes seasoned with a home-made tomato sauce (made with onion, leek, garlic simmered with olive oil)?

2 or more


Appendix 2: Active Australia Survey1. In the last week, how many times have you walked continuously, for at least10 minutes, for recreation, exercise or to get to or from places?

times

2. What do you estimate was the total time that you spent walking in this way in the lastweek?

In hours and/or minutes

minutes

hours

3. In the last week, how many times did you do any vigorous gardening or heavy workaround the yard, which made you breathe harder or puff and pant?

times

4. What do you estimate was the total time that you spent doing vigorous gardening orheavy work around the yard in the last week?


minutes

Hours

The next questions exclude household chores, gardening or yardwork:5. In the last week, how many times did you do any vigorous physical activity which madeyou breathe harder or puff and pant? (e.g. jogging, cycling, aerobics, competitive tennis)

times

6. What do you estimate was the total time that you spent doing this vigorous physicalactivity in the last week?


Minutes

hours

7. In the last week, how many times did you do any other more moderate physical


activities that you have not already mentioned? (e.g. gentle swimming, social tennis,golf)

times

8. What do you estimate was the total time that you spent doing these activities in the lastweek?

In hours and/or minutesminutes

hours

To what extent do you agree or disagree with the following statements about physicalactivity and health?

9(a) Taking the stairs at work or generally being more active for at least 30 minutes each dayis enough to improve your health.

strongly disagree

disagree neither agree nor disagree

agree strongly agree

9(b) Half an hour of brisk walking on most days is enough to improve your health.

strongly disagree



9(c) To improve your health it is essential for you to do vigorous exercise for at least20 minutes each time, three times a week.

strongly disagree



9(d) Exercise doesn’t have to be done all at one time—blocks of 10 minutes are okay.

strongly disagree



9(e) Moderate exercise that increases your heart rate slightly can improve your health.

strongly disagree




Appendix 3: MedDiet checklist for weekly check-in with chatbotChatbot to ask the following questions:

PHYSICAL ACTIVITYo What was your average daily step count for the past week (please

check your [wearable technology] summary data)?o Did you do any steps while not wearing your fitness band?

DIETARY INTAKE: In the past week:o How many serves, on average, of vegetables did you consume per

day? o How many serves, on average, of extra virgin olive oil did you

consume per day?o How many serves, on average, of fruit did you consume per day? o How many glasses of red wine did you consume per day? o How many serves, on average, of grain foods (bread, pasta, cereal,

rice) did you have per day?o How many serves, on average, of dairy foods (milk, cheese,

yoghurt) did you consume per day?o How many serves of legumes did you consume this week? o How many serves of nuts did you consume this week?o How many serves of fish or shellfish did you consume this week?o How many times did you have sofrito sauce this week?o How many serves of chicken/poultry did you have this week?o How many times did you have discretionary foods this week?

OTHERo Have any of your medications, vitamins or other dietary

supplements changed this week?o Have you had any adverse events this week?

If so, please report to study staff as soon as possible. Chatbot will remind participants upon request what a serving size is equal to, and help them calculate their total serves if they are unsure.


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