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Trial registered on ANZCTR


Registration number
ACTRN12619000015145
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
9/01/2019
Date last updated
19/09/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A chatbot delivered Mediterranean lifestyle intervention for adults - a feasibility and pilot study (MedLiPal)
Scientific title
A virtual assistant delivered Mediterranean lifestyle intervention for adults - a feasibility and pilot study
Secondary ID [1] 296530 0
None known
Universal Trial Number (UTN)
U1111-1223-3094
Trial acronym
MedLiPal - Mediterranean Lifestyle Physical Activity study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 310309 0
Physical Inactivity 310959 0
Condition category
Condition code
Diet and Nutrition 309043 309043 0 0
Other diet and nutrition disorders
Cardiovascular 309044 309044 0 0
Hypertension
Cardiovascular 309045 309045 0 0
Coronary heart disease
Diet and Nutrition 309047 309047 0 0
Obesity
Public Health 309410 309410 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a single-arm physical activity and dietary intervention study, delivered through technology (website, virtual assistant, instant messaging service and wearable fitness band).

Technology (website, wearable fitness band, instant messaging service, virtual assistant): Participants will receive access to a purpose-built website with information about the Mediterranean diet and physical activity interventions. Participants will also join an instant messaging service (the cloud-based service “Slack”). Through Slack, they will be able to interact with an embedded virtual assistant (chatbot - named Paola), which will be programmed with information about the intervention. 'Paola' will offer advice and instructions and have the ability to answer questions and link particpants to resources and other external websites. Participants will be able to use Slack to communicate with the chatbot and with other participants, using their smartphones or other electronic devices. Study staff will be able to view and monitor the Slack chatroom. Participants will receive a wearable fitness band to track their daily steps.

Physical activity intervention: The physical activity intervention will be based on increasing daily step count, through increasing incidental activity as well as exercise and other types of physical activity. Participants will set their own step goal. They will be educated on the average daily step count for their age and gender, and encouraged to increase their step count above this by approximately 2000 steps per day, depending on other factors, such as how many steps they do currently. The focus will be on incorporating physical activity into their lifestyle, and being active in as many ways as possible. This might include walking for transport, taking stairs, doing chores manually, and deliberately incoporating walks or other activities into daily routine. No specific types of physical activity will be prescribed.
The wearable fitness band will monitor daily steps. These bands should be worn 24 hours per day, or at the least, during all waking hours. Daily steps are tracked, and an average daily step count for the week is calculated. Each week, Paola will ask participants to review their average daily step count, and report it. This data will be recorded in a spread sheet. They will then review their goal with Paola, who will set the new goal for the next week. At the clinic visits (baseline, week 6 and week 12), participants will complete the Active Australia Survey to report thier physical activity levels.

Mediterranean diet intervention: The dietary intervention will be based on a traditional Mediterranean dietary pattern. Participants will be instructed to consume a wide variety of fresh vegetables, fruits, legumes, nuts and wholegrain products, use extra virgin olive oil as their main added fat, choose white meats and fish over red meat, and restrict processed meats, processed foods and sweets. Recommended servings of foods will be as follows: 2-3 Tbsp extra virgin olive oil, 5-6 serves of vegetables, 2-3 serves fruit, 5 serves breads and cereals, 0-2 serves red wine and 2 serves dairy daily, plus 3-4 serves legumes, 2-3 serves fish, 1-2 serves chicken, 5 serves nuts, less than one serve of red meat and processed meat, less than 6 eggs and sweets 3 times or less per week. This information will be provided to participants via a series of short videos, accessible via the website. Paola will introduce them to the study and website, directing them to watch the educational videos. All information about the dietary requirements will also be written on the website, and Paola will be programmed with this information as well, to enable the chatbot to correctly answer questions about topics such as serving size or number of recommended serves. No food or beverages will be provided to participants, however they will be encouraged to utilise a daily log-sheet, which will track their servings of key foods.

With regards to interacting with the technology, the compulsory components include watching the videos at the baseline visit, weekly check-ins which Paola will initiate, and wearing the fitness band, at least during all waking hours. Use of Paloa, Slack, the wristband and the website will otherwise be at the users discretion.

Both the website and Slack have capabiliites to enable analytics of use, such as number of times accessed. This data will be collected. In addition, use and usefulness of the chatbot will be assessed. Number of times Slack is accessed, and the types of comments and questions being asked will be monitored. To assess the usefulness of the chatbot, a likert scale rating system from 'very bad', 'bad, 'neutral', 'good' and 'very good' will be used. After each interaction with Paola, the participants will be asked to assess her usefulness with this scale.
Study structure: The study will comprise 3 clinic visits (baseline, week 6 and week 12) plus weekly check-ins with the chatbot at home. At baseline, participants will set up accounts/logins for Slack and the website. They will be given their wearable wristbands and instructed to download the associated application. While at their baseline appointment, participants will then engage with the technology to educate themselves with the study requirements. They will set their step goal and view educational videos on the Mediterranean diet and lifestyle. The session will be 'run' by Paola, who will guide participants through accessing the website, watching the videos, setting up their fitness bands and setting a step goal. Study staff will be minimally involved with the education.

Participants will be expected to undertake the recommendations for 12 weeks, increasing their step count to meet their goal each week and altering their diet to a Mediterranean dietary pattern. The chatbot will assist with weekly check-ins, where participants will be required to report their physical activity (average daily step count) and dietary intake. In between weekly check-ins, particpants will have access to Paola, the website and their fitness band at all times. The chatbot will use a motivational style of questioning and counselling to help participants adhere to the intervention.

At baseline, week 6 and 12, participants will attend the clinic and have physical activity and Mediterranean diet adherence assessed. All clinic visits will occur at the Clinical Trials Facility, University of South Australia City East Campus, Frome Rd, Adelaide 5001. Participants will be free living adults and will incorporate the physical activity and dietary changes into their day-to-day lives.
Intervention code [1] 312838 0
Lifestyle
Intervention code [2] 312839 0
Behaviour
Intervention code [3] 313266 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308004 0
Usefulness and user acceptability (composite primary outcome) of a technology delivered Mediterranean diet lifestyle intervention, assessed by:
Feasibility questionnaires (combination of likert scale and open-ended responses) designed for the study (week 6 and week 12)
Number of times virtual assistant is engaged throughout the study by each participant (system analytics - each person will have a logon for Slack and their usage can be tracked)
In-built user assessment within virtual assistant software (after each encounter with participant, chatbot asks for user acceptability rating)
Timepoint [1] 308004 0
6 weeks post baseline
12 weeks post baseline (primary timepoint)
Primary outcome [2] 308005 0
Change in Mediterranean diet adherence, assessed by 14-item questionnaire (designed for study). Higher scores indicate better adherence
Timepoint [2] 308005 0
6 weeks post baseline
12 weeks post baseline (primary timepoint)
Primary outcome [3] 308006 0
Change in physical activity assessed by Active Australia Survey (validated measurement tool for assessing physical activity levels)
Timepoint [3] 308006 0
Week 6 post baseline
Week 12 post baseline (primary timepoint)
Secondary outcome [1] 353630 0
Change in body mass index (kg/m2), following a Mediterranean diet and lifestyle intervention. Body mass index will be assessed using height and weight, measured by trained staff. Calibrated, digital scales will be used to measure weight, and wall-mounted stadiometres will be used to measure height. Participant's height and weight will be measured in light clothing only, without shoes.
Timepoint [1] 353630 0
12 weeks post baseline
Secondary outcome [2] 354719 0
Change in blood pressure (systolic and diastolic, mmHg) following a Mediterranean diet and lifestyle intervention. Blood pressure will be measued using OMRON Healthcare Co. digital blood pressure monitors.
Timepoint [2] 354719 0
12 weeks post baseline
Secondary outcome [3] 354720 0
Change in waist circumference (cm) following a Mediterranean diet and lifestyle intervention. Waist circumference will be measured using a Lufkin steel 6mmx2m anthropometric measuring tape.
Timepoint [3] 354720 0
12 weeks post baseline

Eligibility
Key inclusion criteria
Male or female free-living adults
Age 45-75 yr
Not currently meeting Australian physical activity guidelines (less than 150 minutes of moderate-vigorous activity, AND less than 75 minutes of vigorous activity weekly)
Not currently consuming a Mediterranean diet (score less than 7 out of 14 on MedDiet questionnaire)
Able to use a computer or smart phone (with internet and capable of running Slack)
Speak fluent English
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be presented for baseline characteristics and feasibility data. 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 identify change over time for step count at week 0, 6 and 12, mean Mediterranean diet compliance score as well as secondary outcomes (BMI, BP, waist circumference). 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).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2019
Actual
6/03/2019
Date of last participant enrolment
Anticipated
26/04/2019
Actual
17/04/2019
Date of last data collection
Anticipated
26/07/2019
Actual
16/08/2019
Sample size
Target
30
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 24627 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 301112 0
University
Name [1] 301112 0
University of South Australia
Country [1] 301112 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
University of South Australia
GPO Box 2471, Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 300729 0
None
Name [1] 300729 0
Address [1] 300729 0
Country [1] 300729 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301862 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 301862 0
Ethics committee country [1] 301862 0
Australia
Date submitted for ethics approval [1] 301862 0
01/11/2018
Approval date [1] 301862 0
29/01/2019
Ethics approval number [1] 301862 0

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

Contacts
Principal investigator
Name 88358 0
A/Prof Carol Maher
Address 88358 0
Alliance for Research in Exercise, Nutrition and Activity
University of South Australia, City East Campus
GPO Box 2471, Adelaide, South Australia, 5001
Country 88358 0
Australia
Phone 88358 0
+61 8 83022315
Fax 88358 0
Email 88358 0
carol.maher@unisa.edu.au
Contact person for public queries
Name 88359 0
Carol Maher
Address 88359 0
Alliance for Research in Exercise, Nutrition and Activity
University of South Australia, City East Campus
GPO Box 2471, Adelaide, South Australia, 5001
Country 88359 0
Australia
Phone 88359 0
+61 8 83022315
Fax 88359 0
Email 88359 0
carol.maher@unisa.edu.au
Contact person for scientific queries
Name 88360 0
Carol Maher
Address 88360 0
Alliance for Research in Exercise, Nutrition and Activity
University of South Australia, City East Campus
GPO Box 2471, Adelaide, South Australia, 5001
Country 88360 0
Australia
Phone 88360 0
+61 8 83022315
Fax 88360 0
Email 88360 0
carol.maher@unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be shared for this trial. Because it is a small feasibility study, assessing aspects of feasiblitity for a larger trial, the authors believe there are unlikely to be benefits to sharing IPD, compared to the risks and effort involved. Biomedical data is being collected as secondary outcome meaurements only.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
688Study protocol    376325-(Uploaded-08-01-2019-13-09-50)-Study-related document.docx
689Informed consent form    376325-(Uploaded-11-12-2018-11-57-44)-Study-related document.docx



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.