Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001450505
Ethics application status
Approved
Date submitted
8/10/2024
Date registered
13/12/2024
Date last updated
2/02/2025
Date data sharing statement initially provided
13/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PANDA Trial - Physical activity in Nature for Cardiometabolic Diseases in People Aged 45y+
Scientific title
PANDA Trial - Physical activity in Nature for Cardiometabolic Diseases in People Aged 45y+
Secondary ID [1] 313147 0
Nil
Universal Trial Number (UTN)
Trial acronym
PANDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Cardiac Failure 335416 0
Obesity - Body Mass Index greater than or equal to 30 kg/m squared 335421 0
Stable Coronary Artery Disease 335414 0
Valvular Heart Disease 335417 0
Paroxysmal Atrial Fibrillation 335418 0
Hypertension 335405 0
Diabetes Mellitus 335409 0
Hypercholesterolemia 335406 0
Stable Cerebrovascular Disease 335415 0
Condition category
Condition code
Cardiovascular 331976 331976 0 0
Hypertension
Metabolic and Endocrine 331980 331980 0 0
Metabolic disorders
Cardiovascular 331975 331975 0 0
Coronary heart disease
Metabolic and Endocrine 331979 331979 0 0
Diabetes
Cardiovascular 331977 331977 0 0
Other cardiovascular diseases
Diet and Nutrition 331978 331978 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the PANDA study, adults in the Intervention group will receive a personalised nature prescription consisting of four text messages per week for 12 months from DigiCuris, an AI enabled text messaging platform created by the University of Sydney and Western Sydney Local Health District. Digicuris offers interactive and user-friendly digital tools that enhance participant understanding of the study’s procedures, risks, and benefits. The messages are personalised by Digicuris based on the surveys that participants complete to ensure they are relevant and sustainable for the participants lifestyle. Participants will only receive text messages between the hours of 8am and 6pm. These four messages are designed to: (a) encourage participants to spend time in nature, customised to their baseline data on motivations, barriers, etc; (b) suggest local opportunities to spend time in nature based on where they live (e.g., Landcare, Parkrun, gardens, parks); (c) provide education on the health benefits of spending time in nature, based on their health at baseline (e.g., mental health, loneliness). The participants will also receive a single, one-to-one MS Teams call from a trained Researcher/nurse to inform them of national physical activity guidelines and some suggestions on how that goal might be achieved, based on standard advice that may typically be provided by a General Practitioner (GP) and/or an Accredited Exercise Physiologist (AEP). This duration of this call is approximately 30 minutes.
Participants be required to attend face to face clinic visits with trained researchers/nurses at either Blacktown hospital or Wollongong University Clinics at Baseline, 6 months, 12 months and 18 months during the study to collect the following data: Fasting Bloods via a finger-prick (HbA1c and Lipids)
*Blood Pressure
*Weight
*Height
*Waist Circumference
*Change in medications or study related injuries since the last visit
*Online demographic and physical activity surveys.
They will be given the following equipment and instruction sheets to take home:
*AX3, 3-Axis Logging Accelerometer
*GPS QStarz BL-1000ST Activity Tracker
* Blood Pressure Cuff Aktiia bracelet (non-sleep measurements only).
Participants will leave the study visit wearing the equipment and will receive a short follow-up call within 2 days to check they are using the equipment correctly.
Each of the participant clinic visits at baseline, 6, 12 and 18 months will take approximately 90 minutes.
The participants will also receive monthly a text message and a short phone call and survey at 3 months post baseline visit to check they are okay and ask them if they are following the advice they have been given. They will receive text messages at months 6, 12 and 18 with links to online surveys, to provide reminders for the return of the accelerometers, BP bracelets and GPS equipment, and to provider reminders for when they are to go to have their blood tests on site.
At the 12 and18-month study visit participants will be asked to complete a short process evaluation questionnaire and at 18 months 10–20-minute telephone interview with the research nurse consisting of 10 questions. These surveys will include participants self-report around their adherence to the intervention.

Intervention code [1] 329718 0
Lifestyle
Intervention code [2] 329784 0
Behaviour
Comparator / control treatment
The PANDA control group receive/follow exactly the same procedures as the Intervention group except the DO NOT receive a personalised nature prescription consisting of four text messages per week for 12 months from DigiCuris.
Control group
Active

Outcomes
Primary outcome [1] 339586 0
Total minutes per week of moderate to vigorous physical activity (MVPA) at month 12, compared with month 0 (baseline) between the two groups (nature prescription vs control)
Timepoint [1] 339586 0
Baseline and 12 months post-intervention commencement.
Secondary outcome [1] 442609 0
Loneliness
Timepoint [1] 442609 0
Baseline and 12-months post-intervention commencement
Secondary outcome [2] 440521 0
Body Mass Index.
Timepoint [2] 440521 0
Baseline and 12 months post-intervention commencement.
Secondary outcome [3] 442606 0
General mental health
Timepoint [3] 442606 0
Baseline and 12-months post-intervention commencement
Secondary outcome [4] 440520 0
Movement behaviours between the two groups including total minutes per week spent in nature.
Timepoint [4] 440520 0
Baseline and 12 months post-intervention commencement.
Secondary outcome [5] 440875 0
Motivation for keeping physically active
Timepoint [5] 440875 0
Baseline and 12 months post-intervention commencement.
Secondary outcome [6] 440522 0
Perceptions of local nature
Timepoint [6] 440522 0
Baseline and 12 months post-intervention commencement.
Secondary outcome [7] 442605 0
General Health
Timepoint [7] 442605 0
Baseline and 12-months post-intervention commencement
Secondary outcome [8] 440519 0
Maintenance - Effectiveness of the intervention in maintaining results at 6 months post treatment.
Timepoint [8] 440519 0
12 months post intervention commencement and 18 months post intervention commencement.
Secondary outcome [9] 442612 0
Optimism
Timepoint [9] 442612 0
Baseline and 12-months post-intervention commencement
Secondary outcome [10] 442601 0
Hours per week spent sleeping
Timepoint [10] 442601 0
Baseline and 12-months post-intervention commencement
Secondary outcome [11] 442598 0
total minutes per week spent being physically active in nature
Timepoint [11] 442598 0
Baseline and 12-months post-intervention commencement
Secondary outcome [12] 442608 0
Quality of life
Timepoint [12] 442608 0
Baseline and 12-months post-intervention commencement
Secondary outcome [13] 442603 0
Blood Pressure
Timepoint [13] 442603 0
Baseline and 12-months post-intervention commencement
Secondary outcome [14] 442599 0
Total minutes per week of walking.
Timepoint [14] 442599 0
Baseline and 12-months post-intervention commencement
Secondary outcome [15] 442619 0
Pro-environmental behaviours
Timepoint [15] 442619 0
Baseline and 12-months post-intervention commencement
Secondary outcome [16] 441409 0
Cost-effectiveness
Timepoint [16] 441409 0
Baseline and 12-months post-intervention commencement
Secondary outcome [17] 442617 0
Motivation for spending time in nature
Timepoint [17] 442617 0
Baseline and 12-months post-intervention commencement
Secondary outcome [18] 442602 0
Waist Circumference
Timepoint [18] 442602 0
Baseline and 12-months post-intervention commencement
Secondary outcome [19] 442610 0
Perceived sleep duration and quality
Timepoint [19] 442610 0
Baseline and 12-months post-intervention commencement
Secondary outcome [20] 442615 0
Readiness for change
Timepoint [20] 442615 0
Baseline and 12-months post-intervention commencement
Secondary outcome [21] 442604 0
Lipids and HbA1c
Timepoint [21] 442604 0
Baseline and 12-months post-intervention commencement
Secondary outcome [22] 442607 0
General wellbeing
Timepoint [22] 442607 0
Baseline and 12-months post-intervention commencement
Secondary outcome [23] 442621 0
Social media use
Timepoint [23] 442621 0
Baseline and 12-months post-intervention commencement
Secondary outcome [24] 442600 0
Physical Activity
Timepoint [24] 442600 0
Baseline and 12-months post-intervention commencement
Secondary outcome [25] 442613 0
Psychosocial resilience
Timepoint [25] 442613 0
Baseline and 12-months post-intervention commencement
Secondary outcome [26] 442618 0
Connectedness to nature
Timepoint [26] 442618 0
Baseline and 12-months post-intervention commencement
Secondary outcome [27] 442620 0
Attitudes towards climate change
Timepoint [27] 442620 0
Baseline and 12-months post-intervention commencement
Secondary outcome [28] 442611 0
Perceived pain
Timepoint [28] 442611 0
Baseline and 12-months post-intervention commencement
Secondary outcome [29] 442616 0
Confidence in being physically active.
Timepoint [29] 442616 0
Baseline and 12-months post-intervention commencement
Secondary outcome [30] 442614 0
Enjoyment of physical activity
Timepoint [30] 442614 0
Baseline and 12-months post-intervention commencement

Eligibility
Key inclusion criteria
1) Physically inactive (defined as less than 150 minutes of moderate-intensity activity per week, or equivalent)
2) Fewer than 2 hours spent in nature per week
3) Stable weight for previous 3 months (defined as stable weight +/- 4kgs)
4) Presence of a cardiometabolic disease, diagnosed by a doctor or health professional including at least one of the following:
5) Doctor diagnosed:
a) hypertension (Blood pressure: greater than or equal to 130mm/Hg systolic or greater than or equal to 85mm/Hg diastolic)
b) hypercholesterolemia (Fasting plasma triglycerides:greater than or equal to 1.7mmol/L Fasting plasma HDL-C: less than 1.0mmol/L in males, less than 1.3mmol/L in females)
c) diabetes mellitus (Fasting blood glucose: greater than 5.5 mmol/L, HbA1C: greater than or equal to 6% and/or oral antidiabetic medications) mellitus
d) stable coronary artery disease (greater than 3 months since revascularization or myocardial infarction)
e) stable cerebrovascular disease (greater than 3 months since stroke)
f) congestive cardiac failure (NYHA class I, II)
g) moderate valvular heart disease
h) paroxysmal atrial fibrillation
Self-measured (or by health professional):
i) Waist circumference: greater than or equal to 94cm in males, greater than or equal to 80cm in females
j) Obesity (body mass index greater than or equal to 30 kg/m squared)
6) Willing to receive and respond to text messages throughout the study
7) Willing to use equipment to measure physical activity, blood pressure and location as per instruction manuals including:
a) a ‘wrist worn’ device to record physical activity for 10 days.
b) a wrist worn device to record Blood Pressure for 10 days.
c) carry a GPS tracker throughout the day for 10 days.
8) Speak, read and understand English, as consent and introductory phone call translators are not available.
9) Willing to travel to one of the study sites (Blacktown Hospital or Wollongong University) to perform the assessments in accordance with the assessment schedule.
10) Currently live in Blacktown or surrounding areas, or Wollongong/Shellharbour or surrounding areas, (NSW, Australia).
11) Access to a smartphone (IOS version 15 or newer) or android device (android 8.0 or newer, Bluetooth 4.2 or higher) with an internet connection and feel comfortable using it to download an App.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) A health professional-diagnosed debilitating or terminal medical condition (e.g. end stage cancer)
2) Current significant alcohol or drug abuse (classify significant alcohol intake as drinking more than 2 standard measures of alcohol each day for more than 5 days a week).
3) Severe/untreated mental illnesses (including eating disorders)
4) Advanced cardiac, liver or renal disease (eGFR less than 15 mL/min/1.73 m squared)
5) Active proliferative diabetic retinopathy
6) Unable to give written informed consent
7) Unwilling to use the accelerometer (for measuring physical activity), or refuses to follow the protocol
8) Upper arm circumference of greater than 64cm (BP device size limit) or a wrist circumference of greater than 22 cm (BP device size limit)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation and allocation concealment will be achieved by REDCap. The allocation will be concealed from all study personnel (except the study REDCap programmer), including the investigators and participants. It will not be possible to predict or decipher the next allocation because the sequence will be uploaded to REDCap, accessed and maintained by the REDCap programmer with specific user rights, so that both key study staff and participants would not have access to the sequence and will be blinded to group allocation. The randomisation records will be maintained in REDCap.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised in the electronic study database (REDCap) to either the intervention or control group. Randomisation will be conducted using randomly permuted blocks in a 1:1 ratio with stratification based on location (inland or coastal).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/03/2028
Actual
Sample size
Target
254
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27201 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 43284 0
2500 - Wollongong
Recruitment postcode(s) [2] 43283 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 317590 0
Government body
Name [1] 317590 0
Australian Government Department of Health National Health and Medical Research council 2022 MRFF Effective Treatments and Therapies Program Grant funds 2022/MRF2023914
Country [1] 317590 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 319896 0
None
Name [1] 319896 0
Address [1] 319896 0
Country [1] 319896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316293 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316293 0
Ethics committee country [1] 316293 0
Australia
Date submitted for ethics approval [1] 316293 0
08/10/2024
Approval date [1] 316293 0
18/12/2024
Ethics approval number [1] 316293 0

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

Contacts
Principal investigator
Name 137426 0
Prof Xiaoqi Feng
Address 137426 0
UNSW School of Population Health F25, Samuels Building, Samuel Terry Ave, Kensington NSW 2033
Country 137426 0
Australia
Phone 137426 0
+61 2 93851135
Fax 137426 0
Email 137426 0
[email protected]
Contact person for public queries
Name 137427 0
Xiaoqi Feng
Address 137427 0
UNSW School of Population Health F25, Samuels Building, Samuel Terry Ave, Kensington NSW 2033
Country 137427 0
Australia
Phone 137427 0
+61 2 93851135
Fax 137427 0
Email 137427 0
[email protected]
Contact person for scientific queries
Name 137428 0
Xiaoqi Feng
Address 137428 0
UNSW School of Population Health F25, Samuels Building, Samuel Terry Ave, Kensington NSW 2033
Country 137428 0
Australia
Phone 137428 0
+61 2 9385 1135
Fax 137428 0
Email 137428 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.