Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000448842
Ethics application status
Approved
Date submitted
17/03/2021
Date registered
19/04/2021
Date last updated
5/04/2023
Date data sharing statement initially provided
19/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
South Asian Diet and Activity Intervention
Scientific title
A pilot trial of a co-designed, digitised health promoting intervention for New Zealand South Asian adult migrants to assess acceptability, engagement, uptake and compliance
Secondary ID [1] 303707 0
R-LHR-2021-152418
Universal Trial Number (UTN)
U1111-1266-2057
Trial acronym
SADAI (South Asian Diet and Activity Intervention)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Public Health 321131 0
Condition category
Condition code
Public Health 318925 318925 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a co-designed culturally appropriate diet and activity digital programme delivered as six modules, one per month over six months via a password protected, sophisticated, web-based application. The modules are: 1) Improve awareness of the health impact of dietary patterns and regular activity 2) Improve awareness of healthy breakfast, meal timings and portion sizes on health 3)Why and how to increase fruit, vegetable and lentil consumption; 4) Why and how to decrease dairy fats and oil consumption 5) Why and how to decrease high fat, high salt and high sugar snacks 6) Why and how to increase activity levels. Each module comprises of a mixture of educational comics, motivational, informational and demonstration video clips and corresponding website information including scientific snippets in an easily digestible format suitable for a lay audience.
Participants will be required to spend a maximum of 60 minutes per module, each month, for six months. Participants can do this in shorter intervals if they prefer over the course of the month. All participation and engagement with each module will be time-stamped and analysed for monitoring adherence.
Intervention code [1] 320015 0
Lifestyle
Comparator / control treatment
Standard Care: A static website with link to generic information currently available in New Zealand delivered corresponding to each of the intervention module, one per month over six months via a password protected, sophisticated, web-based application. Links to the Heart Foundation of New Zealand website for the dietary related modules (1-5) and to the Sports New Zealand website for the physical activity module (6) will be sent.
Control group
Active

Outcomes
Primary outcome [1] 326860 0
Acceptability of the intervention i.e. whether the content of the intervention modules is relevant, useful, and understandable.
Data on acceptability of each module will be collected from the intervention group using a 5-point ordinal scale (developed specifically for the study) which will be accessible via a hyperlink on the module webpage.
Timepoint [1] 326860 0
Immediately post engagement with each module
Primary outcome [2] 326862 0
The level of engagement with the intervention.

The level of engagement will be assessed by monitoring engagement of the participants with the six digitised modules, as it happens, using metadata information.
Timepoint [2] 326862 0
Immediately post engagement with each module
Primary outcome [3] 327151 0
Level of knowledge uptake

The level of uptake will be assessed by assessing knowledge. Each module has a set of questions (developed specifically for the study and relating specifically to the intervention components) related to the module, accessible via a hyperlink on the module webpage.
Timepoint [3] 327151 0
Immediately post-engagement with each module
Secondary outcome [1] 393966 0
Level of compliance (Primary outcome)

Compliance to the programme will be assessed based on engagement with all six modules using metadata information and completion of the associated questionnaires (Acceptability and Knowledge).
Timepoint [1] 393966 0
Immediately post-engagement with each module
Secondary outcome [2] 393967 0
The level of engagement in the control group (Primary outcome)

The level of engagement in the control group with the provided link to currently available generic information on diet and physical activity will be measured using the time-stamped metadata information.
Timepoint [2] 393967 0
Immediately post-engagement with each module
Secondary outcome [3] 393968 0
Attrition rates will be assessed based on the completion rate of the follow-up questionnaire at one-month and six-months post intervention.
Timepoint [3] 393968 0
One month post-intervention
Six months post intervention
Secondary outcome [4] 393969 0
Motivation to adopt health promoting dietary habits and activity levels

This will be assessed via study specific questionnaire data
Timepoint [4] 393969 0
One month post-intervention
Six months post intervention
Secondary outcome [5] 393970 0
Knowledge levels of dietary and activity level impacts on disease prevention and development

This will be assessed via study specific questionnaire data
Timepoint [5] 393970 0
One month post-intervention
Six months post-intervention
Secondary outcome [6] 393971 0
Dietary and Activity behavioural changes

This will be assesed via study speciifc questionnaire data
Timepoint [6] 393971 0
One month post-intervention
Six months post-intervention

Eligibility
Key inclusion criteria
South Asian ethnicity, not born in New Zealand; lived in New Zealand for at least 3 years, are citizens of NZ or hold a permanent residency or a work visa; can understand and communicate in English; are regular users of the internet and have access to a computer.
Minimum age
25 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have any diagnosed disease(s), i.e. told by a medical doctor about having a condition that requires modified diet and/or activity levels and/or prevents their full participation in the study.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
stratified for gender
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the pilot study, a total of 100 participants (50 in each group) will be recruited to provide sufficiently precise estimates, including for attrition within each group where 95% CIs for group-specific attrition will be ±14% and overall attrition ±10% (Wald estimates, worst case). Assuming at least 30 participants remain in each group, this will also allow estimating a unit standard deviation with a 95% CI of 0.84–1.25 for baseline measures and 0.80–1.34 for follow-up measures within each group, and 0.88–1.16 and 0.85–1.22 respectively combining both groups. The primary outcomes will be described using appropriate summary statistics (means and SDs, medians and IQRs, and counts and percentages). For the secondary outcomes, an inferential approach will be used with a focus on confidence intervals, and the inclusion of practically important effects, rather than statistical significance. All analyses will be conducted using R 4.0.2 and/or Stata 16.1 (or later versions).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2021
Actual
17/05/2021
Date of last participant enrolment
Anticipated
30/07/2021
Actual
30/07/2021
Date of last data collection
Anticipated
23/09/2022
Actual
23/09/2022
Sample size
Target
100
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 23543 0
New Zealand
State/province [1] 23543 0

Funding & Sponsors
Funding source category [1] 308121 0
Government body
Name [1] 308121 0
Lottery Grants Board
Country [1] 308121 0
New Zealand
Primary sponsor type
Individual
Name
Dr Sherly Parackal
Address
Room 1.88, 55 Hanover Street
Otago Medical School,
Dunedin School of Medicine,
University of Otago,
PO Box 56, Dunedin, 9054, New Zealand
Country
New Zealand
Secondary sponsor category [1] 308877 0
Individual
Name [1] 308877 0
Assoc Prof Tony Savarimuthu
Address [1] 308877 0
Room 7.18, Otago Business School,
University of Otago,
PO Box 56, Dunedin, 9054, New Zealand
Country [1] 308877 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308107 0
University of Otago Human Ethics Committee
Ethics committee address [1] 308107 0
Ethics committee country [1] 308107 0
New Zealand
Date submitted for ethics approval [1] 308107 0
31/08/2020
Approval date [1] 308107 0
12/10/2020
Ethics approval number [1] 308107 0
20/087

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

Contacts
Principal investigator
Name 109562 0
Dr Sherly Parackal
Address 109562 0
Room 1.88, 55 Hanover Street
Otago Medical School,
Dunedin School of Medicine,
University of Otago,
PO Box 56, Dunedin, 9054, New Zealand
Country 109562 0
New Zealand
Phone 109562 0
+64 3 470 7278
Fax 109562 0
Email 109562 0
[email protected]
Contact person for public queries
Name 109563 0
Sherly Parackal
Address 109563 0
Room 1.88, 55 Hanover Street
Otago Medical School,
Dunedin School of Medicine,
University of Otago,
PO Box 56, Dunedin, 9054, New Zealand
Country 109563 0
New Zealand
Phone 109563 0
+64 3 470 7278
Fax 109563 0
Email 109563 0
[email protected]
Contact person for scientific queries
Name 109564 0
Sherly Parackal
Address 109564 0
Room 1.88, 55 Hanover Street
Otago Medical School,
Dunedin School of Medicine,
University of Otago,
PO Box 56, Dunedin, 9054, New Zealand
Country 109564 0
New Zealand
Phone 109564 0
+64 3 470 7278
Fax 109564 0
Email 109564 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


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.