Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001077550
Ethics application status
Approved
Date submitted
24/09/2015
Date registered
13/10/2015
Date last updated
25/10/2023
Date data sharing statement initially provided
14/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Nga Pou O Rongo-Efficacy of a kaupapa Maori approach, within an exercise and lifestyle programme, on cardiovascular disease risk.
Scientific title
Nga Pou O Rongo-Efficacy of a kaupapa Maori approach, within an exercise and lifestyle programme, on cardiovascular disease risk.
Secondary ID [1] 287536 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 296303 0
Condition category
Condition code
Cardiovascular 296582 296582 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individually prescribed exercise, 3 days per week for 12 weeks. Exercise is prescribed by an exercise physiologist based on the findings from the baseline assessment. Exercise session duration will vary based on individual capacity but will be between 40-60mins. Exercise session will either be individual sessions or group sessions are preferred by the participant. All session are supervised and heart rate and blood pressure monitored. Adherence to the programme will be monitored with an attendance register and any missed sessions will be followed up with a phone call to the participant.
6, one-hour lifestyle education sessions will be provided at fortnightly intervals over the 12-week period. Participants are enrolled as 'clusters' into the programme (between 4 and 10 people) and each cluster will determine the topics of their education sessions themselves with guidance from the research team. Possible topics include nutrition, stress management or Maori health priorities. Education sessions will be facilitated by appropriately qualified and/or experienced individuals. An attendance register will monitor adherence to the education sessions.
Participants will undergo a baseline assessment, have a 6-week wait period (control), have a 2nd assessment, then complete the 12-week programme. A final assessment will be performed after the 12 weeks of intervention.
The programme adheres to kaupapa Maori principles and utilises Sir Professor Mason Duries 'interface space' approach. Within the interface key aspects of the usual care programme can be integrated with key aspects of the Maori world to create a programme that has a 'best of both worlds' approach. Participants will be able to shape the structure of their 12 week programme by applying Maori principles important to them, while the programme still maintain clinical rigour with the exercise and clinical measures
Intervention code [1] 292934 0
Lifestyle
Intervention code [2] 292935 0
Prevention
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 296202 0
HDL cholesterol
CardioChek PA point of care device for measurement
Timepoint [1] 296202 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Primary outcome [2] 296203 0
Waist circumference
Lufkin tape measure used
Timepoint [2] 296203 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Secondary outcome [1] 317800 0
Systolic blood pressure
assessed by 3 measurements by sphygmomanometer
Timepoint [1] 317800 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Secondary outcome [2] 317801 0
Total cholesterol : HDL cholesterol ratio
CardioChek PA point of care device for measurement
Timepoint [2] 317801 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Secondary outcome [3] 317803 0
Body weight
Digital scales used
Timepoint [3] 317803 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Secondary outcome [4] 317804 0
Hip circumference
Lufkin tape measure used
Timepoint [4] 317804 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)
Secondary outcome [5] 317805 0
Waist : hip ratio
calculated from measurements
Timepoint [5] 317805 0
Measured at baseline, Time 1 which is a minimum of 6 weeks after baseline (control period) and Time 2 which is 12 weeks after Time 1 (intervention period)

Eligibility
Key inclusion criteria
Inclusion criteria will be Maori individuals, 18 years and older with two or more cardiac risk factors, excluding ethnicity
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be previous myocardial infarction, previous stroke, unstable angina pectoris, hypertrophic cardiomyopathy, heart failure that is not compensated, symptomatic aortic stenosis and severe pulmonary hypertension

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Cluster control trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
16/11/2015
Actual
16/11/2015
Date of last participant enrolment
Anticipated
31/12/2022
Actual
30/05/2023
Date of last data collection
Anticipated
25/10/2023
Actual
Sample size
Target
120
Accrual to date
Final
227
Recruitment outside Australia
Country [1] 7184 0
New Zealand
State/province [1] 7184 0

Funding & Sponsors
Funding source category [1] 292106 0
Charities/Societies/Foundations
Name [1] 292106 0
New Zealand Heart Foundation
Country [1] 292106 0
New Zealand
Funding source category [2] 311939 0
University
Name [2] 311939 0
The University of Auckland
Country [2] 311939 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Centre for Health
Address
PO Box 13068 Tauranga New Zealand 3141
Country
New Zealand
Secondary sponsor category [1] 290783 0
None
Name [1] 290783 0
Address [1] 290783 0
Country [1] 290783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293594 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 293594 0
PO Box 5013
Wellington 6140
Ethics committee country [1] 293594 0
New Zealand
Date submitted for ethics approval [1] 293594 0
16/10/2015
Approval date [1] 293594 0
15/10/2015
Ethics approval number [1] 293594 0
15/STH/186

Summary
Brief summary
Maori are disproportionately affected by CVD and innovative, Maori-centric approaches are required to address this inequity. The purpose of this project is to determine the effects of an exercise and lifestyle-management programme for cardiac risk reduction that is embedded within a kaupapa Maori approach. A controlled trial using kaupapa Maori methods, with a cluster wait-list design is proposed. Participants assigned to the intervention are able to redevelop a usual-care cardiac risk reduction programme to embed a Maori worldview. Clinical measures are assessed pre- and post-programme.
Trial website
Trial related presentations / publications
Public notes
A new funder is providing funding for participants to take part in the intervention stage of the clinical trial. There will be no wait-list period for these participants.

Contacts
Principal investigator
Name 60578 0
Dr Anna Rolleston
Address 60578 0
PO Box 13068 Tauranga New Zealand 3141
Country 60578 0
New Zealand
Phone 60578 0
+64 7 578 6624
Fax 60578 0
Email 60578 0
[email protected]
Contact person for public queries
Name 60579 0
Anna Rolleston
Address 60579 0
PO Box 13068 Tauranga New Zealand 3141
Country 60579 0
New Zealand
Phone 60579 0
+64 7 578 6624
Fax 60579 0
Email 60579 0
[email protected]
Contact person for scientific queries
Name 60580 0
Anna Rolleston
Address 60580 0
PO Box 13068 Tauranga New Zealand 3141
Country 60580 0
New Zealand
Phone 60580 0
+64 7 578 6624
Fax 60580 0
Email 60580 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.