Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000422426p
Ethics application status
Not yet submitted
Date submitted
23/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Date data sharing statement initially provided
8/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Amanaki STEM Academy (ASA) Heart Health Study in Pasifika community
Scientific title
Evaluate the effectiveness of a culturally tailored healthy lifestyle education intervention in improving heart health-related knowledge and behaviours, perceptions, and physiological outcomes among the Pasifika community in Aotearoa
Secondary ID [1] 314244 0
None
Universal Trial Number (UTN)
U1111-1321-5842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Health 337160 0
Condition category
Condition code
Diet and Nutrition 333579 333579 0 0
Other diet and nutrition disorders
Cardiovascular 333683 333683 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of participants (families with a child attending ASA) undergoing a culturally tailored nutrition program (Pacific Heartbeat) developed by the Heart Foundation, which will be adjusted in collaboration with ASA for delivery in their community.
The Pacific Heartbeat team from the Heart Foundation will provide weekly 2-hour training sessions, delivered by trained community facilitators, around nutrition, heart-healthy lifestyle and diet, physical activity, and heart health. These training sessions will involve practical skills, including reading and understanding food labelling and cooking strategies to help support a “heart-healthy” diet from a Pacific perspective. Attendance to these sessions will be logged.
During the intervention period, groups of parents will be put on a roster to cook a meal to share with the ASA students after their afternoon/evening tutoring sessions (~50 students each night). Each parent will be rostered to cook once each week for the 8-week intervention period. The recipes will be provided by the Heart Foundation, and the necessary ingredients will be provided by the study. Additionally, a “Pacific Tastes” recipe book will also be given to all participants, and for each week they cook for the ASA students, a “food bag” style package of heart-healthy ingredients corresponding to a suggested recipe will be given to the parents to take home and cook for their own whanau.

Provided recipes will include the necessary ingredients and the methods.

Below is a brief example of one of the recipes:

Palusami - Taro Leaves parcel (serves 1)

Ingredients:
5 - 6 medium-sized taro leaves
1/2 onion, finely diced
2/3 cup diluted coconut cream
Aluminium foil

Method:
1. Remove the stalk and ribs from the taro leaves. Rinse under running water and shake dry.
2. Mix the onion with the diluted coconut cream.
3. Layer 5–6 taro leaves, so they overlap each other to create a bowl in the palm of your hand.
4. Pour in the onion and coconut cream mixture.
5. Gather up the edges of the taro leaves with your other hand to close the parcel.
6. Place the taro parcel onto the aluminium foil and quickly close to form a tight ball.
7. Place in an oven dish and bake at 200°C for 1 hour or cook in an umu (hangi or underground oven).
8. Serve with green bananas or taro.
Intervention code [1] 330855 0
Lifestyle
Intervention code [2] 330940 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341179 0
Self reported diet
Timepoint [1] 341179 0
Baseline and 6 weeks post-intervention
Primary outcome [2] 341180 0
self reported confidence in understanding health topics
Timepoint [2] 341180 0
Baseline and 6 weeks post-intervention
Primary outcome [3] 341155 0
Attitudes towards cooking
Timepoint [3] 341155 0
Baseline and 6 weeks post-intervention
Secondary outcome [1] 446993 0
Lipid profile
Timepoint [1] 446993 0
Baseline and 6 weeks post-intervention
Secondary outcome [2] 446992 0
Renal function
Timepoint [2] 446992 0
Baseline and 6 weeks post-intervention
Secondary outcome [3] 446662 0
% change in fitness test
Timepoint [3] 446662 0
Baseline and 6 weeks post-intervention
Secondary outcome [4] 446991 0
Glycaemic control
Timepoint [4] 446991 0
Baseline and 6 weeks post-intervention

Eligibility
Key inclusion criteria
Age 16 years and above
All genders
Able to give consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26988 0
New Zealand
State/province [1] 26988 0

Funding & Sponsors
Funding source category [1] 318764 0
Government body
Name [1] 318764 0
Putahi Manawa (a Centre of Research Excellence funded by Tertiary Education Commission)
Country [1] 318764 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321210 0
None
Name [1] 321210 0
Address [1] 321210 0
Country [1] 321210 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317374 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317374 0
Ethics committee country [1] 317374 0
New Zealand
Date submitted for ethics approval [1] 317374 0
09/05/2025
Approval date [1] 317374 0
Ethics approval number [1] 317374 0

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

Contacts
Principal investigator
Name 140854 0
Dr Fiona McBryde
Address 140854 0
Department of Physiology, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland 1023.
Country 140854 0
New Zealand
Phone 140854 0
+64 9 3737 599
Fax 140854 0
Email 140854 0
[email protected]
Contact person for public queries
Name 140855 0
Fiona McBryde
Address 140855 0
Department of Physiology, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland 1023.
Country 140855 0
New Zealand
Phone 140855 0
+64 9 3737 599
Fax 140855 0
Email 140855 0
[email protected]
Contact person for scientific queries
Name 140856 0
Fiona McBryde
Address 140856 0
Department of Physiology, Faculty of Medical and Health Sciences, University of Auckland, 85 Park Road, Grafton, Auckland 1023.
Country 140856 0
New Zealand
Phone 140856 0
+64 9 3737 599
Fax 140856 0
Email 140856 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.