Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000856819p
Ethics application status
Submitted, not yet approved
Date submitted
19/05/2021
Date registered
2/07/2021
Date last updated
2/07/2021
Date data sharing statement initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Healthy NZ Foods Pilot Study for Adults with Metabolic Syndrome
Scientific title
A High Quality Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing in Adults with Metabolic Syndrome: Pilot Intervention Study
Secondary ID [1] 304255 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Obesity 321967 0
Metabolic Syndrome 321968 0
Condition category
Condition code
Diet and Nutrition 319690 319690 0 0
Obesity
Metabolic and Endocrine 319998 319998 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive foods consistent with the Mediterranean diet, 50-75% of their daily intake. Participants will receive food delivered to their home each week by My Food Bag delivery company. This will consist of 5 main meals (participants can choose from the weekly healthy heart options) and extra food for lunches and breakfast including fish, cereals, fruit, vegetables, oil and bread. This food will be delivered weekly for 12 weeks. Participants are not given advice regarding the remaining two main meals each week. Participants will be asked to report each week how much they consumed and of what, using the online form at the time they order their next weeks meals.
Intervention code [1] 320592 0
Lifestyle
Intervention code [2] 320844 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327576 0
The primary outcome is the Metabolic Severity Z-Score at 12 weeks post intervention. The Metabolic Severity Z-Score is calculated using blood pressure assessed using manual sphygmomanometer, fasting blood glucose and fasting lipids from blood test and waist circumference measured in cm by measuring tape.
Timepoint [1] 327576 0
12 weeks post intervention
Secondary outcome [1] 395695 0
Recruitment Rates assessed by audit of study database
Timepoint [1] 395695 0
12 weeks post intervention
Secondary outcome [2] 395696 0
Anthropometric measures including waist circumference (tape measure), weight (standing tanita scales), height (stadiometer) and body mass index (BMI)
Timepoint [2] 395696 0
12 weeks post intervention
Secondary outcome [3] 395697 0
Adherence to Mediterranean diet using 24hr recall
Timepoint [3] 395697 0
12 weeks post intervention
Secondary outcome [4] 395698 0
Kaupapa Ma¯ori Wellbeing questionnaire for participants seen at Kokiri Marae provided by The Centre for Health Tauranga and designed by Anna Rolleston.
Timepoint [4] 395698 0
12 weeks post intervention

Eligibility
Key inclusion criteria
• Adults aged 18-70 years
• Metabolic syndrome severity z-score (MetS-Z) >3.5.
• In addition to the index individual, the other members of their household/wha¯nau will be invited to participate in the research. If household/wha¯nau members that take part meet the inclusion/exclusion criteria they will be included in primary outcome, if not data will be collected for secondary analysis.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of T2DM is uncertain, this will be defined as ever having had two consecutive HbA1c results > or = 50 mmol/mol that are at least three months apart
• Chronic renal disease (eGFR <30 mL/min/1.72m2)
• Serious immune dysfunction (for example HIV/AIDS, immune deficiency diseases)
• Current pregnancy or breastfeeding, or planning to conceive during the study
• Unstable body weight (active weight loss/gain > 5 kg in prior three months)
• Gastrointestinal disorder that alters the digestion and absorption of nutrients (E.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy).
• Food Allergies (anaphylaxis)
• Medication use – current use of immune suppressant medications, medications that modify blood sugar levels, or anticipated regular use of such medications (e.g. frequent use of oral or injected steroids), long-term use of systemic antibiotics
• Does not agree to refrain from donating blood for three months prior to each study visit
• Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study
• Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part

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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis for the main outcome variable will be ANCOVA with the baseline measurement of the MetS-z-score as a continuous co-variate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/08/2021
Actual
Date of last participant enrolment
Anticipated
22/09/2021
Actual
Date of last data collection
Anticipated
22/12/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 23712 0
New Zealand
State/province [1] 23712 0
Wellington

Funding & Sponsors
Funding source category [1] 308634 0
Government body
Name [1] 308634 0
National Science Challenge High Value Nutrition
Country [1] 308634 0
New Zealand
Primary sponsor type
Hospital
Name
Capital and Coast District Health Board
Address
Private Bag 7902
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 309502 0
None
Name [1] 309502 0
Address [1] 309502 0
Country [1] 309502 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308561 0
NZ HDEC
Ethics committee address [1] 308561 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 308561 0
New Zealand
Date submitted for ethics approval [1] 308561 0
06/05/2021
Approval date [1] 308561 0
Ethics approval number [1] 308561 0

Summary
Brief summary
The High Value Nutrition (HVN) National Science Challenge works with scientists and businesses to add nutritional value to fresh and processed food products for the benefit of consumers whether in New Zealand or elsewhere in the world. Funded by HVN, the investigators are leading the development and implementation of He Rourou Whai
Painga, a long-term multi-centre dietary intervention study that will explore whether consumption of high quality New Zealand F&B products in an adapted Mediterranean-style dietary pattern improves metabolic, cardiovascular, and wellbeing profiles in people at risk of cardiometabolic disease. The current proposal describes a pilot study that will be used to finalise the study design, power calculations, and final methodology of the main
intervention study, He Rourou Whai Painga.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111142 0
Prof Jeremy Krebs
Address 111142 0
Capital and Coast DHB
Private Bag 7902
Wellington 6021
Country 111142 0
New Zealand
Phone 111142 0
+64272867324
Fax 111142 0
Email 111142 0
jeremy.krebs@ccdhb.org.nz
Contact person for public queries
Name 111143 0
Mrs Amber Parry Strong
Address 111143 0
Capital and Coast DHB
Private Bag 7902
Wellington 6021
Country 111143 0
New Zealand
Phone 111143 0
+6448062458
Fax 111143 0
Email 111143 0
amber.parry-strong@ccdhb.org.nz
Contact person for scientific queries
Name 111144 0
Mrs Amber Parry Strong
Address 111144 0
Capital and Coast DHB
Private Bag 7902
Wellington 6021
Country 111144 0
New Zealand
Phone 111144 0
+6448062458
Fax 111144 0
Email 111144 0
amber.parry-strong@ccdhb.org.nz

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
SourceTitleYear of PublicationDOI
EmbaseA high quality Aotearoa New Zealand dietary pattern adapting a Mediterranean diet for metabolic health: a feasibility study.2023https://dx.doi.org/10.1186/s40795-023-00805-x
N.B. These documents automatically identified may not have been verified by the study sponsor.