Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000906752
Ethics application status
Approved
Date submitted
1/06/2022
Date registered
24/06/2022
Date last updated
11/08/2022
Date data sharing statement initially provided
24/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga
Scientific title
An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga; a randomised controlled trial of a dietary pattern in adults at metabolic risk and their whanau and the effect on metabolic syndrome z score
Secondary ID [1] 307212 0
ISRCTN89011056
Universal Trial Number (UTN)
Trial acronym
He Rourou Whai Painga (HRWP)
Linked study record
ACTRN12621000856819 is a pilot study which assessed the feasibility of some of the methods to be used in the current study.

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 326441 0
Condition category
Condition code
Diet and Nutrition 323722 323722 0 0
Obesity
Metabolic and Endocrine 323723 323723 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled trial of food provision and dietary change support (Group B) compared with habitual dietary intake (Group A) for 12 weeks.

Index participants will be adults at risk of metabolic and cardiovascular disease and up to 5 members of their household/whanau can be invited to also take part in the study.

The intervention itself (food provision and dietary change support) is delivered over a period of 12 weeks. Participants and their household/whanau will receive the food at their homes on a weekly and/or fortnightly basis. The dietary change support will be available online at all times through the intervention.

The food provision means that participants and their household/whanau will receive up to 75% of their weekly food delivered to their home for 12 weeks. The food, which together forms a dietary pattern, is rich in fruit, vegetables, wholegrains, legumes, olive oil and seafood. The food deliveries will be arranged by the researchers directly with the food delivery companies, and any issues with deliveries will be reported by the food delivery companies to the researcher who will be able to rectify any issues. The specific foods and meals to be delivered may vary depending on availability of items but will all fit within the dietary pattern to be tested. Whether the food deliveries are weekly or fortnightly will not affect the consistency of the intervention delivered across the time period of the intervention.
The dietary change support includes a participant-facing study website with guidance on how to change dietary behaviour, recipes and meals plans, information about the food provided and about the metabolic syndrome. The support includes access to Facebook groups and peer-support online activities. The online support is designed and delivered by research dietitians with a minimum of 5 years’ experience. It is at the participant’s discretion how much time they spend interacting with the dietary change support website and online community groups. Peer-support activities will include posts/polls on the Facebook page that encourage participants to share ideas, recipes and ask questions e.g. peer support online activities such as sharing pictures of meals made with the provided food, asking participants to identify current challenges and develop ideas on overcoming these challenges.

Some of the resources on the participant-facing website have been designed specifically for this study. On this website, the information will be presented in categories e.g. shopping/cooking tips. This category, for instance, will contain links to videos created specifically for this study which are hosted on websites such as youtube, as well as content from other websites e.g. recipes from Heart Foundation New Zealand. Other resources may include down-loadable fact sheets and participant-friendly articles. Participants may also be directed towards the following websites, among others websites and resources:

Meal planning tips video: https://www.youtube.com/watch?v=sqqFzqLFmoY
Meal planning article: https://lovefoodhatewaste.co.nz/meal-planning/
Meal Planner: https://www.lovefoodhatewaste.nsw.gov.au/sites/default/files/2020-09/LFHWMenuPlannerListColour%20210920.pdf
Heart Foundation Recipes: https://www.heartfoundation.org.nz/wellbeing/healthy-recipes
Chopping onion: https://www.youtube.com/watch?v=dCGS067s0zo
Chopping garlic: https://www.youtube.com/watch?v=tDfCdkGivdA
Storing food in fridge: https://www.heart.org/en/healthy-living/healthy-eating/cooking-skills/storing/using-your-fridge-the-right-way
Food portions print out https://assets.heartfoundation.org.nz/documents/shop/nutrition/docs/food-portions-a4.pdf
Food swaps: https://www.youtube.com/watch?v=Onyc0tTogsw&t=59s

In both groups, the 12-week intervention phase will be followed by a secondary randomisation to receive continued dietary change support for a further 12 weeks or entry directly into an observational maintenance phase. During this 12-week period, those participants randomised to receive continued dietary change support will have continued access to the website and online platform only. This period will be followed by a longitudinal observational follow up of all participants out to a total of 52 weeks from the initiation of the intervention diet.

The research visits will take place in four research centres across New Zealand. Depending on whether participants have been randomised to Group A or Group B determines how many times they and their household/whanau participants will visit the research; either 5 or 6 times. Each visit will last approximately 1-4 hours, depending on the measurements to be undertaken at that visit. Visits will take place virtually or in the participant's homes if regulations specify this at the time.

Intervention adherence will be measured through the collection of dietary intake data and the assessment of it against a Mediterranean diet score.

In addition, to understand participants’ experiences in this study, a fully integrated qualitative consumer insights study will be undertaken concurrently to the other assessments. The purpose of this part of the study is to gain insight into the perceptions, attitudes and emotions of participants and to corroborate behavioural data gained in the quantitative study with respect to the adoption and maintenance of the intervention diet. This component is delivered by experts in qualitative research methodology with greater than 5 years’ experience.
Intervention code [1] 323666 0
Lifestyle
Intervention code [2] 323667 0
Behaviour
Comparator / control treatment
The comparator is habitual dietary intake. The group randomised to the habitual dietary intake (Group A) will, after 12 weeks, receive the food provision and dietary change support phase for 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 331487 0
Metabolic syndrome severity z-Score (MetS-z)
Timepoint [1] 331487 0
12 weeks post-intervention commencement
Secondary outcome [1] 410064 0
Weight measured using digital weighing scales
Timepoint [1] 410064 0
12 weeks post-intervention commencement
Secondary outcome [2] 410159 0
Body mass index (BMI) in the full cohort where weight will be measured using a digital weighing scales and height will be measured using a stadiometer. BMI centiles will be used to interpret these data collected from children.
Timepoint [2] 410159 0
12 weeks post-intervention commencement
Secondary outcome [3] 410160 0
Dietary pattern among all participants from whom dietary intake data are collected. Dietary patterns will be measured using a Mediterranean diet score.
Timepoint [3] 410160 0
12 weeks post-intervention commencement.
Secondary outcome [4] 410161 0
Change from baseline in metabolic syndrome severity z-score (MetS-z) in full cohort
Timepoint [4] 410161 0
24 weeks post-intervention commencement
Secondary outcome [5] 410193 0
Change from baseline in metabolic syndrome severity z-score (MetS-z) in full cohort
Timepoint [5] 410193 0
52 weeks post-intervention commencement
Secondary outcome [6] 410216 0
Blood glucose, an individual component of MetS z score, which is measured in a fasting blood sample. This is an outcome in all participants who have provided a blood sample
Timepoint [6] 410216 0
12 weeks post-intervention commencement
Secondary outcome [7] 410217 0
Change in blood glucose, an individual component of the MetS z score, which is measured in a fasting blood sample. This is an outcome in all participants who have provided a blood sample.
Timepoint [7] 410217 0
24 weeks post-intervention commencement.
Secondary outcome [8] 410218 0
Dietary pattern after secondary randomisation to continued support versus no ongoing support between 12 and 24 weeks. Dietary patterns will be assessed using a Mediterranean diet score and will be assessed in all participants from whom dietary intake data are collected.
Timepoint [8] 410218 0
24 weeks post-intervention commencement.
Secondary outcome [9] 410241 0
Change in blood glucose, an individual component of the MetS z score, measured in a fasting blood sample. This is an outcome in all participants who have provided a blood sample.
Timepoint [9] 410241 0
52 weeks post-intervention commencement.
Secondary outcome [10] 410764 0
Fat mass measured using a DXA scan and/or bioelectrical impedance in index participants only
Timepoint [10] 410764 0
12 weeks post-intervention commencement
Secondary outcome [11] 410765 0
Lean mass measured using a DXA scan and/or bioelectrical impedance in index participants only
Timepoint [11] 410765 0
12 week post intervention commencement
Secondary outcome [12] 410766 0
Waist circumference, an individual component of the MetS z score, measured using a measuring tape. This is an outcome in all participants in whom waist circumference is measured.
Timepoint [12] 410766 0
12 weeks post intervention commencement
Secondary outcome [13] 410767 0
Blood pressure, an individual component of the MetS z score, measured using a sphygmomanometer or an automated equivalent. This is an outcome in all participants in whom blood pressure has been measured.
Timepoint [13] 410767 0
12 weeks post intervention commencement
Secondary outcome [14] 410768 0
Lipid profile, an individual component of the MetS z score, measured in a fasting blood sample. This is an outcome in all participants from whom a blood sample is collected.
Timepoint [14] 410768 0
12 weeks post intervention commencement
Secondary outcome [15] 410769 0
Change in waist circumference, an individual component of the MetS z score, measured using a measuring tape. This is an outcome in all participants in whom waist circumference is measured.
Timepoint [15] 410769 0
24 weeks post intervention commencement
Secondary outcome [16] 410770 0
Change in blood pressure, an individual component of the MetS z score, measured using a sphygmomanometer or an automated equivalent. This is an outcome in all participants in whom blood pressure is measured.
Timepoint [16] 410770 0
24 weeks post intervention commencement
Secondary outcome [17] 410771 0
Change in lipid profile, an individual component of the MetS z score, measured in a fasting blood sample. This is an outcome in all participants from whom a blood sample is collected.
Timepoint [17] 410771 0
24 weeks post intervention commencement
Secondary outcome [18] 410772 0
Change in waist circumference, an individual component of the MetS z score, measured using a measuring tape. This is an outcome in all participants in whom waist circumference is measured.
Timepoint [18] 410772 0
52 weeks post intervention commencement
Secondary outcome [19] 410773 0
Change in blood pressure, an individual component of the MetS z score, measured using a sphygmomanometer or an automated equivalent. This is an outcome in all participants in whom blood pressure is measured.
Timepoint [19] 410773 0
52 weeks post intervention commencement
Secondary outcome [20] 410774 0
Change in lipid profile, an individual component of the MetS z score, measured in a fasting blood sample. This is an outcome in all participants from whom a blood sample is collected.
Timepoint [20] 410774 0
52 weeks post intervention commencement
Secondary outcome [21] 410865 0
Participants' reported on their understanding of what a healthy way of eating is. This will be done using an in-depth individual interview with a researcher, semi-structured guide, conducted using an online platform, video recorded
Timepoint [21] 410865 0
6 weeks post commencement of intervention
Secondary outcome [22] 410867 0
Participants' reported on the application of the ‘tools’ they are learning from the programme to assist them in adopting this healthy eating programme. This will be done using an in-depth individual interview with a researcher, semi-structured guide, conducted using an online platform, video recorded.
Timepoint [22] 410867 0
12 weeks post commencement of intervention
Secondary outcome [23] 410868 0
Participants' reported on any empowerment in their ability to follow this new way of healthy eating. This will be done using an in-depth individual interview with a researcher, semi-structured guide, conducted using an online platform, video recorded.
Timepoint [23] 410868 0
24 weeks post commencement of intervention
Secondary outcome [24] 410869 0
Participants reported on their ability to encourage their family to follow this new way of healthy eating. This will be done using an in-depth individual interview with a researcher, semi-structured guide, conducted using an online platform, video recorded.
Timepoint [24] 410869 0
24 weeks post commencement of intervention
Secondary outcome [25] 410870 0
Participants reported their feelings of wellbeing. This will be done using an in-depth individual interview with a researcher, semi-structured guide, conducted using an online platform, video recorded.
Timepoint [25] 410870 0
24 weeks post commencement of intervention
Secondary outcome [26] 410871 0
Participants reported on their ability to follow this new way of healthy eating. This will be done using focus group discussions (4-5- participants) with a researcher, semi-structured guide, conducted over an online platform, video recorded.
Timepoint [26] 410871 0
40 weeks post commencement of intervention
Secondary outcome [27] 410872 0
Participants reported their intentions regarding following this new way of healthy eating after the end of the intervention. This will be done using an on-line survey.
Timepoint [27] 410872 0
52 weeks post commencement of intervention

Eligibility
Key inclusion criteria
Inclusion Criteria: For index individual
• Adults aged 18-70 years
• Metabolic syndrome severity z-score (MetS-Z) >0.35.
• In addition to the index individual, a minimum of one other whanau member in the household agrees to participate; (these additional household members, if they qualify, may also be enrolled as an index individual). Up to 5 whanau are eligible to take part
• Participants and their whanau are planning to live together for the duration of the study
• Access to the internet at home
• Able and willing to attend all site visits
• Is willing to adhere to local health and safety regulations
• For the consumer insights study there needs to be a willingness to be interviewed

Inclusion Criteria: For household/whanau members
• Living in the same household as the index individual
• Consent/assent to consume the intervention diet
All household/whanau members who qualify for inclusion will: a) complete age-appropriate questionnaires; b) be invited to undertake clinical measurements; and c) be invited to provide blood samples if aged 11 years and over.
Minimum age
5 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: For index individual
• 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 greater than or equal to 50 mmol/mol that are at least three months apart
• Total cholesterol greater than or equal to 8 mmol/L
• Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
• Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
• Unstable body weight (active weight loss/gain greater than 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).
• Severe food allergies (anaphylaxis) or intolerances in any household member
• Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
• Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
• 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.

Exclusion criteria for provision of blood samples: For household/whanau members
• Age less than 11 years
• Pre-existing Type 1 diabetes.
• Chronic severe renal disease (eGFR less than 30 mL/min/1.72m2)
• Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures)
• Unstable body weight (active weight loss/gain greater than 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).
• Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids
• Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c)
• 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
• Children living in the household but who do not have a legal guardian also living in the household
• Severe food allergies (anaphylaxis) or intolerances in any household member

Study design
Purpose of the study
Treatment
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)
Index individuals and their household/whanau will be block randomised at site level to either habitual dietary intake (Group A) or food provision and dietary change support (Group B).

Randomisation will be via computer generated sequence. If there is a second person within the household/whanau who meets the criteria for an index participant, then they will be allocated to the same group as the first household index participant.

The secondary randomisation to ongoing support versus no ongoing support after the first 12 weeks of the intervention will also be via computer generated sequence. If there is a second person within the household/whanau who meets the criteria for an index participant, then they will also be allocated to the same group as the first household index participant for the secondary randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a multi-centre wait-list, randomised controlled trial of the intervention which is food provision and dietary change support compared with a habitual dietary intake for 12 weeks.

The group which is initially randomised to habitual dietary intake (Group A) will subsequently enter the intervention comprising food provision and dietary change support for 12 weeks. In all participants, the initial 12-week intervention will be followed by a secondary randomisation to receive continued dietary change support for a further 12 weeks or enter directly into an observational maintenance phase. This will be followed by a longitudinal observational follow up of all participants out to a total of 52 weeks from the initiation of the intervention. Therefore, the overall design is a combination of a 12-week randomised controlled trial and a 12-month longitudinal observation study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The current sample size is based on a clinically important difference to detect of the MetS-Z score of 0.4. This was chosen based on detecting a 'moderate' effect size, as the MetS-Z score can be conceptualised as the number of standard deviations different for overall risk factors for poor cardiovascular outcomes.

The standard deviation is based on the derivation of the MetS-Z score from a large Auckland-based cohort study of these risk factors in a similar sample to that for recruitment and is estimated to be 0.83. A t-test based sample size based on 90% power and a two-sided type I error rate of 0.05 needs 184 total participants and we will recruit 200 index participants to allow for a 10% non-completion rate.

A recently conducted pilot study using the inclusion and exclusion criteria to be employed in this study confirmed the standard deviation to be lower than than the original population estimate at 0.33. If the SD is consistent in this study, we will be have 90% power to detect a difference of 0.2 in the MetS z score.

A smaller effect size is likely to be detectable by using baseline values as a co-variate. We are uncertain how many household/whanau members may wish to participate, a subject of the pilot study, but if there are a substantial proportion this will represent a cluster-randomisation for those households with more than one participant, with an unknown intra-class correlation coefficient. It is likely any design effect induced by this will be offset by using the baseline co-variate in the analysis.

Appropriate data descriptions and plots will be used for all variables. Change from baseline variables will also be described as paired differences but in general baseline values will be used as baseline covariates. The primary analysis for the primary outcome variable will be a mixed-linear model with baseline measurement, addition of relevant medication, and physical activity score as fixed effects, and household clusters as random effects. If in the event there are very few clusters the random effect may not be estimable and then this will be equivalent to ANCOVA. Other continuous outcome variables will use a similar analysis strategy. MetS-Z components can be defined as dichotomous variables (present versus absent), as they are used individual to define the 'Metabolic syndrome', and these will be analysed by logistic regression. The Intra-class correlation for the clustering effect will be estimated directly from the variance components in the mixed linear models, should a cluster effect be estimable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2022
Actual
20/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
5
Final
Recruitment outside Australia
Country [1] 24801 0
New Zealand
State/province [1] 24801 0
Auckland, Wellington, Lower Hutt, Christchurch

Funding & Sponsors
Funding source category [1] 311512 0
Government body
Name [1] 311512 0
National Science Challenge High Value Nutrition, Ministry of Business, Innovation and Employment
Country [1] 311512 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Dr Martin Gagnon
Research and Enterprise
University of Otago
Leith Street
Dunedin
9016
Country
New Zealand
Secondary sponsor category [1] 312935 0
None
Name [1] 312935 0
Address [1] 312935 0
Country [1] 312935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310973 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310973 0
Ethics committee country [1] 310973 0
New Zealand
Date submitted for ethics approval [1] 310973 0
17/03/2022
Approval date [1] 310973 0
25/05/2022
Ethics approval number [1] 310973 0
2022 FULL 12045

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

Contacts
Principal investigator
Name 119550 0
Prof Jeremy Krebs
Address 119550 0
University of Otago, Wellington
PO Box 7343
Newtown
Wellington 6242
Country 119550 0
New Zealand
Phone 119550 0
+6421911008
Fax 119550 0
Email 119550 0
[email protected]
Contact person for public queries
Name 119551 0
Fiona Lithander
Address 119551 0
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road
Grafton
Auckland 1142
Country 119551 0
New Zealand
Phone 119551 0
+64 9 923 6691
Fax 119551 0
Email 119551 0
[email protected]
Contact person for scientific queries
Name 119552 0
Fiona Lithander
Address 119552 0
Faculty of Medical and Health Sciences
University of Auckland
85 Park Road
Grafton
Auckland 1142
Country 119552 0
New Zealand
Phone 119552 0
+64 9 923 6691
Fax 119552 0
Email 119552 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data that underlie the results may be available in published study results including but not limited to reports to the funder, peer-reviewed publications, clinical trial registry websites, scientific meetings, and regulatory/marketing submissions.
When will data be available (start and end dates)?
Beginning 9 months following article publication and ending 36 months following article publication.
Available to whom?
Investigators whose proposed use of the data has been approved by the Senior Leadership Team of this trial.
Available for what types of analyses?
For the purposes outlined in the proposal received from the applicant who wishes to use the deidentified data.
How or where can data be obtained?
Proposals should be directed to the Principal Investigator Prof Jeremy Krebs [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16264Ethical approval    384123-(Uploaded-01-06-2022-12-35-08)-Study-related document.pdf



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