An Aotearoa New Zealand diet for metabolic health and whanau wellbeing: He Rourou Whai Painga
| ISRCTN | ISRCTN89011056 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89011056 |
| Secondary identifying numbers | ACTRN12622000906752 |
- Submission date
- 02/06/2022
- Registration date
- 14/06/2022
- Last edited
- 14/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Cardiovascular disease and diabetes are common in New Zealand and good nutrition plays a role in decreasing the risk of developing these diseases. This research will test whether the consumption of foods which are mostly vegetables, fruit, legumes (beans and peas), fruits, unrefined cereals, nuts, seafood and smaller portions of lean red meat and dairy, offers health benefits to people at risk of cardiometabolic disease and their families. Research has shown that such eating patterns can improve metabolic, cardiovascular, and wellbeing profiles in people at risk of these diseases, but this concept has not been studied in the New Zealand population using New Zealand foods and beverages. The aim of this study is to evaluate the effect, over 12 months, of 12 weeks of nutritious food and dietary support, and whether it will improve the health of adults living in New Zealand and their families.
Who can participate?
Any adult between 18-70 years can volunteer to participate. They will be assessed to see if they meet the eligibility criteria and if so, they are welcome to take part. Each participating adult can invite up to five members of their household to take part.
What does the study involve?
The study involves attending the research centre between 5-6 times over a period of about a year. Participants will undergo clinical assessments and will be asked to complete questionnaires about their health and wellbeing. They will receive up to 75% of the weekly food in addition to behaviour change support for the first or second 12 weeks of the study. They may also be invited to take part in focus groups or interviews to describe their experiences.
What are the possible benefits and risks of participating?
Eating the foods provided may improve the health and wellbeing of participants. There are small risks related to the blood tests such as bruising, fainting or light-headedness. Also, when people change what they eat to include more fibre, they might have some extra flatulence or loose bowel motions. The radiation from the DXA scan is very low risk. Whilst processes will be in place to protect data, no system is completely failsafe. and there is a very small risk of breach of privacy.
Where is the study run from?
University of Otago (New Zealand)
When is the study starting and how long is it expected to run for?
January 2020 to June 2024
Who is funding the study?
High Value Nutrition National Science Challenge (New Zealand)
Who is the main contact?
Dr Fiona Lithander, fiona.lithander@auckland.ac.nz
Contact information
Scientific
University of Auckland
85 Park Road
Grafton
Auckland
1142
New Zealand
 ORCID ID |
0000-0003-4542-7924 |
|---|---|
| Phone | +64 (0)9 923 6691 |
| fiona.lithander@auckland.ac.nz |
Study information
| Study design | Multicentre interventional randomized controlled trial combined with a 12-month longitudinal observation study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | An Aotearoa New Zealand Diet for Metabolic Health and Whanau Wellbeing: He Rourou Whai Painga (HRWP); a randomised controlled trial of a dietary pattern in adults at metabolic risk and their whanau and the effect on metabolic syndrome z score |
| Study acronym | HRWP |
| Study objectives | A 12-week dietary intervention incorporating nutritious New Zealand food and beverage products will improve metabolic health in individuals at risk of developing metabolic disease and their whānau and, with targeted dietary change support, lead to long-term adoption of a healthy plant-rich dietary pattern. |
| Ethics approval(s) | Approved 25/05/2022, Northern B Health and Disability Ethics Committee (Health and Disability Ethics Committees, Ministry of Health, 133 Molesworth Street, PO Box 5013 Wellington 6011, New Zealand; +64 (0)4 819 6877; hdecs@health.gov.nz, hdecs@moh.govt.nz), ref: 2022 FULL 12045 |
| Health condition(s) or problem(s) studied | Metabolic syndrome |
| Intervention | This is a randomised controlled trial of food provision and dietary change support (Group A) compared with a self-selected habitual dietary intake (Group B) for 12 weeks. Randomisation will be via a computer-generated sequence. The group randomised to the self-selected habitual dietary intake (Group B) will, after 12 weeks, receive the food provision and dietary change support phase for 12 weeks. 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 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 diet. Index participants will be adults at risk of metabolic and cardiovascular disease and up to five members of their household/whanau will be invited to also take part in the study. 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, whole grains, olive oil and seafood with limited red meat and dairy. The dietary change support includes a participant-facing study website with guidance on how to change dietary behaviour, recipes and meal plans, and information about the metabolic syndrome and the foods provided. 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 of experience. 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/fortnightly basis. The dietary change support will be available at all times through the intervention and beyond, as necessary. The research visits will take place in four research centers 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 5-6 times. Each visit will last 1-3 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. (added 24/06/2022): To understand participants’ experiences in this study, a full integrated qualitative consumer insights study will be undertaken concurrently to the other assessments. The purpose of this part of the study is to gain insights 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. |
| Intervention type | Mixed |
| Primary outcome measure | Metabolic syndrome severity z-Score (MetS-z) measured using a fasted blood sample (for glucose and lipids), blood pressure and waist circumference at 12 weeks |
| Secondary outcome measures | 1. Weight measured using a weighing scales at 12 weeks 2. Body composition (body mass index [BMI], fat mass and lean mass) measured using a DXA scan, weighing scales and a stadiometer at 12 weeks 3. Dietary pattern among index participants measured using dietary pattern analyses at 12 weeks 4. Change from baseline in metabolic syndrome severity z-score (MetS-z) in full cohort measured using a fasted blood sample (for glucose and lipids), blood pressure and waist circumference at 24 and 52 weeks 5. Individual components of MetS z score measured using a fasted blood sample (for glucose and lipids), waist circumference and blood pressure at 12 weeks 6. Change in individual components of the MetS z score (fasting glucose, waist circumference, blood pressure, lipid profile) in full cohort at 24 weeks 7. Change in individual components of the MetS z score (fasting glucose, waist circumference, blood pressure, lipid profile) in full cohort at 52 weeks 8. Dietary pattern after secondary randomisation to continued support vs no ongoing support measured using dietary pattern analyses from 12 weeks to 24 weeks (added 24/06/2022): Qualitative component outcome measures, measured using NVivo software to assist with a thematic analysis using open and axial coding after the end of the intervention: 1. Participants' reported on their understanding of what a healthy way of eating is. 2. Participants' reported on the application of the ‘tools’ they are learning from the programme to assist them in adopting this healthy eating programme. 3. Participants' reported on any empowerment in their ability to follow this new way of healthy eating. 4. Participants reported on their ability to encourage their family to follow this new way of healthy eating. 5. Participants reported their feelings of wellbeing. 6. Participants reported on their ability to follow this new way of healthy eating. 7. Participants reported their intentions regarding following this new way of healthy eating. |
| Overall study start date | 01/01/2020 |
| Completion date | 10/06/2024 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | All |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 200 |
| Key inclusion criteria | For index individuals: 1. Adults aged 18-70 years 2. Metabolic syndrome severity z-score (MetS-Z) >0.35 3. 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 five whanau are eligible to take part 4. Participants and their whanau are planning to live together for the duration of the study 5. Access to the internet at home 6. Able and willing to attend all site visits 7. Is willing to adhere to local health and safety regulations 8. For the consumer insights study there needs to be a willingness to be interviewed For household/whanau members: 1. Living in the same household as the index individual 2. 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. |
| Key exclusion criteria | For index individuals: 1. Previous bariatric surgery, or pre-existing Type 1, or Type 2 diabetes. Where a previous diagnosis of type 2 diabetes mellitus (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 3 months apart 2. Total cholesterol greater than or equal to 8 mmol/l 3. Chronic severe renal disease (eGFR <30 ml/min/1.72m²) 4. Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures) 5. Unstable body weight (active weight loss/gain >5 kg in the prior 3 months) 6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy) 7. Severe food allergies (anaphylaxis) or intolerances in any household member 8. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids 9. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c) 10. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study 11. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part For household/whanau members (blood samples): 1. Age <11 years 2. Pre-existing Type 1 diabetes 3. Chronic severe renal disease (eGFR <30 ml/min/1.72 m²) 4. Current pregnancy or breastfeeding, or planning to conceive during the study (due to impact on interpreting outcome measures) 5. Unstable body weight (active weight loss/gain >5 kg in prior 3 months) 6. Gastrointestinal disorder that alters the digestion and absorption of nutrients (e.g. ulcerative colitis, Crohn’s disease, coeliac disease, an ileostomy or colostomy) 7. Medication use – current use of medications that modify blood sugar levels, or anticipated regular use of oral or injected steroids 8. Does not agree to refrain from donating blood for three months prior to each study visit (due to impact on HbA1c) 9. Is participating in, or has recently participated in another research study involving an intervention which may alter outcomes of interest to this study 10. Any other condition or situation, which in the view of investigators would affect the compliance or safety of the individual taking part 11. Children living in the household but who do not have a legal guardian also living in the household 12. Severe food allergies (anaphylaxis) or intolerances in any household member |
| Date of first enrolment | 20/06/2022 |
| Date of final enrolment | 28/02/2023 |
Locations
Countries of recruitment
- New Zealand
Study participating centres
Wellington Regional Hospital
Riddiford St, Newtown
PO Box 7902, Wellington South
Welington
6021
New Zealand
85 Park Road
Grafton
Auckland
1142
New Zealand
2 Riccarton Avenue
PO Box 4345
Christchurch
8140
New Zealand
Seaview
Lower Hutt
5010
New Zealand
Sponsor information
University/education
Dr Martin Gagnon
Research and Enterprise
Leith Street
Dunedin
9016
New Zealand
| Phone | +64 (0)3 479 8983 |
|---|---|
| martin.gagnon@otago.ac.nz | |
| Website | http://www.otago.ac.nz/ |
"ROR" |
https://ror.org/01jmxt844 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journals. |
| IPD sharing plan | 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. The name and email address for the investigator/body who should be contacted for access to the datasets: Prof. Jeremy Krebs (Jeremy.krebs@otago.ac.nz). The type of data: de-identified data. When the data will become available and for how long: beginning 9 months following article publication and ending 36 months following article publication. By what access criteria data will be shared including with whom: Investigators whose proposed use of the data has been approved by the Senior Leadership Team of the current trial. For what types of analyses: for the purposes outlined in the proposal received from the applicant who wishes to use the de-identified data. Whether consent from participants was obtained: No. Any data shared would be de-identified. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 11/12/2023 | 27/12/2023 | Yes | No | |
| Results article | 26/07/2024 | 14/08/2024 | Yes | No |
Editorial Notes
14/08/2024: Publication reference added.
10/06/2024: The following changes have been made:
1. The overall study end date was changed from 30/06/2024 to 10/06/2024.
2. The intention to publish date was changed from 30/09/2024 to 30/11/2024.
27/12/2023: Publication reference added.
14/04/2023: The following changes have been made:
1. The recruitment end date has been changed from 01/04/2023 to 28/02/2023.
2. The final enrolment number has been added.
30/06/2022: ANZCTR number added.
24/06/2022: The following changes were made to the trial record:
1. The interventions were updated.
2. The secondary outcome measures were updated.
13/06/2022: Trial's existence confirmed by the Northern B Health and Disability Ethics Committee.
