This metadata record and it's attached files make statements about the kinds of data collected as part of this research, and set out policies for governance of that data, now and in the future.
Description: A national Aotearoa New Zealand dietary intervention study to evaluate the effect of a 12-week whole-diet intervention incorporating nutritious domestically-produced food and beverage products and dietary change support, compared with habitual diet, on the MetS-Z score in individuals at risk of developing metabolic disease in a randomised controlled trial.
Publisher
High Value Nutrition, Ko Nga Kai Whai PaingaTemporal coverage: start
2022-06-30HVN Project / Programme Name
HVN HRWPData access requirements
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. If agreed, access to the data begins 9 months following article publication and ends 36 months following article publication, and will only be available to investigators whose proposed use of the data has been approved by the Senior Leadership Team of this trial.Principal investigator organisation
University of OtagoCollaborating researchers and affiliations
Principal Investigator:
Professor Jeremy Krebs, Department of Medicine, University of Otago and Centre for Endocrine, Diabetes and Obesity Research (CEDOR), Wellington
Collaborating Researchers:
Associate Professor Fiona Lithander (University of Auckland)
Dr Meika Foster (Edible Research Limited)
Professor Richard Gearry (University of Otago)
Professor Mark Weatherall (University of Otago)
Dr Troy Merry (University of Auckland)
Dr Andrea Braakhuis (University of Auckland)
Dr Denise Conroy (Plant and Food Research)
Dr Amber Parry-Strong (Centre for Endocrine, Diabetes and Endocrine Research)
Dr Anna Rolleston (The Centre for Health)
Dr Rajshri Roy (University of Auckland)Data description
Outcomes of the Study and associated data (Abbreviated)
Primary outcome:
- The metabolic syndrome severity z-score (MetS-Z) measured 12 weeks after randomisation.
Associated data: Body composition - waist circumference, fasting blood – HbA1c, lipids and glucose, blood pressure, IPAQ, Change in medication information
Secondary outcomes include:
- MetS-Z 24 and 52 weeks after randomisation
Associated data: Body composition - waist circumference, fasting blood – HbA1c, lipids and glucose, blood pressure, IPAQ, Change in medication information
- Change from baseline MetS-Z
Associated data: Body composition - waist circumference, fasting blood - lipids and glucose, blood pressure, IPAQ, Change in medication information
- Adoption of dietary intervention
Associated data: Impact evaluation for nutrition and behaviour change, FFQ, 24-hr food recalls, Consumer insights interviews, Consumer insights focus groups data, Consumer insights survey (index participants only), Post intervention interviews, Post intervention surveys
Clinical Measurements at 5 visits:
- Anthropometric measures
Associated data: waist circumference, weight, body mass index (BMI), body composition (DXA) and bioimpedence
- Dietary pattern change and intake
Associated data: FFQ and 24-hr food recalls
- Kaupapa Māori Wellbeing questionnaire for Māori participants
Associated data: Kaupapa Māori Wellbeing questionnaire
- Components of MetS-Z score individually
Associated data: Fasting blood- lipids and glucose, blood pressure, waist circumference
- Other metabolic and CVD markers
Associated data: Fasting blood – metabolic and CVD markers
Other data: mixed meal tolerance test (MMTT), Blood - DNA sequencing or SNP analysis, Faecal microbiome - DNASeq, Urine - microalbumin and other markersPrincipal investigator contact email
jeremy.krebs@otago.ac.nz
