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Trial registered on ANZCTR


Registration number
ACTRN12618000418279
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
22/03/2018
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing an Integrated Care Model for Maori Men with Pre-diabetes, cardio vascular disease (CVD) risk, and/or obesity
Scientific title
He Pikinga Waiora: Testing the effectiveness of an Integrated Care Model for Maori Men with Pre-diabetes, CVD risk, and/or obesity on quality of life, HbA1c and body-mass index'.
Secondary ID [1] 294148 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pre-diabetes 306787 0
Cardiovascular disease 306788 0
Obesity/overweight 306789 0
Condition category
Condition code
Public Health 305889 305889 0 0
Health promotion/education
Metabolic and Endocrine 306091 306091 0 0
Metabolic disorders
Cardiovascular 306092 306092 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention has four elements:
a) A kaiarahi (navigator) will build a relationship with men and help them navigate the health system. A key foundation of this relationship will be pono (integrity) and trust. A kaiarahi will be employed as a primary contact and spend time in the community. The kaiarahi will also support the lifestyle intervention and community activism described below and also link patients to needed services in the system.
b) Health promotion fairs (i.e., at least every 3 months for 12 months) will be conducted quarterly (i.e., every three months) to screen men for diabetes risk, CVD risk and obesity risk. Some screening will occur in traditional GP settings with support from the kaiarahi. The screens and interactions with the kaiarahi will be done on individual basis (groups if patients request it).
c) For those who screen at health risk, we will offer a whanau-based (extended family-based) lifestyle Intervention—the men and their mates (they are also welcome to include other family members). The lifestyle programme will include the following activities: a) group exercise/physical activity including competitions within the group and to attend events like Iron Maori (activity programmes will be tailored to needs and interests and include some weight bearing activity and cardio activity; e.g., high intensity interval training for advanced and moderate walking with light weights for beginners), b) nutrition—cooking classes, what food (kai) to buy (e.g., preparing meat and other food with less fat and integrating more fruits and veggies into the diet); and c) education on how to change and educate children and other family/community members (e.g., motivation, overcoming challenges, etc). The programme was loosely adapted from the Diabetes Prevention Programme and tailor to Maori cultural needs. The programme includes active learning and physical activity sessions rather than just education about these elements. The educational sessions will be one-hour each for 12 weeks (12 total sessions; 2 on physical activity, 3 nutrition, 4 related to both activity and nutrition, and 3 on education--didactic and interactive sessions on overcoming barriers, creating opportunities for changing family interactions around healthy eating and activity and changing community around healthy eating and activity). Additional physical activity sessions will be held during each week (3 total per week). Sessions will be group-based in a face-to-face setting. The sessions will be delivered in a combination of a health clinic, social service clinic, or at a local park (e.g., for exercise classes). The programme will be run 3 times over a 12 month period (with 4-5 week break between sessions). Participants can repeat if the programme if they choose to do so. There are not any criteria for repeating the sessions although we will collect data on how many repeat sessions are attended and which ones are attended. Delivery of the programme will be done by the kaiarahi who is trained in physical education and a clinical nurse with expertise in diabetes and nutrition. Intervention adherence will be assessed through attendance sheets completed by the kaiarahi/clinical nurse and activity/food logs completed by the participants.
d) From a smaller subset of those in the lifestyle intervention, we will educate several men/whanau to be community activists and do a variety of primary prevention activities such as work with councils to enhance the community, improve the food environment, etc (e.g., community garden).
Intervention code [1] 300449 0
Lifestyle
Intervention code [2] 300450 0
Prevention
Comparator / control treatment
Standard care; patients will receive usual and customary advice about prevention of health conditions. This standard care is guided by the NZ Ministry of Health on who should be screened for certain conditions. The specific advice is not based on specific guidelines.
Control group
Active

Outcomes
Primary outcome [1] 304931 0
Health Related Quality of Life (SF-8)
Timepoint [1] 304931 0
Pre-intervention and 6-month post-commencement of intervention.
Primary outcome [2] 304932 0
HbA1c based on serum assay
Timepoint [2] 304932 0
Pre-intervention and 6-month post-commencement of intervention
Primary outcome [3] 304933 0
Body Mass Index determined by measuring tape and scale
Timepoint [3] 304933 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [1] 343635 0
Blood pressure (e.g., manual sphygmomanometer)
Timepoint [1] 343635 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [2] 343636 0
Health service utilisation based on self-report
Timepoint [2] 343636 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [3] 343637 0
CVD risk determined by clinician assessment following NZ guidelines
Timepoint [3] 343637 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [4] 343638 0
Physical activity based on self-report of activity
Timepoint [4] 343638 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [5] 343639 0
nutrition based on self-report of questionnaire items from the 2008-09 New Zealand Adult Nutrition Survey
Timepoint [5] 343639 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [6] 343640 0
Food security based on self-report of questionnaire items from the 2008-09 New Zealand Adult Nutrition Survey
Timepoint [6] 343640 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [7] 343641 0
social support based on self-report of questionnaire items adapted from a previously validated survey; Oetzel, J. G., Duran, B., Jiang, Y., & Lucero, J. (2007). Social support and social undermining as correlates for alcohol, drug, and mental disorders in American Indian women presenting for primary care at an Indian Health Service hospital. Journal of Health Communication, 12, 187-206.
Timepoint [7] 343641 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [8] 343642 0
Trust in institutions based on self-report of questionnaire items from Te Kupenga Maori Social Services Questionnaire 2013
Timepoint [8] 343642 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [9] 343643 0
Deprivation index
Timepoint [9] 343643 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [10] 343644 0
resilience based on self-report of questionnaire items adapted from the Brief Resilience Scale Smith, B. W., Dalen, J., Wiggins, K., Tooley, E., Christopher, P., & Bernard, J. (2008). The brief resilience scale: assessing the ability to bounce back. International journal of behavioral medicine, 15(3), 194-200.
Timepoint [10] 343644 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [11] 343645 0
Readiness to change based on self-report of questionnaire items adapted from Shea, C. M., Jacobs, S. R., Esserman, D. A., Bruce, K., & Weiner, B. J. (2014). Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci, 9(7), 1-15.
Timepoint [11] 343645 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [12] 343646 0
community health activism based on questions designed for this study
Timepoint [12] 343646 0
Pre-intervention and 6-month post-commencement of intervention
Secondary outcome [13] 343647 0
Health system enrolments based on medical records
Timepoint [13] 343647 0
Pre-intervention and 6-month post-commencement of intervention

Eligibility
Key inclusion criteria
Maori men; at risk for diabetes, CVD, or obesity/overweight
Minimum age
30 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
already have diabetes or CVD

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
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
75 in each group initially with 50 at follow-up; medium effect size, p < .05; Data analysis will be a ANCOVA with pre-test scores as a covariate, post-test scores in the outcome variables as dependent, and treatment group as independent; Demographic variables not evenly distributed will also be covariates.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
10/04/2018
Actual
Date of last participant enrolment
Anticipated
20/10/2018
Actual
Date of last data collection
Anticipated
20/04/2019
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 9626 0
New Zealand
State/province [1] 9626 0

Funding & Sponsors
Funding source category [1] 298782 0
Government body
Name [1] 298782 0
Healthier Lives National Science Challenge, Ministry of Business, Innovation & Employement
Country [1] 298782 0
New Zealand
Primary sponsor type
University
Name
University of Waikato
Address
Private Bag 3105
Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 297965 0
Charities/Societies/Foundations
Name [1] 297965 0
Poutiri Trust
Address [1] 297965 0
74 Jellicoe Street, Te Puke 3119
Country [1] 297965 0
New Zealand
Secondary sponsor category [2] 297980 0
Charities/Societies/Foundations
Name [2] 297980 0
Manna Integrative Services
Address [2] 297980 0
60 Onslow St Kawerau 3127
Country [2] 297980 0
New Zealand
Secondary sponsor category [3] 297981 0
Charities/Societies/Foundations
Name [3] 297981 0
Eastern Bay Public Health Alliance
Address [3] 297981 0
5 Louvain Street
WHAKATANE 3158
Country [3] 297981 0
New Zealand
Secondary sponsor category [4] 297982 0
Charities/Societies/Foundations
Name [4] 297982 0
Te Puna Ora o Mataatua
Address [4] 297982 0
PO Box 729, Whakatane 3158
Country [4] 297982 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299728 0
University of Waikato, Waikato Management School
Ethics committee address [1] 299728 0
Private Bag 3105
Hamilton 3240
Ethics committee country [1] 299728 0
New Zealand
Date submitted for ethics approval [1] 299728 0
Approval date [1] 299728 0
10/11/2017
Ethics approval number [1] 299728 0

Summary
Brief summary
The aim of this study is to test the efficacy of an intervention for Maori men at risk of diabetes, CVD and/or obesity. The intervention is a lifestyle-based intervention with a patient navigator and was designed using participatory health methods. Outcomes include individual, health service, and community levels. The hypothesis is that the intervention will result in improved outcomes at all three levels when comparing pre- to post-test measures. There is also the expectation that the treatment group will have high post-test measures compared to a control group when controlling for pre-test measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81390 0
Prof John Oetzel
Address 81390 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 81390 0
New Zealand
Phone 81390 0
+647838443`
Fax 81390 0
Email 81390 0
[email protected]
Contact person for public queries
Name 81391 0
John Oetzel
Address 81391 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 81391 0
New Zealand
Phone 81391 0
+647838443`
Fax 81391 0
Email 81391 0
[email protected]
Contact person for scientific queries
Name 81392 0
John Oetzel
Address 81392 0
Private Bag 3105
University of Waikato
Hamilton 3240
Country 81392 0
New Zealand
Phone 81392 0
+647838443`
Fax 81392 0
Email 81392 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study withdrawn


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.