ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

pre-diabetes

Cardiovascular disease

Obesity/overweight

Condition category

Condition code

Public Health

Health promotion/education

Metabolic and Endocrine

Metabolic disorders

Cardiovascular

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]

Lifestyle

Intervention code [2]

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]

Health Related Quality of Life (SF-8)

Timepoint [1]

Pre-intervention and 6-month post-commencement of intervention.

Primary outcome [2]

HbA1c based on serum assay

Timepoint [2]