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Trial registered on ANZCTR


Registration number
ACTRN12616000608460
Ethics application status
Approved
Date submitted
13/04/2016
Date registered
10/05/2016
Date last updated
16/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility of the Huarahi Hauora wellness intervention for obese Maori adults.
Scientific title
Evaluating the feasibility of the Huarahi Hauora wellness intervention for weight loss for obese Maori adults.
Secondary ID [1] 288986 0
Nil Known
Universal Trial Number (UTN)
UTN: U111111792602
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298387 0
Indigenous Health and Wellness 298388 0
Condition category
Condition code
Public Health 298490 298490 0 0
Other public health
Diet and Nutrition 298515 298515 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Duration of intervention 9 months - Trial arm 1; 6 months Trial arm 2 (initial 3 month wait list) - acting as wait list control. Indigenous knowledge and customs - no physical materials will be supplied in this intervention. Indigenous customs will involve whakawhanaungatanga (relationship building), manaakitanga (the process of showing respect, generosity and care for others), kaitiakitanga (guardianship) and karakia (incantation, prayer). The intervention currently described has been designed so that it integrates indigenous knowledge and customs.

Participant’s will become part of a closed Facebook Group. They will be encouraged to make ‘postings’ on Facebook that will be administered by the on-site researcher. The style and content of the postings will be left up to the participants and they will be encouraged to share in any way they see fit – both successes and challenges. Participants will be posting on health related successes and challenges. Weekly contacts by the on-site researcher will be Recordings of all postings will be kept while inappropriate postings will be removed by the administrator in consultation with the off-site researchers. Off-site researchers are the other 4 researchers already named in this proposal (ST, GK, CS and LH) excluding Ricky Bell. Ricky Bell is the University Based on-site researcher. Participants will be encouraged to make ‘postings’ on Facebook that will be administered by the off-site and on-site researchers. This research will adhere to the ethical guidelines and use of social media (Basevi, Reid, & Godbold, 2014). Basevi, R., Reid, D., & Godbold, R. (2014). Ethical guidelines and the use of social media and text messaging in health care: a review of literature. (Report). New Zealand Journal of Physiotherapy, 42(2), 68.

Participant’s will also receive at least one contact per week by the on-site researcher either via phone call, social media, text or email. The purpose of these weekly contacts is intended to encourage participation in physical activity and to encourage posting to the Facebook group. The mode of weekly contact (call, text or email) will be guided by tikanga (custom) and what the participants preference is on enrolment, although this may freely change at the direction of the participant over the course of the trial. Fortnightly gatherings for group physical activity events (PAE) will be made available to participants during the intervention. Initially these will be made available by the on-site researcher (a registered physiotherapist with over 20 years’ experience). Fortnightly PAE gatherings are entirely optional will be in a variety of settings from traditional meeting venues (marae), and the many sites of significance around Te Tai Tokerau (TTT). A variety of venues and locations will be employed given the geographical sparseness of TTT, hence not all participants will be able to attend on each occasion. Importantly, the PAE for physical activity is not the focus of this trial or intervention. The emphasis of this feasibility trial is not to provide passive options for participation in PAE (i.e. more frequent PAE, such as 5 sessions per week at 30minutes each), instead it is to encourage participants to engage in PAE that fit with their lifestyle, time constraints, and within their physical capability. In doing so it positions this research in a real world environment and hopefully will offer more meaningful results. The format and content of the PAE’s will be simple, variable and developed by the on-site researcher. PAE will be graded according to the capacity of each participant. Emphasis will be on participation not intensity level or degree of difficulty of PAE. Fortnightly PAE gatherings will be held at any place chosen by the group, local park, etc. - total duration that these will be made available is a maximum of 9 months. Participants will only be able to attend at the chosen time that suits the majority of the group. PAE events may include walking on the spot, walking, squat variations, lunge variations, and group or whanau PAE events. Fidelity will be monitored by the on-site researcher in collaboration with the off-site researchers. Importantly, other aspects of this trial incorporate indigenous knowledge systems to be retained by the indigenous people of Te Tai Tokerau and are not for the public domain (Bell, R., Tumilty, S., Kira, G., Smith, C., & Hale, L. (2016). Using a community based participatory research model within an indigenous framework to establish an exploratory platform of investigation into obesity. Obesity Medicine, 2, 19-24).
Intervention code [1] 294473 0
Behaviour
Comparator / control treatment
3 month wait list control group
Control group
Active

Outcomes
Primary outcome [1] 297978 0
Rate of recruitment of participants, both GP and whanau/hapu referred - will be noted within the indigenous domain.
Timepoint [1] 297978 0
9 months post commencement of intervention.
Primary outcome [2] 298010 0
Level of engagement/participation levels - with a participation log (will upload the document)
Timepoint [2] 298010 0
9 months post commencement of intervention.
Primary outcome [3] 298011 0
Information elicited from participant and exit questionnaire that have been specifically designed for this study. (attached) The outcome being elicited from participants is satisfaction with the program.
Timepoint [3] 298011 0
9 months post commencement of intervention.
Secondary outcome [1] 322810 0
Te Ao Maori Outcome

Tihei-wa mauri ora - wellness indicator (wairuatanga). See Piripi, T and Body, V (2010). Tihei-wa Mauri Ora. New Zealand Journal of Counselling. 30(1):34-46.
Timepoint [1] 322810 0
9 months post commencement of intervention.
Secondary outcome [2] 322888 0
BMI - is calculated using he formula: weight (kg) / [height (m)]2
Timepoint [2] 322888 0
9 months post commencement of intervention.
Secondary outcome [3] 322889 0
Waist to hip circumference ratio assessed using a tape measure.
Timepoint [3] 322889 0
9 months post commencement of intervention.
Secondary outcome [4] 322890 0
Waist circumference - a tape measure placed around the waist.
Timepoint [4] 322890 0
9 months post commencement of intervention.

Eligibility
Key inclusion criteria
Consenting participants between 18-65 years will be Maori, reside or whakapapa into Te Tai Tokerau and have a BMI greater than or equal to 30 kg/m2. They will have been assessed by their GP to be considered medically safe to participate in this trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-Maori, known pregnancy and any co-morbidity or serious condition(s) which are considered by the researchers to be too at risk of sustaining a serious adverse event such as a cardiac event or death at any time over the course if the trial.

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)
Allocation concealment will be done via central randomisation by phone/fax/computer by the off-site researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software will be employed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/04/2018
Actual
Date of last participant enrolment
Anticipated
31/08/2018
Actual
Date of last data collection
Anticipated
28/02/2019
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7811 0
New Zealand
State/province [1] 7811 0

Funding & Sponsors
Funding source category [1] 293345 0
Government body
Name [1] 293345 0
The Department of Internal Affairs, Lottery Health
Country [1] 293345 0
New Zealand
Primary sponsor type
University
Name
Centre for Health, Activity, and Rehabilitation Research (CHARR), School of Physiotherapy, University of Otago
Address
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 292197 0
None
Name [1] 292197 0
None
Address [1] 292197 0
Country [1] 292197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294817 0
Health and Disability Ethics Committees Ministry of Health
Ethics committee address [1] 294817 0
Health and Disability Ethics Committees
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294817 0
New Zealand
Date submitted for ethics approval [1] 294817 0
11/02/2016
Approval date [1] 294817 0
12/04/2016
Ethics approval number [1] 294817 0
16/NTB/28

Summary
Brief summary
The primary purpose of this feasibility trial is to investigate if indigenous knowledge systems and customs will enable Maori to progress towards a place of wellness. The primary purpose of the study is to determine if a tikanga (protocol) based intervention whose purpose is to enable Maori to progress towards a place of wellness is feasible. We also aim to see if this approach will offer suggestion of improved health outcomes.
Trial website
Trial related presentations / publications


Public notes
Attachments [1] 838 838 0 0
/AnzctrAttachments/370519-HDEC Letter 16NTB28 Approved EXP Application.pdf
Attachments [2] 841 841 0 0
/AnzctrAttachments/370519-Particpation - Compliance Log Huarahi Hauora.doc
Attachments [3] 842 842 0 0
/AnzctrAttachments/370519-Huarahi Hauora exit questionnaire.doc

Contacts
Principal investigator
Name 65134 0
Dr Steve Tumilty
Address 65134 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 65134 0
New Zealand
Phone 65134 0
+64 3 479 7193
Fax 65134 0
Email 65134 0
[email protected]
Contact person for public queries
Name 65135 0
Ricky Bell
Address 65135 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 65135 0
New Zealand
Phone 65135 0
+64212545422
Fax 65135 0
Email 65135 0
[email protected]
Contact person for scientific queries
Name 65136 0
Ricky Bell
Address 65136 0
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 65136 0
New Zealand
Phone 65136 0
+64212545422
Fax 65136 0
Email 65136 0
[email protected]

No information has been provided regarding IPD availability


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.