ANZCTR - Registration

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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]

Nil Known

Universal Trial Number (UTN)

UTN: U111111792602

Trial acronym

Linked study record

Health condition

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

Obesity

Indigenous Health and Wellness

Condition category

Condition code

Public Health

Other public health

Diet and Nutrition

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]

Behaviour

Comparator / control treatment

3 month wait list control group

Control group

Active

Outcomes

Primary outcome [1]

Rate of recruitment of participants, both GP and whanau/hapu referred - will be noted within the indigenous domain.

Timepoint [1]