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Trial registered on ANZCTR


Registration number
ACTRN12617001484336
Ethics application status
Approved
Date submitted
18/10/2017
Date registered
20/10/2017
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Date results information initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
OL@-OR@ trial: a cluster-randomised controlled trial to evaluate a co-designed, culturally-tailored, lifestyle-support mobile health (mHealth) tool, which includes an app and website for Maori and Pasifika in New Zealand
Scientific title
OL@-OR@ (WellTEXT) Project. Supporting healthy lifestyles: A Maori and Pasifika mHealth approach. Phase 2: a cluster-randomised controlled trial to evaluate a culturally tailored, personalised mHealth tool (app and website) for Maori and Pasifika in New Zealand
Secondary ID [1] 293064 0
Nil known
Universal Trial Number (UTN)
U1111-1199-5010
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 305079 0
Heart disease 305082 0
Obesity 305083 0
Condition category
Condition code
Public Health 304396 304396 0 0
Health promotion/education
Diet and Nutrition 304397 304397 0 0
Obesity
Diet and Nutrition 304398 304398 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The OL@-OR@ trial is a pragmatic, community-based, two-arm, cluster randomised trial, including 48 clusters with 40 participants per cluster (24 Maori clusters and 24 Pasifika clusters).
Clusters will be randomly assigned (1:1 ratio) to one of two groups: 1) the full OL@-OR@ mhealth tool (app/web version; intervention group), or 2) a simplified version of the mhealth tool (app/web version; control group). It will be up to the participants how often they utilise the app within the 12 week period and they are able to use the app from any location with internet access.
All participants will be followed for 12 weeks with assessments at baseline, 4 and 12 weeks which includes demographics, lifestyle questions (fruit and vegetable intake, physical activity, smoking and alcohol intake, Maori/ Pasifika wellbeing questions and feedback on the app will also be collected at 12 weeks.
The intervention will be delivered through a mobile app or web version, however Community Coordinators will be involved with recruiting participants and supporting them with registering and using the tool. The Community Coordinators are from our Maori and Pasifika communities who have been involved from the start of the project in the co-design phase.
The full OL@-OR@ tool (app and web versions) includes;
- Support for participants to set goals as an individual or family and invite others to join them in their journey to achieve these goals.
- Participants are encouraged to set additional tasks to help them to achieve their goals.
- Participants receive reward tokens for achieving their goals.
- There are a number of behavioural change culturally tailored resources throughout the app such as lifestyle trackers, recipes, links to helpful websites, nutritional and physical activity information and local activities such as food markets and exercise classes.
- The app also sends regular reminders and motivational messages to help participants reach their goals.
- Participants interact with the content by setting goals, sharing with friends and inviting others to use the app, uploading recipes and local activities and by utilising the tips around physical activity and nutrition.

The simplified version of the tool:
- A countdown until when they will receive the full app
- One message a week letting them know when they will receive the full app
- Reminders to complete the questionnaires at 4 weeks and 12 weeks post registration.
- The only interaction required for the control app is leaving the app on their phone and completing the questionnaires at the required time points.

Adherence will be assessed by collecting data in the app around how a participant interacts with the app. This includes looking at data around:
- The total number of times a participant accesses the app during the study.
- The time elapsed between each session the participant accessed the app
- Number of goals a user sets
This will be monitored by the research team at the National Institute for Health Innovation (NIHI)
NIHI will also monitor whether participants have completed their registration, 4 week questionnaire and 12 week questionnaire. Reminders will go out to participants 1 week prior, on the questionnaire due date and 1 week after the questionnaire is due (if not already completed) to remind participants to complete the questionnaire. An email will also be automatically generated and sent to the participants Community Coordinator to chase up any questionnaires not complete.

Intervention code [1] 299366 0
Prevention
Intervention code [2] 299367 0
Lifestyle
Intervention code [3] 299368 0
Behaviour
Comparator / control treatment
The control treatment will involve a participant downloading a simplified version of the tool which will be used for data collection at baseline, 4 weeks and 12 weeks as per the intervention group and a weekly notification message informing the participant how long they have until they can download the full app at the end of the trial. All participants in the control group will be able to access the full app after 12 weeks once they have completed the 12 week questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 303636 0
The primary outcome is 12 week participant adherence to recommended health guidelines, as defined by a self-reported composite health behaviour score based on the European Prospective Investigation into Cancer (EPIC)-Norfolk Prospective Population Study. This composite score includes: smoking (1= not currently smoking; 0=had greater than or equal to 1 cigarettes in past 7 days); fruit and vegetable intake (1 = great than or equal to 5 servings daily; 0 = less than or equal to 4 servings daily); alcohol intake (1 = less than or equal to 13 units per week; 0 = greater than or equal to 14 units per week); and physical activity (1 = more than or equal to 14 units of moderate-to-vigorous activity/week; 0 = less than or equal to 13 units of moderate-to-vigorous activity/week). Scores range from 0 to 4 based on the number of health guidelines met. Participants are classified as adherent if they score 3 or more out of 4 and non-adherent if they score 2 or less. These measures are measured at an individual leave but analysed and reported at a cluster level (as are the secondary measures).
Timepoint [1] 303636 0
Measured at baseline, 4 weeks from completing registration and 12 weeks post registration.
The primary time point is at 12 weeks.
Secondary outcome [1] 339717 0
Self reported weight (kg) and height (cm)
Timepoint [1] 339717 0
Measured at baseline and 12 weeks post registration
Secondary outcome [2] 339718 0
Holistic wellbeing (Maori participants) including Tuhononga (cultural connections, Mauri and wellbeing, whanaungatanga (whanua wellbeing and social connectedness) and Rangatiratanga (self-determination, motivation and management) measured by 16 questions based on Maori health models Te Whare Tapa Wha and Te Pae Mahutonga and adapted in part from the Hua Oranga Maori mental health assessment questionnaire. Answer categories consist of a 6-point Likert scale and 4 open ended questions.

Holistic wellbeing (Pasifika participants) including spiritual, physical, mental and family wellbeing measured by 10-items based on the Fonofale Model, the Ottawa Charter and Hua Oranga designed for the purpose of this study. All answer categories are measured on a 5-point Likert scale.



Timepoint [2] 339718 0
Measured at baseline and 12 weeks post registration.
Secondary outcome [3] 339720 0
User engagement and interaction with the mhealth toll measured with an engagement index, consisting of a) Click-Depth Index (measures the number of pages participants viewed per session in the app); b) Loyalty Index (frequency of participants accessing the app from when they commenced the intervention); c) Interaction Index (number of push notification opened from those sent through the app); d) Recency Index (time difference between each session the participant accessed the app); e) Feedback index (subjective 20 item measure of participant’s satisfaction with the app.
Timepoint [3] 339720 0
Measured at 12 weeks post registration

Eligibility
Key inclusion criteria
• Member of a Maori or Pasifika group or community who has signed up to take part in the study
• Live in New Zealand;
• Aged 18 years and older
• Regular access to a smartphone, tablet or laptop/computer and regular access to internet (at least once a week);
• Able to provide written consent (e-consent);
• Have an email address or able to create an email address for the trial.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be able to enrol in the trial if they are aged less than 18 years old, do not have regular access to a smartphone, tablet, laptop or computer or do not have access to internet, and if they are a member of a cluster that has already been randomised to another study condition.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The method used will be central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Clusters will be randomly assigned at a 1:1 ratio to either the intervention or control condition using computer-generated randomisation lists
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to the nature of the intervention it will not be possible to blind participants or research staff to the use of the different intervention conditions (full versus basic (data-collection only) version of the smartphone app..
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We aim to recruit 1280 participants in total; 64 clusters with 20 participants per cluster (32 Maori clusters and 32 Pasifika clusters). This sample size will have sufficient power for the analysis of Maori and Pasifika participants separately. More specifically, a total sample size of 640 participants (n=20 per cluster, 16 clusters per treatment group; 32 clusters in total i.e. each ethnic-specific sample) will have 80% power at 5% level of significance (two-sided) to detect a between-group difference of 15% in the primary outcome at 12 weeks post intervention, assuming the proportion of participants adherent to healthy lifestyle behaviours in the control group is 30% and an intracluster correlation coefficient (ICC) of 0.0531.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9282 0
New Zealand
State/province [1] 9282 0

Funding & Sponsors
Funding source category [1] 297687 0
Other
Name [1] 297687 0
Healthier Lives he Oranga Hauora National Science Challenge
Address [1] 297687 0
Research and Enterprise
University of Otago
PO Box 56
Dunedin 9054
Country [1] 297687 0
New Zealand
Primary sponsor type
Individual
Name
Professor Cliona Ni Mhurchu
Address
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland
1142
Country
New Zealand
Secondary sponsor category [1] 296782 0
Individual
Name [1] 296782 0
Dr Lisa Te Morenga
Address [1] 296782 0
School of Health, Victoria University of Wellington, PO Box 600, Wellington. 6140
Country [1] 296782 0
New Zealand
Secondary sponsor category [2] 296783 0
Individual
Name [2] 296783 0
Dr Tupa'ilevaililigi Ridvan Tupa'i-Firestone
Address [2] 296783 0
Centre of Public Health Research
Massey University
PO Box 756
Wellington
6140
Country [2] 296783 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298759 0
Health and Disability Ethics Committee
Ethics committee address [1] 298759 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 298759 0
New Zealand
Date submitted for ethics approval [1] 298759 0
27/07/2017
Approval date [1] 298759 0
14/08/2017
Ethics approval number [1] 298759 0
17/NTB/152

Summary
Brief summary
The Ol@-OR@ trial is part of a larger project to develop and evaluate a culturally tailored, personalised mobile health (mHealth) healthy lifestyle and wellbeing tool for Maori and Pasifika. This project comprises two phases:
- During phase one, a partnership approach was taken in which Maori and Pacific leaders and communities co-designed the mHealth tool with the academic research team. Maori and Pasifika partners confirmed that a smartphone app was the optimal vehicle for the intervention and the results of the co-design phase were used to inform the theory based
behaviour change content of the app.
- In the second phase of the project we will examine the effectiveness of the mHealth tool in a pragmatic, community based cluster randomised controlled trial – the OL@-OR@
trial.
The trial aims to determine if using the mHealth tool for 12 weeks will improve diet, physical activity and other risk factors for non-communicable
diseases. The trial will involve 1920 participants throughout New Zealand (48 clusters [24 Maori and 24 Pasifika) with 40 people in each cluster).
Trial website
www.olaora.auckland.ac.nz
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78138 0
Prof Cliona Ni Mhurchu
Address 78138 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 78138 0
New Zealand
Phone 78138 0
+64 9 923 4494
Fax 78138 0
Email 78138 0
c.nimhurchu@auckland.ac.nz
Contact person for public queries
Name 78139 0
Mrs Jacqui Grey
Address 78139 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 78139 0
New Zealand
Phone 78139 0
+64 9 923 8210
Fax 78139 0
Email 78139 0
jk.grey@auckland.ac.nz
Contact person for scientific queries
Name 78140 0
Prof Cliona Ni Mhurchu
Address 78140 0
National Institute for Health Innovation
School of Population Health
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 78140 0
New Zealand
Phone 78140 0
+64 9 923 4494
Fax 78140 0
Email 78140 0
c.nimhurchu@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not asked participants consent to share data on an individual basis.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1906 0
Study protocol
Citation [1] 1906 0
Link [1] 1906 0
Email [1] 1906 0
Other [1] 1906 0
Study Protocol
Type [2] 1907 0
Informed consent form
Citation [2] 1907 0
Link [2] 1907 0
Email [2] 1907 0
Other [2] 1907 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1908 0
Presentation
Citation/DOI/link/details [1] 1908 0
Ni Mhurchu, C. A co-designed mHealth programme to reduce risk of heart disease, obesity and diabetes in Maori and Pasifika communities in New Zealand: Results from the OL@-OR@ cluster randomised controlled trial. IUHPE: International Union for Health Promotion and Education Conference. 10 April 2019. Rotorua, New Zealand. (Oral Presentation).
Attachments [1] 1908 0
Citation type [2] 1909 0
Conference abstract
Citation/DOI/link/details [2] 1909 0
Ni Mhurchu C. A co-designed mHealth programme to reduce risk factors for heart disease, obesity and diabetes in Maori and Pasifika communities in New Zealand: Results from the OL@-OR@ cluster randomised controlled trial. ANA: Activity and Nutrition Conference. May 2019. Auckland, New Zealand. (oral presentation)
Attachments [2] 1909 0
Citation type [3] 1910 0
Conference abstract
Citation/DOI/link/details [3] 1910 0
Ni Mhurchu C. A co-designed mHealth programme to reduce risk factors for heart disease, obesity and diabetes in Maori and Pasifika communities in New Zealand: Results from the OL@-OR@ cluster randomised controlled trial. ISBNPA: International Society for Behavious Nutrition and Physical Activity. June 2019. Prague, Czech Republic. (oral presentation)
Attachments [3] 1910 0
Results – basic reporting
Results – plain English summary