Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000865617
Ethics application status
Approved
Date submitted
17/05/2023
Date registered
11/08/2023
Date last updated
11/08/2023
Date data sharing statement initially provided
11/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Merne Mwerre Artweye Areye-ke Program: Implementation & Evaluation of a Childhood Diabetes Prevention Program in Remote Australia – adapted Tribal Turning Point
Scientific title
Cluster randomised trial: Assessing effectiveness of the Merne Mwerre Artweye Areye-ke Program on children's body mass indices in Remote Australia.
Secondary ID [1] 309337 0
Nil
Universal Trial Number (UTN)
U1111-1290-1944
Trial acronym
MMAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 329411 0
Diabetes 329412 0
Condition category
Condition code
Metabolic and Endocrine 326356 326356 0 0
Diabetes
Diet and Nutrition 326367 326367 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implementation
The 10-week intervention program will involve the following:
I. Adapted Tribal Turning Point curriculum delivered in a group setting to Aboriginal children and caregivers (Active Learning Group Classes),
II. Individual motivational interviewing (MI) sessions for child/caregiver pairs, and
III. A toolbox of individual and community-specific resources (adapted from Tribal Turning Point).
The first 6 months of the program is of higher intensity (Intervention Core). Numbers of classes, Motivational Interviewing (MI) sessions, boosters delivered is outlined below.

Months 1-6
Intervention Core
10 Active Learning group classes
4 caregiver/child motivational interview sessions

Months 7-12
Intervention Booster
2 Active Learning group classes
3 caregiver/child motivational interview sessions
Intervention Toolbox: available as needed/recommended by coaches/staff (details below)

Active (Intervention) learning group classes
Group classes are made up of a maximum of 10-15 children and their parent/carer, they run for 2 hours, held every 1-2 weeks during school term, at a time recommended by the community (explored during community engagement prior to start of intervention). Classes are attended by children and their parent/caregiver together and include activities. Each class is offered on 2 days of the week to provide flexibility (including last minute changes). Diabetes prevention strategies are incorporated in classes through physical activity (at least 45 minutes, open re type, moderate-to-vigorous for example: a game of basketball, traditional dance or an activity determined by the community group - physical activity will be assessed using self-reported Adolescent Physical Activity questionnaire), interactive learning, incorporation of culture and a group healthy meal. Daily targets are promoted using “2-5-2-1-0” messaging: 2 servings of fruit, 5 vegetables, less than 2 hours screen time, greater than and equal to 1-hour physical activity and 0 servings of sugar-containing beverages or confectionery. Children and parents identify a specific, attainable goal to be achieved before the next session, and make an action plan to achieve the goal. Self-monitoring trackers are used to highlight successes and assist discussion of problem-solving strategies. To promote engagement, incentives are earned for attending classes, submitting goal-tracker forms, attending events, later redeemed for prizes (sport equipment). The Tribal Turning Point curriculum was extensively revised during our formative work, with considerable input from local NT clinicians (dietitians, exercise physiologists, Aboriginal Health Practitioners, health promotion team members, diabetes educators and others) and community members. The sessions of the revised curriculum are outlined below.

Merne Mwerre Artweye Areye-ke (adapted Tribal Turning Point) curriculum

Sessions
1 Welcome, awareness
2 Traditional food
3 Choosing healthy food
4 Mindful eating
5 Joyful movements
6 Balancing plate
7 Healthy environment
8 Eating out
9 Helpful thoughts
10 Stay motivated

Individual motivational interviewing sessions
Motivational interviews with parent-carer/child pairs are performed by trained Aboriginal health facilitators (trained in Year 1) exploring health and behaviour goals. Sessions (1 hour each) are performed in a location of the participant’s choice. Four principles of motivational interviewing guide the sessions: express empathy, develop discrepancy, roll with resistance, and support self-efficacy. Consultants experienced in providing motivational interviewing will be employed to deliver motivational interviewing sessions to participants, and to train and support Aboriginal Community Controlled Organisation Health staff in delivering these sessions.

The TTP toolbox
The toolbox addresses domains of the socio-ecological model of health behaviour, aligning with Aboriginal and Torres Strait Islander wellness models: individual, home/family, school, community, and health systems. Locally developed resources such as the storyboard of the intergenerational chronic disease story (developed by NT Health Aboriginal staff), will be incorporated where appropriate, and the toolbox used to facilitate program intention for each participant.
Toolbox resource examples across domains are
(i) individual level: communication strategies (phone reminders, buddy system), recipes, meal plans;
(ii) family: home food and activity environment review;
(iii) school: facilitate participation in school physical activity and facilitate choosing healthy food;
(iv) community: facilitate programs regarding healthy habits and group support;
(v) health system: facilitate health appointments.
The resources that are used during the sessions will be facilitated by the Aboriginal Community Controlled Health Organisation Staff supported by Menzies Research Staff.
The intervention toolbox resources will be available as needed, or as recommended by coaches/staff and or at the request of families during the intervention core and booster period. For example, handouts to support healthy diet and or physical activity will be available to participants and their families during and after sessions.
The assessment and monitoring of adherence to the intervention will be undertaken through ongoing evaluation at different timepoints (pre, during and post intervention) to understand the factors related to participant engagement (recorded reflective notes post sessions-use of resources), attendance (attendance tracking logs), program delivery and potential for sustained delivery.
An evaluation of the adapted Tribal Turning Point program involves a mixed-methods outcomes and process evaluation, guided by the REAIM (reach, effectiveness, adoption, implementation and maintenance)/PRISM (practical, robust implementation and sustainability model) framework using principles of the Lowitja Institute Evaluation Framework. Methods for exploring program adaptation and appropriate implementation will include surveys, reflective notes, interviews and focus groups with evaluation participants" and "We will conduct formal, recorded, individual research interviews with a sample of program participants at each community. Study staff trained in qualitative research will conduct the interviews at each site, either in person or by phone, depending on participant preference. Parent/caregiver and child/ren (combined) interviews will occur at 12 months, and 24 months (for trial/intervention sites). We will randomly select up to 10 parent/caregiver and child/ren per community, resulting in up to 60 parent/caregivers and child/ren interviews at 12 months and 30 at 24 months. Because we are interested in the motivations, experiences, and perspectives of intervention and control participants, we will aim to interview parent/caregivers from both groups. Interview questions will explore the parent/caregiver’s experience in the program, the results they achieved, the challenges they faced, their confidence to maintain lifestyle changes long-term and for those interviewed at 24 months, what if any lifestyle changes have been maintained and how this has been achieved.
We will also interview stakeholders from the community including program facilitators, at the end of the program (12 months) and after 24 months in the trial/intervention communities. We will interview approximately 5 stakeholders from each community, resulting in up to 30 interviews at the 12 month point and 15 at 24 months. Questions will explore factors including: the challenges and successes to enrolling participants in the program, keeping participants engaged, delivering the intervention as planned, how the program fits within the communities’ goals, priorities, and resources, awareness of diabetes risk in youth, community level factors that may have influenced implementation and effectiveness of the program, how challenges were addressed during the program, and the barriers/facilitators to continued program delivery in each community. The focus of questions at 24 months will be maintenance of program components and other supporting initiatives that may have developed in the community or any significant changes that have been witnessed in relation to the program delivery.
Intervention code [1] 325703 0
Prevention
Intervention code [2] 325704 0
Behaviour
Intervention code [3] 325705 0
Lifestyle
Comparator / control treatment
All wait-list control communities receive the intervention after 12 months. Participants will complete the 12 months data collection in the control period, before the intervention. The data collected at 24 months among participants in control communities will assess the effectiveness of the intervention program within the control community participants only (as the control community receive the intervention from 12 to 24 months). Maintenance of the intervention in the control community participants will not be assessed as part of the trial but may be assessed for clinical reasons by Aboriginal Controlled Community Health Organisation clinical staff.
Control group
Active

Outcomes
Primary outcome [1] 334226 0
Any change in body mass index (BMI) z-score assessed using height measured using a stadiometer and weight measured using digital scales.
Timepoint [1] 334226 0
Assessment time points are: 0, 6, 12 and 24 months (with additional assessment of weight, height and waist at 3 and 9 months).
Secondary outcome [1] 422012 0
Any change in reported sugar sweetened beverage consumption at 0-12 month assessed using a questionnaire designed specifically for this study (Menzies Remote Short-item Dietary Assessment Tool)
Timepoint [1] 422012 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [2] 422013 0
Any change in anthropometric measurements measuring waist circumference using a tape measure.
Timepoint [2] 422013 0
Assessment time points are: 0, 6, 12 and 24 months (with additional assessment of weight, height and waist at 3 and 9 months)
Secondary outcome [3] 422014 0
Any change in baseline body mass index (BMI) z-score less than or equal to 0 assessed using height measured using a stadiometer and weight measured using digital scales.
Timepoint [3] 422014 0
Assessment time points are: 0, 6, 12 and 24 months (with additional assessment of weight, height and waist at 3 and 9 months).'
Secondary outcome [4] 423238 0
Any change in physical activity using the self-report Adolescent Physical Activity questionnaire.
Timepoint [4] 423238 0
Assessment time points are 0, 6, 12 and 24 months
Secondary outcome [5] 423239 0
Any change in body composition (assessing fat free mass) using an Impedimed SFB7 machine.
Timepoint [5] 423239 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [6] 424368 0
Any change in dietary intake using the Menzies Remote Short-item Dietary Assessment Tool
Timepoint [6] 424368 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [7] 424369 0
Any change in social and emotional wellbeing using the Strong Souls Questionnaire
Timepoint [7] 424369 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [8] 424370 0
Any change in screen time using the self-report Adolescent Physical Activity Questionnaire
Timepoint [8] 424370 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [9] 424372 0
Any change in emotional well-being using the Strength and Difficulties questionnaire.
Timepoint [9] 424372 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [10] 424373 0
Any change in blood pressure using an automated device with appropriate cuff size (CARESCAPE V100 with DINAMAP Technology)
Timepoint [10] 424373 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [11] 424374 0
Process measures using attendance, toolbox and goal trackers
Timepoint [11] 424374 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [12] 424375 0
Participant engagement using participant interviews.
Timepoint [12] 424375 0
Assessment time points are: 12 and 24 months
Secondary outcome [13] 424376 0
Implementation factors using staff, stakeholder interviews and focus groups.
Timepoint [13] 424376 0
Assessment time points are: 12 and 24 months
Secondary outcome [14] 424377 0
Sustainability factors using stakeholder interviews and focus groups.
Timepoint [14] 424377 0
Assessment time points are: 12 and 24 months
Secondary outcome [15] 424378 0
Cost intervention within the project tracking staff time and associated implementation costs using activity logs and trackers.
Timepoint [15] 424378 0
Assessment time points are: 0, 6, 12 and 24 months
Secondary outcome [16] 425039 0
Any change in waist to height ratio will be assessed measuring waist circumference using a tape measure and measuring height using a stadiometer.
Timepoint [16] 425039 0
Assessment time points are: 0, 6, 12 and 24 months (with additional assessment of weight, height and waist at 3 and 9 months)

Eligibility
Key inclusion criteria
Aim 1 (Trial)
All Aboriginal and replace Torres Strait Islander children will be invited to participate in the trial who:
- are aged 6-11 years; and
- have at least one parent/primary caregiver willing to actively participate; and
- reside in NT communities participating in the trial

AIM 2 (Evaluation): Health care providers, health care administrators, school and recreation specialists, health researchers, community leaders and parents of school-aged children are identified as stakeholders in the evaluation component. Other evaluation participants include, program participants (children and parent/caregiver), and program facilitators. Ages for aim 2 are from equal to or greater than 6 years of age.
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants, parent or caregiver unable to provide informed consent

Children diagnosed with any serious health concerns that would interfere with participation (e.g., uncontrolled asthma) or plans to move out of the area during the study.

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)
Purpose built secure online database - RedCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will run as a parallel design for the first 12 months, after which participants in the wait-list control communities will receive access to the intervention. All participants will then be followed up for a further 12 months after this time for a total follow-up period of 1-year post-enrolment.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Analysis of Primary and Secondary Outcomes

Using Stata v17.0 or equivalent, summary statistics will describe primary and secondary outcomes and relevant covariates measured over time, for the control and intervention groups. Change over time in the primary outcome (BMI at 3, 6, 9 and 12 months) will be estimated by regressing the outcome on time and on exposure to the intervention (yes/no) using a linear mixed model. Continuous secondary outcomes (anthropometric measures and physical activity) will be analysed with equivalent models. Categorical outcomes (diet) will be regressed on exposure to the intervention (yes/no) using a mixed effects logistic regression model. Each model will include the outcome’s baseline measure as confounding factor, random effects to allow for the clustering effect of community and family and for repeated measures on an individual. Interaction terms between the time variable and the intervention group will be modelled to estimate the intervention effect at each measurement time point (3, 6, 9, and 12, months). Analysis will be performed stratified by gender and baseline BMI. The primary outcome (BMI) and secondary outcomes (behavioural changes including reported sugar sweetened beverage consumption) measure different factors (anthropometric and behavioural change) and thus will be analysed separately with a nominal type I error probability of 0.05 for each.
Secondary analyses will assess effectiveness of intervention in wait-list group, and the maintenance of change in outcomes at 24 months after the intervention.
Primary analyses comparing primary and secondary outcomes between the intervention and control periods related to data at 0, 3, 6, 9 and 12 months only.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT

Funding & Sponsors
Funding source category [1] 313446 0
Other Collaborative groups
Name [1] 313446 0
Central Australian Academic Health Science
Country [1] 313446 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies School of Health Research
Address
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Australia
Country
Australia
Secondary sponsor category [1] 315220 0
Other Collaborative groups
Name [1] 315220 0
Central Australian Aboriginal Congress
Address [1] 315220 0
Congress Head Office
14 Leichhardt Terrace,
Alice Springs NT 0870
Country [1] 315220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312651 0
Human Research Ethics Committee of NT Health and Menzies School of Health Research
Ethics committee address [1] 312651 0
Ethics committee country [1] 312651 0
Australia
Date submitted for ethics approval [1] 312651 0
25/01/2023
Approval date [1] 312651 0
20/03/2023
Ethics approval number [1] 312651 0
Reference number: 2023-4532

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125426 0
A/Prof Renae Kirkham
Address 125426 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Australia
Country 125426 0
Australia
Phone 125426 0
+61 8 8946 8693
Fax 125426 0
+61 8 8946 8464
Email 125426 0
[email protected]
Contact person for public queries
Name 125427 0
Joanna Kelaart
Address 125427 0
Menzies School of Health Research,
PO: Box 2234,
Alice Springs,
NT 0871,
Australia |
Country 125427 0
Australia
Phone 125427 0
+61 8 89595288
Fax 125427 0
Email 125427 0
[email protected]
Contact person for scientific queries
Name 125428 0
Renae Kirkham
Address 125428 0
Menzies School of Health Research
PO Box 41096
Casuarina NT 0811
Australia
Country 125428 0
Australia
Phone 125428 0
+61 8 8946 8693
Fax 125428 0
+61 8 8946 8464
Email 125428 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
Unable to share due to the sensitive nature of the data.


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.