Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001100785
Ethics application status
Approved
Date submitted
2/08/2022
Date registered
9/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
9/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Pasifika Women’s Diabetes Wellness Program (PWDWP)
Scientific title
Evaluating the feasibility and efficacy of a Pasifika Women’s Diabetes Wellness Program on HbA1c levels and diabetes self-care practices.
Secondary ID [1] 307696 0
Nil
Universal Trial Number (UTN)
U1111-1281-1490
Trial acronym
PWDWP
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 327242 0
Condition category
Condition code
Metabolic and Endocrine 324382 324382 0 0
Diabetes
Public Health 324383 324383 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program content and materials were co-designed and co-developed with the Maori and Pasifika communities (2017- 2019) using participatory co-design and talanoa approach, prior to securing the fund to pilot the study.

The intervention participants will be drawn from women living with diabetes in the southern section of South-east QLD (Logan, Ipswich, Gold Coast). They will be geographically separated from the control group (recruited from the northern sector of south-east QLD (Brisbane, Caboolture, Sunshine Coast) to minimise potential for cross-contamination.

All intervention participants will have access to an interactive electronic journal (as well as a hardcopy program journal) via a web interface (including podcasts, a moderated discussion board and self-directed culturally co-developed resources), recipe books, passport for health checks and fact sheets as well as text messages with reinforcing positive motivational behaviours receive a program journal (interactive e journal and printed hard copy), recipe book and fact sheets which they can work through with the support of the CHWs.

The participants will document their journey using the journal and with the support of the community health worker. They will share their stories during the during the Talanoa support group to identify barriers, enablers and on going maintenance support. The community health worker (CHW) will also provide coaching using the journal the women completes during the program. The CHW will work with the women to guide them with documenting the journal. Although it will be encouraged, the documentations in the journal will be at the participant's discretion.

The intervention will include whanau education talanoa workshop (in-person and via zoom), individual talanoa consultations (via Zoom) and talanoa support group (in person and via zoom) over 24 weeks (12 weeks intervention and 12 weeks follow up) with Maori and Pasifika women (MPI) living with type 2 diabetes in Southeast Queensland. It will be delivered by trained MPI Health Professionals consisting of community health workers (CHWs), and a workshop facilitator (or nurse diabetes educator educators / registered nurse (RN) working with the MPI communities.

The Intervention includes:
1.Whanau Talanoa Workshop ((WTW) Weeks 1 -5): 5 x 2hr session delivered in-person and via zoom over 5 weeks covering the wellness components. Whanau talanoa workshops will provide interactive knowledge-based education on targeted health knowledge and behaviours and with culturally specific tools to manage type 2 diabetes within a family, community and spiritual context (Weeks 1 -5 in person and virtual delivery will also depend on the advisory committee to run the education sessions as 2 day forum). It is anticipated that 15 participants will attend face to face session and 15 - 20 participants will attend online via zoom). Registration attendance (name, address, contact details and corresponding participant ID) will be taken for each participant at each session. Each participant who attends the workshop will also complete and evaluation at the end of the workshop. A record will also be kept for those who do not attend with face to face or online education sessions.
2. Individual Talanoa Consultation (ITC) (Weeks 6-7; 13-14; 20-21): 3 x 1hour one-to one talanoa (via zoom) with a trained Pasifika Community Health Worker (CHW). One-to-one talanoa will facilitate tailored education, goal setting and coaching with specialist advice to support individualized plan/goals on healthy weight, diet, physical activity, manage stress, sleep, medication, appropriate screening and routine check-ups (at weeks 6-7 some women will receive this in week 6 while others will receive it in week 7); review and revise goals if necessary, discuss prevention strategies and identify barriers (at weeks 13-14) and review participant progress including barriers to self-management, reinforcement of positive behaviour and setting future goals for maintenance (at weeks 20-21). (Weeks 6-7 preliminary, Weeks 13-14 follow-up and Weeks 20-21 maintenance action plan and moving forward).
3. Talanoa Support Group (TSG) (Weeks 9, 16, 19) & Text messages (8, 10-11, 15, 17-18, 22-23): Follow up with emails, text messages and virtual group talanoa to provide peer support on topics including dealing with stress, barriers, understanding family situations, mindfulness, nutrition/diet, importance of health checks, regular visits to GPs and specialists, monitoring blood sugars, medication adherence and maintenance.
Individual talanoa and support group follow up by trained community health workers.

Intervention component
Whanau Talanoa Workshop ( Weeks 1 - 5), 2 x 2-hours workshop sessions that includes face-to-face and virtual online delivery via zoom for participants who are not able to travel or 'in line with general health recommendations during the global pandemic'.
Individual talanoa consultation and coaching (via zoom 1 hour session) at Weeks 6-7, 13-14, 20-21
Text message at Weeks 8, 10-11, 15, 17-18, 22-23
Talanoa support group (via zoom 1 hour session) at Weeks 9, 16, 19
Talanoa support group (in person 1 hour session) & same time as with data collection (DC) (in-person at Weeks 12, 24)*
Data collection (DC) (T0, T1 and T2) In-person at 0, 12 and 24*
*DC and in-person TSG (This will be in two groups with one group of 15-20 participants in session 1 TSG and 15- 20 participants in DC 1 and then swap over for TSG session 2 and DC 2)

Whanau Talanoa workshop was co-developed with the community and covers culturally specific tailored content for MPI women:
Becoming Healthy- will provide practical information on type 2 diabetes, its symptoms, risk factors, diagnosis, treatment and management, medication and self-care This session will also cover practical and cultural ways to deal with issues related to the shame and stigma of developing type 2 diabetes and the impact of denial.
Healthy Thinking & Feeling- Will provide information and tools to deal and cope with stress, barriers and ways to improve wellness that incorporate elements of Pasifika values, spirituality and faith.
Healthy Eating -Will provide information and tools for healthy eating with a self-care healthy eating plan and strategies for managing cultural hospitality requirements without losing face.
Staying Active -Will cover ways to get moving, types of exercises to do with your family, practical tips to remain motivated to stay active while managing family and community obligations.
Healthy Living -Will encourage, motivate and maintain healthy living including looking after your bones, eyes, kidney and heart, sleep and menopause with spirituality, family and community wellbeing.
These content are part of the program journal which all participants will receive in the study.

Test SMS motivational messages will be developed in consultation with the advisory committee and will use automated Mobile SMS (recommended provider with secure data platform through QUT). This SMS software will send text bulk messaging to participants at scheduled dates/time at weeks (8, 10-11, 15, 17-18, 22-23) and will cover 'Wellness' key messages on dealing with stress, barriers, understanding family situations, mindfulness, nutrition/diet, importance of health checks, regular visits to GPs and specialists, monitoring blood sugars, medication adherence and maintenance, with particular emphasis on cultural, spiritual, family and community. SMS Software will have the capability to track data as the number of messages are sent, delivered, opened or undeliverable. The mobile number will be collected from all participants at baseline and entered into a database. A satisfaction survey for each component will collect information on uptake, satisfaction and sustainability at the three point times (T0, T1, T2).
Intervention code [1] 324167 0
Prevention
Intervention code [2] 324168 0
Treatment: Other
Intervention code [3] 324169 0
Lifestyle
Comparator / control treatment
This group will be drawn from MPI women living with diabetes in the northern sector of south-east QLD (Brisbane, Caboolture, Sunshine Coast). Control participants will receive the usual care with their identified health professionals and a hard copy of the PWDWP program booklet (journal), recipe book and fact sheets as well as SMS text messages which will include general advice available to them about physical activity, diet, diabetes self-care, stress and medication management, tobacco and alcohol abstinence they might offer.. Participants’ exposure to and use of this advice will be documented. Once the pilot study is completed (T2 measurements are taken from the intervention and control groups, the control participants will receive the modified Whanau talanoa sessions in one day.

Control component
Usual care & they will receive a printed hard copy journal that they can work through with their identified provider or with their family or on their own. (Weeks 1 -24). The participants will be asked to document on the study journal (encouraged daily and/or weekly) but will be at their own discretion.
Text message - Weeks 4, 8, 10-11, 15, 17-18, 22-23
Data collection – in person (T0 - baseline, T1- Week 12 , T2- Week 24)
DC – both intervention and control in-person at T0 (Week 0), T1 (Week 12) and T2 (Week 24)

The SMS text messages will be same as the intervention group. The SMS bulk messages will be sent to control participants at scheduled dates/time at weeks (8, 10-11, 15, 17-18, 22-23) as the intervention participants. It will be the same content in relation to the 'Wellness' topics in the journal with key messages on dealing with stress, barriers, understanding family situations, mindfulness, nutrition/diet, importance of health checks, regular visits to GPs and specialists, monitoring blood sugars, medication adherence and maintenance, with particular emphasis on cultural, spirituality, family and community. SMS Software will have the capability to track data as the number of messages are sent, delivered, opened or undeliverable. The mobile number will be collected from all participants at baseline and entered into a database. A satisfaction survey for the control will collect information on uptake, satisfaction and sustainability at the three point times (T0, T1, T2).

Control group
Active

Outcomes
Primary outcome [1] 332183 0
Any change in HbA1c level (blood glucose) of participants.
Timepoint [1] 332183 0
Baseline (before intervention commencement), 12 weeks (post-intervention commencement) (primary timepoint) and 24 weeks (time of the intervention completion)
Secondary outcome [1] 412505 0
Change in BMI measurements closer to recommended healthy range for specific cultural groups as recommended by World Health Organisation (WHO). Height determined by wall/ standing stadiometer and weight determined using electronic scale which has been issued an EC type examination certificate for medical use)
Timepoint [1] 412505 0
At baseline, at Week 12 (post-intervention commencement) and Week 24 (time of intervention completion)
Secondary outcome [2] 412553 0
Any change in waist circumference based on WHO criteria. Waist circumference is measured using a no-elastic tape measure.
Timepoint [2] 412553 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [3] 412554 0
Change in diabetes self-care scores assessed using summary of diabetes self-care activities (SDSCA) (Toobert et al., 2000) and WHO guidelines (WHO, 1995, 2006, 2008, 2011)
Timepoint [3] 412554 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [4] 412555 0
Change in diabetes distress score using the brief Diabetes Distress Scale (DDS) (Fisher et al 2012)
Timepoint [4] 412555 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [5] 412556 0
Change in medication adherence assessed using the Morisky Medication Adherence Scale-8 (Moon et al 2017).
Timepoint [5] 412556 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [6] 412557 0
Any change in food, diet, physical activity assessed using adapted scale developed for living well multicultural lifestyle management program for ethnic populations (Gallegos et al 2020)
Timepoint [6] 412557 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [7] 412558 0
Satisfaction Survey
Timepoint [7] 412558 0
At Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [8] 412668 0
Change in Problem Areas in Diabetes (PAID-5) Score
Timepoint [8] 412668 0
At baseline, at Week 12 post-intervention commencement and Week 24 (time of intervention completion)
Secondary outcome [9] 412669 0
Focus Group
The research assistants (2) of Maori and Pasifika backgrounds with study researcher will conduct focus group.
The focus group will be conducted for 1 and 1/2 hours in a talanoa format facilitated by the study researcher and a Pasifika research assistant.
The focus group will include 6- 8 intervention participants invited to take part in the talanoa focus group. Written consent will be obtained from participants. Consent, confidentiality , respect, integrity will be shared to participants, including purpose of the focus group and how information will be collected, how it will be used and towards what goal.
A semi structured focus group guide will be developed with the Advisory Committee and piloted with small number of women (3-4) to ensure the questionnaire guide is culturally appropriate.
The location of the focus group will also be decided with the advisory committee.
The focus group will be tape recorded and a research assistant will be the note taker and monitor time..
Timepoint [9] 412669 0
Week 24 (time of intervention completion)

Eligibility
Key inclusion criteria
Intervention: Females aged 18 years and over from the Southside of Brisbane, diagnosed with type 2 diabetes, and have access to the internet for intervention and control participants.
Control: Females aged 18 years and over from the northside of Brisbane, diagnosed with type 2 diabetes, have access to the internet for intervention and control participants.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Intervention: Pregnant women and diagnosed with gestational diabetes and those not diagnosed with type 2 diabetes. They are excluded because they may have potential higher risks (especially those with high risk pregnancies). These will also exclude women with type 2 diabetes from northside of Brisbane (based on location).
Control: Pregnant women diagnosed with gestational diabetes (and/ or at high-risk pregnancy). These will also exclude women with type 2 diabetes from southside of Brisbane (based on location).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
This will include following steps:
1. raw data will be examined for missing entries, inconsistencies, and possible data entry error.
2. any identified problems will be corrected by checking the data against the hard copy questionnaire. To further ensure reliability and accuracy of the data entry, the researcher will randomly re-entered 10% of collected data and compare the two files (Pallant, 2013)

Data will be examined for missing data, outliers, normality, and multicollinearity, using procedures outlined in Pallant, 2013.. To check for any invalid response codes, missing data or duplicates, frequency distribution will be run on all variables. The data will be checked for any patterns of missing values and handled using procedures outlined in Pallant, 2013 and the SPSS manual. The variable labels will also be checked for any outliers, normality and multicollinearity. Statistical assumptions will determine any violations resulting in bias or non-significant results. .

Methods of data analysis will include descriptive, bivariate and logistic regression analysis. The levels of statistical significance will be set at p-value less than or equal to 0.05 (p=0.05), to reduce the risk of type 1 errors. The analyses will inform change in primary and secondary outcomes from baseline to T21 and T2 for MPI women with type 2 diabetes who completed the intervention. For instance, sociodemographic and clinical characteristics will be analysed using descriptive statistics.
Mean ± standard deviations (SD) will be reported for continuous variables, and percentages and frequencies for categorical variables. Independent t-tests will be used for continuous
variables and chi-squared for categorical variables will be used to compare mean groups. Normality of the included variables will be evaluated using Shapiro-Wilks normality test and non-parametric test (Mann-Whitney test) are used if data were not normally distributed to detect differences between groups. Two-sided p < .05 is considered
significant for all analyses. Analyses were performed using SPSS 24 (IBM SPSS Inc., Chicago, IL, USA).

Descriptive statistics will examine participant’s baseline measures and participant characteristics and will also explore trends in the data overtime. The study will also provide initial parameter estimates for the primary endpoint from which sample size calculations can be performed to determine sufficient power for the main trial. For the primary endpoint between-group differences at 12 and 24 weeks will be estimated using a linear mixed model with a treatment-time interaction. While aiming for an intention-to-treat analysis, we recognise there will be some withdrawal from the study. A pre-specified multiple imputation model will be used to obtain intention to-treat estimates Sensitivity analyses will explore the impact of non-ignorable missing data. Analysis of secondary endpoints will follow the same approach where changes will be compared in intervention and control groups using linear mixed models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 311964 0
Government body
Name [1] 311964 0
Australian Health Research Alliance (AHRA) Women’s Health Research Translation Network (WHRTN)
Country [1] 311964 0
Australia
Funding source category [2] 311966 0
Charities/Societies/Foundations
Name [2] 311966 0
Diabetes Australia Research Program 2022
Country [2] 311966 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George St, Brisbane City QLD 4000
Country
Australia
Secondary sponsor category [1] 313451 0
None
Name [1] 313451 0
Address [1] 313451 0
Country [1] 313451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311395 0
Queensland University of Technology Human Research Ethics Committee (UHREC)
Ethics committee address [1] 311395 0
2 George St, Brisbane City QLD 4000
Ethics committee country [1] 311395 0
Australia
Date submitted for ethics approval [1] 311395 0
20/06/2022
Approval date [1] 311395 0
18/08/2022
Ethics approval number [1] 311395 0
HREA 2022 -5609-9361 Review Reference

Summary
Brief summary
The program will evaluate the feasibility of the intervention, its delivery and its effectiveness in partnership with Maori & Pasifika community organisations and key stakeholders in Southeast Queensland. It will examine intervention efficacy (i.e. improved HbA1c levels, diabetes self-care, waist circumference and BMI) aimed at reducing risks in MPI women with type 2 diabetes and prevent late hospital presentations from diabetes-related complications.
Objectives
1. Primary objective: to examine efficacy where intervention women with type 2 diabetes have improved HbA1c clinical levels than those in control group from baseline to 24 weeks.
2.Secondary objectives: to determine whether, compared to controls, the intervention group achieves:
•Change to bring body-composition measurements closer to recommended healthy range for specific cultural groups (e.g. BMI is less than or equal to 30 kg/m2; waist circumference <80cm based on WHO Criteria).
• Improved diabetes self-care scores on diet, physical activity, routine health checks, diabetes distress and medication assessed using summary of diabetes self-care activities (SDSCA) (Toobert et al 2000)
Hypothesis
H1: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management report improved HbA1c levels at 12 weeks (end of intervention) and 24 weeks (post-intervention sustainability)
H2: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management will have reduced waist circumference and BMI at 12 weeks and 24 weeks
H3: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management have improved diabetes self-care at 12 weeks (end of intervention) and 24 weeks
Expected Outcomes
The primary outcome measure is HbA1c. Secondary outcome are changes in BMI, waist circumference, diabetes self-care, diet and physical activity and stress will be assessed. That is all endpoints will be measured at baseline (T0), 12 weeks (T1) and 24 weeks (T2) to assess program sustainability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120938 0
Dr Heena Akbar
Address 120938 0
Pasifika Women’s Diabetes Wellness Program
Woolworths Centre for Childhood Nutrition Research
Queensland University of Technology
Graham Street, South Brisbane, 4101
Queensland
Country 120938 0
Australia
Phone 120938 0
+61 7 3069 7305
Fax 120938 0
Email 120938 0
[email protected]
Contact person for public queries
Name 120939 0
Dr Heena Akbar
Address 120939 0
Pasifika Women’s Diabetes Wellness Program
Woolworths Centre for Childhood Nutrition Research
Queensland University of Technology
Graham Street, South Brisbane, 4101
Queensland
Country 120939 0
Australia
Phone 120939 0
+61 7 3069 7305
Fax 120939 0
Email 120939 0
[email protected]
Contact person for scientific queries
Name 120940 0
Dr Heena Akbar
Address 120940 0
Pasifika Women’s Diabetes Wellness Program
Woolworths Centre for Childhood Nutrition Research
Queensland University of Technology
Graham Street, South Brisbane, 4101
Queensland
Country 120940 0
Australia
Phone 120940 0
+61 7 3069 7305
Fax 120940 0
Email 120940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Only those data underlying published results will be available.
When will data be available (start and end dates)?
All data will be stored on the QUT research U drive and be made available to other researchers on application immediately 12 months post-last data collection. No end date determined.
Available to whom?
Data will be made available to other researchers on application and review of appropriate and methodologically sound proposal.
Available for what types of analyses?
Data will be data will be available only to achieve the aims in the approved proposal,
How or where can data be obtained?
Access subject to approvals by Principal Investigator (CI [email protected] and CCI [email protected])


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.