Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001101976
Ethics application status
Approved
Date submitted
5/08/2020
Date registered
23/10/2020
Date last updated
23/10/2020
Date data sharing statement initially provided
23/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Pasifika Preventing Diabetes Programme: A lifestyle intervention through community activation and peer support among Pasifika people
Scientific title
The Pasifika Preventing Diabetes Programme: A stepped wedge cluster randomised trial investigating the effect of a lifestyle intervention involving community activation and peer support, on HbA1c levels among Pasifika people
Secondary ID [1] 300668 0
None
Universal Trial Number (UTN)
Trial acronym
PPDP
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Diabetes 316467 0
Cardiovascular Disease 316649 0
Diabetes Related Eye Disease 316650 0
Obesity 318967 0
Depression 318968 0
Condition category
Condition code
Public Health 314713 314713 0 0
Health promotion/education
Diet and Nutrition 314714 314714 0 0
Obesity
Metabolic and Endocrine 314715 314715 0 0
Diabetes
Cardiovascular 314894 314894 0 0
Hypertension
Mental Health 315973 315973 0 0
Depression
Cardiovascular 316935 316935 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Community activator (CAs) will receive extensive training on intervention delivery. This will include an initial 2 days of presentations and interactive individual and group activity based workshops to learn and practice motivational interviewing, behavioural science based behaviour change techniques and community activation techniques, to up-skill them in undertaking community-based work in a culturally sensitive and ethical manner and to ensure they have a thorough understanding of the trial design, overall intervention and their specific roles and responsibilities within the intervention. These training sessions will be delivered by the CI research team. CAs will be provided with a CA toolkit of resources (i.e. workshop intervention messages including discussion guides) that can be used to facilitate intervention delivery and a CA folder with copies of all of the content of the workshop sessions. The CA training will be provided before the Peer Support Facilitators (PSFs) within churches are recruited so that CAs can drive PSF recruitment after baseline and mid data collection but before the intervention commences delivery within the first step of churches. CAs will meet weekly, either face to face, online or via telephone to support each other through sharing experiences and to identify any barriers to intervention delivery. CAs will also have regular booster workshops (motivational interviewing/behavioural training) with the intervention support team on a monthly basis and additional support as required between booster sessions.
PSFs will attend a 1-day workshop lasting 6 hours to up-skill them in delivering peer support. It is expected that these workshops will be delivered after baseline/mid data collection and 1-4 weeks prior to commencement of the intervention within their given church. The training will cover motivational interviewing skill development and how to use behaviour change techniques to guide peer support sessions, as well as an overview of the research and how to ensure ethical standards are maintained throughout intervention delivery. PSFs will receive a training manual and a similar toolkit as the CAs with the content of the sessions included. On completion of training, PSFs are required to complete a knowledge questionnaire capturing their competency.
PSFs will have monthly booster sessions lasting 90 minutes each, facilitated by a CA. These will be church based or across multiple churches where churches express interest in doing so (e.g. some churches may wish to group together for such meetings by church denomination). PSFs will discuss their experiences of delivering the programme, particularly the barriers and facilitators of delivery, and booster motivational interviewing communications skill training will be provided to reinforce their initial training. A newsletter and short video summarising the content of booster session meetings will be created and circulated to all PSFs, so that those that are unable to attend are kept up to date. CAs will also have regular weekly contact with PSFs either face to face, online or over telephone in a group or one-to-one format depending on the availability of the PSFs within a given church.
Each PSF will be allocated a given number of peers. The allocation ratio will depend on the total number of peers and PSFs within a church and the availability of the PSFs. It is expected that each PSF will have approximately 10 peers allocated to them. There will be no restriction on how many peers can join a peer support group session but we would recommend to PSFs that they aim to have approximately 10 peers within a given session, as this would limit the interactions possible within a group. Peers are not asked to attend the intervention activities in a highly structured way – PSFs will facilitate activities towards convenient times and choosing activities from the 12 lifestyle and 10 diabetes messages and other contemporary issues. Peers will have a weekly contact from their PSF and PSFs will be asked to run at least 1 peer group session per month each. Additional activities may run in addition to the monthly peer group sessions (eg group exercise activities such as Zumba or a cooking class).
The 12 healthy lifestyle and 10 diabetes management messages will be translated and delivered to participants in Pasifika languages using multiple methods including peer support group sessions, PowerPoint presentations, demonstrations of healthy foods and cooking methods as well as various physical activity sessions (e.g. Zumba). All participants will receive a toolkit including a pedometer, water bottle and a diary, which includes details of resources available in the area (such as outdoor gyms and walking groups) as well as supporting materials relating to the messages (eg healthy lifestyle behaviour brochures and leaflets developed by the Australian government and other reliable sources such as the Heart Foundation).
Churches select when and how they want to focus on each message, with the PSFs running peer support sessions and other activities aligned with the messages. Peer support sessions are based on Social Cognitive Theory, the Transtheoretical Model and the Stages of Change in relation to physical activity, diet and weight. The sessions incorporate motivational interviewing and behavioural science techniques (eg achievable goal setting, action planning, barrier identification and planning ways of overcoming barriers, to make reaching goals achievable, self-monitoring, progress reviewing and goal and action plan adjustment).
The overall duration of the intervention for each church group will depend on when the block of churches are randomised into the intervention. The intervention time will be 6-33 months in 32 churches and 6-24 months in 16 churches depending on randomisation.
In terms of adherence, attendance records will be requested at all intervention sessions . PSFs will be asked to record the number and duration of interactions they have with peers.
The intervention will be delivered using a whole of community approach. Whilst there are sub-groups that will be compared, the intervention in terms of the healthy lifestyle messages will not be delivered in different ways to these sub-groups – all sub-groups be invited to attend any of these sessions and they will not be tailored to specific sub-groups. There are an additional 10 messages for those specifically that have known and newly diagnosed diabetes to manage their condition. PSFs that have diabetes will be asked to deliver peer group sessions that relate to these 10 messages only to peers that have diabetes, in addition to the 12 healthy lifestyle messages (there is some overlap between the diabetes management and lifestyle messages). Whilst children and adolescents are a sub-group within this study, no specific materials for these age groups will be developed but rather the filtration of the intervention through adults within the community down through to the children and adolescents will be explored.
Intervention code [1] 316997 0
Lifestyle
Intervention code [2] 317109 0
Prevention
Intervention code [3] 317110 0
Behaviour
Comparator / control treatment
No formalised peer support will be in place in the churches during the control period. Usual church practice consists of church services (either face to face or online), prayer and other spiritual meetings and also may include existing ‘games nights’ where congregants e.g. play volleyball where congregant informally support each other. Local health services are interested in improving the health of the Pacific community and may decide to establish interventions outside of the research project. They have been asked not to establish lifestyle programmes but might establish e.g. immunisation programmes. The research team have no control over initiatives established by the congregation or the local health services. Changes that are observed will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 323064 0
Proportion of non-diabetic adults with an HbA1c level greater than or equal to 5.7% assessed by haemoglobin A1c.
Timepoint [1] 323064 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Primary outcome [2] 324082 0
Proportion with known diabetes with an HbA1c level greater than or equal to 5.7% assessed by haemoglobin A1c.
Timepoint [2] 324082 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Primary outcome [3] 324083 0
Change in BMI z score with BMI based upon weight measure using balance scales and height measured using a stadiometer
Timepoint [3] 324083 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [1] 380633 0
Change in glycaemic level determined by haemoglobin A1c measurements
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [1] 380633 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [2] 381394 0
Change in systolic blood pressure (using a sphygmomanometer),
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [2] 381394 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [3] 381395 0
Change in Body mass index calculated as (weight (kg) / (height (m) x height (m) (height determined by stadiometer, and weight determined using balance scales:
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [3] 381395 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [4] 381396 0
Change in fat consumed assessed by a 7-item fat index, validated in Samoan people in New Zealand (Simmons D, Mandell C, Fleming C, Gatland B, Leakehe L. Evaluation of a diabetes knowledge and behaviour (DKB) questionnaire. Asia Pacific journal of clinical nutrition. 1994;3(4):193-200.)
• in the overall adult (18yrs and above) sample
• among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
• among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
• among those without known or new diabetes.
Timepoint [4] 381396 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [5] 381397 0
Change in quality of life determined by the EQ5-D
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [5] 381397 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [6] 381399 0
Change in diabetes knowledge assessed The diabetes knowledge and behaviour (DKB) questionnaire
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [6] 381399 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [7] 381400 0
Change in BMI z-scores (height determined by stadiometer, and weight determined using balance scales) in children and adolescents aged 4-17 years.
Timepoint [7] 381400 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [8] 381401 0
Change in Body mass index calculated as (weight (kg) / (height (m) x height (m) (height determined by stadiometer, and weight determined using balance scales) in children and adolescents aged 4-17 years
Timepoint [8] 381401 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [9] 381402 0
Change in diastolic blood pressure, using a sphygmomanometer, in children and adolescents aged 4-17 years.
Timepoint [9] 381402 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [10] 381403 0
Change in fat intake assessed by the E-Kindex: Dietary Screening Tool in children and adolescents aged 4-17 years. (Lazarou C, Panagiotakos DB, Spanoudis G, Matalas A-LJJotACoN. E-KINDEX: a dietary screening tool to assess children's obesogenic dietary habits. 2011;30(2):100-12.)
Timepoint [10] 381403 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [11] 381404 0
Change in quality of life determined by the EQ5-D in children and adolescents aged >8 years.
Timepoint [11] 381404 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [12] 381405 0
Recruitment rate will be assessed by calculating proportion of congregants on the church register who consent to participate in the programme
Timepoint [12] 381405 0
The recruitment rate will be calculated at the start of the control period (10-16 months depending on the wedge the church is randomised to).
Secondary outcome [13] 381406 0
To determine the cost-effectiveness of the intervention. The main outcome measures will be for the different components: average cost, average effectiveness, average cost effectiveness and cost utility ratios, and incremental cost-effectiveness and cost-utility ratios.
The cost effectiveness will be assessed from a healthcare perspective that includes all measurable opportunity costs, representing all healthcare impacted by the program. To assess program costs, both fixed and variable costs will be measured. This includes the start-up costs of pre-implementation phase, comprising of planning, consensus meetings, organizing, training of the personnel, printing material and informing and post start-up costs: the costs of implementing and running the program.

The costs of management level for coordinating of the intervention in each participating church and costs at participant level, includes all resources used at the point of delivery including costs of biochemical testing, educating, medical and lifestyle changes. Health care utilisation costs will be measured through retrospective medical record abstraction of ambulance, emergency, hospital, primary care and pharmaceuticals.

This will be a composite secondary outcome and will be reported as ICER/QALY
Timepoint [13] 381406 0
Data will be extracted for time periods:
1. 3 years prior to baseline
2. For the control period (minimum 10 months to maximum 44 months from baseline based on which wedge the church is randomised to)
3. Post control period including participation time in the programme (minimum 9 months to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [14] 384095 0
Change in diastolic blood pressure (using a sphygmomanometer),
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [14] 384095 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [15] 384096 0
Change in % body fat determined using standardised bio-electrical impedance scales
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [15] 384096 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [16] 384097 0
Change in waist circumference (using a measuring tape)
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [16] 384097 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [17] 384098 0
Change in Heart rate (pulse) as obtained with sphygmomanometer
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [17] 384098 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [18] 384099 0
Change in systolic blood pressure (using a sphygmomanometer), in children and adolescents aged 4-17 years.
Timepoint [18] 384099 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [19] 384100 0
Change in % body fat in children and adolescents aged 4-17 years determined using standardised Bio-electrical Impedance scales.
Timepoint [19] 384100 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [20] 384101 0
Change in arm circumference (using a measuring tape), in children and adolescents aged 4-17 years
Timepoint [20] 384101 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [21] 384102 0
Change in heart rate (pulse) in children and adolescents aged 4-17 years as obtained with the sphygmomanometer.
Timepoint [21] 384102 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [22] 384105 0
Change in mental well being determined by the Five Well-Being Index (WHO-5) score in children and adolescents aged >8 years.
Timepoint [22] 384105 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [23] 384106 0
Change in mental well being determined by Five Well-Being Index (WHO-5) scores
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [23] 384106 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [24] 384107 0
Change in diabetes knowledge questionnaire using diabetes and behavioural knowledge questionnaire (DKBQ) (Simmons D, Mandell C, Fleming C, Gatland B, Leakehe L. Evaluation of a diabetes knowledge and behaviour (DKB) questionnaire. Asia Pacific journal of clinical nutrition. 1994;3(4):193-200.)
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [24] 384107 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [25] 384108 0
Change in mean arterial pressure (estimated from systolic and diastolic blood pressure measured using a sphygmomanometer)
o in the overall adult (18yrs and above) sample
o among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
o among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
o among those without known or new diabetes.
Timepoint [25] 384108 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [26] 384109 0
Change in mean arterial pressure (estimated from systolic and diastolic blood pressure measured using a sphygmomanometer), in children and adolescents aged 4-17 years.
Timepoint [26] 384109 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [27] 387076 0
Change in physical activity levels assessed by the short-form International Physical Activity Questionnaire (Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, et al. International physical activity questionnaire: 12-country reliability and validity. Medicine and science in sports and exercise. 2003;35(8):1381-95)
• in the overall adult (18yrs and above) sample
• among those with known diabetes. (i.e. self-reported diagnosis of diabetes or individuals taking diabetes medications).
• among those with new diabetes (identified with HbA1c of greater than or equal to 5.7% during data collection).
• among those without known or new diabetes.
Timepoint [27] 387076 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [28] 387077 0
Change in physical activity levels assesses by the Physical Activity Questionnaire for Older Children (PAQ-C) in children and adolescents aged 4-17 years (Benítez-Porres J, López-Fernández I, Raya JF, Álvarez Carnero S, Alvero-Cruz JR, Álvarez Carnero EJJoSH. Reliability and Validity of the PAQ-C Questionnaire to Assess Physical Activity in Children. 2016;86(9):677-85.).
Timepoint [28] 387077 0
Baseline, Follow up pre-intervention (minimum 3 months to maximum 34 months from baseline based on which wedge the church is randomised to), and Follow up post intervention (minimum 30 to maximum 44 months from baseline based on which wedge the church is randomised to).
Secondary outcome [29] 387184 0
Intervention attendance will be recorded by use of a ‘smartcard’ which contains a barcode which the session deliver will be able to scan on their phone with the data then transferred to the participants record on the secure database
Timepoint [29] 387184 0
Weekly attendance will be recorded for a maximum of 33 months
Secondary outcome [30] 387185 0
Fidelity assessed on first delivery of the one to two sessions by each PSF and a random proportion (at least 5%) each month thereafter or if any issues arise.
Timepoint [30] 387185 0
5% of sessions will be randomly selected to be assessed for fidelity over the duration of the intervention delivery over 33 months
Secondary outcome [31] 387325 0
Ongoing post intervention costs.
Timepoint [31] 387325 0
Utility measures for the participants will be extracted from the EQ5D questionnaire and there, the quality adjusted life years (QALYs) gained for the intervention will be elicited. As diabetes management is a continuous process, the ongoing post intervention costs will be estimated at 5 years, 10 years and 20 years, the costs and QALYs will be discounted at 3% rate. The research project’s health economists will be intricately involved in this component.

Eligibility
Key inclusion criteria
• Be an adult (>=18 years) or child/adolescents (4-17 years) associated with participating churches in Greater Western and South Eastern Sydney
• Be associated with a target church through attendance themselves or through a family member attending one of the target churches (for those who have not been attending church)
• Churches are required to have at least 70% of their congregation from a Pasifika background
Minimum age
4 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
Central Randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be undertaken using an electronic randomiser independently of the study team. Randomisation will be in blocks of 4 churches to commence further data collection after 6, 15, 24 and 33 months in the first 16 churches that achieve 70% participation. The second 16 churches will be randomised similarly after data collection over 7 months with further data collection after 6, 18, 27 and 36 months. The last 16 churches will be randomised after a 10-month data collection period, with further data collection after 6, 12, 18 and 24 months.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A stepped wedge cluster RCT involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. In this study, new clusters will be randomised following their attainment of a minimum of 70% of the registered congregants identified on the church register in blocks of 4-16 churches. The timing depends on the size of the block.
The intervention will be administered following a control period for each cluster after they have been randomised, with the control periods ranging from 10-42 months
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study statistician who operates independently of the data collection and intervention teams will undertake statistical analysis. Data in the control wedge – no intervention period - will be compared with data in the intervention wedge period using generalized linear mixed-effects models (GLMM) to evaluate the effect of the intervention program. A random effect for local health district and church and fixed effects for the intervention and time will be modelled. Time (time from start of the study and data collection) will be included in the model to account for potential secular trends over time. Binary outcomes will be analysed using mixed-effects logistic regression. A Log Poisson model with robust variance estimates will be used if the model fails to converge. Continuous outcomes will be analysed using a mixed-effects linear regression model. In all analyses, a repeated effect of participant will be modelled. Measures of effect will be presented with adjusted 95% confidence intervals. Covariate adjustment of differences between baseline variables in each wedge may be required if there are significant changes in the cohort demographics over time (this will address the effect of e.g. age over time). The single primary outcome of the trial, change in the proportion of participants with HbA1c >=5.7%, will be presented as an adjusted odds ratio (95% confidence interval).

Experienced qualitative researchers using an inductive thematic analysis approach will conduct qualitative data analysis. This method has been selected as it suits questions related to people’s experiences, and is a commonly used method for identifying, reporting and interpreting patterns within qualitative data. An inductive coding approach will be used for data analysis undertaken by independent members of the research team who have qualitative expertise. These responses will then be assigned to themes. The researchers will use strategies throughout to ensure that study inter-rater reliability and rigour were upheld by ensuring trustworthiness in coding. This includes triangulation of the data using independent coding as well as member checking, where participants will be offered the opportunity to review transcribed interviews for accuracy prior to data analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2021
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
3600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305094 0
Government body
Name [1] 305094 0
NHMRC Partnership Project Grant
Country [1] 305094 0
Australia
Funding source category [2] 305097 0
Government body
Name [2] 305097 0
NSW Ministry of Health
Country [2] 305097 0
Australia
Funding source category [3] 305098 0
Government body
Name [3] 305098 0
NSW Health Pathology
Country [3] 305098 0
Australia
Funding source category [4] 305099 0
Commercial sector/Industry
Name [4] 305099 0
Sanofi-Aventis Australia Pty Ltd
Country [4] 305099 0
Australia
Funding source category [5] 305100 0
Government body
Name [5] 305100 0
Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)
Country [5] 305100 0
Australia
Funding source category [6] 305101 0
Government body
Name [6] 305101 0
Wentworth Healthcare
Country [6] 305101 0
Australia
Funding source category [7] 305102 0
Commercial sector/Industry
Name [7] 305102 0
Diabetes NSW and ACT
Country [7] 305102 0
Australia
Funding source category [8] 305103 0
Charities/Societies/Foundations
Name [8] 305103 0
EIS Health Ltd
Country [8] 305103 0
Australia
Funding source category [9] 305104 0
Government body
Name [9] 305104 0
South Western Sydney Primary Health Network (SWSPHN)
Country [9] 305104 0
Australia
Funding source category [10] 305105 0
Government body
Name [10] 305105 0
South Eastern Sydney Local Health District (SESLHD)
Country [10] 305105 0
Australia
Funding source category [11] 305106 0
Government body
Name [11] 305106 0
Nepean Blue Mountains Local Health District (NBMLHD)
Country [11] 305106 0
Australia
Funding source category [12] 305107 0
Government body
Name [12] 305107 0
Western Sydney Local Health District (WSLHD)
Country [12] 305107 0
Australia
Funding source category [13] 305108 0
Government body
Name [13] 305108 0
South Western Sydney Local Health District (SWSLHD)
Country [13] 305108 0
Australia
Funding source category [14] 306024 0
Government body
Name [14] 306024 0
WentWest Limited
Country [14] 306024 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 305471 0
None
Name [1] 305471 0
Address [1] 305471 0
Country [1] 305471 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305484 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305484 0
Ethics committee country [1] 305484 0
Australia
Date submitted for ethics approval [1] 305484 0
26/02/2020
Approval date [1] 305484 0
19/06/2020
Ethics approval number [1] 305484 0

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

Contacts
Principal investigator
Name 100522 0
Prof David Simmons
Address 100522 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 100522 0
Australia
Phone 100522 0
+61 2 46344899
Fax 100522 0
Email 100522 0
da.simmons@westernsydney.edu.au
Contact person for public queries
Name 100523 0
Claudia Bishop
Address 100523 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 100523 0
Australia
Phone 100523 0
+61 2 46344593
Fax 100523 0
Email 100523 0
ppdp@westernsydney.edu.au
Contact person for scientific queries
Name 100524 0
David Simmons
Address 100524 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country 100524 0
Australia
Phone 100524 0
+61 2 46344899
Fax 100524 0
Email 100524 0
da.simmons@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data from PPDP can be shared with other researchers. This will include participant ID (study allocated to ensure confidentiality of data), age, gender, blood glucose and blood pressure results, weight, height, waste circumference, lifestyle, quality of life, medication use and diabetes knowledge and physical activity. Data needed for specific research purposes will be shared.
When will data be available (start and end dates)?
Data will be available 5 years post PPDP completion (estimated to be completed in 2024) and ending 15 years for adults and for 25 years for paediatric participants, following main results publication as per NSW requirements for record retention of data from clinical trials. The term of access will be the agreed duration of the study for which data is being sort
Available to whom?
Data will be available to third parties with the specific variables that were requested for.
Available for what types of analyses?
Data analysis will be available to achieve the aims of the study for which the request was made and for secondary analyses by the research team or third party (only with permission) to answer additional secondary research questions stemming from this programme or other related projects. This will include data from biospecimen analysis, focus group discussions and interviews.
How or where can data be obtained?
Access to de-identified data can be obtained by emailing the Principal Investigator on ppdp@westernsydney.edu.au. The terms of access will be the agreed duration of the study, provided a valid approval or renewals are in hand. A renewal of application will be required if data is to be used beyond the agreed duration. PPDP core research team will be co-authors in all publications.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7345Study protocol  ppdp@westernsydney.edu.au Project website-to be updated once available



Results publications and other study-related documents

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Documents added automatically
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