ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

PPDP

Linked study record

Health condition

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

Diabetes

Cardiovascular Disease

Diabetes Related Eye Disease

Obesity

Depression

Condition category

Condition code

Public Health

Health promotion/education

Diet and Nutrition

Obesity

Metabolic and Endocrine

Diabetes

Cardiovascular

Hypertension

Mental Health

Depression

Cardiovascular

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]

Lifestyle

Intervention code [2]

Prevention

Intervention code [3]

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]

Proportion of non-diabetic adults with an HbA1c level greater than or equal to 5.7% assessed by haemoglobin A1c.

Timepoint [1]

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]

Proportion with known diabetes with an HbA1c level greater than or equal to 5.7% assessed by haemoglobin A1c.

Timepoint [2]

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]

Change in BMI z score with BMI based upon weight measure using balance scales and height measured using a stadiometer

Timepoint [3]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Change in diastolic blood pressure, using a sphygmomanometer, in children and adolescents aged 4-17 years.

Timepoint [9]

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]

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]

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]

Change in quality of life determined by the EQ5-D in children and adolescents aged >8 years.

Timepoint [11]

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]

Recruitment rate will be assessed by calculating proportion of congregants on the church register who consent to participate in the programme

Timepoint [12]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Change in systolic blood pressure (using a sphygmomanometer), in children and adolescents aged 4-17 years.

Timepoint [18]

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]

Change in % body fat in children and adolescents aged 4-17 years determined using standardised Bio-electrical Impedance scales.

Timepoint [19]

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]

Change in arm circumference (using a measuring tape), in children and adolescents aged 4-17 years

Timepoint [20]

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]

Change in heart rate (pulse) in children and adolescents aged 4-17 years as obtained with the sphygmomanometer.

Timepoint [21]

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]

Change in mental well being determined by the Five Well-Being Index (WHO-5) score in children and adolescents aged >8 years.

Timepoint [22]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Weekly attendance will be recorded for a maximum of 33 months

Secondary outcome [30]

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]

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]

Ongoing post intervention costs.

Timepoint [31]

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

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]

Government body

Name [1]

NHMRC Partnership Project Grant

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

NSW Ministry of Health

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

NSW Health Pathology

Country [3]

Australia

Funding source category [4]

Commercial sector/Industry

Name [4]

Sanofi-Aventis Australia Pty Ltd

Country [4]

Australia

Funding source category [5]

Government body

Name [5]

Sydney Partnership for Health, Education, Research and Enterprise (SPHERE)

Country [5]

Australia

Funding source category [6]

Government body

Name [6]

Wentworth Healthcare

Country [6]

Australia

Funding source category [7]

Commercial sector/Industry

Name [7]

Diabetes NSW and ACT

Country [7]

Australia

Funding source category [8]

Charities/Societies/Foundations

Name [8]

EIS Health Ltd

Country [8]

Australia

Funding source category [9]

Government body

Name [9]

South Western Sydney Primary Health Network (SWSPHN)

Country [9]

Australia

Funding source category [10]

Government body

Name [10]

South Eastern Sydney Local Health District (SESLHD)

Country [10]

Australia

Funding source category [11]

Government body

Name [11]

Nepean Blue Mountains Local Health District (NBMLHD)

Country [11]

Australia

Funding source category [12]

Government body

Name [12]

Western Sydney Local Health District (WSLHD)

Country [12]

Australia

Funding source category [13]

Government body

Name [13]

South Western Sydney Local Health District (SWSLHD)

Country [13]

Australia

Funding source category [14]

Government body

Name [14]

WentWest Limited

Country [14]

Australia

Primary sponsor type

University

Name

Western Sydney University

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

Research Directorate
Locked Bag 7103
LIVERPOOL BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/02/2020

Approval date [1]

19/06/2020

Ethics approval number [1]

Summary

Brief summary

The Pasifika Preventing Diabetes Programme (PPDP) primarily aims to test whether a community activation and peer support delivered lifestyle programme across churches in the Greater Western Sydney and South Eastern Sydney Pacific communities can improve a blood marker called HbA1c, an indicator of glucose (sugar) level in the blood. The programme also aims to improve other clinical measures such as weight, waist circumference and blood pressure, through changes in lifestyle behaviours particularly healthy eating and physical activity. The aim is also to see if the programme can help the body weight of children in the church families. This programme is an expansion of a pilot study, Le Taeao Afua (LTA) where the same lifestyle and peer support programme was delivered through three Sydney Samoan Churches. The PPDP is a much larger trial testing the LTA intervention into atleast 48 Sydney Pacific churches over the next 51 months.

Trial website

Public notes

Pilot Study - Le Taeao Afua

https://doi.org/10.1016/j.diabres.2020.108000
https://doi.org/10.1002/hpja.276
https://doi.org/10.3390/ijerph15050882

Contacts

Principal investigator

Name

Prof David Simmons

Address

Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 46344899

Email

[email protected]

Contact person for public queries

Name

Claudia Bishop

Address

Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 46344593

Email

[email protected]

Contact person for scientific queries

Name

David Simmons

Address

Western Sydney University
Locked Bag 1797
Penrith NSW 2751

Country

Australia

Phone

+61 2 46344899

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically