ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001034325

Ethics application status

Approved

Date submitted

30/07/2026

Date registered

21/08/2026

Date last updated

21/08/2026

Date data sharing statement initially provided

21/08/2026

Date results provided

21/08/2026

Type of registration

Retrospectively registered

Titles & IDs

Public title

An Intervention to Promote Healthy Behaviors and service utilisation for Hypertension and Diabetes Management in Rural Bangladesh: A pilot randomised controlled trial.

Scientific title

An Intervention to Promote Healthy Behaviours and Service Utilisation for Hypertension and Diabetes Management in Adults Living in Rural Bangladesh: A Pilot Randomised Controlled Trial

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Diabetes

Hypertension

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Cardiovascular

Hypertension

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Intervention overview and components: The intervention was a structured, 12-week community–facility programme for adults living with coexisting hypertension and diabetes in Chirirbandar Upazila, Dinajpur District, rural Bangladesh.

The intervention comprised four integrated components, including individualised home-based counselling, an interactive group workshop, guided visits to government healthcare facilities, and educational and self-monitoring materials.
Individualised counselling addressed knowledge of hypertension and diabetes and their risk factors; healthy diet, including increased fruit and vegetable intake and reduced salt intake; physical activity; smoking cessation and reduced alcohol consumption where applicable; reduction of exposure to household or indoor air pollution; medication adherence; stress and other barriers to self-care; blood pressure and blood glucose monitoring; recognition of complications and warning signs; individual health-goal setting; regular check-ups and follow-up; and appropriate use of qualified healthcare providers. Counselling was tailored to each participant’s baseline circumstances, existing health behaviours, medication use, healthcare-utilisation practices, personal goals, and reported barriers.
The interactive workshop reinforced knowledge of hypertension and diabetes, healthy behaviours, medication and treatment adherence, self-care, prevention of complications, and disease-monitoring skills. It included practical demonstrations of blood pressure and blood glucose monitoring and enabled direct communication between participants, government healthcare providers, local administrators, elected local representatives, and community leaders. Participants could ask questions about available services, service costs, medicines, diagnostic tests, follow-up requirements, and procedures for obtaining care.
Guided health-service visits introduced participants to formal government primary healthcare services. Participants were shown relevant service points, laboratory and diagnostic facilities, medicine-supply arrangements, the non-communicable disease corner, and the steps required to register, consult a healthcare provider, receive blood pressure or blood glucose measurements and other investigations, obtain treatment or medicines where available, and arrange referral or follow-up care. These visits were intended to reduce uncertainty or hesitation about government facilities, improve health-system literacy, strengthen trust in qualified healthcare providers, and help participants use services independently.
Educational and self-monitoring materials included health diaries, posters, leaflets, and practical self-care information presented in accessible language. The materials covered hypertension and diabetes basics, symptoms and risk factors, healthy behaviours, medication adherence, self-monitoring, signs requiring professional medical attention, and the process of accessing government healthcare services. Participants used the diaries to record health-related activities, medication-taking practices, healthcare visits, and blood pressure or blood glucose information where available, and to support discussion during subsequent counselling visits.

Intervention providers and relevant expertise: Two Community Health Workers served as the principal frontline intervention facilitators. They were drawn from community health programmes and local field networks supported by the James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh. The Community Health Workers had experience in community engagement, health education, basic disease-related support, participant follow-up, referrals, point-of-care activities, and linkage with local healthcare services. They delivered the individualised home-based counselling, motivational and behavioural support, telephone support, follow-up, reinforcement of educational messages, and guidance on accessing healthcare services.
Before implementation, the two Community Health Workers completed an intensive five-day training programme. The training covered the clinical basics of hypertension and diabetes; symptoms, risk factors, complications, and management; healthy diet, salt reduction, physical activity, medication adherence, and other behavioural practices; blood pressure and blood glucose monitoring; government hypertension and diabetes services; practical healthcare navigation and referral; communication and counselling skills; motivational support; individual goal setting; problem-solving; and methods of addressing barriers to behaviour change, treatment adherence, self-management, and healthcare utilisation.
Government healthcare personnel participated in the facility-based components. The Upazila Health and Family Planning Officer, doctors, nurses, and other personnel at the Upazila Health Complex explained available hypertension and diabetes services, service costs, clinical processes, laboratory facilities, medicine availability, regular check-ups, and follow-up procedures.

Mode of delivery: The intervention used an integrated community–facility delivery approach combining individual face-to-face counselling, group education, practical exposure to healthcare facilities, printed educational and self-monitoring resources, and telephone support.
Individualised counselling was delivered face to face and one to one in each participant’s home. The Community Health Workers used the 5A’s Motivational Interviewing Approach to assess existing practices, provide personalised education, agree on achievable goals, support healthy behaviours and medication adherence, review progress, identify barriers, and develop practical solutions. The home-based format allowed counselling to be tailored to participants’ living conditions, family circumstances, dietary practices, daily routines, treatment practices, healthcare use, and access barriers.
The interactive workshop was delivered face to face as a group activity at the Upazila Health Complex, the main government healthcare facility operating at the subdistrict level. It combined health education, practical demonstrations, discussion, and direct interaction with healthcare providers, local administrators, elected local council representatives, and community leaders.
Guided health-service activities were delivered face to face at the Upazila Health Complex and local Community Clinics. Community Clinics are government primary healthcare facilities situated closer to rural communities. The Community Health Workers, lead researcher, and facility personnel physically demonstrated where and how participants could obtain consultations, blood pressure and blood glucose measurements, diagnostic tests, treatment, medicines where available, referral, and follow-up. Participants were also introduced to the non-communicable disease corner, a designated service point for non-communicable disease screening and management within the government health system.
Educational materials were supplied for use at home throughout the intervention. Telephone communication supplemented the face-to-face contacts. Community Health Workers provided encouragement, reminders, follow-up, and problem-solving support by telephone throughout the intervention period. Telephone support was used to reinforce healthy behaviours, medication adherence, self-monitoring, attendance at planned intervention activities, use of government healthcare services, and follow-up after participants encountered difficulties accessing care.

Frequency and duration: The intervention was delivered over 12 weeks. Each intervention participant received four individual, face-to-face, home-based counselling sessions in Weeks 1, 4, 8, and 12. Each counselling session lasted approximately 30 minutes.
The Week 1 session focused on rapport building, assessment of existing practices, disease education, behavioural risk reduction, and individual goal setting. The sessions in Weeks 4 and 8 reviewed progress, reinforced healthy behaviours and medication adherence, addressed barriers, and supported self-monitoring and practical problem-solving using the health diaries and educational materials. The final session in Week 12 focused on maintaining healthy practices, medication adherence, disease monitoring, and continuing engagement with community- and facility-based healthcare services.
A three-hour interactive workshop and an approximately two-hour guided visit to the Upazila Health Complex were conducted during Week 2. Guided visits to local Community Clinics occurred during Weeks 6–7. Telephone encouragement, reminders, follow-up, and problem-solving support were provided between scheduled counselling sessions and as needed throughout the 12-week intervention. Educational and self-monitoring materials and telephone access to the Community Health Workers remained available throughout the intervention period.

Intervention setting: The intervention was conducted in Chirirbandar Upazila, Dinajpur District, rural Bangladesh.
Individual counselling and review of participants’ educational materials and health diaries were undertaken at participants’ homes. The group workshop and principal guided health-service activities were conducted at the Chirirbandar Upazila Health Complex, a government subdistrict-level healthcare facility. Additional guided visits were conducted at government Community Clinics located closer to participants’ residences. Telephone follow-up and support were delivered remotely between scheduled face-to-face contacts.
The combination of participants’ homes, community settings, and government healthcare facilities was intended to connect daily healthy behaviours, medication use, disease monitoring, and self-management practices with continuing access to qualified healthcare services.

Adherence, reminders, monitoring and fidelity: Participant adherence was supported through four scheduled home-based counselling sessions in Weeks 1, 4, 8, and 12, telephone reminders and follow-up, access to Community Health Worker support during the 12-week intervention, individual goal setting, health diaries, educational materials, and tailored problem-solving.
Attendance at counselling sessions, the interactive workshop, and guided healthcare-facility activities was recorded using intervention attendance and follow-up logs. During follow-up contacts, Community Health Workers reviewed participants’ progress in healthy behaviours, including diet, salt intake, physical activity, smoking and alcohol-related practices where applicable, medication adherence, blood pressure and blood glucose monitoring, regular check-ups, and use of qualified healthcare services. Participants’ health diaries were reviewed to reinforce self-monitoring, identify barriers, correct misunderstandings, and revise individual goals where necessary.
Intervention fidelity was supported through structured preparation, standardised materials, supervision, and monitoring of the two Community Health Workers. Before implementation, both Community Health Workers completed the five-day training programme described above. Before full intervention delivery, the Community Health Workers conducted moderated counselling with three to four selected cases. This allowed the research team to assess their performance, provide feedback, and standardise the quality and content of counselling.
Standardised counselling guidance, healthy-behaviour guidelines, educational materials, intervention schedules, attendance records, and follow-up logs were used throughout the intervention. The lead researcher provided ongoing supervision and implementation monitoring, while the supervisory team provided scientific, clinical, public health, methodological, and local implementation oversight.
Implementation fidelity, feasibility, and acceptability were also assessed during and after the intervention through quantitative and qualitative process-evaluation methods informed by the RE-AIM framework. The evaluation examined participant reach and engagement, adherence to intervention activities, perceived changes and useful intervention components, fidelity of delivery, implementation challenges, adaptations made during delivery, additional support requirements, stakeholder adoption, and the potential maintenance and sustainability of healthy behaviours, medication adherence, self-management, and healthcare-service utilisation.

Intervention code [1]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

Rehabilitation

Description of the comparator or control

Comparator overview: Participants allocated to the control group continued to receive usual care for hypertension and diabetes throughout the 12-week trial period. Usual care referred to the healthcare, medication, disease-monitoring, self-management, and health-seeking practices ordinarily available to and used by participants in the absence of the study intervention.
The research team did not prescribe, standardise, enhance, restrict, or otherwise modify the usual care received by control participants. The comparator was therefore not an active or study-designed programme.
Control participants did not receive the organised intervention package delivered to the intervention group, including structured Community Health Worker counselling, group education, facilitated healthcare navigation, study-provided self-management materials, or intervention-related telephone support.
Comparator providers and relevant expertise: The comparator was usual care and was not delivered by the research team, Community Health Workers, study supervisors, or the James P Grant School of Public Health, BRAC University, Dhaka, Bangladesh. Any healthcare accessed by control participants was provided through the existing healthcare system by the providers they would ordinarily consult. The trial did not assign a specific healthcare professional, provider type, or facility to the control group. Research-team contact was limited to recruitment, informed consent, and baseline and 12-week endline assessments and did not include structured health education, counselling, goal setting, educational materials, or healthcare-navigation support.
Mode of delivery: No active or study-designed comparator programme was delivered. Control participants continued to manage their hypertension and diabetes and seek healthcare according to their usual practices, individual needs, and available services. Any care received, including clinical consultations, medication-related care, or blood pressure and blood glucose monitoring, was independently accessed and was not arranged, delivered, or supervised by the trial team. Baseline and endline assessments were research procedures and were not part of usual care.
Frequency and duration: The control condition continued throughout the 12-week trial period. The trial did not specify the frequency or duration of healthcare visits, consultations, medication-related contacts, monitoring, or other usual-care services. These depended on participants’ health needs, usual practices, provider advice, service availability, and personal decisions. Control participants completed baseline and 12-week endline assessments, with no scheduled comparator sessions between assessments.
Comparator setting: Usual care was not restricted to a study-designated setting. Control participants could use the healthcare providers and facilities they ordinarily accessed within or around Chirirbandar Upazila, Dinajpur District, rural Bangladesh. The research team did not direct participants to a particular government, private, community-based, or other healthcare facility as part of the comparator condition.
Adherence, reminders and monitoring: Because usual care was not a structured or standardised trial programme, there was no comparator-specific schedule, adherence requirement, reminder system, or fidelity-monitoring procedure. The research team did not provide reminders or follow-up intended to change control participants’ healthy behaviours, medication adherence, disease monitoring, healthcare attendance, or provider choice. Participant retention and completion of baseline and endline assessments were monitored as research procedures, while healthcare utilisation, medication adherence, healthy behaviours, and disease-management practices were measured as study outcomes.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility: Recruitment rate

Timepoint [1]

During the recruitment period

Primary outcome [2]

Feasibility: Retention rate

Timepoint [2]

Throughout the 12-week intervention period

Primary outcome [3]

Feasibility: Intervention adherence

Timepoint [3]

At 12 weeks after intervention commencement.

Secondary outcome [1]

Healthy Behaviour: Physical Activity

Timepoint [1]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [2]

Healthy Behaviour: Fruit and vegetable intake

Timepoint [2]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [3]

Healthy Behaviour: Smoked or smokeless tobacco use - this will be assessed as a composite outcome

Timepoint [3]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [4]

Healthy Behaviour: Alcohol Consumption

Timepoint [4]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [5]

Healthy Behaviour: Medication Adherence

Timepoint [5]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [6]

Healthy behavior: Indoor air pollution

Timepoint [6]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [7]

Service Utilization: Service awareness

Timepoint [7]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [8]

Service Utilization: Number of healthcare visits during the previous three months

Timepoint [8]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [9]

Physical measurements & disease control: BMI

Timepoint [9]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [10]

Physical measurements & disease control: Blood pressure

Timepoint [10]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [11]

Physical measurements & disease control: Blood glucose

Timepoint [11]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [12]

Process evaluation: Reach

Timepoint [12]

At 12 weeks after intervention commencement (endline).

Secondary outcome [13]

Process evaluation: Effectiveness

Timepoint [13]

At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.

Secondary outcome [14]

Process evaluation: Implementation

Timepoint [14]

At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.

Secondary outcome [15]

Process Evaluation: Maintenance

Timepoint [15]

At 12 weeks after intervention commencement (endline).

Secondary outcome [16]

Process evaluation: Adoption

Timepoint [16]

At 6 weeks (midline) and 12 weeks (endline) after intervention commencement.

Secondary outcome [17]

Feasibility: Acceptability—this is a primary outcome

Timepoint [17]

At 12 weeks after intervention commencement.

Secondary outcome [18]

Healthy Behavior: Salt Intake

Timepoint [18]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [19]

Healthy Behavior: Diabetic plate practice

Timepoint [19]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [20]

Healthy Behavior: Sugar Intake

Timepoint [20]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [21]

Healthy Behavior: Food pyramid use

Timepoint [21]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [22]

Healthy behavior: Frequency of smoked or smokeless tobacco use - this will be assessed as a composite outcome

Timepoint [22]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [23]

Service Utilization: Service cost awareness

Timepoint [23]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [24]

Service Utilization: Ever visited a healthcare service

Timepoint [24]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [25]

Service Utilization: Use of a non-qualified service provider

Timepoint [25]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [26]

Service Utilization: Recent regular healthcare visits

Timepoint [26]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [27]

Service Utilization: Comprehensive service utilisation

Timepoint [27]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [28]

Service Utilization: Ever had blood pressure measured by a professional

Timepoint [28]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [29]

Service Utilization: Blood pressure monitoring during the previous three months

Timepoint [29]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [30]

Service Utilization: Use of a trained professional for blood pressure measurement

Timepoint [30]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [31]

Service Utilization: Receipt of clinical advice for hypertension during the previous three months

Timepoint [31]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [32]

Service Utilization: Did not follow clinical advice for hypertension

Timepoint [32]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [33]

Service Utilization: Ever had blood glucose measured by a professional

Timepoint [33]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [34]

Service Utilization: Blood glucose monitoring during the previous three months

Timepoint [34]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [35]

Service Utilization: Use of a trained professional for blood glucose measurement

Timepoint [35]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [36]

Service Utilization: Receipt of clinical advice for diabetes during the previous three months

Timepoint [36]

Baseline before randomisation and 12 weeks after intervention commencement.

Secondary outcome [37]

Service Utilization: Did not follow clinical advice for diabetes

Timepoint [37]

Baseline before randomisation and 12 weeks after intervention commencement.

Eligibility

Key inclusion criteria

Patients diagnosed with both hypertension and diabetes. Residents must live in the rural community with access to basic healthcare facilities. Residents must live in the catchment of Chirirbandar Upazila.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

Individuals with physical disabilities that limit participation were excluded. Individuals already engaged in any other healthcare intervention or programs related to noncommunicable diseases (NCD) care were also excluded. Individuals with any third co-morbidities, for example, cancer, heart disease, etc., were also excluded.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation was concealed until participant enrolment and baseline assessment were completed. Neither the participants nor the research personnel responsible for recruitment and baseline assessment knew the upcoming group assignment. Individual allocation was generated using a computer-generated random sequence and was revealed only after the participant had been enrolled and baseline data collection had been completed. Participants were then informed of their assigned group.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

A computer-generated random sequence

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Sample size was calculated for comparison of proportions between the two groups, assuming an expected outcome of 25% in the control group and 50% in the intervention group, based on anecdotal evidence from local healthcare workers in the absence of formal local data. Using a two-sided significance level of 0.05 and 80% power, approximately 55 participants were required per group. Allowing 10% for anticipated attrition, the recruitment target was 60 participants per group (120 participants in total).

Data will be summarised using appropriate descriptive statistics. Between-group differences in outcomes at 12 weeks will be assessed using statistical methods appropriate to the type and distribution of each outcome, with adjustment for baseline values where applicable. Effect estimates will be reported with 95% confidence intervals using a two-sided significance level of 0.05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

9/07/2025

Date of last participant enrolment

Anticipated

Actual

27/07/2025

Date of last data collection

Anticipated

Actual

31/10/2025

Sample size

Target

131

Accrual to date

Final

127

Recruitment outside Australia

Country [1]

Bangladesh

State/province [1]

Chirirbandar, Dinajpur

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

Country [1]

Australia

Funding source category [2]

University

Name [2]

James P Grant School of Public Health, BRAC University, Bangladesh

Address [2]

Country [2]

Bangladesh

Primary sponsor type

University

Name

The University of Queensland

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee B

Ethics committee address [1]

https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/04/2025

Approval date [1]

05/06/2025

Ethics approval number [1]

2025/HE000524

Ethics committee name [2]

The Institutional Review Board (IRB) of the BRAC James P Grant School of Public Health, BRAC University

Ethics committee address [2]

BRAC James P Grant School of Public Health, BRAC University, Floor 10-13, 65 Bir Uttom A K Khandakar Road, Mohakhali, Dhaka - 1212, Bangladesh

Ethics committee country [2]

Bangladesh

Date submitted for ethics approval [2]

18/02/2025

Approval date [2]

24/04/2025

Ethics approval number [2]

IRB-2025-IS-07

Summary

Brief summary

This study evaluated whether a 12-week community-based programme could be delivered successfully and help adults living with both hypertension and diabetes in rural Bangladesh manage their health better. In this pilot trial, 131 participants were randomly assigned to receive either the structured intervention or usual care. The intervention included weekly one-to-one counselling, educational materials, an interactive workshop, guided visits to government healthcare facilities, and telephone support. We expected the programme to be feasible and acceptable and to improve healthy behaviours, medication adherence, awareness and use of healthcare services, blood pressure, and random blood glucose compared with usual care. The findings were intended to inform refinement of the programme and the design of a larger, fully powered trial before considering wider scale-up.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Arifuzzaman

Address

School of Health and Rehabilitation Sciences, The University of Queensland, Level 3, Therapies Annexe (Building 84A), St Lucia, QLD 4072, Australia

Country

Australia

Phone

+61 0480587000

Fax

[email protected]

Contact person for public queries

Name

Arifuzzaman

Address

School of Health and Rehabilitation Sciences, The University of Queensland, Level 3, Therapies Annexe (Building 84A), St Lucia, QLD 4072, Australia

Country

Australia

Phone

+61 0480587000

Fax

[email protected]

Contact person for scientific queries

Name

Arifuzzaman

Address

School of Health and Rehabilitation Sciences, The University of Queensland, Level 3, Therapies Annexe (Building 84A), St Lucia, QLD 4072, Australia

Country

Australia

Phone

+61 0480587000

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Other Details	Attachment
Informed consent form	Consent form for the intervention	Supplemementary_A_Consent.docx
Informed consent form	Consent form for the process evaluation	Supplementary_B_Consent_PrEv.docx
Informed consent form	Information sheet for the intervention	Supplementary_A_info.docx
Informed consent form	Information sheet for the process evaluation	Supplementary_B_info_PrEv.docx
Other	Emergency protocol	Supplementary_E_Emergency_Protocol.docx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Protocol	No	Protocol file	Protocol ANZCTR.docx
Supplementary materials	No	Questionnaire for intervention	Supplementary_C_Questionnaire_Intv.docx
Supplementary materials	No	Questionnaire for Process evaluation	Supplementary_C_Questionnairer_PrEv.docx
Statistical analysis plan	No		Statistical Analyses Plan.docx

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically