Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000719639
Ethics application status
Approved
Date submitted
17/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exploring how to support regional and rural communities with delivering obesity prevention interventions to improve child health.
Scientific title
A pilot randomised controlled trial examining the feasibility of applying implementation science strategies to support rural/regional communities in implementing community-generated systems interventions to prevent childhood obesity.
Secondary ID [1] 309812 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current pilot RCT is a sub-study of ACTRN12618001986268

Health condition
Health condition(s) or problem(s) studied:
obesity 330225 0
nutrition 330226 0
physical activity 330227 0
Condition category
Condition code
Public Health 327098 327098 0 0
Health promotion/education
Diet and Nutrition 327369 327369 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot trial is a sub-study of the Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND) stepped wedge trial. The RESPOND trial seeks to adopt systems change interventions to increase community capacity in the identification and delivery of community-generated systems interventions. The RESPOND trial comprises FIVE components (described in a previous registration ACTRN12618001986268). These are:
1. Systems approach capacity building
2. Community-led intervention activity
3. School Monitoring System and analysis
4. Knowledge and Engagement
5. Collaborative Governance and Implementation Structure (Collective Impact).

All communities in the RESPOND trial would receive a series of workshops and support sessions, to identify community-generated systems actions targeting childhood obesity prevention in their community. In addition to this, the four communities in the intervention arm of the current pilot study will receive additional implementation strategies to address specific barriers to implementation at the community level. The implementation strategies will be delivered across six months to the community facilitation team, who consists of health promoters situated in community health services or local councils and other relevant organisations with a prevention role in the local context. The implementation strategies include:
a. Prioritisation support to select evidence-based and locally appropriate actions for implementation.
This includes a presentation of evidence around the priority action ideas that have been identified by the community using the systems-approach, e.g. establishing a community vegetable garden, the “walking school bus” program and installing new water fountains. The research team will support the facilitation team with prioritising their action ideas, using frameworks such as the APEASE (Acceptability, Practicability, Effectiveness, Affordability, Spill-over effects, Equity) Criteria. Support will also be provided to further refine action ideas to best reflect the evidence and is appropriate for their local context. This will be delivered at the beginning of the 6-month study period to the facilitation team via two sessions.
b. Education workshops and resources.
At the beginning of the 6-month study period, the research team will deliver a 5-hour workshop to support the facilitation team with implementation. This will include a presentation of research evidence (refer to strategy a), small group refining of implementation action ideas, identification of barriers and enablers to implementation using a systems-mapping process, identification of evidence-based implementation action ideas and development of an action plan (formal implementation blueprint).
c. Using systems-processes to identify, map and track implementation actions.
Each community will be supported to use systems approaches to identify key levers for implementation, using the Systems Thinking in Community Knowledge Exchange software (STICKE). This software supports the generation of causal maps to guide the facilitation team with thinking about broader determinants to implementation and subsequently move the team into implementation action generation. A research member with extensive experience in systems thinking will demonstrate and support the communities with undertaking this process. This will be delivered as part of the education workshop (strategy b). The facilitation team will also be supported to use STICKE to continue to track changes in determinants and actions across the study period.
d. Engaging a local implementation champion (advocate).
Each community will be asked to identify an implementation champion at the beginning of the study, who will work with the research team to support the implementation of the prioritised action idea. A brief outline of the roles and responsibilities of the champion will be provided including supporting the development and implementation of an action plan, monitoring and tracking implementation progress. Throughout the study, the Champion will also provide encouragement and support to the broader facilitation team to overcome any barriers that may arise.
e. Provide local centralised technical assistance.
A research team member with extensive health promotion experience and connection with the local community will touch-base with the implementation champion and/or facilitation team, at up to three occasions during the 6-month study (approx. every 2 months), via online meetings or phone. The main purpose of this session is to review the action plan, support any problem solving, support reflection on the causal maps, action tracking and modifying the action plan if required.

An internal study tracking spreadsheet will be used to record dates and attendees of the education workshop and dates and brief minutes of touch-base occasions of each community. Action plans and subsequent changes will be recorded on STICKE.

Data collection for this pilot study will be staggered depending on community recruitment and completion of the RESPOND Trial. This study leverages on the completion of RESPOND by incorporating additional implementation strategies and evaluation following the completion of RESPOND.
Intervention code [1] 326244 0
Prevention
Comparator / control treatment
The control group will have received the RESPOND trial however will not receive targeted implementation support as described above. They will have access to the STICKE software however will not be supported to apply these to implementation challenges.
Control group
Active

Outcomes
Primary outcome [1] 334958 0
Fidelity of implementing obesity prevention actions in the community.
(Note: this is an impact outcome related to implementation)
Timepoint [1] 334958 0
Baseline (beginning of intervention) and Post-intervention (approximately 6-months after Baseline). This will be assessed using a self-reported questionnaire completed by the facilitation team. This questionnaire was specifically designed for this study; the items are based on previously validated measures of implementation. Participants are asked to rank on a seven point Likert Scale the extent, frequency, and mobilisation of action implementation in the community.
Primary outcome [2] 334959 0
Intentions to implement obesity prevention actions in the community.
(Note: this is an impact outcome related to implementation)
Timepoint [2] 334959 0
Baseline (beginning of intervention) and Post-intervention (approximately 6-months after Baseline). This will be assessed using a self-reported questionnaire completed by the facilitation team. This questionnaire was specifically designed for this study; the items are based on previously validated measures of implementation. Participants are asked to rank on a seven-point Likert Scale intention to implement the identified action.
Secondary outcome [1] 422546 0
Acceptability of the implementation strategies (intervention communities only)
Timepoint [1] 422546 0
Baseline (beginning of intervention) and Post-intervention (approximately 6-months after Baseline). This will be assessed using a self-reported questionnaire completed by the facilitation team. This questionnaire was specifically designed for this study; the items are based on previously validated measures of implementation.
Secondary outcome [2] 423095 0
Cost of delivering the implementation strategy and action
Timepoint [2] 423095 0
Post-intervention only (approximately 6-months after Baseline). This will be assessed using a self-reported questionnaire completed by the facilitation team. This questionnaire was specifically designed for this study; the items are based on previously validated measures of implementation.
Secondary outcome [3] 423096 0
Adaptation of implementation strategy delivery and actions
Timepoint [3] 423096 0
Post-intervention only (approximately 6-months after Baseline). This will be tracked using internal records developed by the research team and using the STICKE software.
Secondary outcome [4] 423097 0
Appropriateness of implementation strategy (intervention communities only)
Timepoint [4] 423097 0
Post-intervention only (approximately 6-months after Baseline). This will be assessed using a self-reported questionnaire completed by the facilitation team. This questionnaire was specifically designed for this study; the items are based on previously validated measures of implementation.

Eligibility
Key inclusion criteria
The overall inclusion criteria for this study is at 'community' level (i.e. local government areas in Victoria)
Communities that are included within the geographical area considered as rural/regional and have agreed to participate in a larger trial (ACTRN12618001986268) will be eligible to participate.
Eight Local Government Areas (LGAs) in Victoria are included. It is noted that while these communities have already consented to participate in the larger study, consent is sought separately to participate in this study.
1. Wangaratta
2. Benalla
3. Alpine
4. Towong
5. Murrindindi
6. Mansfield
7. Indigo
8. Wodonga
Specifically, this study involves the facilitation team in each of these communities, who consists of health promoters situated in community health or local councils and other relevant organisations with a prevention role in the local context. The facilitation team of each community was formed as part of the larger RESPOND Trial. There are no specific inclusion criteria for members to be part of the current study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Not within the pre-specified LGAs.

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)
No allocation concealment. Allocation will occur at the level of whole communities to intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur at the level of whole communities (local government areas) conducted by a statistician with no knowledge of the communities. The eight LGAs were ranked in order of population size and divided in four pairs.
One community from each pair were randomly allocated to receive either the intervention or control using a random list generated by the study statistician who will not be involved with any aspect of the enrolment process.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a pilot study, the primary outcomes are around potential impact on fidelity of implementation, acceptability and feasibility of trial methods and outcome assessment. As such, potential impact on implementation fidelity scores may be assessed using a linear regression controlling for baseline and clustering. Descriptive statistics will be generated for acceptability and appropriateness.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
60
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313998 0
Government body
Name [1] 313998 0
National Health and Medical Research Council
Country [1] 313998 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
1 Gheringhap Street
Geelong 3220
Victoria
Australia
Country
Australia
Secondary sponsor category [1] 315880 0
Individual
Name [1] 315880 0
Serene Yoong
Address [1] 315880 0
Deakin University
1 Gheringhap Street
Geelong 3220
Victoria
Australia
Country [1] 315880 0
Australia
Secondary sponsor category [2] 315959 0
Individual
Name [2] 315959 0
Prof Steve Allender
Address [2] 315959 0
Deakin University
1 Gheringhap Street
Geelong 3220
Victoria
Australia
Country [2] 315959 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313136 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313136 0
Human Research Ethics Office
Deakin University
221 Burwood Hwy
Burwood, VIC 3125
Ethics committee country [1] 313136 0
Australia
Date submitted for ethics approval [1] 313136 0
03/04/2023
Approval date [1] 313136 0
01/06/2023
Ethics approval number [1] 313136 0
HEAG-H 12_2019

Summary
Brief summary
Despite the promise of whole of systems community-based obesity prevention interventions to improve the health of the population, there has been challenges with the implementation of such initiatives. Such interventions are inherently complex in nature and present unique implementation challenges that require targeted implementation support. This pilot RCT and feasibility study therefore seeks to assess the i) potential usefulness of strategies to support the implementation of evidence-based and locally appropriate solutions generated via systems mapping approaches in rural or regional communities, and to pilot certain elements of the research to inform the conduct of a fully powered RCT . Implementations team in the intervention arm will receive support to prioritise local and evidence-based actions for implementation, use a systems mapping lens to identify key determinants to implementation and generate suitable solutions and support from an experienced facilitators to troubleshoot any implementation challenges for approximately 6 months. The key outcomes of the study include describing potential changes in implementation fidelity and intention, as well as describing the process of recruiting, data collection and any adaptations to delivery protocol.
This study address an important gap in the literature, and provide important data to inform the development of future studies supporting community-based implementation of obesity prevention programs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127110 0
A/Prof Serene Yoong
Address 127110 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220
Victoria
Australia
Country 127110 0
Australia
Phone 127110 0
+61433949140
Fax 127110 0
Email 127110 0
s.yoong@deakin.edu.au
Contact person for public queries
Name 127111 0
A/Prof Serene Yoong
Address 127111 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220
Victoria
Australia
Country 127111 0
Australia
Phone 127111 0
+61433949140
Fax 127111 0
Email 127111 0
s.yoong@deakin.edu.au
Contact person for scientific queries
Name 127112 0
A/Prof Serene Yoong
Address 127112 0
Global Obesity Centre (GLOBE)
Deakin University
1 Gheringhap St
Geelong 3220
Victoria
Australia
Country 127112 0
Australia
Phone 127112 0
+61433949140
Fax 127112 0
Email 127112 0
s.yoong@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot study and data generate will be used to ascertain feasibility rather than to establish impact.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.