- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07804550
Network-Based Support to Help Community Coalition Members Choose and Use Strategies to Improve Child Health
Pilot Trial of Network-Based Implementation Strategies to Increase Coalition Adoption and Early Implementation of Evidence-Informed Strategies for Child Health
Community coalitions bring together residents and organizations to improve child health, but they may need support to identify and put research-supported strategies into practice. This study will examine whether a program called FICAS can be delivered successfully and is useful to coalition members. FICAS uses information about relationships within a coalition to help involve people with relevant perspectives, share evidence, compare possible strategies, make decisions, and adjust support as the coalition's work develops.
Three community coalitions will participate. All three will eventually receive Catalyzing Communities, a program that provides facilitated meetings, collaborative planning, technical assistance, and funding for coalition-led action. One coalition will begin the program later, one will receive Catalyzing Communities alone, and one will receive Catalyzing Communities with FICAS. The study will help determine whether FICAS and the study procedures should be refined and tested in a larger study.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Travis R Moore, PhD
- Phone Number: 512-914-4880
- Email: trm250@pitt.edu
Study Contact Backup
- Name: Yuilyn A Chang Chusan, MS
- Email: Yuilyn.Chang_Chusan@tufts.edu
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15216
- University of Pittsburgh
-
Contact:
- Travis R Moore, PhD
- Phone Number: 512-914-4880
- Email: trm250@pitt.edu
-
Principal Investigator:
- Travis R Moore, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Coalition-level criteria
- Coalition focuses on child health, childhood obesity prevention, healthy eating, active living, nutrition security, policy, systems, or environmental change, or related community health priorities.
- Coalition works in or serves a community experiencing socioeconomic disadvantage.
- Coalition has multisector participation.
- Coalition has identifiable leadership or backbone capacity to participate in the study.
- Coalition is willing to participate in study procedures and data collection and accept randomized coalition-level assignment.
- Coalition has a feasible membership roster or is able to work with the study team to construct one and has an identifiable leadership contact.
- Coalition can support participant recruitment and scheduling without coercing individual participation.
Individual-level criteria
- Age 18 years or older.
- Coalition member, leader, staff member, partner, changemaker, committee or core-group participant, named network connection, survey-only participant, invited guest, or other adult with relevant community, organizational, policy, professional, or implementation expertise or connections.
- Able to provide informed consent.
- Able to participate in English.
- For direct committee or core-group participants, able to participate through the internet, telephone, or another study-supported mode.
- Willing to complete the study activities applicable to the participant's role, which may include meetings, surveys, network assessments, or interviews.
Exclusion Criteria
Coalition-level criteria
- Coalition is unable to participate in required study activities.
- Coalition lacks a feasible membership roster or the ability to construct one with study-team assistance, or lacks an identifiable leadership contact.
- Coalition is unwilling to accept randomized coalition-level assignment.
- Coalition is participating in a comparable formal coalition intervention that would prevent interpretation of the study findings.
Individual-level criteria
- Younger than 18 years.
- Unable to provide informed consent.
- Unable to participate in English.
- Does not have an eligible coalition, professional, community, organizational, policy, or implementation role, expertise, or connection.
- For direct committee or core-group participants, unable to participate through an available study-supported mode.
- Participation would create an unmanaged conflict or undue pressure that cannot be resolved.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Delayed Control
During the initial comparison period, this coalition will receive study assessments and retention contacts but no active Catalyzing Communities or FICAS intervention.
After the prespecified pre-crossover assessment, the coalition will cross over to Catalyzing Communities only.
It will not receive the FICAS augmentation during the registered comparison period.
|
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding.
The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation.
Activities may be delivered virtually or in person and continue across the active intervention period.
|
|
Active Comparator: Positive Control: Catalyzing Communities
This coalition will receive the Catalyzing Communities base implementation-support platform, including coalition convening, group model building, technical assistance, and seed funding to support coalition-led selection and early implementation of an evidence-informed strategy.
It will not receive the FICAS augmentation.
|
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding.
The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation.
Activities may be delivered virtually or in person and continue across the active intervention period.
|
|
Experimental: Augmented Treatment: Catalyzing Communities Plus FICAS
This coalition will receive the Catalyzing Communities base implementation-support platform plus the FICAS multicomponent implementation intervention.
FICAS adds data-informed committee selection, opinion leader engagement, structured evidence review, structured decision support, and online network monitoring and adaptation.
|
Catalyzing Communities is a coalition-centered implementation-support platform that includes facilitated coalition convening, group model building, technical assistance, and seed funding.
The platform supports shared systems understanding, identification of action opportunities, selection of an evidence-informed strategy, action planning, and early coalition-led implementation.
Activities may be delivered virtually or in person and continue across the active intervention period.
FICAS is a multicomponent implementation intervention delivered as an augmentation to Catalyzing Communities.
It includes five strategies: using roster and network data to strengthen committee representation and connectivity; identifying and engaging influential or bridging coalition members; progressively assembling and reviewing research, practice, community, and policy evidence; using structured criteria and deliberation to select an evidence-informed strategy; and monitoring coalition network data to guide adaptations.
Components are delivered at relevant milestones across evidence review, strategy selection, and early implementation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation and Reach
Time Frame: From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
|
The number of eligible coalition members who provide informed consent and complete at least one study data-collection activity will be divided by the total number of eligible coalition members invited to participate and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater study reach.
|
From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
|
|
Percentage of Enrolled Participants Retained Through the Primary Endpoint
Time Frame: Baseline through intervention month 12
|
The number of participants in the baseline cohort who complete the final scheduled primary assessment will be divided by the number enrolled in the baseline cohort and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater retention.
|
Baseline through intervention month 12
|
|
Mean Acceptability of Intervention Measure Score for FICAS
Time Frame: Intervention months 6, 9, and 12
|
Acceptability of FICAS will be measured using the four-item Acceptability of Intervention Measure.
Each item is scored from 1, completely disagree, to 5, completely agree.
Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived acceptability.
Mean scores will be reported separately at each assessment.
|
Intervention months 6, 9, and 12
|
|
Mean Intervention Appropriateness Measure Score for FICAS
Time Frame: Intervention months 6, 9, and 12
|
Perceived appropriateness of FICAS will be measured using the four-item Intervention Appropriateness Measure.
Each item is scored from 1, completely disagree, to 5, completely agree.
Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness.
Mean scores will be reported separately at each assessment.
|
Intervention months 6, 9, and 12
|
|
Mean Feasibility of Intervention Measure Score for FICAS
Time Frame: Intervention months 6, 9, and 12
|
Perceived feasibility of FICAS will be measured using the four-item Feasibility of Intervention Measure.
Each item is scored from 1, completely disagree, to 5, completely agree.
Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived feasibility.
Mean scores will be reported separately at each assessment.
|
Intervention months 6, 9, and 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Selected-Strategy Adoption Milestones Completed
Time Frame: Intervention months 9 and 12
|
Coalition progress will be assessed using eight prespecified milestones: naming and actively considering a candidate strategy, formally selecting a strategy, assigning implementation roles, drafting an implementation plan, securing resources or commitments, completing launch preparation, initiating the first implementation activity, and beginning early monitoring or refinement.
Each completed milestone receives one point.
The number completed will be divided by eight and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater progress from strategy consideration through adoption and early action.
|
Intervention months 9 and 12
|
|
Normalized Early Implementation Readiness and Action-Initiation Score
Time Frame: Intervention months 9 and 12
|
Readiness and action initiation will be assessed using a nine-indicator study-specific rubric.
Indicators address confirmation of the selected strategy, implementation leadership, assigned responsibilities, a written implementation plan, timelines and milestones, resources and supports, partner commitments, launch preparation, and initiation of the first implementation action.
Each applicable indicator is scored from 0, no evidence, to 3, completed or fully documented.
Scores will be summed, divided by the maximum possible score for applicable indicators, and multiplied by 100.
Scores range from 0 to 100.
Higher scores indicate greater implementation readiness and action initiation.
|
Intervention months 9 and 12
|
|
Coalition Child-Health Discussion Network Density
Time Frame: Pre-intervention baseline and monthly through intervention month 12
|
At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion.
Coalition network density will be calculated as the number of observed directed child-health discussion ties among rostered coalition members divided by the total number of possible directed ties, excluding self-ties.
Scores range from 0 to 1. Higher values indicate a more densely connected coalition discussion network.
|
Pre-intervention baseline and monthly through intervention month 12
|
|
Percentage of Child-Health Discussion Ties Connecting Different Sectors
Time Frame: Pre-intervention baseline and monthly through intervention month 12
|
The number of reported child-health discussion ties connecting people from different organizational or community sectors will be divided by the number of reported ties with sector information and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater cross-sector connectivity.
|
Pre-intervention baseline and monthly through intervention month 12
|
|
Percentage of Prespecified Strategic Representation Categories Represented
Time Frame: Pre-intervention baseline and intervention months 6, 9, and 12
|
Before intervention delivery, the study team and coalition will identify the sectors, roles, perspectives, and community constituencies needed for the coalition or core committee.
At each assessment, the number of prespecified categories represented by at least one active member will be divided by the total number of prespecified categories and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater strategic representation.
|
Pre-intervention baseline and intervention months 6, 9, and 12
|
|
Mean Coalition-Wave Dyadic Trust Score
Time Frame: Pre-intervention baseline and monthly through intervention month 12
|
Participants will rate each named coalition connection using one item, "How much do you trust this person?"
Responses range from 1, I do not trust this person, to 5, I trust this person.
A mean trust score will first be calculated across each respondent's rated ties.
Respondent-level means will then be averaged within each coalition and assessment wave.
Scores range from 1 to 5. Higher scores indicate greater trust among coalition members.
|
Pre-intervention baseline and monthly through intervention month 12
|
|
Mean Number of Child-Health Discussion Ties per Participant
Time Frame: Pre-intervention baseline and monthly through intervention month 12
|
At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion.
The number of reported discussion ties will be calculated for each participant and averaged within each coalition.
Scores range from 0 to 20 ties per participant.
Higher values indicate that participants report more child-health discussion connections.
|
Pre-intervention baseline and monthly through intervention month 12
|
|
Mean Perceived Relative Advantage Score for the Selected Evidence-Informed Strategy
Time Frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
relative advantage will be assessed using five adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument.
Each item is scored from 1, extremely disagree, to 7, extremely agree.
Item scores will be averaged.
Scores range from 1 to 7. Higher scores indicate greater perceived advantage of the selected strategy compared with current approaches.
|
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
|
Mean Perceived Compatibility Score for the Selected Evidence-Informed Strategy
Time Frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
Perceived compatibility will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument.
Each item is scored from 1, extremely disagree, to 7, extremely agree.
Item scores will be averaged.
Scores range from 1 to 7. Higher scores indicate greater perceived compatibility with coalition needs, activities, and ways of working.
|
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
|
Mean Perceived Ease-of-Use Score for the Selected Evidence-Informed Strategy
Time Frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
Perceived ease of use will be assessed using three adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument.
Each item is scored from 1, extremely disagree, to 7, extremely agree.
Item scores will be averaged.
Scores range from 1 to 7. Higher scores indicate that the selected strategy is perceived as easier to understand and use.
|
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
|
Mean Perceived Result-Demonstrability Score for the Selected Evidence-Informed Strategy
Time Frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
Perceived result demonstrability will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument.
Each item is scored from 1, extremely disagree, to 7, extremely agree.
One negatively worded item will be reverse-coded, and the four item scores will be averaged.
Scores range from 1 to 7. Higher scores indicate that the expected results of the selected strategy are perceived as more observable and easier to communicate.
|
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
|
Mean Perceived Trialability Score for the Selected Evidence-Informed Strategy
Time Frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
Perceived trialability will be assessed using two adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument.
Each item is scored from 1, extremely disagree, to 7, extremely agree.
Item scores will be averaged.
Scores range from 1 to 7. Higher scores indicate greater perceived ability to test the selected strategy before full implementation.
|
Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified
|
|
Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use
Time Frame: Intervention months 6, 9, and 12
|
Evidence acquisition will be assessed using the six-item Input domain of the Structured Interview for Evidence Use brief form.
Items assess how often participants obtain evidence from professional networks, experts, academic journals, and training materials.
Each item is scored from 1, not at all, to 5, all the time.
Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate more frequent acquisition of evidence.
Mean scores will be reported separately for each assessment time point.
|
Intervention months 6, 9, and 12
|
|
Mean Evidence-Appraisal Process Domain Score on the Structured Interview for Evidence Use
Time Frame: Intervention months 6, 9, and 12
|
Evidence appraisal will be assessed using the seven-item Process domain of the Structured Interview for Evidence Use brief form.
Items assess the importance participants place on factors such as study methods, use of multiple sources, strengths and limitations of the evidence, source trustworthiness, relevance, and cost.
Each item is scored from 1, not important, to 5, very important.
Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on systematically evaluating evidence.
Mean scores will be reported separately for each assessment time point.
|
Intervention months 6, 9, and 12
|
|
Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use
Time Frame: Intervention months 6, 9, and 12
|
Evidence application will be assessed using four Output-domain items from the Structured Interview for Evidence Use brief form.
Items assess the importance of using evidence to support adoption decisions, determine fit with community needs, assess potential harms, and compare available strategies.
Each item is scored from 1, not important, to 5, very important.
Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on applying evidence in coalition decisions.
Mean scores will be reported separately for each assessment time point.
|
Intervention months 6, 9, and 12
|
|
Percentage of Structured Evidence-Review Milestones Completed
Time Frame: Intervention months 6 and 12
|
Coalition progress will be assessed using four prespecified milestones: evidence was reviewed, candidate strategies were compared, a selection decision was made, and the selected evidence-informed strategy was documented.
Each completed milestone receives one point.
The number of completed milestones will be divided by four and multiplied by 100.
Scores range from 0% to 100%.
Higher percentages indicate greater progress through the structured evidence-review and selection process.
|
Intervention months 6 and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Travis R Moore, PhD, University of Pittsburgh
Publications and helpful links
General Publications
- Moore TR, Chusan YAC, Sanderson E, Calancie L, Hennessy E, Appel JM, Ulseth M, Economos CD. Community-led change: Progress toward policy, systems, and environmental impacts through the Catalyzing Communities initiative. PLoS One. 2025 Nov 10;20(11):e0336482. doi: 10.1371/journal.pone.0336482. eCollection 2025.
- Moore TR, Calancie L, Hennessy E, Appel J, Economos CD. Changes in systems thinking and health equity considerations across four communities participating in Catalyzing Communities. PLoS One. 2024 Oct 23;19(10):e0309826. doi: 10.1371/journal.pone.0309826. eCollection 2024.
- Moore TR, Hennessy E, Chusan YC, Ashcraft LE, Economos CD. Considerations for using participatory systems modeling as a tool for implementation mapping in chronic disease prevention. Ann Epidemiol. 2025 Jan;101:42-51. doi: 10.1016/j.annepidem.2024.12.002. Epub 2024 Dec 15.
- Moore TR, Chusan YAC, Pachucki M, Kim B. A participatory systems approach for visualizing and testing implementation strategies and mechanisms: evidence adoption in community coalitions. Implement Sci Commun. 2025 Oct 1;6(1):96. doi: 10.1186/s43058-025-00788-9.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY26070049
- 4R00HD109456-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.