CClinicalTrials.gg
Not yet recruitingNCT07804550Updated Sep 4, 2026

Network-Based Support to Help Community Coalition Members Choose and Use Strategies to Improve Child Health

An interventional study of Catalyzing Communities and FICAS Implementation Intervention in Childhood Obesity, Evidence-Based Practice and Food Systems, sponsored by University of Pittsburgh. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
3,300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Childhood Obesity
  • Evidence-Based Practice
  • Food Systems
  • Food Policy

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Keywords

  • Community coalition
  • Implementation science
  • Implementation strategy
  • Network intervention
  • Evidence-informed strategy
  • Group model building
  • Policy, systems, and environmental change
  • Feasibility trial
  • Food Policy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
3,300 participants (estimated)

Study arms

  • 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.

    Behavioral: Catalyzing Communities

  • 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.

    Behavioral: Catalyzing Communities

  • 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.

    Behavioral: Catalyzing Communities · Behavioral: FICAS Implementation Intervention

Interventions

  • BehavioralCatalyzing Communities

    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.

  • BehavioralFICAS Implementation Intervention

    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.

05

What researchers measure

Primary outcomes

  1. Participation and Reach

    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.

    Time frame: From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation

  2. Percentage of Enrolled Participants Retained Through the Primary Endpoint

    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.

    Time frame: Baseline through intervention month 12

  3. Mean Acceptability of Intervention Measure Score for FICAS

    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.

    Time frame: Intervention months 6, 9, and 12

  4. Mean Intervention Appropriateness Measure Score for FICAS

    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.

    Time frame: Intervention months 6, 9, and 12

  5. Mean Feasibility of Intervention Measure Score for FICAS

    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.

    Time frame: Intervention months 6, 9, and 12

Secondary outcomes

  1. Percentage of Selected-Strategy Adoption Milestones Completed

    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.

    Time frame: Intervention months 9 and 12

  2. Normalized Early Implementation Readiness and Action-Initiation Score

    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.

    Time frame: Intervention months 9 and 12

  3. Coalition Child-Health Discussion Network Density

    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.

    Time frame: Pre-intervention baseline and monthly through intervention month 12

  4. Percentage of Child-Health Discussion Ties Connecting Different Sectors

    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.

    Time frame: Pre-intervention baseline and monthly through intervention month 12

  5. Percentage of Prespecified Strategic Representation Categories Represented

    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.

    Time frame: Pre-intervention baseline and intervention months 6, 9, and 12

  6. Mean Coalition-Wave Dyadic Trust Score

    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.

    Time frame: Pre-intervention baseline and monthly through intervention month 12

  7. Mean Number of Child-Health Discussion Ties per Participant

    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.

    Time frame: Pre-intervention baseline and monthly through intervention month 12

  8. Mean Perceived Relative Advantage Score for the Selected Evidence-Informed Strategy

    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.

    Time frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified

  9. Mean Perceived Compatibility Score for the Selected Evidence-Informed Strategy

    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.

    Time frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified

  10. Mean Perceived Ease-of-Use Score for the Selected Evidence-Informed Strategy

    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.

    Time frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified

  11. Mean Perceived Result-Demonstrability Score for the Selected Evidence-Informed Strategy

    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.

    Time frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified

  12. Mean Perceived Trialability Score for the Selected Evidence-Informed Strategy

    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.

    Time frame: Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified

  13. Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use

    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.

    Time frame: Intervention months 6, 9, and 12

  14. Mean Evidence-Appraisal Process Domain Score on the Structured Interview for Evidence Use

    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.

    Time frame: Intervention months 6, 9, and 12

  15. Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use

    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.

    Time frame: Intervention months 6, 9, and 12

  16. Percentage of Structured Evidence-Review Milestones Completed

    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.

    Time frame: Intervention months 6 and 12

06

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15216, United States
    • Travis R Moore, PhD · Contact · trm250@pitt.edu · 512-914-4880
    • Travis R Moore, PhD · Principal investigator
07

References and documents

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. PubMed 41212862 ↗
  • 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. PubMed 39441877 ↗
  • 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. PubMed 39681242 ↗
  • 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. PubMed 41035014 ↗

Individual participant data

Plan to share: Yes — De-identified individual participant data included in the final analytic datasets underlying reported results will be shared. These data may include cleaned participant-level survey responses, outcome scores, and derived participant-level variables. Associated data dictionaries, codebooks, variable-derivation documentation, and analytic code will also be provided. Direct identifiers, contact and linkage files, recordings, transcripts that cannot be safely de-identified, raw network-nomination files, and data presenting an unacceptable risk of deductive disclosure will not be shared. Detailed network data may be masked, aggregated, or made available through controlled access following disclosure-risk review.

Supporting information: Study protocol, Sap, Analytic code

08

Registry details

Key details

Study ID
NCT07804550
Lead sponsor
University of Pittsburgh
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Travis R Moore (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 4, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
Sep 4, 2026

Study contacts

Travis R Moore, PhD
Contact
trm250@pitt.edu
512-914-4880
Yuilyn A Chang Chusan, MS
Contact
Yuilyn.Chang_Chusan@tufts.edu
Travis R Moore, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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