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

NCT07804550 | Not Yet Recruiting

• 2 other identifiers: STUDY260700494R00HD109456-03
• Study Type: interventional
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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

  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

  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

  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 Outcomes (16)

• Percentage of Selected-Strategy Adoption Milestones Completed

  Intervention months 9 and 12

• Normalized Early Implementation Readiness and Action-Initiation Score

  Intervention months 9 and 12

• Coalition Child-Health Discussion Network Density

  Pre-intervention baseline and monthly through intervention month 12

• Percentage of Child-Health Discussion Ties Connecting Different Sectors

  Pre-intervention baseline and monthly through intervention month 12

• Percentage of Prespecified Strategic Representation Categories Represented

  Pre-intervention baseline and intervention months 6, 9, and 12

Study Arms (3)

Delayed Control

OTHER

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

Positive Control: Catalyzing Communities

ACTIVE COMPARATOR

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

Augmented Treatment: Catalyzing Communities Plus FICAS

EXPERIMENTAL

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

Catalyzing Communities BEHAVIORAL

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.

Augmented Treatment: Catalyzing Communities Plus FICAS; Delayed Control; Positive Control: Catalyzing Communities

FICAS Implementation Intervention BEHAVIORAL

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.

Augmented Treatment: Catalyzing Communities Plus FICAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15216, United States

Location

Related Publications (4)

• 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.

  PMID: 41212862 BACKGROUND

• 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.

  PMID: 39441877 BACKGROUND

• 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.

  PMID: 39681242 BACKGROUND

• 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.

  PMID: 41035014 BACKGROUND

Related Links

• Catalyzing Communities Website

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Travis R Moore, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Travis R Moore, PhD

CONTACT

512-914-4880; trm250@pitt.edu

Yuilyn A Chang Chusan, MS

CONTACT

Yuilyn.Chang_Chusan@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants, investigators, and intervention personnel cannot be masked because intervention delivery requires active collaboration with participating coalitions. Selected qualitative coding and quantitative analyses may be conducted without condition labels when feasible, but these procedures do not constitute formal masking of an outcomes assessor.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three community coalitions will be cluster randomized in a 1:1:1 ratio to delayed control, positive control, or augmented treatment. During the initial comparison period, the delayed-control coalition will receive assessments and retention contacts only; the positive-control coalition will receive Catalyzing Communities; and the augmented-treatment coalition will receive Catalyzing Communities plus FICAS. After its prespecified pre-crossover assessment, the delayed-control coalition will cross over to Catalyzing Communities. The primary conceptual comparison is Catalyzing Communities alone versus Catalyzing Communities plus FICAS.

Study Record Dates

• First Submitted: August 27, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data and supporting information will become available no later than the date of the first associated publication or the end of the award period, whichever occurs first. Materials will remain available for at least 10 years, subject to repository policies.
• Access Criteria: Data will be deposited in ICPSR or another appropriate NIH-compliant repository. Qualified researchers may request access by submitting a research proposal describing the scientific purpose, requested data, analysis plan, data-security procedures, and plans for dissemination. Requests will be reviewed for scientific appropriateness, privacy and deductive-disclosure risk, consistency with participant consent, and compliance with applicable IRB and institutional requirements. Access may require a data use agreement, appropriate ethics approval, secure data storage, and agreement not to re-identify or contact participants, redistribute the data, or use the data beyond the approved purpose. Detailed network data may be restricted, masked, or aggregated when necessary to protect participants and participating coalitions.

Locations

US (1)