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Childhood ObesityNCT07804550

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

A study testing Catalyzing Communities and FICAS Implementation Intervention in people with Childhood Obesity and Evidence-Based Practice, run by University of Pittsburgh at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Catalyzing Communities and FICAS Implementation Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,300 participants
Where
1 siteUnited States
Study dates
Jan 2027to Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Travis R Moore, PhD contact

512-914-4880

trm250@pitt.edu

Yuilyn A Chang Chusan, MS contact

Yuilyn.Chang_Chusan@tufts.edu

United States1 site
  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15216

    Travis R Moore, PhD, 512-914-4880, trm250@pitt.edu

    Travis R Moore, PhD

Other trials in United States

About this study

Official title: 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.

Being tested
Catalyzing Communities, FICAS Implementation Intervention
Keywords
Community coalition, Implementation science, Implementation strategy, Network intervention, Evidence-informed strategy, Group model building, Policy, systems, and environmental change, Feasibility trial, Food Policy
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Catalyzing CommunitiesBehavioural

    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 Implementation InterventionBehavioural

    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.

Study groups in NCT07804550
Study groupRoleWhat they receive
Delayed ControlOtherDuring 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.
Receives: Behavioral: Catalyzing Communities
Positive Control: Catalyzing CommunitiesActive comparatorThis 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.
Receives: Behavioral: Catalyzing Communities
Augmented Treatment: Catalyzing Communities Plus FICASExperimentalThis 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.
Receives: Behavioral: Catalyzing Communities; Behavioral: FICAS Implementation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Intervention months 6, 9, and 12

Secondary outcomes (16)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Intervention months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
3,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07804550
Sponsor's protocol ID
STUDY26070049
Other IDs
4R00HD109456-03
Status last verified
Aug 2026
First submitted
27 Aug 2026
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Catalyzing Communities and FICAS Implementation Intervention in people with Childhood Obesity and Evidence-Based Practice, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Travis R Moore, PhD (512-914-4880, trm250@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participation and Reach (time frame: From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07804550, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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