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.
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
- Conditions the study is for
- Childhood Obesity, Evidence-Based Practice, Food Systems
- What is being tested?
- Catalyzing Communities and FICAS Implementation Intervention
- Type of treatment
- Lifestyle or therapy programme
- 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.
Yuilyn A Chang Chusan, MS contact
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15216
Travis R Moore, PhD, 512-914-4880, trm250@pitt.edu
Travis R Moore, PhD
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.
- Conditions
- Childhood Obesity, Evidence-Based Practice, Food Systems, Food Policy
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. 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.
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted4 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Travis R Moore, University of Pittsburgh
- Investigators
- Travis R Moore, PhD, Principal investigator, University of Pittsburgh
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 41212862Moore 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 39441877Moore 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 39681242Moore 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Network-Based Implementation Strategies to Increase Coalition Adoption and Early Implementation of Evidence-Informed Strategies for Child Health
- ClinicalTrials.gov ID
- NCT07804550
- Acronym / sponsor ID
- STUDY26070049
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Delayed Control | Other | Behavioral: Catalyzing CommunitiesDuring 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. |
| Positive Control: Catalyzing Communities | Active comparator | Behavioral: Catalyzing CommunitiesThis 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. |
| Augmented Treatment: Catalyzing Communities Plus FICAS | Experimental | Behavioral: Catalyzing Communities, Behavioral: FICAS Implementation InterventionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catalyzing CommunitiesCatalyzing 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. | Behavioural | Augmented Treatment: Catalyzing Communities Plus FICAS, Delayed Control, Positive Control: Catalyzing Communities |
| FICAS Implementation InterventionFICAS 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. | Behavioural | Augmented Treatment: Catalyzing Communities Plus FICAS |
Primary outcome
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.
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.
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.
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.
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.
16 secondary outcomes
Percentage of Selected-Strategy Adoption Milestones Completed
Time frame: Intervention months 9 and 12
Normalized Early Implementation Readiness and Action-Initiation Score
Time frame: Intervention months 9 and 12
Coalition Child-Health Discussion Network Density
Time frame: 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
Percentage of Prespecified Strategic Representation Categories Represented
Time frame: 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
Mean Number of Child-Health Discussion Ties per Participant
Time frame: 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
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
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
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
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
Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use
Time frame: 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
Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use
Time frame: Intervention months 6, 9, and 12
Percentage of Structured Evidence-Review Milestones Completed
Time frame: Intervention months 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 41212862Moore 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.
- Background: PubMed 39441877Moore 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.
- Background: PubMed 39681242Moore 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.
- Background: PubMed 41035014Moore 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.
- Catalyzing Communities WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Childhood Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Recruiting
Cities for Better Health Childhood Obesity Prevention Initiative in JAPAN
Quality of Life (QOL), Nutrition
Not yet recruiting
Weight Gain in Pediatric Leukemia Survivors
Leukemia, Pediatric Acute Lymphoblastic Leukemia
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuilyn A Chang Chusan, MS contact
Travis R Moore, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
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.