Childhood Obesity, Evidence-Based Practice, Food Policy, Food Systems
Conditions
Keywords
Community coalition, Implementation science, Implementation strategy, Network intervention, Evidence-informed strategy, Group model building, Policy, systems, and environmental change, Feasibility trial, Food Policy
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.
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.
Sponsors
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation and Reach | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Selected-Strategy Adoption Milestones Completed | Intervention months 9 and 12 | Coalition progress will be assessed using eight prespecified milestones: naming and actively considering a candidate strategy, formally selecting a strategy, assigning implementation roles, drafting an implementation plan, securing resources or commitments, completing launch preparation, initiating the first implementation activity, and beginning early monitoring or refinement. Each completed milestone receives one point. The number completed will be divided by eight and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater progress from strategy consideration through adoption and early action. |
| Normalized Early Implementation Readiness and Action-Initiation Score | Intervention months 9 and 12 | Readiness and action initiation will be assessed using a nine-indicator study-specific rubric. Indicators address confirmation of the selected strategy, implementation leadership, assigned responsibilities, a written implementation plan, timelines and milestones, resources and supports, partner commitments, launch preparation, and initiation of the first implementation action. Each applicable indicator is scored from 0, no evidence, to 3, completed or fully documented. Scores will be summed, divided by the maximum possible score for applicable indicators, and multiplied by 100. Scores range from 0 to 100. Higher scores indicate greater implementation readiness and action initiation. |
| Coalition Child-Health Discussion Network Density | Pre-intervention baseline and monthly through intervention month 12 | At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion. Coalition network density will be calculated as the number of observed directed child-health discussion ties among rostered coalition members divided by the total number of possible directed ties, excluding self-ties. Scores range from 0 to 1. Higher values indicate a more densely connected coalition discussion network. |
| Percentage of Child-Health Discussion Ties Connecting Different Sectors | Pre-intervention baseline and monthly through intervention month 12 | The number of reported child-health discussion ties connecting people from different organizational or community sectors will be divided by the number of reported ties with sector information and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater cross-sector connectivity. |
| Percentage of Prespecified Strategic Representation Categories Represented | Pre-intervention baseline and intervention months 6, 9, and 12 | Before intervention delivery, the study team and coalition will identify the sectors, roles, perspectives, and community constituencies needed for the coalition or core committee. At each assessment, the number of prespecified categories represented by at least one active member will be divided by the total number of prespecified categories and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater strategic representation. |
| Mean Coalition-Wave Dyadic Trust Score | Pre-intervention baseline and monthly through intervention month 12 | Participants will rate each named coalition connection using one item, "How much do you trust this person?" Responses range from 1, I do not trust this person, to 5, I trust this person. A mean trust score will first be calculated across each respondent's rated ties. Respondent-level means will then be averaged within each coalition and assessment wave. Scores range from 1 to 5. Higher scores indicate greater trust among coalition members. |
| Mean Number of Child-Health Discussion Ties per Participant | Pre-intervention baseline and monthly through intervention month 12 | At each assessment, participants may identify up to 20 people with whom they currently discuss child health promotion. The number of reported discussion ties will be calculated for each participant and averaged within each coalition. Scores range from 0 to 20 ties per participant. Higher values indicate that participants report more child-health discussion connections. |
| Mean Perceived Relative Advantage Score for the Selected Evidence-Informed Strategy | Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified | relative advantage will be assessed using five adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived advantage of the selected strategy compared with current approaches. |
| Mean Perceived Compatibility Score for the Selected Evidence-Informed Strategy | Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified | Perceived compatibility will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived compatibility with coalition needs, activities, and ways of working. |
| Mean Perceived Ease-of-Use Score for the Selected Evidence-Informed Strategy | Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified | Perceived ease of use will be assessed using three adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate that the selected strategy is perceived as easier to understand and use. |
| Mean Perceived Result-Demonstrability Score for the Selected Evidence-Informed Strategy | Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified | Perceived result demonstrability will be assessed using four adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. One negatively worded item will be reverse-coded, and the four item scores will be averaged. Scores range from 1 to 7. Higher scores indicate that the expected results of the selected strategy are perceived as more observable and easier to communicate. |
| Mean Perceived Trialability Score for the Selected Evidence-Informed Strategy | Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified | Perceived trialability will be assessed using two adapted items from the Moore and Benbasat Perceived Characteristics of Innovating instrument. Each item is scored from 1, extremely disagree, to 7, extremely agree. Item scores will be averaged. Scores range from 1 to 7. Higher scores indicate greater perceived ability to test the selected strategy before full implementation. |
| Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use | Intervention months 6, 9, and 12 | Evidence acquisition will be assessed using the six-item Input domain of the Structured Interview for Evidence Use brief form. Items assess how often participants obtain evidence from professional networks, experts, academic journals, and training materials. Each item is scored from 1, not at all, to 5, all the time. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate more frequent acquisition of evidence. Mean scores will be reported separately for each assessment time point. |
| Mean Evidence-Appraisal Process Domain Score on the Structured Interview for Evidence Use | Intervention months 6, 9, and 12 | Evidence appraisal will be assessed using the seven-item Process domain of the Structured Interview for Evidence Use brief form. Items assess the importance participants place on factors such as study methods, use of multiple sources, strengths and limitations of the evidence, source trustworthiness, relevance, and cost. Each item is scored from 1, not important, to 5, very important. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on systematically evaluating evidence. Mean scores will be reported separately for each assessment time point. |
| Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use | Intervention months 6, 9, and 12 | Evidence application will be assessed using four Output-domain items from the Structured Interview for Evidence Use brief form. Items assess the importance of using evidence to support adoption decisions, determine fit with community needs, assess potential harms, and compare available strategies. Each item is scored from 1, not important, to 5, very important. Item scores will be averaged to produce a score ranging from 1 to 5. Higher scores indicate greater importance placed on applying evidence in coalition decisions. Mean scores will be reported separately for each assessment time point. |
| Percentage of Structured Evidence-Review Milestones Completed | Intervention months 6 and 12 | Coalition progress will be assessed using four prespecified milestones: evidence was reviewed, candidate strategies were compared, a selection decision was made, and the selected evidence-informed strategy was documented. Each completed milestone receives one point. The number of completed milestones will be divided by four and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater progress through the structured evidence-review and selection process. |
Countries
United States
Contacts
CONTACTTravis R Moore, PhD
CONTACTYuilyn A Chang Chusan, MS
PRINCIPAL_INVESTIGATORTravis R Moore, PhD
University of Pittsburgh
Outcome results
None listed