Trial Outcomes & Findings for Evaluation of an Enhanced Delivery Model for Go NAPSACC (NCT NCT03938103)

Childcare centers are clustered within TA coaches. TA coaches delivered part of the intervention and served as the unit of randomization. Information used to quantify aspects of each center was collected from the TA coach, directors, and staff. To clearly represent the groups of people recruited within each arm three "periods" are defined below. Periods do not reflect a time element for this study, but the three groups of people measured for center-level data (unit).

Unit of analysis: ChildCare Centers

missing data - participants failed to report age on questionnaire

Each center's nutrition environment was assessed using the Environment and Policy Assessment and Observation- Self Report (EPAO-SR), a self-report measure filled out through online surveys by child care center directors and preschool classroom teachers. In addition, directors upload a month of menus and policy handbooks, which are reviewed and scored by a trained staff members. An overall nutrition environment score will be derived with scores ranging from 0-3, where higher scores indicate better (more supportive) nutrition environments.

Each center's physical activity environment was assessed using the Environment and Policy Assessment and Observation- Self Report (EPAO-SR), a self-report measure filled out through online surveys by child care center directors and preschool classroom teachers. In addition, directors upload policy handbooks, which were reviewed by a trained staff member. An overall physical activity environment score was derived with scores ranging from 0-3, where higher scores indicate better (more supportive) physical activity environments.

The number of participating centers will be captured by the Go NAPSACC website and extracted using the Go NAPSACC registration report. The registration report documents all child care centers that have completed registration and created a Go NAPSACC account. Creation of an account will be used to define participation/adoption.

Number of Go NAPSACC core program components completed was captured by the Go NAPSACC website and extracted using the Detailed Activity Report. These data serve as indicators of fidelity. The Detailed Activity report captures centers' completion of key steps in the improvement process (completion of a self-assessments and creation/completion of action plans). For this study, centers were expected to complete a cycle of the improvement process for Nutrition and one for Physical Activity, including all key steps.

Child nutrition self-assessment scores are captured on the Go NAPSACC website when a center director completed a self-assessment at the start and end of an improvement cycle. Completing self-assessments is an intervention component that may, or may not, be used by centers. Each self-assessment item is rated on a 1-4 point scale, where higher points indicate closer compliance with best practices, with a score of 4 indicating "meets best practice". Scores are then computed as percent of best practices met (range 0 to 100%). Self-assessment data will be extracted using the Go NAPSACC Child Nutrition Self-Assessment Report pulled immediately post-intervention.

Child physical activity self-assessment scores are captured on the Go NAPSACC website when a center completed a self-assessment at the start and end of an improvement cycle. Completing self-assessments is an intervention component that may, or may not, be used by centers. Each self-assessment item is rated on a 1-4 point scale, where higher points indicate closer compliance with best practices, with a score of 4 indicating "meets best practice". Scores are then computed as percent of best practices met (range 0 to 100%). Self-assessment data will be extracted using the Go NAPSACC Child Physical Activity Self-Assessment Report pulled immediately post-intervention.

Mean total EPAO-SR scores (percent best practices met) for centers starting with high or low contextual setting support reported by directors. Director report of contextual support was assessed using baseline surveys. Specifically, Fernandez's consolidated framework for implementation research (CFIR) inner setting measure was used to assess Culture, Culture Stress, Culture Effort, Implementation Climate, Leadership Engagement, Information access, and Available Resources. Scores from theses sub-scales were averaged to create a composite "inner setting" score. To assess the impact of baseline inner setting score and intervention group on nutrition and physical activity environment best practice scores, composite "inner setting" scores were classified as high or low using a median split. This high/low indicator of contextual support was included as interaction term in analysis models (i.e. Time \[baseline-followup\] \* Intervention Group \[basic-enhanced\] \* Context level\[high-low\]).

Mean total EPAO-SR scores (percent best practices met) for centers starting with high or low contextual setting support reported by staff. Staff report of contextual setting support was assessed using baseline surveys. Specifically, Fernandez's consolidated framework for implementation research (CFIR) inner setting measure was used to assess Culture, Culture Stress, Culture Effort, Implementation Climate, Leadership Engagement, Information access, and Available Resources. Scores from theses sub-scales were averaged to create a composite "inner setting" score. To assess the impact of baseline inner setting score and intervention group on nutrition and physical activity environment best practice scores, composite "inner setting" scores were classified as high or low using a median split. This high/low indicator of contextual support was included as interaction term in analysis models (i.e. Time \[baseline-followup\] \* Intervention Group \[basic-enhanced\] \* Context level\[high-low\]).

Costs of implementation per center include TA coaches time and any resources required to train and support centers for 12 months. Cost tracking used the TA Activity Log to capture TA coaches' time and a supplemental log of additional costs (e.g., mileage, printing). These data were combined to calculate the average cost per center for implementing Go NAPSACC. Final amounts are expressed as cost (dollar $) per center.

Completion of these Go NAPSACC program components was captured using the TA activity log in Go NAPSACC website and tracking data maintained by the study interventionist and project manager. These data serve as indicators of fidelity. In the TA Activity Log all coaches document their implementation activities for each center they serve. Based on their prescribed implementation model (basic or enhanced), these data were used to calculate the percentage of a TAs centers completing the prescribed implementation activities.

TA coaches in the ENHANCED implementation arm were asked to hold 3 cross-center meeting during the 1 year intervention. These meeting could be online or in-person, but were intended to include directors from all centers the TA coach served. The study interventionist and project manager tracked each meeting. These data were used to calculate the percentage of prescribed implementation activities completed.

TA coaches were asked to log implementation activities and contacts with each center in the TA Activity Log through the Go NAPSACC website. Information for analysis was extracted from the website using the TA Activity Report.

TA coaches were asked to attend trainings with the study interventionist. The study interventionist and project manager tracked attendance at each training session. TA coaches in the BASIC arm were asked to attend three training sessions, while TA coaches in the ENHANCED arm were asked to attend 6 sessions. Based on their prescribed implementation model (basic or enhanced), these data were used to calculate the percentage of prescribed implementation activities completed.

TA coaches were asked to attend group check-ins with the study interventionist. The study interventionist and project manager tracked attendance at each group check-in. TA coaches in the BASIC arm were asked to attend one group check-in, while TA coaches in the ENHANCED arm were asked to attend 12 group check-ins and 3 one-on-one check-ins with study interventionist Based on their prescribed implementation model (basic or enhanced), these data were used to calculate the percentage of prescribed implementation activities completed.