A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program

This research study will use a type 3 hybrid effectiveness-implementation design with a randomized controlled trial to evaluate the impact of Go NAPSACC when using basic vs enhanced implementation models (i.e., Basic Go NAPSACC vs. Enhanced Go NAPSACC). To evaluate impact, measures collected at baseline and post-intervention will be used to assess change in centers' use of evidence-based nutrition and physical activity practices. Cost of delivery will also be monitored throughout implementation. Study participants will include 28 TA coaches from Child Care Aware of Kentucky and 97 child care centers from 7 regions of central Kentucky.

ORIGINAL RECRUITMENT: First, TA coaches will attend an orientation session where they will be introduced to the research study and their roles both as study participants and implementation partners. If they agree to participate, they will be asked to sign consent. TA coaches will then be trained on how to introduce the research study to child care centers using provided recruitment materials. They will be instructed to target these efforts toward a randomly selected list of centers (drawn from their current caseload) provided by the research team. Coaches will be responsible for gauging initial interest of centers, and relaying that information to the research team. Research staff will follow up directly with all centers who express initial interest to confirm eligibility and interest, review study details, and answer questions. Once a center director's eligibility and interest is confirmed, the research team will work with the director to recruit a randomly selected 3-4-year-old classroom teacher and at least three 3-4-year-old children from that classroom.

RELAUNCH RECRUITMENT: TA coaches will attend a re-orientation session where they will be informed of modifications to the study due to the pandemic restrictions. For the first two waves, TA coaches will be instructed to inform their previously enrolled centers of the modifications to the study. They will be provided with materials to inform centers and relay any relevant information about their centers to the research staff. Research staff will follow-up directly with all previously enrolled centers who are currently open. The research study staff will review study details, confirm interest, and answer any questions. Once a center director's interest is confirmed, the staff will work with the director to recruit two randomly selected preschool classroom teachers. Wave 3 TA coaches will be informed of modifications to study and follow a similar protocol to the original recruitment steps as measurement wasn't complete at the time of the pause due to the pandemic. The TA coaches will use provided recruitment materials and will be instructed to target these efforts toward a randomly selected list of centers (drawn from their current caseload) provided by the research team. Coaches will be responsible for gauging initial interest of centers, and relaying that information to the research team. Research staff will follow up directly with all centers who express initial interest to confirm eligibility and interest, review study details, and answer questions. Once a center director's eligibility and interest is confirmed, the research team will work with the director to recruit two randomly selected preschool classroom teachers.

ORIGINAL BASELINE MEASURES: Several measures will be collected at baseline on centers, children, directors, teachers, and TA coaches using a combination of observation, physical assessments, and self-report surveys. Most measures will be collected during a 1-day site visit conducted with each center by a trained research team member. Measures will assess centers' use of evidence-based nutrition and physical activity practices, children's dietary intakes and physical activity while at child care, and children's height and weight. Demographic information will be captured through surveys completed by parents, directors, teachers, and TA coaches. Implementation context will be captured through surveys completed by directors, teachers, and TA coaches.

RELAUNCH BASELINE MEASURES: Several measures will be collected at baseline on centers, directors, teachers and TA coaches using online self-report surveys. All measures will be collected using the Qualtrics online survey tool. For TA coaches, measures will assess demographics information, implementation context, and COVID-19 impact. For center directors, measures will assess demographics, center demographics, implementation context, COVID-19 impact, and nutrition and physical activity practices. For preschool teachers, measures will assess demographics, implementation context, and nutrition and physical activity practices.