Clinical trial NCT03938103: Evaluation of an Enhanced Delivery Model for Go NAPSACC
Official title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: preschool
child care centers
nutrition
physical activity
organizational readiness
behavior change
cost-effectiveness
implementation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Kentucky
name: Child Care Aware of Kentucky
First posted: 2019-05-06
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.

Detailed description: 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.

RANDOMIZATION: Once all baseline measures with centers are scheduled, TA coaches will be randomly assigned to either deliver Basic or Enhanced Go NAPSACC with their enrolled centers. For Wave 3, once all online baseline measures are completed, TA coaches will be randomly assigned to either deliver Basic or Enhanced Go NAPSACC with their enrolled centers.

INTERVENTION ARMS: Go NAPSACC is a suite of online tools designed to help child care programs improve their nutrition and physical activity practices. TA coaches will support centers' use of Go NAPSACC using either a Basic or Enhanced implementation model.

TA coaches assigned to Basic Go NAPSACC will participate in 2 two hour-long training sessions and a homework assignment. Training sessions will cover the role of child care programs in shaping children's eating and physical activity behaviors, Go NAPSACC's 5-step improvement, and the tools available for child care programs and TA coaches to support their work. Additionally, coaches will have an online check-in meeting 1 month post-training to answer any remaining questions/concerns. TA coaches assigned to Enhanced Go NAPSACC will participate in 2 two hour long and 2 hour-long training sessions and a homework assignment. In addition to the topics listed above, trainings will also introduce elements unique to the enhanced implementation model. During implementation, these TA coaches will also participate in monthly conference calls and 2-3 one-on-one coaching sessions with a Go NAPSACC specialist .

For centers receiving Basic Go NAPSACC, center directors will be invited by their TA coach to register for Go NAPSACC accounts. The director will receive a 1-hour orientation from their TA coach on how to use Go NAPSACC's online tools and resources. Once trained, the director will complete 2 cycles of Go NAPSACC's 5-step improvement process focusing on child nutrition and physical activity. A cycle of Go NAPSACC includes completing nutrition and physical activity self-assessments, choosing at least 6 goals (3 goals per self-assessment), creating an action plan for each goal, working to implement the action plans drawing from the tips and materials resource library, and logging progress and completion of goals. Each cycle will take approximately 6 months to complete. At the end of the 12 months, the director will retake the self-assessments on child nutrition and physical activity. Throughout the 12 months, the director will receive brief monthly check-ins from their TA coach. TA coaches will log their implementation activities using the TA Activity Log in Go NAPSACC.

For centers receiving Enhanced Go NAPSACC, center directors will work with their TA coach to identify an implementation team that will contribute to Go NAPSACC efforts. Before starting Go NAPSACC, the team will work with their TA coach to conduct an assessment of their center's needs, capacity, and resources. A needs assessment survey will be completed by various center staff and scored by the TA coach. Summarized results will be presented and discussed with the team to identify priority issues the team would like extra support from the TA coach as they work through Go NAPSACC. Once this needs assessment is complete, the team will begin using Go NAPSACC and with support from their TA coach will create a 12-month plan to guide their Go NAPSACC efforts. Similar to those assigned to Basic Go NAPSACC, the team will complete 2 cycles of the 5-step improvement process focusing on nutrition and physical activity. They will follow the same steps described above. Additionally, the team will receive brief check-ins with tailored support from their TA coach. Further, their TA coach will host 2-3 one-hour meetings with different centers from the same region so that teams can reflect on their efforts and share lessons learned. TA coaches will be asked to log all of their implementation activities using the TA Activity Log in Go NAPSACC.

REFRESHER INTERVENTION TRAINING SESSIONS: For Waves 1 and 2, Basic TA coaches will have 2 hour and a half long online refresher training sessions. The first training session will cover a refresher on the 5-step process, the provider and consultant online tools, and timeline updates. The second session will focus on providing support remotely and on how Go NAPSACC best practices may be impacted by pandemic restrictions. Enhanced coaches will have a 2-hour training session focused on a reminder of the big picture of the Enhanced support approach, the updated timeline, leadership team formation, the readiness check, and providing support remotely. Regular monthly meetings will be used to further refresh on topics relevant to Enhanced support approach and how best practices could be impacted by pandemic restrictions.

POST-INTERVENTION MEASURES: Measures will be repeated following 12 months of Go NAPSACC participation. Data collection procedures will be the same as those described in relaunch baseline measures. In addition, trained research staff will complete phone interviews with a random selection of TA coaches to gather feedback about their experiences implementing Go NAPSACC. Phone interviews will also be completed with randomly selected center directors and when relevant, members of the implementation teams.

Eligibility criteria: Inclusion Criteria:

TA Coaches

* Must either be a Quality coach or a Health and Safety coach
* Must be able to read and speak English

Child Care Centers

* Must be a part of a participating TA coach's current caseload
* Have no plans to close in the coming year
* Serve at least lunch to the children
* Not serve special needs children exclusively

Child Care Providers

* Teacher must be the lead teacher in a preschool classroom
* Center directors and teachers must be able to read and speak English

Exclusion Criteria:

Child Care Centers

* Serve special needs children exclusively
* Serve only non-English speaking families

Primary outcomes:
measure: Mean Nutrition Environment Score
timeFrame: Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)
measure: Mean Physical Activity Environment Score
timeFrame: Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)
Secondary outcomes:
measure: Number of Centers That Created a Go NAPSACC Website Account
timeFrame: Measures collected 3-12 weeks prior to start of intervention (Baseline)
measure: Go NAPSACC Core Program Components Completed by Centers
timeFrame: Measures collected during the 1 year intervention period.
measure: Percent of Nutrition Best Practices Met Computed From Self-assessments Completed on Go NAPSACC Website
timeFrame: Within 3 months of starting intervention and again within 12 months of initiating intervention
measure: Percent of Physical Activity Best Practices Met Computed From Self-assessments Completed on Go NAPSACC Website
timeFrame: Within 3 months of starting intervention and again within 12 months of initiating intervention
measure: Contextual Setting (Director Report) - Impact of Center Culture, Implementation Climate, Leadership Engagement, Available Resources, and Information Access at Baseline on Intervention Effects
timeFrame: Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)
measure: Contextual Setting (Staff Report) - Impact of Center Culture, Implementation Climate, Leadership Engagement, Available Resources, and Information Access at Baseline on Intervention Effects
timeFrame: Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)
measure: Cost of Implementation for Enhanced and Basic Models
timeFrame: Measures collected throughout the 1 year intervention period
measure: Go NAPSACC Core Program Components: Percent of a TA Coaches Centers Completing Implementation Components
timeFrame: Measures collected during the 1 year intervention period.
measure: Go NAPSACC Core Program Components: TA Coach Held Cross-Center Meetings
timeFrame: Measures collected during the 1 year intervention period.
measure: Go NAPSACC Core Program Components: TA Coach Complete Logs
timeFrame: Measures collected during the 1 year intervention period.
measure: Go NAPSACC Core Program Components: TA Coach Training Attendance
timeFrame: Measures collected during the 1 year intervention period.
measure: Go NAPSACC Core Program Components: TA Coach Attended Check-ins With Study Team
timeFrame: Measures collected during the 1 year intervention period.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Dianne Ward, EdD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carollina at Chapel Hill
name: Derek Hales, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Vaughn AE, Studts CR, Powell BJ, Ammerman AS, Trogdon JG, Curran GM, Hales D, Willis E, Ward DS. The impact of basic vs. enhanced Go NAPSACC on child care centers' healthy eating and physical activity practices: protocol for a type 3 hybrid effectiveness-implementation cluster-randomized trial. Implement Sci. 2019 Dec 5;14(1):101. doi: 10.1186/s13012-019-0949-4.