Evaluation of an Enhanced Delivery Model for Go NAPSACC

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938103
• Other study ID #: 19-0406
• Secondary ID: R01HL137929
• Status: Completed
• Phase: N/A
• Start date: April 10, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: December 31, 2022
• Est. primary completion date: October 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Enhanced Go NAPSACC
In the Enhanced delivery model, TA coaches will help centers create an implementation team and conduct a needs assessment to identify organizational strengths and challenges. TA coaches will also provide an orientation to Go NAPSACC and its online tools and help the team develop a plan to guide their Go NAPSACC efforts. The team will then work through 2 cycles of Go NAPSACC over 12 months. During each cycle (6 months), centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. Throughout this 12-month period, TA coaches will provide monthly check-ins incorporating tailored support based on the results from the needs assessment. They will also organize 2-3 meetings among teams from different centers to reflect and share lessons learned.
• Basic Go NAPSACC
In the Basic delivery model, TA coaches will provide an orientation to Go NAPSACC and its online tools to the center director. The director will then work 2 cycles of Go NAPSACC over 12 months. During each cycle (6 months), centers will take self-assessments on nutrition and physical activity, choose 6 goals (3 from each), create action plans, and take action to achieve their chosen goals. Throughout this 12-month period, TA coaches will provide monthly brief check-ins.

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	University of Kentucky	Lexington	Kentucky

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Child Care Aware of Kentucky, National Heart, Lung, and Blood Institute (NHLBI), University of Kentucky

Country where clinical trial is conducted

United States, 

References & Publications (4)

Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008 Dec;26(14):1557-65. doi: 10.1080/02640410802334196. — View Citation

Fernandez ME, Walker TJ, Weiner BJ, Calo WA, Liang S, Risendal B, Friedman DB, Tu SP, Williams RS, Jacobs S, Herrmann AK, Kegler MC. Developing measures to assess constructs from the Inner Setting domain of the Consolidated Framework for Implementation Research. Implement Sci. 2018 Mar 27;13(1):52. doi: 10.1186/s13012-018-0736-7. — View Citation

Lehman WE, Simpson DD, Knight DK, Flynn PM. Integration of treatment innovation planning and implementation: strategic process models and organizational challenges. Psychol Addict Behav. 2011 Jun;25(2):252-61. doi: 10.1037/a0022682. — View Citation

Seward K, Wolfenden L, Wiggers J, Finch M, Wyse R, Oldmeadow C, Presseau J, Clinton-McHarg T, Yoong SL. Measuring implementation behaviour of menu guidelines in the childcare setting: confirmatory factor analysis of a theoretical domains framework questionnaire (TDFQ). Int J Behav Nutr Phys Act. 2017 Apr 4;14(1):45. doi: 10.1186/s12966-017-0499-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in nutrition and physical activity environment score from baseline to 12 months	Each center's nutrition and physical activity environment will be 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 lead teachers. When directors upload a month of menus and policy handbooks, a trained staff member will fill out relevant items. If not, the directors will fill out those items. An overall nutrition and physical activity environment score will be derived with scores ranging from 0-57, where higher scores indicate better (more supportive) nutrition and physical activity environments.	Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention
Secondary	Number of participating centers	The number of participating centers will be captured by the Go NAPSACC website and extracted using the Go NAPSACC Registration Report. This 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.	Measures collected 3-12 weeks prior to start of intervention
Secondary	Percent of Go NAPSACC core program components completed by centers	Percent of Go NAPSACC core program components completed will be captured by the Go NAPSACC website and extracted using the Detailed Activity Report. These data will serve as indicators of fidelity. The Detailed Activity report captures centers' completion of key steps in the improvement process (completion of a self-assessment, selection of goals, creation of action plans, etc.). For this study, centers will be expected to complete 2 cycles of the improvement process, including all key steps. These data will be used to calculate the percentage of steps completed.	Measures collected during the 1 year intervention period.
Secondary	Percent of Go NAPSACC core program components completed by TAs	Percent of Go NAPSACC core program components completed will be captured by the Go NAPSACC website and extracted using the TA Activity Report. These data will serve as indicators of fidelity. The TA Activity Report all coaches to document their implementation activities. Based on their prescribed implementation model (basic or enhanced), these data will be used to calculate the percentage of prescribed implementation activities completed.	Measures collected during the 1 year intervention period.
Secondary	Changes in child nutrition self-assessment scores at 6 and 12, and 18 months post-intervention	Child nutrition self-assessment scores are captured on the Go NAPSACC website each time child care centers complete a self-assessment for that module. Each self-assessment item is scored 1-4 points, where higher points indicate closer compliance with best practices. Responses are then used to calculate a total score (total points/total possible points x 100). As an indicator of maintenance, self-assessment data will be extracted using the Go NAPSACC Child Nutrition Self-Assessment Report pulled immediately post-intervention, as well as 6, 12, and 18 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.	Measures will be collected at 6, 12, and 18 months post-intervention
Secondary	Changes in physical activity self-assessment scores at 6, 12, and 18 months post-intervention	Physical activity self-assessment scores are captured on the Go NAPSACC website each time child care centers complete a self-assessment for that module. Each self-assessment items is scored 1-4 points, where higher points indicate closer compliance with best practices. Responses are then used to calculate a total score (total points/total possible points x 100). As an indicator of maintenance, self-assessment data will be extracted using the Go NAPSACC Physical Activity Self-Assessment Report pulled immediately post-intervention, as well as 6, 12, and 18 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.	Measures will be collected at 6, 12, and 18 months post-intervention
Secondary	Contextual factors scores- Culture, implementation climate, leadership engagement, and available resources	Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. Specifically, Fernandez's CFIR Inner Setting measure will be used to assess Culture, Culture Stress, Culture Effort, Implementation Climate, Leadership Engagement, and Available Resources. Items are scored 1-5. Items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual factors. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.	Measures collected 3-12 weeks prior to the start of intervention
Secondary	Contextual factors scores- Networks and communications and access to knowledge and information	Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. TCU's Organizational Readiness for Change Survey will be used to assess Networks and Communications and Access to Knowledge and Information. Items are scored 1-5 and items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual scores. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.	Measures collected 3-12 weeks prior to the start of intervention
Secondary	Contextual factors scores- Knowledge, beliefs, and consequences and self-efficacy	Contextual factors will be assessed using surveys completed by directors, teachers, and TA coaches. Seward's Theoretical Domains Framework Questionnaire will be used to assess Knowledge, Beliefs and Consequences, and Self-Efficacy. Items are scored 1-7. Items within subscales will be averaged to determine the scale score. Higher scores indicate better contextual scores. These scores will be used to examine how context predicts changes in nutrition and physical activity environment scores.	Measures collected 3-12 weeks prior to the start of intervention
Secondary	Cost of basic and enhanced implementation models	Costs of implementation include TA coaches time and any resources required to train and support centers for 12 months. Cost tracking will use the TA Activity Log to capture TA coaches' time and TA coaches will be asked to fill out a supplemental log of additional costs (e.g., mileage, printing). These data will be combined to calculate the total cost per center for implementing Go NAPSACC. Average cost per center for basic and enhanced implementation models will also be calculated. To explore the cost-effectiveness of basic and enhanced implementation models, these data will be combined with data on the change in nutrition and physical activity environment scores to calculate the incremental cost-effectiveness ratio (average incremental cost of delivering Enhanced Go NAPSACC relative to Basic Go NAPSACC divided by the average incremental change in effectiveness from delivering Enhanced Go NAPSACC relative to Basic Go NAPSACC).	Measures collected throughout the 1 year intervention period
Secondary	Change in children's diet quality served at child care from baseline to 12 months (exploratory)	Center-level dietary intake of food served to preschool children will be assessed via the foods and beverages provided section of the EPAO-SR as filled out online by the director on 2 different days of the week. Center-level served dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores to produce a center-level estimate of children's diet quality. Scores will range from 0-100, where scores closer to 100 will indicate higher diet quality.	Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention
Secondary	Change in time provided for physical activity for preschool children at child care from baseline to 12 months (exploratory)	A center-level score for time provided for active play for preschool children will be assessed via the daily activities section of the of the EPAO-SR as filled out online by 2 classroom teachers on 2 different days of the week. Active play time blocks will be summed each day and then averaged across the 2 days to calculate a center-level estimate, where higher scores indicate more active play time provided.	Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention