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Evaluation of an Enhanced Delivery Model for Go NAPSACC

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ClinicalTrials.gov Identifier: NCT03938103
Recruitment Status : Suspended (Temporarily halted as a precautionary measure due to COVID-19 pandemic.)
First Posted : May 6, 2019
Last Update Posted : May 6, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Kentucky
Child Care Aware of Kentucky
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date May 6, 2020
Actual Study Start Date  ICMJE April 10, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
Change in nutrition and physical activity environment score from baseline to 12 months [ Time Frame: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention ]
Each center nutrition and physical activity environment will be assessed using the Environment and Policy Assessment and Observation (EPAO), an observational measure conducted by trained data collectors during a 1-day site at the center. 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Number of participating centers [ Time Frame: Measures collected 3-12 weeks prior to start of intervention ]
    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.
  • Percent of Go NAPSACC core program components completed by centers [ Time Frame: Measures collected during the 1 year intervention period. ]
    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.
  • Percent of Go NAPSACC core program components completed by TAs [ Time Frame: Measures collected during the 1 year intervention period. ]
    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.
  • Changes in child nutrition self-assessment scores at 6 and 12, and 24 months post-intervention [ Time Frame: Measures will be collected at 6, 12, and 24 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 24 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.
  • Changes in physical activity self-assessment scores at 6, 12, and 24 months post-intervention [ Time Frame: Measures will be collected at 6, 12, and 24 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 24 months post to calculate changes in scores over time. No change and/or positive change would indicate that the intervention effect was maintained.
  • Contextual factors scores- Culture, implementation climate, leadership engagement, and available resources [ Time Frame: Measures collected 3-12 weeks prior to the start of intervention ]
    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.
  • Contextual factors scores- Networks and communications and access to knowledge and information [ Time Frame: Measures collected 3-12 weeks prior to the start of intervention ]
    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.
  • Contextual factors scores- Knowledge, beliefs, and consequences and self-efficacy [ Time Frame: Measures collected 3-12 weeks prior to the start of intervention ]
    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.
  • Cost of basic and enhanced implementation models [ Time Frame: Measures collected throughout the 1 year intervention period ]
    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).
  • Change in children's diet quality at child care from baseline to 12 months [ Time Frame: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention ]
    Dietary intakes of three 3-4-year-old children will be assessed via direct observation of foods consumed at child care using the Diet Observation at Child Care protocol. Child dietary intake data will be used to calculate Healthy Eating Index 2015 (HEI2015) scores. HEI2015 scores from individual children will then be averaged 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.
  • Change in children's physical activity at child care from baseline to 12 months [ Time Frame: Measures collected 3-12 weeks prior to start of intervention and 1-8 weeks post-12-month intervention ]
    Physical activity of 3-4-year-old children will be assessed via accelerometry using ActiGraph monitors worn on the wrist while at child care. Age appropriate cut-points will be applied to calculate minutes spend in different levels of physical activity (sedentary, light, moderate, and vigorous). Activity data from individual children will then be averaged to calculate a center-level estimate of time spend in moderate to vigorous physical activity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of an Enhanced Delivery Model for Go NAPSACC
Official Title  ICMJE A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
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 25 TA coaches from Child Care Aware of Kentucky and 97 child care centers from 4 regions of central Kentucky.

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.

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.

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.

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 hour-long trainings and a homework assignment. Trainings 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. TA coaches assigned to Enhanced Go NAPSACC will participate in 4 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.

POST-INTERVENTION MEASURES: Measures will be repeated following 12 months of Go NAPSACC participation. Given the high turn-over in child enrollment over a 1-year period, parent and child recruitment will need to be repeated. Data collection procedures will be the same as those used above. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Enhanced Go NAPSACC
    Enhanced delivery model
    Intervention: Behavioral: Enhanced Go NAPSACC
  • Active Comparator: Basic Go NAPSACC
    Basic delivery model
    Intervention: Behavioral: Basic Go NAPSACC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019)
1189
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Have at least 3 parents from a randomly selected 3-4-year-old classroom consent for their children to participate
  • Serve at least lunch to the children
  • Not serve special needs children exclusively

Child Care Providers

  • Teacher must be the lead teacher in a 3-4-year-old classroom
  • Center directors and teachers must be able to read and speak English

Children

  • Must be enrolled in the randomly selected 3-4-year-old classroom
  • The consenting primary caregiver of the child must be able to read and speak English
  • Special needs children must not have a chronic health issue that severely impacts their diet and physical activity

Exclusion Criteria:

Child Care Centers

  • Serve special needs children exclusively
  • Serve only non-English speaking families
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03938103
Other Study ID Numbers  ICMJE 19-0406
R01HL137929 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
Access Criteria: The investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Kentucky
  • Child Care Aware of Kentucky
Investigators  ICMJE
Principal Investigator: Dianne Ward, EdD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP