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Evaluation of an Enhanced Delivery Model for Go NAPSACC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Enhanced Go NAPSACC Behavioral: Basic Go NAPSACC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : June 2022

Arm Intervention/treatment
Experimental: Enhanced Go NAPSACC
Enhanced delivery model
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.

Active Comparator: Basic Go NAPSACC
Basic delivery model
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938103


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
United States, North Carolina
UNC Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
University of Kentucky
Child Care Aware of Kentucky
Investigators
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Principal Investigator: Dianne Ward, EdD University of North Carolina, Chapel Hill
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03938103    
Other Study ID Numbers: 19-0406
R01HL137929 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
preschool
child care centers
nutrition
physical activity
organizational readiness
behavior change
cost-effectiveness
implementation
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms