Evaluation of an Enhanced Delivery Model for Go NAPSACC

NCT03938103 | Completed Results DMC

• 2 other identifiers: 19-0406R01HL137929
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

preschool; child care centers; nutrition; physical activity; organizational readiness; behavior change; cost-effectiveness; implementation

Outcome Measures

Primary Outcomes (2)

• Mean Nutrition Environment Score

  Each center's nutrition environment was 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 teachers. In addition, directors upload a month of menus and policy handbooks, which are reviewed and scored by a trained staff members. An overall nutrition environment score will be derived with scores ranging from 0-3, where higher scores indicate better (more supportive) nutrition environments.

  Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)

• Mean Physical Activity Environment Score

  Each center's physical activity environment was 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 teachers. In addition, directors upload policy handbooks, which were reviewed by a trained staff member. An overall physical activity environment score was derived with scores ranging from 0-3, where higher scores indicate better (more supportive) physical activity environments.

  Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)

Secondary Outcomes (12)

• Number of Centers That Created a Go NAPSACC Website Account

  Measures collected 3-12 weeks prior to start of intervention (Baseline)

• Go NAPSACC Core Program Components Completed by Centers

  Measures collected during the 1 year intervention period.

• Percent of Nutrition Best Practices Met Computed From Self-assessments Completed on Go NAPSACC Website

  Within 3 months of starting intervention and again within 12 months of initiating intervention

• Percent of Physical Activity Best Practices Met Computed From Self-assessments Completed on Go NAPSACC Website

  Within 3 months of starting intervention and again within 12 months of initiating intervention

• Contextual Setting (Director Report) - Impact of Center Culture, Implementation Climate, Leadership Engagement, Available Resources, and Information Access at Baseline on Intervention Effects

  Measures collected 3-12 weeks prior to start of intervention (Baseline) and 1-8 weeks post-12-month intervention (Follow-up)

Study Arms (2)

Enhanced Go NAPSACC

EXPERIMENTAL

Enhanced delivery model

Behavioral: Enhanced Go NAPSACC

Basic Go NAPSACC

ACTIVE COMPARATOR

Basic delivery model

Behavioral: Basic Go NAPSACC

Interventions

Enhanced Go NAPSACC BEHAVIORAL

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.

Enhanced Go NAPSACC

Basic Go NAPSACC BEHAVIORAL

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.

Basic Go NAPSACC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Child Care Centers
• Serve special needs children exclusively
• Serve only non-English speaking families

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Kentucky: collaborator
• Child Care Aware of Kentucky: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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.

  PMID: 29587804 BACKGROUND

• 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.

  PMID: 21443294 BACKGROUND

• 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.

  PMID: 28376892 BACKGROUND

• 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.

  PMID: 18949660 BACKGROUND

• 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.

  PMID: 31805973 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Derek Hales, PhD
• Organization: University of North Carolina at Chapel Hill

derekh@email.unc.edu

919-966-6089

Study Officials

• Dianne Ward, EdD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Derek Hales, PhD

  University of North Carollina at Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 6, 2019
• Study Start: April 10, 2019
• Primary Completion: October 7, 2022
• Study Completion: December 31, 2022
• Last Updated: August 15, 2024
• Results First Posted: August 15, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)