Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare
NCT ID: NCT03075085
Last Updated: 2021-09-05
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
696 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-26
Study Completion Date
2019-12-15
Brief Summary
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Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).
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Detailed Description
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Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).
Conditions
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Obesity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Investigators will use a Type 3 Hybrid Design to test the effectiveness of the enhanced implementation strategy (i.e., facilitation) on uptake while also assessing impacts of the intervention on child outcomes. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis. RE-AIM provides an evaluation framework to assess key aspects of intervention programs implemented in real-word settings. Investigators will modify and use The Organizational Readiness to Change Assessment (ORCA) as developed for use with the i-PARiHS framework to assesses change commitment (e.g., We value this change) and change efficacy (e.g., We can keep the momentum going) both prior to and during implementation.
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
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Basic WISE strategy
These participants will be asked to implement the basic WISE strategy used in previous studies.
Group Type
ACTIVE_COMPARATOR
WISE (We Inspire Smart Eating)
Intervention Type
BEHAVIORAL
An enhanced implementation strategy for evidence-based obesity prevention in childcare
Enhanced WISE strategy
These participants will be asked to implement the enhanced WISE strategy.
Group Type
EXPERIMENTAL
WISE (We Inspire Smart Eating)
Intervention Type
BEHAVIORAL
An enhanced implementation strategy for evidence-based obesity prevention in childcare
Interventions
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WISE (We Inspire Smart Eating)
An enhanced implementation strategy for evidence-based obesity prevention in childcare
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Early childhood educators from our partnering Head Start agency
* Children aged 3-5 years old in our partnering Head Start agency
* Children aged 3-5 years old in our partnering Head Start agency
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
University of Arkansas
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Taren M Swindle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Site Status
Countries
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United States
References
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Swindle T, McBride NM, Selig JP, Johnson SL, Whiteside-Mansell L, Martin J, Staley A, Curran GM. Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial. Implement Sci. 2021 May 1;16(1):48. doi: 10.1186/s13012-021-01119-x.
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Swindle T, Selig JP, Rutledge JM, Whiteside-Mansell L, Curran G. Fidelity monitoring in complex interventions: a case study of the WISE intervention. Arch Public Health. 2018 Aug 29;76:53. doi: 10.1186/s13690-018-0292-2. eCollection 2018.
Reference Type
DERIVED
Swindle T, Johnson SL, Whiteside-Mansell L, Curran GM. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial. Implement Sci. 2017 Jul 18;12(1):90. doi: 10.1186/s13012-017-0624-6.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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205335
Identifier Type: -
Identifier Source: org_study_id
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