Clinical trial NCT03075085: Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare
Official title: Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-03-09
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Early childhood educators from our partnering Head Start agency

Exclusion Criteria:

* Secondary Outcome Inclusion Criteria:
* Children aged 3-5 years old in our partnering Head Start agency

Primary outcomes:
measure: Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
timeFrame: From Baseline Up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Taren M Swindle, PhD
role: PRINCIPAL_INVESTIGATOR
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