Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: WISE (We Inspire Smart Eating)

• Registration Number: NCT03075085
• Lead Sponsor: University of Arkansas

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).

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Study Start: 2018-01-26
• Primary Completion: 2019-12-15
• Study Completion: 2019-12-15
• Results First Submitted: 2021-06-16
• Status Verified: 2021-07
• Results First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Results First Posted: 2021-09-05
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced WISE strategy	WISE (We Inspire Smart Eating)	These participants will be asked to implement the enhanced WISE strategy.
Basic WISE strategy	WISE (We Inspire Smart Eating)	These participants will be asked to implement the basic WISE strategy used in previous studies.

Primary Outcome Measures

Name	Time	Method
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices	From Baseline Up to 8 months	The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WISE.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States