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

NCT03075085 | Completed Results

• 2 other identifiers: 205335K01DK110141-01
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices

  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.

  From Baseline Up to 8 months

Study Arms (2)

Basic WISE strategy

ACTIVE COMPARATOR

These participants will be asked to implement the basic WISE strategy used in previous studies.

Behavioral: WISE (We Inspire Smart Eating)

Enhanced WISE strategy

EXPERIMENTAL

These participants will be asked to implement the enhanced WISE strategy.

Behavioral: WISE (We Inspire Smart Eating)

Interventions

WISE (We Inspire Smart Eating) BEHAVIORAL

An enhanced implementation strategy for evidence-based obesity prevention in childcare

Basic WISE strategy; Enhanced WISE strategy

Eligibility Criteria

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

You may qualify if:

• Early childhood educators from our partnering Head Start agency

You may not qualify if:

• Children aged 3-5 years old in our partnering Head Start agency

Sponsors & Collaborators

• University of Arkansas: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

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• 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.

  PMID: 28720140 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

SOSTDC1 protein, human

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The turnover documented in this study (43% of teacher positions overall) is notably higher than national estimates for Head Start turnover (17-20%). Further, the uncertainty of the program's funding and the news of coming layoffs and site/classroom moves near the end of the trial were disruptive. The research team adapted to these changes in delivery of implementation strategies (e.g., facilitation to new educators) and data interpretation (i.e., focus on univariate analyses).

Results Point of Contact

• Title: Dr. Taren Swindle
• Organization: University of Arkansas for Medical Sciences

tswindle@uams.edu

870-236-0997

Study Officials

• Taren M Swindle, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 9, 2017
• Study Start: January 26, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: September 5, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)