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

August 10, 2021 updated by: University of Arkansas
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

696

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Basic WISE strategy
These participants will be asked to implement the basic WISE strategy used in previous studies.
Behavioral: WISE (We Inspire Smart Eating)
An enhanced implementation strategy for evidence-based obesity prevention in childcare
Experimental: Enhanced WISE strategy
These participants will be asked to implement the enhanced WISE strategy.
Behavioral: WISE (We Inspire Smart Eating)
An enhanced implementation strategy for evidence-based obesity prevention in childcare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Educators' Observed Implementation Fidelity Scores for Use of Evidence-Based Obesity Practices
Time Frame: 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.
From Baseline Up to 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Taren M Swindle, PhD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2018

Primary Completion (Actual)

December 15, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205335
  • K01DK110141-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on WISE (We Inspire Smart Eating)

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  • Harvard Pilgrim Health Care
    Brigham and Women's Hospital; Centers for Disease Control and Prevention; University... and other collaborators
    Active, not recruiting
    The INSPIRE-ASP PNA Trial
    Pneumonia
    United States
  • University of Edinburgh
    NHS Tayside
    Completed
    Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
    Anorexia Nervosa | Bulimia Nervosa | Binge Eating Disorder | Other Specified Feeding or Eating Disorder
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