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

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ClinicalTrials.gov Identifier: NCT03075085
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Obesity Behavioral: WISE (We Inspire Smart Eating) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 940 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare
Actual Study Start Date : January 26, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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. Additionally, overall scores on the fidelity form are created by summing scores across items (range = 0 - 32). Inter-rater reliability of 85% will be ensured.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075085


Contacts
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Contact: Taren Swindle, PhD (501)526-7058 tswindle@uams.edu

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Taren Swindle, PhD    501-526-7058    tswindle@uams.edu   
Sponsors and Collaborators
University of Arkansas
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Taren M Swindle, PhD University of Arkansas

Publications:
Levi J, Segal L, St. Laurent R, Rayburn J. The state of obesity: Better policies for a healthier America. Princeton (NJ): Robert Wood Johnson Foundation and Trust for America's Health; 2014 Sept. Available from: http://www.rwjf.org/en/library/research/2014/09/the-state-of-obesity.html
Segal LM, Rayburn J, Martin A. Adult Obesity in the United States. Princeton (NJ): Robert Wood Johnson Foundation and Trust for America's Health; 2015. Available from: http://stateofobesity.org/adult-obesity/
Frisvold DE, Lumeng JC. Expanding exposure: Can increasing the daily duration of head start reduce childhood obesity? The Journal of Human Resources 46(2): 373-402, 2011.
Thomsen MR, Nayga RM, Alviola PA, Rouse HL. The effect of food deserts on the body mass index of elementary school children. American Journal of Agricultural Economics 98(1): 1-18, 2015.
Dev DA, Speirs KE, McBride BA, Donovan SM, Chapman-Novakofski K. Head Start and child care providers' motivators, barriers and facilitators to practicing family-style meal service. Early Childhood Research Quarterly 29(4): 649-659, 2014.
Child Care Aware of America. Child care in America: 2012 state fact sheets; 2012. Available from: http://usa.childcareaware.org/advocacy-public-policy/resources/reports-and-research/
Whiteside-Mansell L, Bradley R, Conners N, Bokony P. The family map: Structured family interview to identify risks and strength in Head Start families. NHSA Dialog 10(3-4): 189-209, 2007.
Darvin ME, Sterry W, Lademann J, Vergou T. The role of carotenoids in human skin. Molecules 16(12): 10491-10506, 2011.
Darvin ME, Gersonde I, Meinke M, Sterry W, Lademann J. Non-invasive in vivo determination of the carotenoids beta-carotene and lycopene concentrations in the human skin using the Raman spectroscopic method. Journal of Physics D: Applied Physics 38(15): 2696, 2005.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03075085     History of Changes
Other Study ID Numbers: 205335
K01DK110141-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms