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Healthy Caregivers-Healthy Children (HC2) Phase II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02697565
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : March 7, 2019
Information provided by (Responsible Party):
Ruby Natale, University of Miami

Brief Summary:
One in four U.S. children under the age of 5 years old are either overweight or obese with ethnic-minority children being disproportionately affected. Low-income preschool children, many from ethnic minority backgrounds, receive childcare in federal/state subsidized centers where daily meals are provided. Nationally, the Quality Rating and Improvement Systems (QRIS) organization is responsible for rating the quality of childcare centers. However, nutrition and physical activity policy standards have not been incorporated into QRIS childcare center policies. Therefore, the goal of this project is to address the 2014 AFRI program area priority of Childhood Obesity Prevention by building on the phase I "Healthy Caregivers, Healthy Children (HC2)" NRI/AFRI funded project (2010-2013), in partnership with the Miami Dade County Cooperative Extension team, to evaluate the program via randomized-controlled trial outcomes, and deliver an evidence-based effective childcare center-based program/toolkit. This project (phase II) will expand HC2 Phase I findings by transferring the evidence-based HC2 program/toolkit to QRIS childcare centers via a train-the-trainers (TTT) model. The following specific aims are proposed; (1) to evaluate the TTT model of delivery for the evidence-based HC2 toolkit's effectiveness versus an attention control on parent and teacher adoption of healthy lifestyle role modeling behaviors, and policy integration; (2) to evaluate the impact of a TTT delivery model versus an attention control on child body composition and short- and long-term behavioral health outcomes, and (3) to disseminate the HC2 early childhood obesity prevention toolkit TTT model within the QRIS early childhood network at the Miami Dade County-level.

Condition or disease Intervention/treatment Phase
Pediatric Obesity Obesity Behavioral: Healthy Caregivers- Healthy Children Toolkit Behavioral: Safety Curriculum Not Applicable

Detailed Description:

While all states are responsible for childcare licensing standards, 26 states serving over 1 million preschool-age children currently implement QRIS. In MDC, QRIS-affiliated childcare facilities (collectively called Quality Counts or QC centers from this point forward) provide care to 1/3 of MDC's preschool-age children (80% are ethnic minorities) in 417 centers. At this time there are no nutrition policies included in the QRIS standards for childcare centers. Therefore, in light of the current childhood obesity epidemic, this project will address a major gap in knowledge and the disparities in access to healthy food consumption in the childcare center setting through HC2 implementation.

This study builds on previously funded work and will maximize the initial 3-year (2010-2013) investment the USDA made in phase I of the project to test effective obesity prevention strategies in the early childhood setting utilizing both educators and parents as nutritional gatekeeper, healthy lifestyle role models for 2-to-5 year-old children. The goal of this proposed project (phase II) is to expand the phase I evidence-based HC2 findings by giving ownership of the program/toolkit to the childcare centers via a train-the-trainers model and by implementing nutrition and physical activity standards into the Quality Rating Improvement System.

The proposed integrated project is responsive to the USDA's National Institute of Food and Agriculture (formerly CSREES) functions by addressing all three areas of the agricultural knowledge system, including (1) a scientifically-based and rigorous Research design that assesses obesity prevention efforts with young children in a novel setting of childcare facilities; (2) the development of an Educational tool kit to improve training and capacity of teachers and parents/families. Extension and capacity building will be enhanced through HC2 toolkits delivered to the centers and train-the-trainer program manuals for use throughout the QRIS network and in cooperation with Florida FNP. Finally, by incorporating HC2 practices into permanent QRIS policy, centers can sustain the project's benefits for future children, teachers, and families. Additionally, the investigators will collaborate with two community nutritionists to provide services to a large number of childcare centers in the county therefore, extending project materials. Lastly, the toolkit will sustain education and extension functions beyond the life of the project by giving ownership of HC2 to the childcare centers.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Caregivers-Healthy Children (HC2) Phase II: Integrating Culturally Sensitive Childhood Obesity Prevention Strategies Into Policy
Study Start Date : April 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Train-the-Trainers Arm
Intervention Arm receives the Healthy Caregivers- Healthy Children Toolkit (healthy lifestyle role modeling intervention) via a nutritional gate keeper. The toolkit reinforces center health and activity policy standards.
Behavioral: Healthy Caregivers- Healthy Children Toolkit
The treatment arm will receive the train-the-trainer model (utilizing Quality Counts coaches) to deliver the evidence- based HC2 toolkit.

Attention Control Arm
Control Arm that receives an attention control safety curriculum.
Behavioral: Safety Curriculum
Centers randomized to the control arm will receive an attention control consisting of three visits from 'Safety Sam,' a character and safety curriculum that was fully developed and implemented in phase I of HC2. The same delivery model (train-the-trainers utilizing Quality Counts coaches) will be implemented.

Primary Outcome Measures :
  1. Change in The Environment and Policy Assessment and Observation tool (EPAO) score [ Time Frame: 3 years ]
    The EPAO will examine childcare center environmental changes. The EPAO will assess the level of implementation of the snack, screen time, physical activity, and beverage policies through direct observation of diet and physical activity. Child health behaviors and parent and teacher health behaviors will also be measured.

Secondary Outcome Measures :
  1. Observed pre-post maintenance on Child's Body Mass Index (BMI) [ Time Frame: 2 years ]
    BMI is based on height and weight of the child as per CDC guidelines

  2. Change of caregiver role modeling behavior [ Time Frame: 2 years ]
    The HC2 self assessment tool has a role modeling scale, measuring role modeling behavior

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • QC centers must meet the following criteria to be included: (1) have > 30 children ages 2-5 enrolled; (2) Serve low income families; (3) be a part of the USDA food program and Supplemental Nutrition Assistance Program (SNAP) eligible; (3) Reflect the ethnic diversity of the MDC Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment (see Documents of Collaboration).

Exclusion Criteria:

  • Centers with a high prevalence of special needs children.

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 identifier (NCT number): NCT02697565

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Ruby Natale, PhD, PsyD University of Miami
Natale R, Page M, Sanders L. Nutrition and physical activity practices in childcare centers versus family childcare homes. Early Childhood Educ J. 2013; [Epub] DOI 10.1007/s10643-013-0607-4.
American Academy Of Pediatrics, American Public Health Association, National Resource Center for Health and Safety in Child Care and Early Education. 2011. Caring for our Children: National health and safety performance standards; Guidelines for early care and education programs. 3rd edition. Elk Grove Village, IL: American Academy of Pediatrics; Washington, DC: American Public Health Association. Available at
Institute of Medicine. Early Childhood Obesity Prevention Policies. Washington, DC: National Academy Press; 2011.
Ball SC, Benjamin SE, Hales DP, Marks J, McWilliams, P, Ward DS. The Environment and Policy Assessment and Observation (EPAO) Child Care Nutrition and Physical Activity Instrument. Chapel Hill, NC: Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill; 2005.
Benjamin SE. Preventing Obesity in the Child Care Setting: Evaluating State Regulations. Accessed October 22, 2010.
Townsend MS, Slyva K, Davidson C, Leavens L, Sitnick SL, Design: Chao LK. Healthy Kids: Pediatric Obesity Risk Assessment Tool. [45 items reflecting 23 behaviors and 12 determinants of obesity identified in our research.] University of California Cooperative
McAlearney, Edwards. Organizational Readiness to Change Survey, Version 2.0. Published 2008. Accessed January 12, 2014.
Townsend M, Kaiser L, Graphic Designer: Chao LK. Fruit and Vegetable Inventory. Accessed March 25, 2014.
U.S. Department of Health and Human Services, HRSA: Health Resources and Services. Growth Charts Training. Administration, Maternal and Child Health Bureau,. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention; 2008. nhanes_01_02/body_measures_year_3.pdf. Accessed January 5, 2014.
U.S. Center for Disease Control, National Center for Chronic Disease Prevention and Health Promotion, Division of Nutrition, Physical Activity and Obesity. Obesity among low-income preschool children. Retrieved June 16, 2014 from
Birch LL, Anzman SL. Learning to eat in an obesogenic environment: A developmental systems perspective on childhood obesity. Child Dev Persp. 2010; 4:138-143.
Natale R, Messiah SE, Lopez-Mitnik G, Barth J, Sanders L. Prevalence of overweight and related health behaviors in an inner-city minority preschool population. Int J Interdisc Soc Sci. 2008;(3)4:17-28.
Fox M, Glantz F, Endahl J, J. W. Early Childhood and Child Care Study. Alexandria, VA: 1 Bibliography & References Cited U.S. Department of Agriculture; 1997.
Bandura A. Social Foundations of Thought and Action: A Social Cognitive Theory. Upper Saddle River, NJ: Prentice Hall;1986.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ruby Natale, Associate Professor of Clinical Pediatrics, University of Miami Identifier: NCT02697565    
Other Study ID Numbers: 20140876
2015-68001-23232 ( Other Grant/Funding Number: USDA )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Keywords provided by Ruby Natale, University of Miami:
childhood obesity
role model
pediatric obesity
early childhood
train the trainer
Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight