Healthy Caregivers-Healthy Children (HC2) Phase II
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|ClinicalTrials.gov Identifier: NCT02697565|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pediatric Obesity Obesity||Behavioral: Healthy Caregivers- Healthy Children Toolkit Behavioral: Safety Curriculum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2289 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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
- Change of caregiver role modeling behavior [ Time Frame: 2 years ]The HC2 self assessment tool has a role modeling scale, measuring role modeling behavior
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): NCT02697565
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Ruby Natale, PhD, PsyD||University of Miami|