Please select the eligibility criteria that correspond to the clinical trial below.
Title: Healthy Caregivers-Healthy Children (HC2) Phase II: Integrating Culturally Sensitive Childhood Obesity Prevention Strategies Into Policy
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.


Options:
A: Inclusion Criteria:

TA Coaches

* Must either be a Quality coach or a Health and Safety coach
* Must be able to read and speak English

Child Care Centers

* Must be a part of a participating TA coach's current caseload
* Have no plans to close in the coming year
* Serve at least lunch to the children
* Not serve special needs children exclusively

Child Care Providers

* Teacher must be the lead teacher in a preschool classroom
* Center directors and teachers must be able to read and speak English

Exclusion Criteria:

Child Care Centers

* Serve special needs children exclusively
* Serve only non-English speaking families
B: Inclusion Criteria:

* SITE level Local authorities (or other associations that commission HENRY in Children's Centres), Children's Centres and parents meeting all of the relevant inclusion criteria, and none of the relevant exclusion criteria, will be considered for participation in the study.

Local authorities (and service providers if applicable):

* Local Authorities must nominate a minimum of 6 Children's Centres and formally agree to allow randomisation of the Centres. Where possible, Centres should be in geographically separate areas to protect against contamination (judged on a case by case basis). Local authorities using external teams outside of the Centre to deliver HENRY programmes (e.g. health visitors) will be eligible, in addition to those wishing to train internal Centre staff to deliver programmes (the most common model currently used).
* Included local authorities may be completely new to HENRY (having never trained or delivered HENRY) or contain at least 6 Centres that are within HENRY 'naïve' clusters. Clusters are defined as a number of Children's Centres that are close to each other or grouped for management purposes. HENRY naive clusters are:
* A group of Centres within a cluster that do not include any Centres that are (a) currently delivering HENRY or (b) have been trained to, or delivered HENRY within the past 2 years.

PARENT level The target population for the intervention are parents of preschool children; mothers, fathers and carers (e.g. with children living in stable /long-term foster care).

* Parents must have at least 1 child aged 6 months - 5 years (18 months-6 years at follow-up). If more than one child in the family fulfils eligibility criteria, the youngest child (by birth timing if twins) will be considered as the reference child (from which data will be collected).
* Parents must be willing to attend the programme sessions (intervention Centres) and willing to provide data in accordance with the data collection protocol. Parents will be provided with full details of the data collection requirements in advance so that they can make informed decisions as to whether to participate.
* Parents must speak English, unless they wish to bring their own interpreter with them (e.g. family member) (the intervention and data collection forms are currently only available in English).

Exclusion Criteria:

* - SITE level

  * Children's Centres that have delivered HENRY programmes within the last 2 years or where staff have received HENRY training within the last 2 years.

PARENT level

* Parents with severe learning difficulties that preclude them taking part in group sessions in which they need to be able to read and write, judged on a case by case basis with consultation with the HENRY team where appropriate.
* Parents whose reference child is tube fed (PEG or nasogastric) or with other known clinical conditions likely to affect growth over the period of the trial (e.g. cancer, coeliac disease, or renal or cardiac problems). A detailed list of excluded conditions will be provided at screening, with any uncertainties resolved via clinical input from the HENRY team.
* Parents who have attended a HENRY group for a previous child.
C: Inclusion Criteria:

* In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy.

Exclusion Criteria:

* If the randomly selected child care center has an open case of child abuse or neglect.
D: 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.

Answer: D