Please select the eligibility criteria that correspond to the clinical trial below.
Title: Healthy Caregivers/Healthy Children
Brief Summary: Background: Many unhealthy dietary and physical activity habits that foster the development of obesity are established by the age of five. Presently, approximately 70 percent of children in the United States are currently enrolled in early childcare facilities, making this an ideal setting to implement and evaluate childhood obesity prevention efforts. We describe here the methods for conducting an obesity prevention intervention randomized trial in the child care setting.

Methods/Design: A randomized, controlled obesity prevention trial in 28 low-income, ethnically diverse child care centers located throughout Miami-Dade County, FL is currently being conducted over two years (2010-present) to test the efficacy of an intervention that poises teachers and parents as lifestyle change agents. The Healthy Caregivers-Healthy Children (HC2) program includes a curriculum focusing specifically on healthy food choices, increased exercise, and role modeling. The program targets food policy changes throughout the school, and via the child, caregiver, and teacher. Major outcome measures include child body mass index percentile and z score, fruit and vegetable and other nutritious food intake, and amount of physical activity.

Discussion: Although few attempts have been made to prevent obesity during the first years of life, this period may represent the best opportunity for obesity prevention. Findings from this investigation should inform both the fields of childhood obesity prevention and early childhood research about the effects of an obesity prevention program housed in the childcare setting. (H1) A child care center-based obesity prevention intervention program that includes a teacher and parent nutritional gatekeeper and role modeling program will be more effective in maintaining BMI in 3-5 year olds compared to a control group.

(H2) Role modeling (teacher and parent) will be identified as a significant mediator in preventing obesity among intervention children versus controls.

(H3) A child care center-based multi-level obesity prevention intervention program will improve child nutrition (increased consumption of fruits and vegetables, decreased consumption of sweetened beverages) and increase physical activity level compared to a control group.


Options:
A: Inclusion Criteria:

Local authorities:

* Local authorities providing data from at least 4 Children's Centres
* Courses delivered by trained staff who have been certified by HENRY

Children's Centres:

* At least one course to be delivered per Centre per year
* Sites with a history of providing process data for the previous year.

There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.

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Exclusion Criteria:

Local authorities:

* Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.

Children's Centres:

* Centres where ethnography has taken place during Study 2
* Centres who are not planning on running HENRY programmes during the trial period
B: Inclusion Criteria. Centers must have met the following criteria to be included: (1) have \> 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County 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. Studies were excluded if they did not meet these criteria.
C: Inclusion Criteria:

* Attendance from first to sixth grade
* Ages 6-12 years
* BMI ≥ 85th percentile for age and sex
* Hispanic origin
* Both parents Hispanic
* Low socioeconomic status
* Signed consent from both parents/care givers and active assent from children

Exclusion Criteria:

* Disapproval by the children's physician due to any at-risk medical condition known by the parents
D: Inclusion Criteria:

* FCCH must have at least 2 children between the ages of 1.5 and 4 years currently enrolled. \* At least 2 children/families must agree to take part for the FCCH to remain eligible. (Note: Children ages 0-17 months may take part in height and weight measurements only)
* FCCH must have been in business for at least 2 years.
* FCCH must have a working telephone number.
* Provider must be able to read and speak English.

Exclusion Criteria:

* FCCHs cannot serve exclusively special needs children.
* FCCHs cannot close down during the summer months.

Answer: B