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. 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.
B: Inclusion Criteria:

* Enrolling in WIC for the first time for that pregnancy or infant
* Able to complete interviews in either English or Spanish

Exclusion Criteria:

* Having enrolled in WIC previously for that pregnancy or child
* The child being older than 2.5 months old at the time of recruitment
* Adolescent mothers under age 16 were not eligible to participate.\\
* Adolescents who were in foster care at the time of enrollment were not eligible to participate, as foster parents cannot typically provide consent for research participation.
* Foster parents who were enrolling foster infants in WIC also were not eligible, as they cannot provide consent for the child's records.
* As defined by HHS regulations at 45 CFR part 46.303(c), prisoners were excluded from this research.
C: Inclusion Criteria:

* 3 years of age of beginning of intervention for each cohort (2)
* enrolled in participating Head Start
* informed consent signed by parent or legal guardian

Exclusion Criteria:

* 4 years of age or more at beginning of intervention for each cohort (2)
* not enrolled in a participating Head Start
* informed consent not provided
D: Inclusion Criteria:

* full-term infant(\> 37 0/7 weeks gestational age)discharged from hospital without significant morbidity
* singleton infant
* nursery/NICU/maternity stay of 7 days or less
* primiparous mother
* English speaking mother

Exclusion Criteria:

* presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease
* any major maternal morbidities and/or pre-existing condition that would affect postpartum care such as cancer, multiple sclerosis, lupus, etc.
* maternal age \<=20 years
* prenatal ultrasound presence of intrauterine growth retardation (IUGR)
* infant birth weight \<2500 grams plan for newborn to be adopted
* plan to move from Central Pennsylvania within 3 years
* inability to complete contact form with name, address, phone numbers, etc.
* Practicing pediatrician or pediatric resident

Answer: A