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:

* Healthy, term infants and their mothers
* Infants 2 wks (+/- 2 wk of age)
* Mothers and infants exclusively breastfeeding or exclusively feeding a cows-milk based formula
* Mothers must be older than 18 years of age

Exclusion Criteria:

* Infants who were preterm or have medical conditions that interfere with feeding or eating
* Mothers who had gestational diabetes or are diagnosed with a major illness requiring treatment or surgery
* Mothers who will be going back to work full-time before the infant is 4 months old
* Mothers who are allergic to any vegetables
* Subjects will not be excluded because of economic status, gender, race or ethnicity.
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:

Caregivers

* Mothers and fathers (biologic/adoptive/step parents/legal guardians) of pediatric cancer survivors
* 18 years or older
* Fluent in English

Pediatric Cancer Survivors

* Diagnosis of cancer
* between 5-13 years of age at study entry
* off active cancer treatment for 6 months to 4 years,
* reside with a participating caregiver
* able to engage in PA tailored to current medical status
* NOT taking medications that affect body weight, e.g., steroids within 6 months of enrollment
* at or above the 85th BMI %ile.

Exclusion Criteria:

Caregivers

* are non-ambulatory
* do not reside with the PCS at least 50% of the time.

Pediatric cancer survivor

* relapse during the intervention
* taken a medication known to affect body weight such as oral steroids or antipsychotic medications within 6 months of enrollment
D: Inclusion Criteria:

* English-speaking
* Parent or legal guardian of a child in the household between the ages of two and 12 years
* Self-reported income less than 185% of the Federal Poverty Level or report enrollment in SNAP, WIC, or Head Start
* Has access to a computer from which s/he can complete on-line data collection
* Has an active e-mail account or willing to create an e-mail account
* Has not participated in CSA in the past three years
* Willing to purchase the 50% CO-CSA share (can use SNAP benefits if desired and available)
* Willing to attend CSA-tailored education sessions
* Willing to make a firm commitment to three years of participation (2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
* Complete baseline survey
* Pay deposit to farm

Exclusion Criteria:

* Non-English-speaking
* Not the parent or legal guardian of a child in the household between the ages of two and 12 years
* Self-reported income equal to or greater than 185% of the Federal Poverty Level and no report of SNAP, WIC, or Head Start enrollment
* Does not have access to a computer from which s/he can complete on-line data collection
* Does not have an active e-mail account or is not able or willing to create an e-mail account
* Has participated in CSA in the past three years
* Not able or willing to purchase the 50% CO-CSA share
* Not able or willing to attend CSA-tailored education sessions
* Not able or willing to make a firm commitment to three years of participation (for 2016 enrollment) or two years of participation (2017 enrollment), with timing of the off-set benefit determined by randomization
* Not able or willing to complete baseline survey
* Not able or willing to pay deposit to farm

Answer: B