Please select the arm or intervention descriptions that belong 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: Arm Label: Optimisation + HENRY; Type: EXPERIMENTAL; Interventions: Behavioral: Optimisation + HENRY | Arm Label: HENRY as standard; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HENRY as standard | Intervention Type: BEHAVIORAL; Name: Optimisation + HENRY; Assigned to Arm(s): Optimisation + HENRY | Intervention Type: BEHAVIORAL; Name: HENRY as standard; Assigned to Arm(s): HENRY as standard
B: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Other: Childhood Obesity | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Childhood Obesity; Assigned to Arm(s): Treatment
C: Arm Label: Individualized dietetic intervention; Type: OTHER; Interventions: Behavioral: Individualized dietetic intervention-eating habits | Intervention Type: BEHAVIORAL; Name: Individualized dietetic intervention-eating habits; Assigned to Arm(s): Individualized dietetic intervention
D: Arm Label: Healthy Lifestyles Group; Type: EXPERIMENTAL; Interventions: Behavioral: Keys to Healthy Family Child Care Homes | Arm Label: Healthy Business Group; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Keys to Healthy Family Child Care Homes | Intervention Type: BEHAVIORAL; Name: Keys to Healthy Family Child Care Homes; Assigned to Arm(s): Healthy Business Group, Healthy Lifestyles Group

Answer: B