Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Site Specific Approaches to Prevention or Management of Pediatric Obesity: Child Health Initiative for Lifelong Eating and Exercise--CHILE
Brief Summary: Child Health Initiative for Lifelong Eating and Exercise (CHILE) is a trans-community multidisciplinary site-specific intervention and evaluation plan for a Head Start and family-based culturally and developmentally appropriate intervention. The primary goals are to increase physical activity and improve dietary intake through increased consumption of fruits, vegetables and whole grain and decrease consumption of sweetened drinks and high-fat foods,decrease television and other screen time, and decrease obesity in three to five year old Hispanic and American Indian children enrolled in Head Start programs in rural New Mexico. The trans-community intervention includes: A classroom curriculum for children; an in-service training program for Head Start teachers and educational aides; a school food service component; a family intervention; a community leader/local health care provider component; and a grocery store component.

Participants include 16 Head Start programs serving Hispanic and Native American children and families from underserved communities in rural New Mexico. This is a randomized trial with an Intervention Condition and Control Condition. One cohort of three-year old Head Start students will be followed and measured for two years. During the two years in Head Start those children, their teachers, and families enrolled in the Intervention Condition will receive a program of activities to modify their dietary, physical activity, and screen viewing behaviors. Also addressed are the Head Start and community environments and policies, local grocery stores, and health care providers.

CHILE uses an ecological framework including social cognitive theory, intervention mapping, environmental and policy changes, developmental theory, and sound educational practices. The approach includes in from the community to ensure acceptability, cultural appropriateness, feasibility, sustainability, and later transferability to similar communities.

The primary outcome measures include changes in physical activity levels, dietary fiber intake, dietary fat intake, intake of sugared drinks, television viewing and other screen time, in BMI. Secondary measures include changes in the Head Start and community environments and policies related to physical activity, school food service, school snacks, and availability of healthful options. We will also examine the role of community leaders, especially health care providers, in raising awareness and creating a supportive and sustainable environment for the prevention of obesity.


Options:
A: Arm Label: Little Holy One intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules | Arm Label: Nutrition control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active nutrition control | Intervention Type: BEHAVIORAL; Name: Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules; Assigned to Arm(s): Little Holy One intervention | Intervention Type: BEHAVIORAL; Name: Active nutrition control; Assigned to Arm(s): Nutrition control
B: Arm Label: 1- physical activity tailored; Type: EXPERIMENTAL; Interventions: Behavioral: physical activity tailored | Arm Label: 2 - physical activity standard; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: physical activity standard | Intervention Type: BEHAVIORAL; Name: physical activity tailored; Assigned to Arm(s): 1- physical activity tailored | Intervention Type: BEHAVIORAL; Name: physical activity standard; Assigned to Arm(s): 2 - physical activity standard
C: Arm Label: intervention 1; Type: EXPERIMENTAL; Interventions: Behavioral: classroom curriculum, Behavioral: In-service training for Head Start teachers/aides, Behavioral: Training for Head Start food service, Behavioral: Family intervention component, Behavioral: Food source, Behavioral: Health care providers, Behavioral: CHILE Head Start Intervention | Arm Label: control 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: classroom curriculum; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: In-service training for Head Start teachers/aides; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: Training for Head Start food service; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: Family intervention component; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: Food source; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: Health care providers; Assigned to Arm(s): intervention 1 | Intervention Type: BEHAVIORAL; Name: CHILE Head Start Intervention; Assigned to Arm(s): intervention 1
D: Intervention Type: DRUG; Name: Fluoride varnish; Assigned to Arm(s): N/A

Answer: C