Please select the eligibility criteria that correspond 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: * INCLUSION CRITERIA:

  1. Child age 8.0-16.9 years
  2. T1D: classical presentation and/or antibody positivity
  3. Diabetes duration greater than or equal to 12 months
  4. Daily insulin dose greater than or equal to 0.5 units/kilogram
  5. Hemoglobin A1c greater than or equal to 7.0% and less than or equal to 9.5%
  6. Insulin regimen

     * a. Greater than or equal to 3 injections daily, OR
     * b. Continuous subcutaneous insulin infusion (insulin pump) (CSII)
  7. Blood glucose monitoring frequency: Greater than or equal to 3 checks daily
  8. Stable living situation (guardian and address) for greater than or equal to 6 months
  9. Joslin Clinic attendance

     * a. At least one Joslin Clinic visit in last year, AND
     * b. Anticipated care at Joslin Clinic for duration of study

EXCLUSION CRITERIA:

1. Daily use of premixed insulin
2. Transition to CSII (insulin pump) therapy in last 3 months
3. Continuous glucose monitoring use in last 3 months
4. Participation in a different intervention study in the last 6 months
5. Presence of co-morbid conditions (any of the following):

   * a. Celiac disease, inflammatory bowel disease, or other significant gastrointestinal condition
   * b. Systemic glucocorticoid use (cumulative 1 month during last year)
   * c. Significant multiple food allergies
   * d. Significant mental illness defined by either:

     * 1. Major psychiatric disorder (e.g., eating disorder, major psychoses), OR
     * 2. Inpatient psychiatric admission during last 6 months
6. Significant medical or psychiatric illness in caregiver that would prevent active participation in the study
7. Intent to enroll in another intervention study during the course of this study
B: Inclusion Criteria:

* Healthy singleton term born infants of appropriate size for gestational age (AGA) according to the Centers for Disease Control growth charts based on weight at birth between the 5th and 95th percentiles for sex; and born to healthy breastfeeding women. This allows us to assess growth and bone mineral accretion without bias of intrauterine growth restriction.

Exclusion Criteria:

* Infants of mothers with history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes due to malabsorption of vitamin D (celiac disease, Crohn's etc.); and multiple births.
* Should any exclusion criteria be identified after recruitment, the infant will be excluded from the main analyzes, but followed in a separate arm as intent-to-treat.
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:

* Healthy
* non-patient
* normals
* African-american
* Hispanic-american
* 3 to 5 y olds

Exclusion Criteria:

* pregnant woman
* neonates
* dietary restrictions
* chronic disease
* developmental disabilities
* special education
* does not read or write in spanish or english

Answer: C