Please select the eligibility criteria that correspond to the clinical trial below.
Title: Healthy Children, Strong Families: American Indian Communities Preventing Obesity
Brief Summary: Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. The study works with six rural and urban American Indian communities across the US to test the ability of the intervention to increase adoption of healthy lifestyles and to reduce the prevalence of obesity among preschool aged American Indian children and their primary caregivers - creating healthier children, healthier families and healthier communities. Our primary hypothesis is that children and their primary caregivers who receive the HCSF-2 intervention will have better obesity related outcomes than those who do not receive HCSF-2.


Options:
A: Inclusion Criteria:

* Children must be enrolled in participating childcare centers.

Exclusion Criteria:

* Allergy or intolerance to any of the foods or beverages served.
B: 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
C: Inclusion Criteria:

* Adult caregiver with a 2-5 year old child
* 2-5 year old child with a caregiver
* Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
* Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
* Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
* Valid mailing address where participant can receive mail and packages
* Basic English fluency and literacy sufficient for understanding the intervention materials and completing questionnaires

Exclusion Criteria:

* Adults with no children or whose only children are younger than 2 or older than 5
* Children younger than 2 or older than 5 years of age
* No cell phone or unwilling to receive regular text messages as part of study participation
* Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
* Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
* No valid mailing address
* Unwillingness to accept random allocation to study arm
* Spouse/partner of another caregiver-child pair who is living in same home \& who has already enrolled (e.g. only one adult-child pair per household may be enrolled)
D: * 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

Answer: C