Please select the eligibility criteria that correspond to the clinical trial below.
Title: Linking Primary Care, Communities and Families to Prevent Obesity Among Preschoolers
Brief Summary: The goal of the Minnesota center is to integrate primary care, home, and community-based intervention strategies to promote sustained patterns of change in food intake, physical activity, and body weight among low income, ethnically diverse children. A culturally matched family connector will create linkages among the settings to support parents in making home environment and parenting behavior changes conducive to healthy growth and development in their children.

Specific Aim 1 To evaluate the effects of a three-year multi-setting parent-targeted randomized controlled intervention on the primary outcome, child BMI, compared to a standard primary care-only intervention among 500 low income ethnic minority two to four year old children who are at or above the 50th percentile of BMI for age and gender.

Hypothesis 1: Children in the multi-setting parent-targeted intervention will have a lower BMI at 24 and 36 months, compared with children in the standard primary care only control group.

Specific Aim 2 To evaluate the effects of a three-year multi-setting parent-targeted intervention on secondary outcomes, including change in child energy intake and physical activity energy expenditure, compared to a standard primary care-only intervention.

Hypothesis 2: Children in the multi-setting parent-targeted intervention will have lower energy intake and higher energy expenditure over the three-year period, compared with children in the standard primary care-only control group.

Specific Aim 3 To evaluate the effects of the multi-setting parent-targeted intervention on hypothesized mediators of change in dietary intake, physical activity, and BMI.

Hypothesis 3: It is hypothesized that changes in parenting behaviors and the home food and physical activity environment will mediate changes in child energy intake and expenditure, and body mass index (BMI).


Options:
A: Inclusion Criteria:

* A child and his or her parent(s) will be eligible for the study if:

  * the two to four year old child is scheduled to receive or eligible for (based on an upcoming birthday) a recommended well child visit conducted by a pediatric or family practice care provider;
  * the child has no medical problems that would preclude study participation as determined by the physician conducting the well child visit (e.g. serious disease that would make following guidelines for parent encouragement of healthy diet and physical activity infeasible);
  * the child's BMI is greater than or equal to the 50th percentile according to CDC age and sex reference standards http://www.cdc.gov/nchs/data/nhanes/growthcharts/bmiage.txt;
  * the child's parent/guardian agrees to participation in the study and is not planning to move out of the state in the next three years
  * the primary caregiver is willing and able to complete the evaluation measures and participate in intervention activities if assigned to the active intervention group.
  * the parent speaks either English or Spanish.

Exclusion Criteria:

* A child will be excluded if she or he does not meet the above eligibility criteria
B: Inclusion Criteria:

* Attendance from first to sixth grade
* Ages 6-12 years
* BMI ≥ 85th percentile for age and sex
* Hispanic origin
* Both parents Hispanic
* Low socioeconomic status
* Signed consent from both parents/care givers and active assent from children

Exclusion Criteria:

* Disapproval by the children's physician due to any at-risk medical condition known by the parents
C: Specific Inclusion Criteria at the parent-child dyad level will include:

* Consent from a primary caregiver (i.e., parent or legal guardian)
* Caregiver's ability to speak English or Spanish
* Infant presenting for a 2 month well-child visit (child is 6 ≥ 12 weeks old)
* Caregiver agrees to participate in the study, and agrees to bring their child to all well-child care visits until their 2 year well-child care visit.

Specific Exclusion Criteria at the parent-child dyad level will include:

* Child born prior to 32 weeks' gestational age or with a birth weight \< 1500 grams
* Child with weight/length \< 3rd percentile at 2 months of age
* Child with a diagnosis of failure to thrive or with weight that has dropped ≥ 2 percentile curves since the previous well child visit
* Child with known medical problems that may affect their ability to thrive or requires a special diet (e.g. metabolic disease, uncorrected congenital heart disease, renal disease, lung disease)
* Caregiver with significant mental or neurologic illness likely to impair their ability to participate
* Caregiver age \< 18 years
* Caregiver with known plans to move out of the immediate area during the study period
* Caregiver with poor visual acuity (i.e. vision worse than 20/50 with Rosenbaum Pocket Screener as assessed at the time of recruitment)

Specific Inclusion Criteria at the Pediatric Resident level will include:

* Participation in the medical center's pediatric resident training program
* Providing regular care (\> 3 sessions per month) in the pediatric resident primary care clinic; AND
* Consent to participate in the study

Specific Exclusion Criteria at the Pediatric Resident level will include:

* Providing no regular care in the pediatric resident primary care clinic (e.g., transitional-year resident, Medicine/Pediatrics resident); OR
* Known plans to leave the training program during the ensuing 6 months
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: A