Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Students enrolled in any grade between grades one and twelve
* Student ID number matches that on a list of randomly selected student ID numbers from the population of student enrolled in school
* Students who elect to receive a hot entree at lunch
* Students who assent to participate

Exclusion Criteria:

* Students in detention
* Students in special education
* Students in Kindergarten
* Students not in school for any reason (e.g. illness, vacation)
B: Inclusion Criteria. Centers must have met the following criteria to be included: (1) have \> 30 children ages 2-5 enrolled; (2) Serve low income families who are a part of the USDA food program and SNAP eligible; (3) Reflect the ethnic distribution of the Miami-Dade County Public School System (63 percent Hispanic, 19 percent African American, 18 percent white); and (4) Center directors agree to participate and sign a letter of commitment. Studies were excluded if they did not meet these criteria.
C: Inclusion Criteria:

Local authorities:

* Local authorities providing data from at least 4 Children's Centres
* Courses delivered by trained staff who have been certified by HENRY

Children's Centres:

* At least one course to be delivered per Centre per year
* Sites with a history of providing process data for the previous year.

There will be no exclusions based on the demographics of Children's Centres, but location will be monitored to ensure inclusion of those with diverse social and environmental characteristics.

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Exclusion Criteria:

Local authorities:

* Areas which have plans to decommission the HENRY intervention during the course of the trial; or who are not planning on running HENRY programmes during the trial period.

Children's Centres:

* Centres where ethnography has taken place during Study 2
* Centres who are not planning on running HENRY programmes during the trial period
D: * INCLUSION CRITERIA - MAIN TRIAL
* All participants in the main trial will be healthy adult parents 18 years and older
* Inclusion criteria include:

  1. being the parent of a biological child who is between 4 and 7 years old with no major allergies or dietary-related health conditions;
  2. having some responsibility for child s dietary intake ;
  3. having the ability to read, write, and converse in English;
  4. being able to come to the NIH Clinical Center for one visit.

EXCLUSION CRITERIA - MAIN TRIAL

* Exclusion criteria include:

  1. having received information about the study purpose;
  2. being an NHGRI employee;
  3. being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.

     EXCLUSION CRITERIA - VIRTUAL REALITY
* Exclusion criteria related to use of the virtual reality environment include:

  1. having a medical susceptibility to dizziness, disorientation or nausea;
  2. having a seizure disorder or epilepsy;
  3. having a high propensity for motion sickness;
  4. lacking freedom of movement;
  5. known pregnancy;
  6. low, uncorrected vision and hearing.

INCLUSION CRITERIA - PILOT

* Participants in the Pilot test will be healthy adult parents 18 years and older.
* Inclusion criteria include:

  1. being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions, but only for the first 10 participants;
  2. having the ability to read, write, and converse in English;
  3. being able to come to the NIH Clinical Center for one visit.

EXCLUSION CRITERIA - PILOT

1. having received information about the study purpose;
2. being an NHGRI employee;
3. low, uncorrected vision and hearing.

INCLUSION CRITERIA - BUFFET SERVING EVALUATION

* Participants in the secondary Buffet Serving Evaluation will be healthy adult parents 18 years and older
* Inclusion criteria include:

  1. being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions;
  2. having some responsibility for child s dietary intake ;
  3. having the ability to read, write, and converse in English;
  4. being able to come to the NIH Clinical Center for one visit.

EXCLUSION CRITERIA - BUFFET SERVING EVALUATION (MAIN)

1. being an NHGRI employee;
2. being from a family wherein another household member or co-parent of a biological child has already participated or is scheduled to participate.

EXCLUSION CRITERIA - BUFFET SERVING EVALUATION (VIRTUAL REALITY)

* Exclusion criteria related to use of the virtual reality environment include:

  1. having a medical susceptibility to dizziness, disorientation or nausea;
  2. having a seizure disorder or epilepsy;
  3. having a high propensity for motion sickness;
  4. lacking freedom of movement;
  5. known pregnancy;
  6. low, uncorrected vision and hearing.

     INCLUSION CRITERIA- OLFACTORY AWARENESS TEST:
* Participants in the Olfactory Awareness Test will be healthy adults between the ages of 18 and 59

Inclusion criteria include:

1. Having the ability to read, write and converse in English
2. Able to come to the clinical center for on visit.

We may also include the following inclusion criteria:

1. Being the parent of a biological child who is between 3 and 7 years old with no major allergies or dietary-related health conditions
2. Having some responsibility for child s dietary intake; however, if we encounter recruitment difficulties, we may instead sample nonparent participants who are of the same general age range as parents who participated in our past studies using the virtual buffet. For the pilot test, we will sample non-parents in the age range of past parent participants

EXCLUSION CRITERIA-OLFACTORY AWRAENESS TEST:

1. Being an NHGRI employee;
2. Having participated in the Parents TAKE study conducted previously in this lab.

Exclusion criteria related to use of the virtual reality environment include:

1. Having a medical susceptibility to dizziness, disorientation or nausea;
2. Having a seizure disorder or epilepsy;
3. Having a high propensity for motion sickness;
4. Lacking freedom of movement;
5. Known pregnancy;
6. Weak, uncorrected vision, hearing, and/or smell. No adults older than age 59 will be able to participate in this study because older adults tend to experience a decline in olfactory function

Answer: B