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:

* attenders at the relevant child care center

Exclusion Criteria:

* allergy or sensitivity to any test food
B: Inclusion Criteria:

* Children between the ages of 12 and 24 month old.
* Children attending daycare at least 3 days a week.
* Children with a parental-report of being hummus-naive.

Exclusion Criteria:

* Any child following a specific dietary regimen or that has religious restrictions or food allergies that may affect food consumption.
* Children with parent-reported antibiotic use in the previous 6 months.
C: * 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
D: 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)

Answer: D