Please select the eligibility criteria that correspond to the clinical trial below.
Title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
Brief Summary: The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.

The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.

Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices


Options:
A: Inclusion Criteria:

Inclusion Criteria for Children and Parents/Primary Caregivers

* child's age between 9 to 12 years
* child body mass index (BMI) 85th percentile for age and sex
* child has T2D risk factors:

  * 1st or 2nd degree relative with T2D
  * conditions associated with insulin resistance/metabolic syndrome (e,g, acanthosis nigricans, hypertension, dyslipidemia, PCOS, or small for gestational age birth weight, maternal history of T2D or gestational diabetes)
* parent/primary caregiver must be willing to participate in intervention sessions and activities (note: primary caregiver is the adult guardian who most frequently prepares/obtains food, regulates media use, and provides physical activity opportunities for the child)
* parent/child willing to use a study-provided mobile device during intervention
* parent and child speak and read English

Exclusion Criteria:

Exclusion Criteria for Children (Index Participants) and Parents/Primary Caregivers

* child/parent unwillingness to participate in group activities or to use study-provided mobile device
* child previously diagnosed T1 or T2D
* child with psychiatric disturbances or mental illness
* child with inability to be physically active
* child/parent inability to speak and read English
* child takes weight loss medications or medications known to cause weight gain or affect appetite.
B: Inclusion Criteria:

* 8-10 years old
* healthy
* African American
* parent willing to participate in data collection
* internet access
* personal email address

Exclusion Criteria:

* mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
* taking medications that influence dietary behaviors, appetite, and/or physical activity
C: Inclusion Criteria:

* Latina mother \> 18 years with singleton uncomplicated pregnancy
* Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
* Mother to be primary caregiver of child
* Mother speaks fluent English or Spanish

Exclusion Criteria:

* Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
* Family does not have a phone
* Infants with severe medical problems that may affect feeding
D: Inclusion Criteria:

* Families with healthy adults and children

Exclusion Criteria:

* Various

Answer: C