Please select the eligibility criteria that correspond to the clinical trial below.
Title: Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
Brief Summary: This study aims to assess the impact of a home-visiting program, called "Family Spirit Nurture" (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN intervention targets parent feeding practices, young children's diet and physical activity (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early childhood obesity and, consequently, risk for obesity over the life course. The investigators will also explore whether maternal psychosocial factors (stress, depression and substance use), household food/water security and/or constrained physical activity environments moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers; and, children's diets, PA patterns, and weight status. Finally, the investigators will examine how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity and whether social and behavioral interventions can impact infant metabolic health. The investigators evaluation will employ a randomized controlled design, in which both the intervention and comparison condition receive assisted transportation to prenatal and well-baby visits (called "Optimized Standard Care"), and the comparison condition also receives potentially beneficial injury prevention education at 8 assessment visits.

Primary Aims:

Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24 months postpartum:

Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC mothers will be more likely to meet breastfeeding and complementary feeding recommendations and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers.

Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2. FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity and reduced screen time/other sedentary activities compared to IPE + OSC children.

Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will be closer to zero (the mean age- and sex- specific BMI z-score for the World Health Organization standard reference population) compared to IPE + OSC children.


Options:
A: Inclusion Criteria:

* mother of infant aged 2-12 months
* sedentary
* healthy, able to do moderate intensity physical activity
* BMI = 18.5-40
* not planning to become pregnant in next year
* woman aged 18-45
* able speak and read English

Exclusion Criteria:

* pregnant
* planning to leave Oahu, Hawaii in the next year (permanently move away)
* a diagnosis of cancer, coronary heart disease (including atrial fibrillation), insulin-dependent diabetes mellitus (IDDM), and other atherosclerotic cardiovascular diseases (e.g., stroke),
B: Inclusion Criteria:

1. Willingness to participate
2. 14 to 24 years old at the time of conception
3. \< 32 weeks gestation at the time of enrollment
4. Reside within 1 hour (50 miles) of local Indian Health Service medical facility
5. Willingness to undergo random assignment and participate in all aspects of the study

Exclusion Criteria:

1. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)
C: Inclusion Criteria:

* Families in the Oahu community who delivered newborns between November 1994 and November 1995
* If enrolled in the control group, must not have been previously enrolled in Hawaii's Healthy Start Program

Exclusion Criteria:

* Insufficient understanding of English
D: Inclusion Criteria:

* Native American pregnant teens or young women ages 12-22 years old at the time of conception.
* Women ages 20-22 years at the time of conception must be pregnant for the first time.
* Partners of pregnant teens must be between the ages of 12-24.
* Pregnant \<28 weeks gestation and able to meet the requirements for completing the program in a timely way.
* An enrolled tribal member.
* Reside in the Reservation Service Unit Catchment Area and within 60 mile of the Indian Health Service Unit Headquarters.

Exclusion Criteria:

* Severe mental illness - schizophrenia, bipolar disorder, incapacitating depression, or Substance abuse/dependence in need of intensive and specific treatment
* Active legal problems - subjects will not be enrolled if they are incarcerated or if program participation has been made a condition of parole
* Ongoing social service involvement for abuse and neglect

Answer: B