Please select the arm or intervention descriptions that belong 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: Arm Label: Family Spirit Nurture (FSN); Type: EXPERIMENTAL; Interventions: Behavioral: Family Spirit Nurture (FSN), Other: Optimized Standard Care (OSC) | Arm Label: Control Program; Type: OTHER; Interventions: Other: Injury Prevention Education (IPE), Other: Optimized Standard Care (OSC) | Intervention Type: BEHAVIORAL; Name: Family Spirit Nurture (FSN); Assigned to Arm(s): Family Spirit Nurture (FSN) | Intervention Type: OTHER; Name: Injury Prevention Education (IPE); Assigned to Arm(s): Control Program | Intervention Type: OTHER; Name: Optimized Standard Care (OSC); Assigned to Arm(s): Control Program, Family Spirit Nurture (FSN)
B: Arm Label: motivational counseling; Type: EXPERIMENTAL; Interventions: Behavioral: motivational counseling | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: motivational counseling; Assigned to Arm(s): motivational counseling
C: Arm Label: Healthy Lifestyles Group; Type: EXPERIMENTAL; Interventions: Behavioral: Keys to Healthy Family Child Care Homes | Arm Label: Healthy Business Group; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Keys to Healthy Family Child Care Homes | Intervention Type: BEHAVIORAL; Name: Keys to Healthy Family Child Care Homes; Assigned to Arm(s): Healthy Business Group, Healthy Lifestyles Group
D: Arm Label: Optimisation + HENRY; Type: EXPERIMENTAL; Interventions: Behavioral: Optimisation + HENRY | Arm Label: HENRY as standard; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HENRY as standard | Intervention Type: BEHAVIORAL; Name: Optimisation + HENRY; Assigned to Arm(s): Optimisation + HENRY | Intervention Type: BEHAVIORAL; Name: HENRY as standard; Assigned to Arm(s): HENRY as standard

Answer: A