Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Preventing Early Childhood Obesity, Part 1: Family Spirit Nurture, 3-9 Months
Brief Summary: This study aims to assess the impact of a brief home-visiting module, called "Family Spirit Nurture" (FSN), on American Indian (AI) parent feeding practices associated with increased risk for early childhood obesity, with a primary focus on delaying introduction of infants' Sugar Sweetened Beverage (SSB) (including soda, energy drinks, juice with added sugar and other drinks with added sugar) intake while teaching mothers complementary feeding and responsive parenting practices. The investigators will also assess how water insecurity may moderate parents' feeding of SSBs to young children. Finally, the investigators will explore whether maternal knowledge of oral health practices and/or reduction of infants' SSB intake influences early indicators of infant's oral health (i.e., infants' oral microbiome and plaque formation). Our evaluation will employ a randomized controlled design, in which the control condition receives a beneficial home-safety educational model and assistance in safety proofing their homes for small children. Assessments in both groups will occur at baseline (between 6 and 10 weeks postpartum) and 4 months, 6 months, 9 months and 12 months postpartum.

Primary Aims:

Aim 1: To determine the effectiveness of the brief (6 lessons) FSN home-visiting parent feeding practice module on reducing SSB initiation and frequency among infants between 3 and 12 months of age. Hypothesis 1: Infants whose mothers receive FSN vs. controls will be less likely to introduce SSBs between 3 and 12 months of age.

Aim 2: To determine the effectiveness of FSN to promote optimal complementary feeding and responsive parenting practices. Hypothesis 2: Mothers who receive FSN vs. controls will be more likely to practice recommended complementary feeding and responsive parenting practices between 3 and 12 months of age.

Aim 3: To determine the impact of water insecurity on SSB consumption among infants between 3 and 6 months of age. Hypothesis 2: Parents who report water insecurity vs. those who do not will be more likely to give infants SSBs between 3 and 6 months of age.

Secondary Aims:

Secondary Aim 1: To explore if provision of water to families reduces SSB intake among mothers and infants ages 6 to 9 months of age.

Secondary Aim 2: To explore if infants in the FSN intervention have better oral health outcomes than control infants up to 12 months postpartum.


Options:
A: Intervention Type: BEHAVIORAL; Name: Home Visiting; Assigned to Arm(s): N/A
B: 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)
C: Arm Label: Family Spirit Nurture (FSN); Type: EXPERIMENTAL; Interventions: Behavioral: Family Spirit Nurture (FSN), Other: Water Delivery | Arm Label: Control Program; Type: OTHER; Interventions: Other: Control Program, Other: Water Delivery | Intervention Type: BEHAVIORAL; Name: Family Spirit Nurture (FSN); Assigned to Arm(s): Family Spirit Nurture (FSN) | Intervention Type: OTHER; Name: Control Program; Assigned to Arm(s): Control Program | Intervention Type: OTHER; Name: Water Delivery; Assigned to Arm(s): Control Program, Family Spirit Nurture (FSN)
D: Arm Label: Healthy Children, Strong Families (first); Type: EXPERIMENTAL; Interventions: Behavioral: Healthy Children, Strong Families, Behavioral: Child Safety | Arm Label: Child Safety (first); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Healthy Children, Strong Families, Behavioral: Child Safety | Intervention Type: BEHAVIORAL; Name: Healthy Children, Strong Families; Assigned to Arm(s): Child Safety (first), Healthy Children, Strong Families (first) | Intervention Type: BEHAVIORAL; Name: Child Safety; Assigned to Arm(s): Child Safety (first), Healthy Children, Strong Families (first)

Answer: C