Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
Condition: Obesity; Infant Obesity; Mother-Child Relations; Dietary Habits; Breast Feeding; Physical Activity; Childhood Obesity; Feeding Behavior
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

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.
    

Detailed description: 
      Secondary Aims:

      Secondary Aim 1. To explore whether maternal psychosocial factors (stress, depression and
      substance use), and household food/beverage security and/or constrained physical activity
      environments moderate FSN intervention impacts on: infant and young children's feeding
      behaviors; and, infant/young children's diets, PA patterns, and weight status.

      Secondary Aim 2. To explore 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.

      Aim 2a. At delivery, examine how measures of infant metabolic health (fasting glucose,
      insulin, leptin, adiponectin, lipids, and c-reactive protein) are a) correlated with maternal
      biologic measures of metabolic health (fasting glucose, insulin, leptin, adiponectin, lipids,
      and c-reactive protein) and b) are impacted by sociodemographic, biological and psychosocial
      characteristics of mothers at baseline (e.g. age, parity, water/food security, BMI,
      gestational weight gain, gestational diabetes, depression, perceived stress). Hypothesis:
      Infant biologic measures of metabolic health will be highly correlated with maternal levels
      of metabolic health at birth and will vary by maternal baseline characteristics.

      Aim 2b. Between delivery and 12 months postpartum, examine how biologic measures of infant
      metabolic health change in relation to a) maternal biologic measures of metabolic health, b)
      sociodemographic, biological and psychosocial characteristics of mothers at baseline, and c)
      maternal/infant behaviors (e.g. responsive feeding practices, infant diet, introduction of
      sugar-sweetened beverages, early physical activity, etc.). Hypothesis: Biologic measures of
      infant metabolic health over the first 12 months of life will begin to diverge from maternal
      levels; and, infant metabolic health between delivery and 12 months postpartum will vary by
      maternal baseline characteristics and maternal/infant behaviors across study groups.

      Aim 2c. Infant metabolic health. Hypothesis: FSN + OSC infants will have better metabolic
      health (defined by fasting glucose, insulin, leptin, adiponectin, lipid and c-reactive
      protein levels) at 12 months postpartum compared with IPE + OSC infants.

      Secondary Aim 3. To explore how specific community- and tribal level policy, systems, and
      environmental (PSE) factors affect child feeding practices, healthy weight status, SSB and
      water consumption, and safe water access on the Navajo Nation.

      Aim 3a. Assess the impact of actual and perceived water insecurity on child feeding practices
      and children's weight and metabolic status. Hypothesis: Participants who do not have or do
      not trust their household water sources breastfeed less, and feed more SSBs and less water to
      children, impacting weight and metabolic status at 24 months of life.

      Aim 3b. Explore community readiness and political will to address water insecurity among
      policy, systems, and environmental leaders on the Navajo Nation. Hypothesis: Examination of
      community- and tribal-level policy, systems, and environmental facilitators and barriers to
      safe water access will provide key knowledge to promote children's water vs. SSB intake and
      healthy weight status.

      Aim 3c. Compare actual vs. perceived household water safety and determine the distance it
      takes water insecure households to access safe drinking water. Hypothesis: The distance
      participants travel to access safe water affects what beverages they feed young children.

      Secondary Aim 4. To explore how the COVID-19 pandemic impacted infant/child feeding
      practices, food and water security, and study participation. Hypothesis: Examination of how
      the COVID-19 pandemic impacted study outcomes will provide important knowledge about how
      future home-visiting interventions can best adapt to community-level crises.

      The investigators will conduct a randomized 1:1 controlled trial with 338 mothers (ages 14 to
      24) and their children (ages 0-24 months) living in the three study sites (2 Navajo; 1
      Apache). Assessments in both groups will occur at baseline (< 32 weeks gestation), 36 weeks
      gestation, delivery (blood sample collection only), 2 weeks, 2 months, 4 months, 6 months, 9
      months, 12 months, 18 months, and 24 months postpartum.

      Intervention: The intervention group (n=169) will receive the FSN + OSC. OSC consists of
      transportation assistance to prenatal and well-baby clinic visits as recommended by the
      Indian Health Service (IHS) and American Academy of Pediatrics (AAP) and rescue services
      through linkages to community agencies as needed. The FSN home-visiting module consists of 36
      60-minute lessons delivered by trained local FHCs, from 28 weeks gestation to 18 months
      postpartum. The lessons will be delivered bi-weekly from 28 weeks gestation to birth, weekly
      from birth to 3 months postpartum, bi-weekly from 3 to 6 months postpartum and monthly from 6
      to 18 months postpartum. The lessons focus on three key content domains: 1) promotion of
      optimal breastfeeding, complementary and responsive feeding across early childhood; 2)
      promotion of healthy infant/toddler diet and physical activity, as well as reduced screen
      time and sedentary lifestyle; and 3) promotion of maternal psychosocial well-being,
      optimization of healthy food/beverage availability and identification/creation of safe play
      spaces in the home environment.

      Comparison Condition: The comparison group will receive IPE + OSC. The IPE home-visiting
      module consists of 8 30-minute lessons delivered by trained local Family Health Liaisons
      (FHL), from 28 weeks gestation to 18 months postpartum. The lessons will be delivered at the
      following assessment time points: 36 weeks gestation, 2 weeks, 2 months, 4 months, 6 months,
      9 months, 12 months, and 18 months postpartum. Injury prevention lessons focus on injury
      prevention topics relevant to the participating communities but that will not overlap in
      anyway with FSN content, including: motor vehicle safety for mothers and children; preventing
      scald burns; fire safety; child-proofing a home; preventing falls; preventing poisonings; and
      preventing animal bites.

      OSC transportation visits for both the intervention and comparison groups include
      transportation for up to 6 prenatal visits from 28 weeks gestation to birth and 8 well-baby
      visits during the first 18 months of life. OSC was selected because it optimizes the standard
      of care for young mothers and their children within reservation communities, addresses
      transportation and access barriers, provides beneficial and ecologically-valid services in
      the participants' settings, and was previously approved and endorsed by Community Advisory
      Boards and tribal Institutional Review Boards. By providing OSC to both intervention and
      control groups, the quality and dose of OSC is controlled so differences between study arms
      can be validly attributed to the FSN intervention. Two hours is allotted for each OSC visit
      (for transportation and waiting at clinic visit) x 14 visits = 28 hours of
      obstetric/pediatric care support. OSC visits will also be used to administer maternal
      self-reports at relevant time points for both study arms.

      Both the intervention and comparison condition participants will receive a follow-up
      assessment at 24 months, but no education sessions will take place with either study group
      between 18 and 24 months postpartum.
    

Intervention name(s): Family Spirit Nurture (FSN); Injury Prevention Education (IPE); Optimized Standard Care (OSC)
Intervention type(s): Behavioral; Other; Other
Intervention description(s): The FSN home-visiting module consists of 36 60-minute lessons delivered by trained local FHCs, from 28 weeks gestation to 18 months postpartum. The lessons focus on three key content domains: 1) promotion of optimal breastfeeding, complementary and responsive feeding across early childhood; 2) promotion of healthy infant/toddler diet and physical activity, as well as reduced screen time and sedentary lifestyle; and 3) promotion of maternal psychosocial well-being, optimization of healthy food/beverage availability and identification/creation of safe play spaces in the home environment.; The control group will receive Injury Prevention Education (IPE). The IPE home-visiting module consists of 8 30-minute lessons delivered by trained local Family Health Liaisons (FHL), from 28 weeks gestation to 18 months postpartum. Injury prevention lessons focus on injury prevention topics relevant to the participating communities, including: motor vehicle safety for mothers and children; preventing scald burns; fire safety; child-proofing a home; preventing falls; preventing poisonings; and preventing animal bites.; OSC will be available to both in the FSN intervention and control groups. OSC consists of transportation assistance to prenatal and well-baby clinic visits as recommended by the Indian Health Service (IHS) and American Academy of Pediatrics (AAP) and rescue services through linkages to community agencies as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sugar; sweetened; beverages; responsive