Clinical trial NCT03334266: Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
Official title: Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Infant Obesity
Mother-Child Relations
Dietary Habits
Breast Feeding
Physical Activity
Childhood Obesity
Feeding Behavior
Keywords: sugar
sweetened
beverages
responsive
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 259
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment.
timeFrame: 2 weeks - 24 months postpartum
measure: Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire.
timeFrame: 2 months-12 months postpartum
measure: Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ).
timeFrame: 24 months postpartum
measure: Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time.
timeFrame: 6 and 24 months postpartum
measure: Group differences in children's physical activity levels as assessed by accelerometry.
timeFrame: 18 months-24 months postpartum
measure: Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment.
timeFrame: 2 weeks-24 months postpartum
measure: Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time.
timeFrame: 2 weeks-24 months postpartum
Secondary outcomes:
measure: Group differences in levels of maternal stress over time as assessed by the Perceived Stress Scale 4 (PSS-4).
timeFrame: <32 weeks gestation-24 months postpartum
measure: Group differences in depression scores over time as assessed by the Centers for Epidemiological Studies Depression Scale-Revised-10 (CESDR-10).
timeFrame: <32 weeks gestation-24 months postpartum
measure: Group differences in alcohol and drug use over time as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).
timeFrame: <32 weeks gestation-24 months postpartum
measure: Group differences in how infant biologic measures of metabolic health at delivery and 6 months postpartum correlate to maternal biologic measures of metabolic health.
timeFrame: Delivery-6 months postpartum
measure: Group differences in infant metabolic health at delivery, 6 and 12 months postpartum.
timeFrame: Delivery-12 months postpartum
measure: Examination of whether group differences in infant metabolic health at delivery, 6, 12 months postpartum are moderated/mediated by sociodemographic, biological (pre-pregnancy BMI, etc), and psychosocial characteristics of mothers at baseline.
timeFrame: Delivery-12 months postpartum
measure: Examination of how the COVID-19 pandemic impacted infant/child feeding practices, food and water security, and study participation.
timeFrame: 32 weeks gestation - 24 months postpartum
measure: Explore how and why the COVID-19 pandemic impacted infant/child feeding practices, food and water security, and study participation (with a subset of 25% of participants).
timeFrame: 12 months postpartum - 36 months postpartum
Other outcomes:
Locations:
city: Fort Defiance
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
city: Whiteriver
country: United States
facility: Johns Hopkins Center for American Indian Health
state: Arizona
city: Shiprock
country: United States
facility: Johns Hopkins Center for American Indian Health
state: New Mexico
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Allison Barlow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingalls A, Rosenstock S, Foy Cuddy R, Neault N, Yessilth S, Goklish N, Nelson L, Reid R, Barlow A. Family Spirit Nurture (FSN) - a randomized controlled trial to prevent early childhood obesity in American Indian populations: trial rationale and study protocol. BMC Obes. 2019 May 6;6:18. doi: 10.1186/s40608-019-0233-9. eCollection 2019.