Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 14 - 24 |
| Updated: | 11/16/2018 |
| Start Date: | September 25, 2017 |
| End Date: | December 31, 2021 |
| Contact: | Allison Barlow, PhD |
| Email: | abarlow@jhu.edu |
| Phone: | 410-955-6931 |
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.
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.
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.
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.
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.
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.
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. First or second time mothers
6. 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.)
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