Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months

NCT03334266 | Completed DMC

• 1 other identifier: 7871
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 3

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.

Conditions

Obesity; Infant Obesity; Mother-Child Relations; Dietary Habits; Breast Feeding; Physical Activity; Childhood Obesity; Feeding Behavior

Keywords

sugar; sweetened; beverages; responsive

Outcome Measures

Primary Outcomes (7)

• 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.

  Mothers will be asked questions from an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15) in addition to items developed by the study team and based on previous studies conducted by the co-investigators. The assessment will be used to assess feeding practices, duration of exclusive and non-exclusive breastfeeding, timing of introduction of complementary foods and types of first foods, and introduction of SSBs among infants/toddlers, including questions about the frequency and amount of child's beverage intake

  2 weeks - 24 months postpartum

• Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire.

  The Infant Feeding Behavior Questionnaire (IFBQ) (administered at 2, 6, and 12 months postpartum) asks mothers to indicate how often they engage in specific feeding behaviors to assess maternal feeding styles. There are 5 subscales that are used to assess maternal feeding style; Responsive, Forceful, Restrictive, Indulgent, and Uninvolved. There is no total scale score. The assessment is valid and reliable. This 24-item scale is scored with a 3-point Likert scale. A mean score is calculated for each subscale, with a range of 0 to 2. The range of the 3-point Likert scale is as follows: 0 (never), 1 (sometimes), 2 (always). Higher scores reflect higher levels of feeding style indicated by a given subscale. So, for example, for responsive feeding a higher score would be better, and for forceful feeding a higher score would be worse.

  2 months-12 months postpartum

• Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ).

  The TFBQ (administered at 24 months postpartum) asks mothers to indicate how often they engage in specific feeding behaviors to assess maternal feeding styles. There are 5 subscales that are used to assess maternal feeding style; Responsive, Forceful, Restrictive, Indulgent, and Uninvolved. There is no total scale score. The assessment is valid and reliable. This 27-item scale is scored with a 3-point Likert scale. A mean score is calculated for each subscale, with a range of 0 to 2. The range of the 3-point Likert scale is as follows: 0 (never), 1 (sometimes), 2 (always). Higher scores reflect higher levels of feeding style indicated by a given subscale. So, for example, for responsive feeding a higher score would be better, and for forceful feeding a higher score would be worse.

  24 months postpartum

• Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time.

  Mothers will be asked questions about child's fruit and vegetable consumption beginning at 6 months postpartum and at all subsequent time points. These items have been added to the standardized 18-item U.S. Department of Agriculture (USDA) food security survey. Fruit and vegetable (F\&V) consumption will be measured by asking mothers how much and how often her child eats F\&Vs and whether she feels she is able to provide her child with the F\&Vs he or she needs. To obtain weekly fruit and vegetable servings consumption, the number of times per week F\&Vs are consumed will be multiplied by the number of servings consumed each time. Serving size will be age adjusted. To assess sugar sweetened beverage (SSB) consumption, mothers will be asked questions from an adapted version of the Pre-School-Aged Beverage Intake Questionnaire (BEVQ-15) in addition to items developed by the study team and based on previous studies conducted by the co-investigators.

  6 and 24 months postpartum

• Group differences in children's physical activity levels as assessed by accelerometry.

  Child's PA will be measured objectively using accelerometry. We will use the Actical accelerometer (formerly MiniMitter Co, Philips Respironics, Bend, OR), a small waterproof device (28x27x10mm) weighing 17g, which is omnidirectional (sensing motion in all planes), and integrates the degree and intensity of motion. We will use procedures co-investigators have used successfully in previous studies of young adolescents, toddlers and their mothers, placing the accelerometer on the non-dominant ankle with a non-removable, reinforced hospital band worn next to the skin, under socks, for 7 consecutive days. Accelerometers will be attached on the day of the 18- and 24-month assessment battery and removed one week later. Data will be collected in 1-minute epochs. The time-stamped data will be examined. Summary statistics will include average and total activity counts and minutes in moderate to vigorous physical activity (MVPA)

  18 months-24 months postpartum

• Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment.

  This 14-item self-report assessment includes questions about tummy time, crawling, walking, sedentary behavior and screen time for infants and toddlers. Questions were compiled based on a body of literature related to assessing infant/toddler physical activity.

  2 weeks-24 months postpartum

• Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time.

  Child weight (to the nearest ounce) and recumbent length (to the nearest 1/8 inch) will be measured using a digital scale and a recumbent measuring board (in accordance with IHS guidelines). All measurements will be taken in triplicate, removing the most disparate measurement, and averaging the remaining two. Averages will be used to calculate BMI z-scores using age- and sex-specific World Health Organization (WHO) Child Growth Standards.

  2 weeks-24 months postpartum

Secondary Outcomes (8)

• Group differences in levels of maternal stress over time as assessed by the Perceived Stress Scale 4 (PSS-4).

  <32 weeks gestation-24 months postpartum

• Group differences in depression scores over time as assessed by the Centers for Epidemiological Studies Depression Scale-Revised-10 (CESDR-10).

  <32 weeks gestation-24 months postpartum

• Group differences in alcohol and drug use over time as assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST).

  <32 weeks gestation-24 months postpartum

• Group differences in how infant biologic measures of metabolic health at delivery and 6 months postpartum correlate to maternal biologic measures of metabolic health.

  Delivery-6 months postpartum

• Group differences in infant metabolic health at delivery, 6 and 12 months postpartum.

  Delivery-12 months postpartum

Study Arms (2)

Family Spirit Nurture (FSN)

EXPERIMENTAL

The intervention group (n=169) will receive the Family Spirit Nurture (FSN) + Optimized Standard Care (OSC). The FSN home-visiting module consists of 36, 60-minute lessons delivered by trained local Family Health Coaches (FHCs), from 28 weeks gestation to 18 months postpartum. 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.

Behavioral: Family Spirit Nurture (FSN); Other: Optimized Standard Care (OSC)

Control Program

OTHER

The control group will receive Injury Prevention Education (IPE) + Optimized Standard Care (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.

Other: Injury Prevention Education (IPE); Other: Optimized Standard Care (OSC)

Interventions

Family Spirit Nurture (FSN) BEHAVIORAL

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.

Family Spirit Nurture (FSN)

Injury Prevention Education (IPE) OTHER

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.

Control Program

Optimized Standard Care (OSC) OTHER

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.

Control Program; Family Spirit Nurture (FSN)

Eligibility Criteria

• Age: 14 Years - 24 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Willingness to participate
• to 24 years old at the time of conception
• \< 32 weeks gestation at the time of enrollment
• Reside within 1 hour (50 miles) of local Indian Health Service medical facility
• Willingness to undergo random assignment and participate in all aspects of the study

You may not qualify if:

• \. Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.)

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (3)

Johns Hopkins Center for American Indian Health

Fort Defiance, Arizona, 86504, United States

Location

Johns Hopkins Center for American Indian Health

Whiteriver, Arizona, 85941, United States

Location

Johns Hopkins Center for American Indian Health

Shiprock, New Mexico, 87420, United States

Location

Related Publications (1)

• 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.

  PMID: 31080627 DERIVED

MeSH Terms

Conditions

Obesity; Pediatric Obesity; Feeding Behavior; Breast Feeding; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Study Officials

• Allison Barlow, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: November 7, 2017
• Study Start: September 25, 2017
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)