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临床试验/NCT03334266
NCT03334266已完成不适用

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

Johns Hopkins Bloomberg School of Public Health4 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2017年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
259
试验地点
4
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Willingness to participate
  • 14 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

排除标准

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

结局指标

主要结局

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.

时间窗: 2 weeks - 24 months postpartum

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

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

时间窗: 2 months-12 months postpartum

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.

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

时间窗: 24 months postpartum

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.

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

时间窗: 6 and 24 months postpartum

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.

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

时间窗: 18 months-24 months postpartum

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)

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

时间窗: 2 weeks-24 months postpartum

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.

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

时间窗: 2 weeks-24 months postpartum

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.

次要结局

  • 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)
  • Examination of how the COVID-19 pandemic impacted infant/child feeding practices, food and water security, and study participation.(32 weeks gestation - 24 months postpartum)
  • 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).(12 months postpartum - 36 months postpartum)
  • 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.(Delivery-12 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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