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临床试验/NCT04502979
NCT04502979已完成不适用

Enhancing Caregiver-Infant Communication to Prevent Obesity

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年9月26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
71
试验地点
2
主要终点
Infant Weight-for-Length Z Scores

研究概览

简要总结

Infancy is an important target period for obesity prevention because once obese as an infant, the relative risk of remaining obese appears to rise with increasing age at great cost to both individuals and society. The ability to self-regulate energy intake (eating when hungry and stopping when full) is vital to obesity prevention and it is thought that this ability can be derailed by a chronic mismatch between parental feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness). The study will test a novel intervention to help parents and pre-verbal infants better understand one another during feeding and it will offer new insight into how self-regulation of energy intake develops during infancy.

详细描述

Once obese as an infant, the relative risk of remaining obese appears to rise with increasing age. Thus, the early years of life have been posited as an important target period for obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental factors, obesity fundamentally reflects an imbalance between energy intake and expenditure. Self-regulation of energy intake aligned with physiologic need is essential to this balance. The process(es) by which infants begin to disassociate eating behavior from physiologic need is unclear, thus it is crucial to better understand predictors of individual differences in self-regulation of energy intake. It is well established that autonomic regulation may support infant behavioral regulation, suggesting that autonomic function may be a critical area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction quality during infancy, and findings reveal that more responsive interactions are associated with more effective autonomic regulation. A chronic mismatch between a caregiver's feeding behavior and the infant's state (feeding in the absence of hunger and/or feeding beyond fullness), is thought to contribute to obesity by undermining the infant's capacity to self-regulate intake; the current proposal will be the first to examine the effects on autonomic regulation. The investigators propose an intervention to enrich the capacity of mother-infant dyads to perform their respective interactive tasks. The investigators plan to teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety, which they will in turn teach their preverbal infant. This training in ASL will be augmented with targeted information for mothers about infants' capacities to self-regulate energy intake in response to hunger and satiety and communicate those states with intention. Mothers also will be taught about expected development of infants' eating behaviors and nutritional requirements to support healthy growth.

Using a two-group randomized repeated measures design, this study aims to 1) evaluate the feasibility and acceptability of the intervention and study methods, including recruitment, enrollment, and data collection (self-report, anthropometrics, video observations, and respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial impact of the intervention on observed feeding interactions, reported infant feeding behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth; and, 3) explore preliminary data on concordance between dyadic feeding interactions and autonomic regulation in both mothers and infants (RSA). In addition to a variety of self-report and anthropometric measures, this study will use integrated behavioral (video) and physiologic (RSA) measures to better understand feeding dynamics and their relationship with obesity risk. Understanding these processes is essential for developing appropriate preventions, or interventions, that will help reduce the prevalence of early childhood obesity and its extension into later childhood and beyond.

Study Phases:

Screening: screening for eligibility and obtaining consent

Study Treatment: study intervention/experimental treatment from baseline visit ([Time 1 (T1)]: age 4-9-months) monthly until 3-months post-baseline ([Time 2 (T2)]: age 7-12-months)

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
Single (Investigator)

入排标准

年龄范围
3 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Parent Inclusion:
  • Must be able to read, understand, and speak English or Spanish and be willing to be randomized and participate in data collection.
  • Those who are randomized into the experimental group must also be willing to learn ASL specific to communication of hunger, thirst, and fullness.
  • Infant Inclusion:
  • Aged at least 3 months at the time of recruitment

排除标准

  • Parent Exclusion:
  • > 50 years of age
  • Infant Exclusion:
  • Aged more than 9 months at the time of recruitment
  • born more than 6 weeks earlier than their estimated due date,
  • have any developmental delays or disabilities that make it difficult for them to eat, drink, or communicate,
  • attend regular daycare,
  • will be younger than 4 months or older than 9 months at the time of the first ASL training.

结局指标

主要结局

Infant Weight-for-Length Z Scores

时间窗: 6 Months Post-Baseline (T3)

The infant's length and weight (in clean dry diaper only) will be measured in triplicate, using a calibrated length board and digital scale. The mean of the three length measurements (cm) and the mean of the three weight measurements (kg) will be combined to report a sex-specific weight-for-length z score. Weight-for-Length Z scores are measures of relative weight adjusted for child length and sex. The Z-score indicates the number of standard deviations away from a reference population in the same age range and with the same sex. A Z-score of 0 is equal to 50th percentile (median). Negative numbers indicate values lower than the median and positive numbers indicate values higher than the median.

次要结局

  • Mean Infant Caloric Intake Compared to Estimated Energy Requirements(6 Months Post-Baseline (T3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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