跳至主要内容
临床试验/NCT05783765
NCT05783765招募中不适用

Role of Energy Balance Behaviors in Modifying Biobehavioral Risk Factors for Childhood Obesity

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2023年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
242
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

A genetic risk for obesity does not always translate to the development of obesity among children, which points to the presence of risk-modifying factors that likely relate to energy balance behaviors as key behavioral drivers. Using an integrated approach to comprehensively examine the interplay between genotype and phenotype, this study will systematically assess the extent to which energy balance behaviors, alone or in combination, in conjunction with family-level influences can modify behavioral and genetic predispositions to childhood obesity in a high-risk sample of predominantly minority children from low-resource backgrounds. Identifying protective factors that may mitigate the impact of obesity risk on weight and adiposity outcomes is critical for moving the prevention of childhood obesity into a new direction.

详细描述

This study examines the interplay between genotype and phenotype and assesses if energy balance behaviors in the context of the family environment, alone or in combination, can modify behavioral and genetic predispositions to childhood obesity. The research aims to prospectively evaluate the extent to which associations of a heightened drive to eat (HDE) on 1-year changes in weight and adiposity outcomes are independent or additive to those of a genetic risk for obesity among children. In addition, the study aims to prospectively examine risk-modifying energy balance behaviors in areas of diet, physical activity, and sleep that may mitigate the detrimental impact of a HDE or high genetic risk on weight and adiposity outcomes and test whether these factors differ for HDE versus a high genetic risk of obesity on those outcomes. Lastly, the research aims to examine the impact of family-level influences in areas of family functioning and parent feeding on risk-modifying energy balance behaviors in children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children
  • Children ages 5-7 years
  • Children with BMI equal to or greater 5th percentile
  • Mother must be children's biological mother and primary caregiver
  • Mother must be able to read and understand English

排除标准

  • Children with serious medical conditions or medication use known to affect food intake, body weight, physical activity, or sleep
  • Children with developmental and/or psychiatric conditions that may impact study compliance
  • Children with food allergies related to study foods or lactose intolerance
  • Children with low preference for study foods

结局指标

主要结局

Waist circumference

时间窗: Change from baseline to 1-year follow-up

Abdominal waist circumference (cm)

Body Mass Index (BMI)

时间窗: Change from baseline to 1-year follow-up

BMI z-score

Body fat

时间窗: Change from baseline to 1-year follow-up

Body fat percentage

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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