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临床试验/NCT04027608
NCT04027608已完成不适用

Sensitization of the Reinforcing Value of Food as a Predictor of Weight Change in Adolescents

State University of New York at Buffalo0 个研究点目标入组 201 人开始时间: 2016年6月29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
201
主要终点
zBMI Change

研究概览

简要总结

While a substantial body of research suggests that RRV is related to obesity, there is very little research on factors that contribute to the RRV of food, particularly how patterns of eating can increase or decrease the motivation to eat specific foods. Previous work has demonstrated that a subset of individuals with obesity show increases in RRV of food after repeated consumption of large portions of high energy density (HED) snack foods, which has been conceptualized as sensitization. Preliminary data suggest that sensitization of the RRV of HED food is a predictor of weight gain over time. However, more work needs to be done to address this relationship using a planned, prospective study design, using adolescent research subjects, and examining potential moderators of this relationship.

The purpose of this study is to identify risk and protective factors to excess zBMI change in adolescents over time. Aim 1 was to measure the relative reinforcing value (RRV) of a preferred HED and low energy density (LED) snack food before and after 2-weeks of daily exposure. Aim 2 was to assess the RRV of exercise and sedentary activity. Hypotheses include 1) sensitization to HED food will be associated with greater zBMI at the time of testing as well as greater zBMI change over time 2) sensitization to LED food will be associated with lower zBMI at the time of testing in adolescents and less zBMI change over time. 3) Greater RRV of exercise will be protective against zBMI increases over time.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • between 12-14yoa (male and female)
  • zBMI: -1.5 to +2.0 (*determined by Height/weight measurement at Visit 1)
  • neutral or higher liking of the study foods
  • Willingness to complete 9 study visits over 2 years.

排除标准

  • -metabolic or endocrine disorder
  • use of medications known to effect appetite (Ritalin, Adderall, Concerta, Wellbutrin, Prednisone, etc)
  • Unwilling to complete the study visits
  • allergy to study foods
  • dislike of study foods (*determined via Preference for Study foods forms at Visit 1)
  • parent report that child reads below 4th grade reading level
  • parent report that child cannot complete light physical activity without assistance
  • No English Speaking parent or legal guardian (therefore cannot provide consent in English nor answer questionnaires for this study) * all other exclusion criteria are assessed from Survey monkey screening in advance of the first appointment vis parental report. At the first appointment the child is directly asses for height, weight, and The linking of study foods.

结局指标

主要结局

zBMI Change

时间窗: through study completion, an average of 24 months from baseline.

BMI z-score change over time. zBMI is a standardized index of body mass index used in children that is standardized to age and sex specific measurements from a national sample. 0 represents the national average. A positive number reflects a body mass index that is higher than the national average and a negative number reflects a body mass index that is lower than the national average.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Temple

Associate Professor

State University of New York at Buffalo

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