跳至主要内容
临床试验/NCT03611296
NCT03611296已完成不适用

Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月6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
30
试验地点
1
主要终点
Baseline energy intake

研究概览

简要总结

The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive factors related to appetite, and objectively-measured food intake in a subsample of children and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective cohort. The primary study also collects data on habitual physical and sedentary activity, body weight and body composition, and cardiometabolic health markers.

详细描述

The investigators will enroll 30 boys and girls (50% female) between the ages of 10-16 years and above the 85th BMI percentile (i.e., overweight to severe obesity) in this pilot ancillary study. The objective is to examine interactions between the following energy-balance related factors:

  1. Ad libitum post-exercise food intake
  2. Cognitive factors, including inhibitory control, food wanting, and motivation for food
  3. Exercise-related factors, including cardiorespiratory fitness, substrate utilization (carbohydrate versus fat), and perceived exertion
  4. Habitual physical and sedentary activity
  5. Body composition and cardiometabolic health

The prospective, longitudinal nature of the study will allow the investigators to examine these variables cross-sectionally and quantify change over two years. Of particular interest is whether cognitive factors related to energy balance, including perceived exertion, inhibitory control, food wanting, and food motivation, vary across time or are relatively stable. Finally, the investigators will assess the ability of these factors to predict changes in body composition and cardiometabolic health over two years.

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
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Eligible for the TIGER Kids primary study
  • BMI >/= 85th percentile
  • Height >/= 4 feet 6 inches
  • Weight < 350 pounds

排除标准

  • American College of Sports Medicine (ACSM) contraindications to exercise testing (i.e., medical history of cardiovascular or pulmonary conditions, physical conditions that affect the ability to exercise)

结局指标

主要结局

Baseline energy intake

时间窗: Year 0

Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal. Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.

Change in energy intake over 2 years

时间窗: Year 0 and Year 2

Ad libitum energy intake in kilocalories is measured using a in-laboratory dinner test-meal. Participants can eat as much or as little as they would like from the available food, which is provided in excess of energy needs.

Baseline cardiorespiratory fitness

时间窗: Year 0

Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.

Change in cardiorespiratory fitness over 2 years

时间窗: Year 0 and Year 2

Cardiorespiratory fitness, or VO2peak in mL/kg/min, is measured using a graded cycle ergometer test to volitional fatigue.

次要结局

  • Baseline appetite-related Visual Analog Scales (VAS)(Year 0)
  • Change in inhibitory control over 2 years(Year 0 and Year 2)
  • Change in Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2) over 2 years(Year 0 and Year 2)
  • Baseline Three Factor Eating Questionnaire - Revised 18-item version 2 (TFEQ-R18v2)(Year 0)
  • Change in appetite-related Visual Analog Scales (VAS) over 2 years(Year 0 and Year 2)
  • Baseline inhibitory control(Year 0)

研究者

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

S. Nicole Fearnbach

Assistant Professor - Research

Pennington Biomedical Research Center

研究点 (1)

Loading locations...

相似试验