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临床试验/NCT02060279
NCT02060279已完成不适用

A 6-month Family-based, Intense Lifestyle Intervention Program and Carotenoid Supplementation for Children With Obesity: A Pilot Study

Nemours Children's Clinic1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in β-carotene

研究概览

简要总结

This is a pilot study of children between the ages of 8 to 11 years of age who are obese and participating in an intense family based intervention with a family-focused multi-component lifestyle intervention. In addition, a beta-carotene supplement will be administered to randomized participants.

详细描述

The spread of childhood obesity across all ethnic and socioeconomic classes in North America is alarming. The close link between morbid obesity and type II diabetes (T2DM) and in childhood is undisputed fact and recent statistics reported by the American Diabetes Association suggest that newly diagnosed cases are on the rise. The link between decreased exercise, increased calorie and fat intake, decrease intake of fruits and vegetables and increased frequency of T2DM are well established. Complications of child obesity include risks for heart disease, high cholesterol, high blood pressure, diabetes, and even some cancers. The lack of fruit and vegetable consumption may be responsible for specific nutrient deficiencies such as low β-carotene, which has recently been identified as an important regulator of body fat. Nemours and Wolfson Children's Hospital have taken the initiative to explore factors that contribute to childhood obesity including well controlled studies examining the effects of intensive nutritional and behavioral education, healthy eating and increased exercise as ways to help prevent the rise in childhood obesity. This study aims to institute an intensive 2 week in-patient intervention which will serve as a model for behavioral changes required in children and families to successfully address the rapid progression of obesity. We will administer a supplement of β-carotene and follow the changes in abdominal fat accumulation over six months. At the third week of intervention we will obtain a blood sample that will determine if any beneficial changes have already taken place in white blood cells that clear cholesterol from the arteries using genetic testing. At the end of the study we will compare the amount of abdominal fat that accumulates or decreases in each subject. An intensive educational program that leads to healthy eating and the habitual exercise for the whole family will help promote significant benefits in the rate of weight gain and delay the progression to diabetes.

研究设计

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

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age 8 years to 11 years at enrollment
  • BMI percentile ≥ 95th percentile

排除标准

  • Any major chronic diseases, cognitive impairments, or any organic cause of obesity
  • any orthopedic or neuromuscular condition that prevents/impedes age-appropriate physical activity
  • confirmed diagnosis of Prader-Willi syndrome
  • any metal implants that would preclude subject from safely having the MRI procedure

结局指标

主要结局

Change in β-carotene

时间窗: 6 months

BMI Z-score

时间窗: 6 months

Body Mass Index (kg/m\*2) was calculated using body mass and height. Body Mass Index z-scores were generated according to the U.S. Centers for Disease Control and Prevention reference criteria. Z-scores range from -3 to 3 and a z-score of 0 represents the population mean. Higher z-score values indicate worse outcomes. The Centers for Disease Control has defined obesity as a z-score \> 1.64 and overweight as a z-score \> 1.04.

Waist to Height Ratio

时间窗: 6 months

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

Amanda Lochrie

Principal Investigator

Nemours Children's Clinic

研究点 (1)

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