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临床试验/NCT01517139
NCT01517139已完成不适用

Pilot Study to Test the Methods for the Diet, Nutrition and Physical Activity Feasibility Study of Early Life Determinants of Adult Cancers in a Chinese Cohort of Adolescents and Their Mothers

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 278 人开始时间: 2012年3月1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
278
试验地点
1
主要终点
Participation rates >60%

研究概览

简要总结

Background:

  • Researchers want to collect information on diet, physical activity, and sun exposure in children and young adults. The data can provide information on the effect these factors might have on the development of cancer and other diseases. Information collected only from adults does not accurately measure these factors. To collect more accurate information, both mothers and children will provide information. Study participants will be from Hebei province in northeastern China and Jiangsu province in eastern China.

Objectives:

  • To collect and study diet, activity, and sun exposure data from Chinese adolescents and their mothers.

Eligibility:

  • Adolescents between 15 and 17 years of age from Hebei and Jiangsu provinces in China.
  • Mothers of the study adolescents.

Design:

  • Participants will answer questions about their diet, physical activity, and time in the sun.
  • Participants will wear a pedometer to measure activity for 7 days. They will also wear a badge to measure sun exposure for 3 days.
  • Participants will record their activities and food and drinks consumed for 3 days. Urine samples will be collected for a full day.
  • Participants will have a grip strength test. On the last day of the study, they will provide blood, saliva, and toenail samples.
  • A smaller separate group of adolescents will provide saliva samples only and complete a food questionnaire.

详细描述

Background:

Emerging epidemiological evidence suggests that early-life exposures in conjunction with genetic makeup and variability may be important in the etiology of many common adult cancers. Prospectively collected information on adolescent and early adulthood exposures is lacking and current evidence often relies on adult recall of the past with a limited array of exposure variables.

Long Term Objective:

  1. To investigate the feasibility of assessing exposures that may be linked to early life exposures and to later diseases. Exposures include diet, physical activity, UV-exposure, DNAmethylation status, body size and reproductive factors. This feasibility work will inform additional research in an existing large Chinese-U.S. CDC collaborative project conducted in 1993 - 1995, the Community Intervention Program (CIP) (n = 247,000).

Short Term Objectives: 2. To determine the feasibility of collecting and assessing the quality of data on current diet, nutritional status, physical activity, physical strength, UV exposure, DNA methylation status and other environmental exposures as early life determinants of adult cancer in adolescents 15 - 17 years of age and early adulthood in their mothers. 3. To assess differences in methylation status of DNA between those exposed to periconceptional folic acid supplementation and those unexposed. 4. To compare dietary and physical activity self-reporting instruments against objective measures of dietary intake and physical activity, respectively.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Participation rates >60%

时间窗: At the end of the study, July 2012

Participation rates were 66% in the rural community and 87% in the urban community.

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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