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临床试验/NCT01657422
NCT01657422已完成不适用

PACE+: Counseling Adolescents for Exercise and Nutrition

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 819 人开始时间: 2000年8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
819
试验地点
4
主要终点
Dietary fat, fruits & vegetable consumption

研究概览

简要总结

PACE+ was developed to address the increased number of adolescents in our country that are at risk for cardiovascular disease, cancer, and other diseases due to inactivity, obesity, and malnourishment. PACE+ will evaluate the efficacy of an integrated clinical and home-based intervention to improve physical activity and nutrition behaviors in adolescents ages 11-15 over a period of 2 years.

This study is unique in that it will be one of the first to evaluate a combined physical activity and nutrition intervention for youth that revolves around the primary health care setting. The PACE+ intervention is particularly innovative in that three components - computer, provider counseling, and an extended home-based intervention - are unified through a common theoretical framework.

详细描述

Improved physical activity (PA) and nutrition behaviors in adolescents show great promise to reduce risk of cancers and other diseases. Fewer than 20% of adolescents meet recommendations for fat or fruits & vegetables consumption, and only 50% of adolescent girls and 67% of boys meet recommendations for vigorous PA. PACE+ will evaluate an integrated clinical and home-based intervention to improve physical activity (PA) and nutrition behaviors in adolescents. The intervention has three integrated components: a computer assessment and action planner; provider counseling; and 24 months of extended phone & mail contact. 768 male and female adolescents age 11 through 15; will be recruited from six healthcare settings. Subjects will be randomly assigned within practices to two successive one-year "doses" of PACE+ or a comparison condition involving counseling for sun protection behaviors. PACE+ assesses four behaviors: 1) dietary fat, 2) fruits & vegetable consumption, 3) physical activity, and 4) sedentary behavior. Primary behavioral outcomes, secondary outcomes, and selected mediators and process variables will be measured prior to the first office visit and at 6, 12 and 24 months. Primary outcomes will be measured by the 7-day physical activity recall and 3-day food record of fruits & vegetables and fat at 12 months. Secondary outcomes include adiposity, fitness, BMI, psychosocial mediators of change, and body image. Potential risks are psychological and physical, however the risks are slight and of low likelihood. Benefits include helping bring about healthier lifestyles to prevent weight gain and reduce premature morbidity and mortality due to cancer, cardiovascular disease and other health problems. This study will be the first to evaluate a combined physical activity and nutrition intervention for youth that revolves around the primary health care setting.

研究设计

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

入排标准

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

入选标准

  • Subjects must be in good general health and have the ability to read and speak English.

排除标准

  • A known eating disorder,
  • pregnancy,
  • any cardiovascular or musculoskeletal problems that would limit their ability to comply with physical activity recommendations, and
  • being in foster care (due to difficulty in obtaining follow-up measures).

结局指标

主要结局

Dietary fat, fruits & vegetable consumption

时间窗: 12months

Equal in importance to the other two primary outcome measures, physical activity and sedentary behaviors

Physical activity

时间窗: 12 months

Equal in importance to the other two primary outcome measures, dietary fat, fruits and vegetables, and sedentary behaviors

sedentary behavior

时间窗: 12 months

equal in importance to the other two primary outcome measures: physical activity and diet fat, fruits and vegetable consumption

次要结局

  • dietary fat, fruits and vegetables(24 months)
  • physical activity(24 months)
  • sedentary behavior(24 months)

研究者

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

Kevin Patrick, MD, MS

Kevin Patrick, MD, MS, Principal Investigaor and Professor

University of California, San Diego

研究点 (4)

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