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临床试验/NCT00367029
NCT00367029已完成3 期

Achieving Physical Activity Guidelines Through an Enhanced Print Intervention

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
256
试验地点
2
主要终点
Achievement of 150 minutes per week of at least moderate intensity physical activity

研究概览

简要总结

Individuals who are not physically active are at risk for developing heart disease, stroke, and diabetes. Using motivational print materials is one way to encourage individuals to increase their physical activity. This study will evaluate the effect that an enhanced version of an individualized, print-based motivational program has on increasing physical activity among sedentary individuals.

详细描述

Currently, only 32% of adults in the United States participate in regular physical activity. Several healthcare organizations, including the Centers for Disease Control and Prevention, the National Institutes of Health, and the American Heart Association recommend that adults engage in a minimum of 2 ½ hours of physical activity each week. In a previous study, individuals who received motivational print materials in the mail increased their weekly physical activity more than individuals who received no motivational materials or who received motivational support over the telephone. However, about half of those who were mailed the print materials still did not reach the recommended goal of 2 ½ hours of physical activity per week. The purpose of this study is to compare the effectiveness of an enhanced version of an individualized, print-based motivational program versus a previously tested print-based motivational program at increasing physical activity levels in sedentary individuals.

This study will enroll healthy, sedentary individuals. Participants will be randomly assigned to either a print-based, individually tailored motivational program or an enhanced version of the same program. All participants will attend a baseline study visit, which will include body measurements, physical activity assessments, and health and psychological questionnaires. A select group of participants will also take part in an exercise test. Participants will then document their monthly physical activity. Study researchers will use this information, as well as the completed questionnaires, to develop individualized reports, manuals, and tip sheets that include feedback and strategies for increasing physical activity for each participant. Materials will be mailed to participants 14 times throughout the year. Participants in the enhanced intervention will receive additional materials that focus on increasing social support, self regulation, and outcome expectations, as well as materials on how to effectively monitor physical activity levels. They will also attend one study visit to assess their goals with the research staff. At Months 6 and 12, baseline evaluations will be repeated and all participants will be interviewed to assess physical activity levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In good general health
  • Sedentary
  • Able to speak and read English
  • Planning to live in the area for the duration of the study

排除标准

  • Currently participates in 91 or more minutes of moderate or vigorous physical activity per week
  • Heart disease
  • Cerebrovascular disease
  • Peripheral vascular disease
  • Chronic obstructive pulmonary disease
  • High blood pressure
  • History of gastric bypass surgery
  • Psychoses
  • Any serious medical problem that would make exercise unsafe or unwise
  • Prior participation in a hospital-based or medically supervised weight loss program
  • Excessive alcohol consumption
  • Pregnant or plans to become pregnant

结局指标

主要结局

Achievement of 150 minutes per week of at least moderate intensity physical activity

时间窗: Measured by the 7-day Physical Activity Recall test at Months 6 and 12

次要结局

  • Cost-effectiveness(Measured at Months 6 and 12)
  • Moderators and mediators of the intervention (e.g., motivation and enjoyment)(Measured at Months 6 and 12)

研究者

申办方类型
Other

研究点 (2)

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