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临床试验/NCT01294657
NCT01294657Unknown不适用

Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans

研究概览

简要总结

The goal of this research study is to learn if a motivation and problem solving (MAPS) program can help improve diet and levels of physical activity in African Americans who are overweight.

详细描述

Day 1 Study Visit:

If you are found eligible to take part in this study, the following tests and procedures will be performed on Day 1 (the same day you complete the screening tests and sign this consent form):

  • You will complete a computer-based survey about your mood, diet, and physical activity. The survey should take about 90 minutes total to complete.
  • Your blood pressure will be measured.
  • Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
  • Your non-fasting blood glucose and cholesterol levels will be measured (with 2 small finger pricks).
  • You will be asked to provide a 7-day record of your physical activity using a small device called an accelerometer. The accelerometer will be worn on your hip and measures the amount of physical activity you do. You will be given a prepaid envelope to return the accelerometer to the study staff.

Study Groups and Study Procedures:

At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups.

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

入选标准

  • Self-reported African American race
  • Ability to engage in low to moderate physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q) or by physicians clearance (letter from physician or nurse practitioner) if currently taking medication for blood pressure or diabetes.
  • Blood pressure reading <140/90 mm Hg or by physicians clearance (letter from physician or nurse practitioner) if blood pressure reading >=140/90 mm Hg.
  • Functioning telephone number
  • 18-65 years of age
  • Overweight or obese as defined by BMI
  • Not currently exercising (<150 minutes/week) and/or not consuming 5 or more servings of fruits and vegetables per day

排除标准

  • Pressure readings >140/90 mm Hg, as defined by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, will be excluded from the study.
  • Currently taking medication for blood pressure or heart condition, or other physical limitations that might be aggravated by participation in moderate-intensity PA as measured using the PA Readiness Questionnaire, and any physical limitation that prevents engaging in PA.
  • Pregnant or thinking about becoming pregnant during the study period
  • Another household member enrolled in the study
  • Member of the church advisory board

结局指标

主要结局

Efficacy of a Motivation and Problem Solving (MAPS) Approach to Promoting and Facilitating Positive Health Behavior Change Among African Americans

时间窗: 6 months

Effects of MAPS on each of modifiable risk factors, assessed at 6 and 12-month follow-up visits using, using Questionnaire Design System (QDS), a computer-administered self-interview format.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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