Reducing Cancer Disparities Among Latinos in Texas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction
研究概览
简要总结
The goal of this research study is to learn if a wellness program can help improve diet and physical activity levels and encourage smoking cessation in Latino individuals 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 be asked to complete some computer-based questionnaires or paper/pencil questionnaires that will include questions about your feelings, moods, and smoking status. These will take 60-90 minutes to complete.
- You will have your height, weight, and waistline measured.
- Your blood pressure will be measured by a trained research staff member
- You will complete a breath test to help researchers estimate (guess) the amount of cigarette smoke you inhale. The breath test uses a disposable cardboard tube that is attached to a machine, and you will be asked to blow a long, slow, steady breath into it.
- You will be given an accelerometer to wear for 7 days. An accelerometer is a small device that is worn on the waistline of your pants that measures your level of physical activity. After 7 days, you will be asked to "turn off" and mail back the accelerometer using a prepaid envelope provided by the study staff.
- You will give a saliva sample at this visit. To collect the saliva sample, you will place a piece of cotton in your mouth for 3 minutes. The saliva sample is used to check the amount of cotinine in the body. Cotinine is a chemical that is produced in your saliva when your body breaks down nicotine.
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. There is an equal chance of being assigned to either group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Latino adults
- •18 years of age or older
- •Current smoker with a history of smoking an average of at least 1 cigarette per day during the last year
- •Overweight/obese (BMI greater than or equal to 25)
- •Functioning telephone number
- •Valid home address
- •Ability to engage in low to moderate physical activity as determined by the Physical Activity Readiness Questionnaire (PAR-Q)
- •Blood Pressure readings <140/90 mm Hg as defined by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; Pressure readings >/=140/90 mm Hg will be deemed ineligible to participate and excluded from the study. They will be referred to their family physician or community services. Those ineligible based on their initial blood pressure reading are allowed to participate if they provide a letter from a physician who will continue to monitor the participant during the research study.
- •Can speak, read, and understand Spanish and/or English
排除标准
- •Pregnancy or lactation
- •Participants who were recruited for the pilot and focus groups are not eligible for the randomized trial.
- •Contraindication for nicotine patch use
- •Regular use of tobacco products
- •Current use of tobacco cessation medications
- •Currently enrolled in another smoking cessation study
- •Another household member enrolled in the study
- •Scores below 38 on the Short Assessment of Health Literacy for Spanish Adults (SAHLSA)
- •Active substance abuse or dependence
- •Scores below the 6th grade literacy level on the Rapid Estimate of Adult Literacy in Medicine (REALM)
研究组 & 干预措施
Health Education (HE)
HE of brief counseling and self-help materials addressing 3 risk behaviors, referrals to available resources, and a home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed.
干预措施: Health Education (Behavioral)
Health Education (HE)
HE of brief counseling and self-help materials addressing 3 risk behaviors, referrals to available resources, and a home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed.
干预措施: Questionnaires (Behavioral)
Health Education (HE)
HE of brief counseling and self-help materials addressing 3 risk behaviors, referrals to available resources, and a home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed.
干预措施: Nicotine Patches (Drug)
Motivation and Problem Solving (MAPS)
HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period.
干预措施: Health Education (Behavioral)
Motivation and Problem Solving (MAPS)
HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period.
干预措施: Questionnaires (Behavioral)
Motivation and Problem Solving (MAPS)
HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period.
干预措施: Telephone Counseling Sessions (Behavioral)
Motivation and Problem Solving (MAPS)
HE counseling, self-help materials, and resource referrals, and home-based exercise kit; 6-week supply of nicotine patches for smoking cessation if needed. Plus 9 proactive, telephone counseling sessions over the 18 month period.
干预措施: Nicotine Patches (Drug)
结局指标
主要结局
Efficacy of Motivation and Problem Solving (MAPS) in Cancer Risk Reduction
时间窗: 6 months
Generalized linear mixed model regression (GLMM) used in analyzing the effects of motivation and problem solving (MAPS) on the primary outcomes across the 6, 12, and 18-month time points.
次要结局
未报告次要终点