INtervention Study In overweiGHT Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 684
- 试验地点
- 39
- 主要终点
- Six Minute Walk Test
研究概览
简要总结
Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years or older at time of eligibility screening;
- •Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
- •Smoked more than 10 pack-years of cigarettes;
- •Shortness of breath;
- •Able to participate fully in all study protocol/procedures including written informed consent process.
排除标准
- •Inability to speak, read, or understand English;
- •Active weight loss interventions;
- •Expected weight loss because of alternate explanations, such as from illness;
- •Unable to ambulate to weight scale for weight measurement;
- •Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <18 months;
- •Pregnant, lactating, or planning to become pregnant during the study period;
- •Participation in other intervention studies.
研究组 & 干预措施
Lifestyle intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
干预措施: Lifestyle Intervention (Behavioral)
Usual Care
Participants continue with usual diet and exercise activities as they desire
结局指标
主要结局
Six Minute Walk Test
时间窗: 12 months
distance walked in six minutes
次要结局
- Systolic Blood Pressure(12 months)
- Modified Borg Scale(12 months)
- Body Mass Index (BMI)(12 months)
- Non-laboratory Framingham Risk Score(12 months)
- St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score(12 months)
- St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score(12 months)
- Weight(12 months)
- Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)(12-months)
- Waist Circumference(12 months)
- St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score(12 months)
- Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)(12 months)
- St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score(12 months)