NCT00901095已完成2 期
Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 14
- 主要终点
- Asthma Control Questionnaire
研究概览
简要总结
The goal of the study is to investigate the efficacy of an evidence-based weight loss intervention, on a background of quality health care, on asthma control among obese adults. The intervention will employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will meet all of the following:
- •Age: 18-70 years of age;
- •Obesity: BMI >30.0 kg/m2;
- •Physician-diagnosed asthma that is poorly controlled:
- •Documented diagnosis of asthma on the current medical problem list
- •Currently prescribed an anti-asthma medication
- •Overall score <20 on the Asthma Control Test (ACT)64 or a score<3 on any of the first four ACT questions regarding symptoms, nighttime awakening, interference with normal activity, and SABA use for symptom relief
- •Demonstrable airway reversibility
- •Seen in primary care at Kaiser at least once in the preceding 24 months;
- •KPNC member for >1 year.
排除标准
- •Any of the following will exclude participants from the study:
- •Inability to speak, read or understand English;
- •Intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms < 2x/week and nocturnal symptoms < 2x/month and no use of long-term control medications);
- •Diagnosis of COPD (emphysema or chronic bronchitis) on the current medical problem list or suggested by spirometry at baseline;
- •Unwilling to attempt weight loss, including unwillingness to perform self-monitoring;
- •Body weight change (+/-) > 10 pounds or use of weight-loss medications in the preceding 3 months;
- •Inability to perform pulmonary function tests by spirometry in a consistent manner;
- •Significant medical co-morbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
- •Diagnosis of psychiatric disorders that would limit adequate informed consent or ability to comply with study protocol;
- •Regular use of medications that can cause weight gain (e.g., oral corticosteroids, insulin, certain oral hypoglycemics, certain antidepressants, etc.);
- •Under treatment for cancer or another condition that may prevent completion of follow-up;
- •Diagnosis of a terminal illness and/or in hospice care;
- •Use of a pacemaker or other implanted medical devices;
- •Pregnant, planning to become pregnant, or lactating;
- •Actively enrolled in a care management program focused on weight loss at Kaiser or elsewhere;
- •Already enrolled or planning to enroll in a research study that would limit full participation in the study or confound the observation and interpretation of the study's findings;
- •Family household member already enrolled in the study;
- •No longer receiving primary care from Kaiser, or planning not to do so within the study period;
- •PCP determination that the study is inappropriate or unsafe for the patient;
- •Investigator discretion for clinical safety or protocol adherence reasons.
结局指标
主要结局
Asthma Control Questionnaire
时间窗: Baseline, 6- and 12-months
次要结局
- Patient Satisfaction(Baseline and 12-month)
- BMI, diet, and physical activity(Baseline, 6- and 12-months)
- Adverse Events(6- and 12-months)
- Lung function(Baseline, 6-, and 12-months)
- Quality of Life(Baseline, 6- and 12-months)
- Symptom-free days(Baseline, 6- and 12-month)
- Asthma-related and total health care utilization(Baseline, 6- and 12-month)
研究者
Jun Ma, MD, PhD
Associate Investigator
Palo Alto Medical Foundation
研究点 (14)
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