Asthma and Obesity: Pilot Study
关键词
抽象
描述
Of the 400 obese and non-obese adult asthmatics in New York City and Denver during the 18-month observational phase of this study, the study team will randomize 80 participants (40 in NYC and 40 in Denver) into a 4-week group session pilot study focused on beliefs and behaviors associated with asthma and obesity self-management behaviors (SMB). Eligibility will be determined based on Asthma Control Questionnaire (ACQ) score and body mass index (BMI) at their 12-month visit. Participants will be randomized into an intervention or an active control arm after completing their 18-month visit. Participants will be consented into the pilot study during or after their 18-month visit. Participants will be put into groups of 7-10 for the pilot. Once formed, groups will have four 1-hour weekly visits. A person will be allowed to make up one missed session. The make-up session will be conducted on the phone or in-person depending on scheduling availability of both participant and care coach. Participants will be given accelerometers at sessions 1 and 4 that they will be asked to wear for seven days and return along with an activity diary. A follow-up survey will be administered about 30 days after the last pilot session in order to reassess the patient's asthma, obesity, exercise and medication beliefs and their adherence to asthma SMB. At the time of the follow-up survey, participants will also be given accelerometers that they will be asked to wear for seven days and return along with an activity diary.
日期
| 最后验证: | 05/31/2020 |
| 首次提交: | 09/30/2019 |
| 提交的预估入学人数: | 09/30/2019 |
| 首次发布: | 10/02/2019 |
| 上次提交的更新: | 06/01/2020 |
| 最近更新发布: | 06/03/2020 |
| 实际学习开始日期: | 10/02/2019 |
| 预计主要完成日期: | 03/31/2021 |
| 预计完成日期: | 03/31/2021 |
状况或疾病
干预/治疗
Behavioral: Asthma and Exercise Lifestyle Change
Behavioral: Asthma Education
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Asthma and Exercise Lifestyle Change Participants receive asthma and lifestyle change education related to exercise | Behavioral: Asthma and Exercise Lifestyle Change Participants in the asthma and exercise lifestyle change arm will participate in 4 sessions focused on behavioral change and goal-setting education to teach them how to better incorporate exercise into their daily lives and better manage their asthma. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data. |
| Placebo Comparator: Asthma Education No lifestyle change education | Behavioral: Asthma Education General asthma education, but no discussion of the role of exercise and other lifestyle habits in asthma self-management. Following sessions 1 and 4, these participants will use the accelerometer to track activity, but will be blinded to the data. |
资格标准
| 有资格学习的年龄 | 21 Years 至 21 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 21-64 years of age - BMI ≥ 30 - Asthma diagnosis made by a health care provider - Poor Asthma Control (ACQ score ≥ 0.75) - English speaking Exclusion Criteria: - BMI < 30 - Good asthma control (ACQ score <0.75) - Diagnosis of dementia - Diagnosis of chronic obstructive pulmonary disease (COPD) or other chronic respiratory illness - Smoking history of ≥15 pack-years owing to possible undiagnosed COPD |
结果
主要结果指标
1. Change in Beliefs about Illness Perception Questionnaire (BIPQ) [At 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit]
次要成果指标
1. Change in Medication Adherence Rating Scale (MARS) [At 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit]
2. Changes in Physical Activity [Week 2, Week 4, at 4 weeks Post-pilot follow-up visit and at 12 weeks Post-pilot follow-up visit]
3. Change in Asthma Control Questionnaire (ACQ) [Post-pilot follow-up visit]
4. Change in Asthma Quality of Life Questionnaire (AQLQ) [Post-pilot follow-up visit]
