Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT00901095
Eligibility Criteria:
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00901095
Study Brief:
Protocol Section:
NCT00901095