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View Clinical Trial (Medical Research Study)
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Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults? - NCT00901095-94115 (Clinical Trial 292085)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy292085.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94115 |
| Conditions: |
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Asthma - Obesity |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
Participants will meet all of the following:
- Age: 18-70 years of age;
- Obesity: BMI of 30.0-39.9 kg/m2 (due to safety issues surrounding medical treatment
and engaging in unsupervised physical activity for persons with BMI > 40);
- Physician-diagnosed asthma that is poorly controlled:
- a doctor's diagnosis of asthma on the current medical problem list;
- currently taking anti-asthma medications;
- >1 control problems identified using the modified ATAQ (see 5.3.4.);
- 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. |
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| Study is available at: |
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Kaiser Permanente, San Francisco Medical Center
San Francisco, CA 94115
United States
Primary Contact:
Kathy Stamm
Email: stammk@pamfri.org
Phone: 650-330-4515 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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