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Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults? - NCT00901095-(Clinical Trial 292086)



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City:  Santa Clara
State:  
CA
Zip Code:
Conditions: Asthma - Obesity
Purpose: 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.
Study summary:
Criteria: 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.
Study is available at: Kaiser Permanente
Santa Clara, CA
United States

Primary Contact:
Kathy Stamm
Email: stammk@pamfri.org
Phone: 650-330-4515
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: ClinicalTrials.gov
Date Processed: March 23, 2011
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