Status:
COMPLETED
Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?
Lead Sponsor:
Palo Alto Medical Foundation
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Conditions:
Asthma
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00901095
Start Date
February 1 2010
End Date
March 1 2014
Last Update
March 19 2014
Active Locations (8)
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1
Kaiser Permananete, Fremont Medical Center
Fremont, California, United States, 94538
2
Kaiser Permananete, Hayward Medical Center
Hayward, California, United States, 94545
3
Kaiser Permananete, Novato Medical Center
Novato, California, United States, 94945
4
Kaiser Permanente
Oakland, California, United States, 94611