Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?

Completed · Phase 2

Conditions studied: Asthma, Obesity

In brief

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.

Key facts

Study ID

NCT00901095

Run by

Palo Alto Medical Foundation

People needed

330

Starts

2010-02-01

Expected to finish

2014-03-01

Last updated by the study team

2014-03-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Kaiser Permananete, Fremont Medical Center — Fremont, California, United States
• Kaiser Permananete, Hayward Medical Center — Hayward, California, United States
• Kaiser Permananete, Novato Medical Center — Novato, California, United States
• Kaiser Permanente — Oakland, California, United States
• Kaiser Permanente — Richmond, California, United States
• Kaiser Permanente, San Francisco Medical Center — San Francisco, California, United States
• Kaiser Permananete, San Jose Medical Center — San Jose, California, United States
• Kaiser Permanente — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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