NCT00901095CompletedPhase 2
Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Palo Alto Medical Foundation8 sites in 1 country330 target enrollmentStarted: February 1, 2010Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Palo Alto Medical Foundation
- Enrollment
- 330
- Locations
- 8
- Primary Endpoint
- Asthma Control Questionnaire
Study Overview
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 employ a combination of recommended dietary and physical activity changes, and behavioral modification techniques.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
No Intervention
Usual Care
Lifestyle intervention
Experimental
The Lifestyle intervention group consists of in-person meetings co-led by an exercise specialist and dietician as well as follow-ups with an interventionist by phone.
Intervention: Lifestyle intervention (Behavioral)
Outcomes
Primary Outcomes
Asthma Control Questionnaire
Time Frame: Baseline, 6- and 12-months
Secondary Outcomes
- Patient Satisfaction(Baseline and 12-month)
- BMI, diet, and physical activity(Baseline, 6- and 12-months)
- Adverse Events(6- and 12-months)
- Lung function(Baseline, 6-, and 12-months)
- Quality of Life(Baseline, 6- and 12-months)
- Symptom-free days(Baseline, 6- and 12-month)
- Asthma-related and total health care utilization(Baseline, 6- and 12-month)
Investigators
Jun Ma, MD, PhD
Associate Investigator
Palo Alto Medical Foundation
Study Sites (8)
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