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

Study Overview
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Brief Summary
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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.

Official Title
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Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults

Conditions
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Asthma, Obesity

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual Care | |
| Experimental: Lifestyle intervention<br>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. | Behavioral: Lifestyle intervention<br>* Participants will attend a 15 weekly class sessions during the first 4 months. Classes will be co-lead by a dietician and exercise specialist and will involve a private weigh-in, a group discussion, a presentation of a lifestyle topic, 30 minutes of supervised moderate physical activity, followed by action-planning and goal-setting. During the next 2 months, participants will meet with a dietician on an individual basis for a private weigh-in, personal discussion and problem solving, review of self-monitoring records, and action-planning. The last 6 months will consist of applying and maintaining what has been learned in previous class sessions. Self-monitoring records, questions and problems will be discussed with interventions at least once every 2 months or more frequently if needed.<br>* Other names: In-person sessions and self-monitoring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Questionnaire |  | Baseline, 6- and 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| BMI, diet, and physical activity |  | Baseline, 6- and 12-months | 
| Adverse Events |  | 6- and 12-months | 
| Patient Satisfaction |  | Baseline and 12-month |