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

Palo Alto Medical Foundation6 sites in 1 country330 target enrollmentFebruary 2010

ConditionsAsthma Obesity

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Asthma
Sponsor: Palo Alto Medical Foundation
Enrollment: 330
Locations: 6
Primary Endpoint: Asthma Control Questionnaire
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

March 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Palo Alto Medical Foundation

Responsible Party

Principal Investigator

Jun Ma, MD, PhD

Associate Investigator

Palo Alto Medical Foundation

Eligibility Criteria

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.);