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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00901095
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : March 19, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Stanford University
Information provided by (Responsible Party):
Jun Ma, MD, PhD, Palo Alto Medical Foundation

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.

Condition or disease Intervention/treatment Phase
Asthma Obesity Behavioral: Lifestyle intervention Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Study Start Date : February 2010
Actual Primary Completion Date : September 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Usual Care
Experimental: Lifestyle intervention
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
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.
Other Name: In-person sessions and self-monitoring

Primary Outcome Measures :
  1. Asthma Control Questionnaire [ Time Frame: Baseline, 6- and 12-months ]

Secondary Outcome Measures :
  1. Lung function [ Time Frame: Baseline, 6-, and 12-months ]
  2. Quality of Life [ Time Frame: Baseline, 6- and 12-months ]
  3. Symptom-free days [ Time Frame: Baseline, 6- and 12-month ]
  4. Asthma-related and total health care utilization [ Time Frame: Baseline, 6- and 12-month ]
  5. BMI, diet, and physical activity [ Time Frame: Baseline, 6- and 12-months ]
  6. Adverse Events [ Time Frame: 6- and 12-months ]
  7. Patient Satisfaction [ Time Frame: Baseline and 12-month ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00901095

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United States, California
Kaiser Permananete, Fremont Medical Center
Fremont, California, United States, 94538
Kaiser Permananete, Hayward Medical Center
Hayward, California, United States, 94545
Kaiser Permananete, Novato Medical Center
Novato, California, United States, 94945
Kaiser Permanente
Oakland, California, United States, 94611
Kaiser Permanente
Richmond, California, United States, 94801
Kaiser Permanente, San Francisco Medical Center
San Francisco, California, United States, 94115
Kaiser Permananete, San Jose Medical Center
San Jose, California, United States, 95119
Kaiser Permanente
Santa Clara, California, United States, 95051
Sponsors and Collaborators
Palo Alto Medical Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Kaiser Permanente
Stanford University
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Principal Investigator: Jun Ma, M.D.,Ph.D. Palo Alto Medical Foundation
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jun Ma, MD, PhD, Associate Investigator, Palo Alto Medical Foundation Identifier: NCT00901095    
Other Study ID Numbers: 1R01HL094466 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Weight Loss
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Body Weight Changes
Body Weight