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

NCT ID: NCT00901095

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-03-31

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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Lifestyle intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

In-person sessions and self-monitoring

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.);
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Palo Alto Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Jun Ma, MD, PhD

Associate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Ma, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Palo Alto Medical Foundation

Locations

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

Countries

United States

References

Xiao L, Lv N, Rosas LG, Au D, Ma J. Validation of clinic weights from electronic health records against standardized weight measurements in weight loss trials. Obesity (Silver Spring). 2017 Feb;25(2):363-369. doi: 10.1002/oby.21737. Epub 2017 Jan 6.

Reference Type: DERIVED

PMID: 28059466 (View on PubMed)

Ma J, Strub P, Xiao L, Lavori PW, Camargo CA Jr, Wilson SR, Gardner CD, Buist AS, Haskell WL, Lv N. Behavioral weight loss and physical activity intervention in obese adults with asthma. A randomized trial. Ann Am Thorac Soc. 2015 Jan;12(1):1-11. doi: 10.1513/AnnalsATS.201406-271OC.

Reference Type: DERIVED

PMID: 25496399 (View on PubMed)

Ma J, Strub P, Camargo CA Jr, Xiao L, Ayala E, Gardner CD, Buist AS, Haskell WL, Lavori PW, Wilson SR. The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: a randomized controlled trial. BMC Pulm Med. 2010 Mar 24;10:16. doi: 10.1186/1471-2466-10-16.

Reference Type: DERIVED

PMID: 20334686 (View on PubMed)

Other Identifiers

1R01HL094466

Identifier Type: NIH

Identifier Source: org_study_id

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