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| Sponsor: | Palo Alto Medical Foundation |
|---|---|
| Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Kaiser Permanente Stanford University |
| Information provided by: | Palo Alto Medical Foundation |
| ClinicalTrials.gov Identifier: | NCT00901095 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Asthma Obesity |
Behavioral: Lifestyle intervention |
Phase II |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Can Diet- & Exercise-Induced Weight Loss Improve Asthma Control in Adults |
| Estimated Enrollment: | 324 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control: No Intervention
Usual Care
|
|
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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.
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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.
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Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants will meet all of the following:
Physician-diagnosed asthma that is poorly controlled:
Exclusion Criteria:
Any of the following will exclude participants from the study:
Contacts and Locations| Contact: Kathy Stamm | 650-330-4515 | stammk@pamfri.org |
| United States, California | |
| Kaiser Permanente, San Francisco Medical Center | |
| San Francisco, California, United States, 94115 | |
| Kaiser Permanente | |
| Santa Clara, California, United States | |
| Kaiser Permanente | |
| Oakland, California, United States | |
| Kaiser Permanente | |
| Richmond, California, United States | |
| Principal Investigator: | Jun Ma, M.D.,Ph.D. | Palo Alto Medical Foundation |
More Information
| Responsible Party: | Palo Alto Medical Foundation Research Institute ( Jun Ma, M.D., Ph.D. ) |
| Study ID Numbers: | 1R01HL094466 |
| Study First Received: | May 12, 2009 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00901095 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Bronchial Diseases Immune System Diseases Asthma Overweight Body Weight Signs and Symptoms Lung Diseases, Obstructive Hypersensitivity |
Respiratory Tract Diseases Lung Diseases Weight Loss Body Weight Changes Hypersensitivity, Immediate Nutrition Disorders Overnutrition Respiratory Hypersensitivity |