AsthmaPhase 2NCT00901095
Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?
A Phase 2 study testing Lifestyle intervention in people with Asthma and Obesity, run by Palo Alto Medical Foundation at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 8 sitesUnited States
- Study dates
- Feb 2010to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Kaiser Permananete, Fremont Medical Center
Fremont, California, 94538
Kaiser Permananete, Hayward Medical Center
Hayward, California, 94545
Kaiser Permananete, Novato Medical Center
Novato, California, 94945
Kaiser Permanente
Oakland, California, 94611
Kaiser Permanente
Richmond, California, 94801
Kaiser Permanente, San Francisco Medical Center
San Francisco, California, 94115
Kaiser Permananete, San Jose Medical Center
San Jose, California, 95119
Kaiser Permanente
Santa Clara, California, 95051
About this study
Official title: Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
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.
- Being tested
- Lifestyle intervention
- Medical subject headings
- Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionBehavioural
Also called In-person sessions and self-monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care |
| 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. Receives: Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Questionnaire
Measured: Baseline, 6- and 12-months
Secondary outcomes (7)
Lung function
Measured: Baseline, 6-, and 12-months
Quality of Life
Measured: Baseline, 6- and 12-months
Symptom-free days
Measured: Baseline, 6- and 12-month
Asthma-related and total health care utilization
Measured: Baseline, 6- and 12-month
BMI, diet, and physical activity
Measured: Baseline, 6- and 12-months
Adverse Events
Measured: 6- and 12-months
Patient Satisfaction
Measured: Baseline and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startFeb 2010
- Primary completionSep 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Medical Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University
- Responsible party
- Principal investigator, Jun Ma, MD, PhD, Palo Alto Medical Foundation
- Investigators
- Jun Ma, M.D.,Ph.D., Principal investigator, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901095
- Sponsor's protocol ID
- 1R01HL094466
- Status last verified
- Mar 2014
- First submitted
- 12 May 2009
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28059466Ma 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.
PubMed 25496399Ma 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.
PubMed 20334686
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
- ClinicalTrials.gov ID
- NCT00901095
- Acronym / sponsor ID
- 1R01HL094466
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Palo Alto Medical FoundationUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Kaiser Permanente, Stanford University
- Study start
- Feb 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care |
| Lifestyle intervention | Experimental | Behavioral: Lifestyle interventionThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-70 years of age;
- Obesity: BMI >30.0 kg/m2;
- Physician-diagnosed asthma that is poorly controlled:
- Seen in primary care at Kaiser at least once in the preceding 24 months;
- KPNC member for >1 year.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionAlso: In-person sessions and self-monitoringParticipants 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. | Behavioural | Lifestyle intervention |
Primary outcome
Asthma Control Questionnaire
Time frame: Baseline, 6- and 12-months
7 secondary outcomes
Lung function
Time frame: Baseline, 6-, and 12-months
Quality of Life
Time frame: Baseline, 6- and 12-months
Symptom-free days
Time frame: Baseline, 6- and 12-month
Asthma-related and total health care utilization
Time frame: Baseline, 6- and 12-month
BMI, diet, and physical activity
Time frame: Baseline, 6- and 12-months
Adverse Events
Time frame: 6- and 12-months
Patient Satisfaction
Time frame: Baseline and 12-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
- Derived from this study: PubMed 28059466Xiao 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.
- Derived from this study: PubMed 25496399Ma 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.
- Derived from this study: PubMed 20334686Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ma, M.D.,Ph.D. principal investigator
Palo Alto Medical Foundation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lifestyle intervention in people with Asthma and Obesity, run by Palo Alto Medical Foundation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (time frame: Baseline, 6- and 12-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901095, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.