Clinical trial NCT00901095: Can Diet- and Exercise-Induced Weight Loss Improve Asthma Control in Adults?
Official title: Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Obesity
Lead sponsor: Palo Alto Medical Foundation
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Kaiser Permanente
name: Stanford University
First posted: 2009-05-13
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Asthma Control Questionnaire
timeFrame: Baseline, 6- and 12-months
Secondary outcomes:
measure: Lung function
timeFrame: Baseline, 6-, and 12-months
measure: Quality of Life
timeFrame: Baseline, 6- and 12-months
measure: Symptom-free days
timeFrame: Baseline, 6- and 12-month
measure: Asthma-related and total health care utilization
timeFrame: Baseline, 6- and 12-month
measure: BMI, diet, and physical activity
timeFrame: Baseline, 6- and 12-months
measure: Adverse Events
timeFrame: 6- and 12-months
measure: Patient Satisfaction
timeFrame: Baseline and 12-month
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Kaiser Permananete, Fremont Medical Center
state: California
city: Hayward
country: United States
facility: Kaiser Permananete, Hayward Medical Center
state: California
city: Novato
country: United States
facility: Kaiser Permananete, Novato Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente
state: California
city: Richmond
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente, San Francisco Medical Center
state: California
city: San Jose
country: United States
facility: Kaiser Permananete, San Jose Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Palo Alto Medical Foundation
name: Jun Ma, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.