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

Obesity Clinical Trial

Official title:

Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901095
• Other study ID #: 1R01HL094466
• Status: Completed
• Phase: Phase 2
• First received: May 12, 2009
• Last updated: March 17, 2014
• Start date: February 2010
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Palo Alto Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (4)

Lead Sponsor	Collaborator
Palo Alto Medical Foundation	Kaiser Permanente, National Heart, Lung, and Blood Institute (NHLBI), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Questionnaire		Baseline, 6- and 12-months	No
Secondary	Lung function		Baseline, 6-, and 12-months	No
Secondary	Quality of Life		Baseline, 6- and 12-months	No
Secondary	Symptom-free days		Baseline, 6- and 12-month	No
Secondary	Asthma-related and total health care utilization		Baseline, 6- and 12-month	No
Secondary	BMI, diet, and physical activity		Baseline, 6- and 12-months	No
Secondary	Adverse Events		6- and 12-months	No
Secondary	Patient Satisfaction		Baseline and 12-month	No