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

Sponsor
Palo Alto Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT00901095
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Kaiser Permanente (Other), Stanford University (Other)
330
Enrollment
8
Locations
2
Arms
48.9
Duration (Months)
41.3
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyle intervention
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
330 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Health Services Research
Official Title:
Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults
Study Start Date :
Feb 1, 2010
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Usual Care
Experimental: 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.

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.
Other Names:
  • In-person sessions and self-monitoring

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Asthma Control Questionnaire [Baseline, 6- and 12-months]

    Secondary Outcome Measures

    1. Lung function [Baseline, 6-, and 12-months]

    2. Quality of Life [Baseline, 6- and 12-months]

    3. Symptom-free days [Baseline, 6- and 12-month]

    4. Asthma-related and total health care utilization [Baseline, 6- and 12-month]

    5. BMI, diet, and physical activity [Baseline, 6- and 12-months]

    6. Adverse Events [6- and 12-months]

    7. Patient Satisfaction [Baseline and 12-month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kaiser Permananete, Fremont Medical Center Fremont California United States 94538
    2 Kaiser Permananete, Hayward Medical Center Hayward California United States 94545
    3 Kaiser Permananete, Novato Medical Center Novato California United States 94945
    4 Kaiser Permanente Oakland California United States 94611
    5 Kaiser Permanente Richmond California United States 94801
    6 Kaiser Permanente, San Francisco Medical Center San Francisco California United States 94115
    7 Kaiser Permananete, San Jose Medical Center San Jose California United States 95119
    8 Kaiser Permanente Santa Clara California United States 95051

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Jun Ma, M.D.,Ph.D., Palo Alto Medical Foundation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jun Ma, MD, PhD, Associate Investigator, Palo Alto Medical Foundation
    ClinicalTrials.gov Identifier:
    NCT00901095
    Other Study ID Numbers:
    • 1R01HL094466
    First Posted:
    May 13, 2009
    Last Update Posted:
    Mar 19, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Asthma
    Weight Loss

    Study Results

    No Results Posted as of Mar 19, 2014