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

This study has been completed.
Sponsor:
Collaborators:
Kaiser Permanente
Stanford University
Information provided by (Responsible Party):
Jun Ma, MD, PhD, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier:
NCT00901095
First received: May 12, 2009
Last updated: March 17, 2014
Last verified: March 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: Can Diet- & Exercise-induced Weight Loss Improve Asthma Control in Adults

Resource links provided by NLM:


Further study details as provided by Palo Alto Medical Foundation:

Primary Outcome Measures:
  • Asthma Control Questionnaire [ Time Frame: Baseline, 6- and 12-months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lung function [ Time Frame: Baseline, 6-, and 12-months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Baseline, 6- and 12-months ] [ Designated as safety issue: No ]
  • Symptom-free days [ Time Frame: Baseline, 6- and 12-month ] [ Designated as safety issue: No ]
  • Asthma-related and total health care utilization [ Time Frame: Baseline, 6- and 12-month ] [ Designated as safety issue: No ]
  • BMI, diet, and physical activity [ Time Frame: Baseline, 6- and 12-months ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 6- and 12-months ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: Baseline and 12-month ] [ Designated as safety issue: No ]

Enrollment: 330
Study Start Date: February 2010
Study Completion Date: March 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: In-person sessions and self-monitoring

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901095

Locations
United States, California
Kaiser Permananete, Fremont Medical Center
Fremont, California, United States, 94538
Kaiser Permananete, Hayward Medical Center
Hayward, California, United States, 94545
Kaiser Permananete, Novato Medical Center
Novato, California, United States, 94945
Kaiser Permanente
Oakland, California, United States, 94611
Kaiser Permanente
Richmond, California, United States, 94801
Kaiser Permanente, San Francisco Medical Center
San Francisco, California, United States, 94115
Kaiser Permananete, San Jose Medical Center
San Jose, California, United States, 95119
Kaiser Permanente
Santa Clara, California, United States, 95051
Sponsors and Collaborators
Palo Alto Medical Foundation
Kaiser Permanente
Stanford University
Investigators
Principal Investigator: Jun Ma, M.D.,Ph.D. Palo Alto Medical Foundation
  More Information

No publications provided by Palo Alto Medical Foundation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jun Ma, MD, PhD, Associate Investigator, Palo Alto Medical Foundation
ClinicalTrials.gov Identifier: NCT00901095     History of Changes
Other Study ID Numbers: 1R01HL094466
Study First Received: May 12, 2009
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Obesity
Weight Loss
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on July 20, 2014