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

March 17, 2014 updated by: Jun Ma, MD, PhD, Palo Alto Medical Foundation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

330

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Kaiser Permananete, Fremont Medical Center
      • Hayward, California, United States, 94545
        • Kaiser Permananete, Hayward Medical Center
      • Novato, California, United States, 94945
        • Kaiser Permananete, Novato Medical Center
      • Oakland, California, United States, 94611
        • Kaiser Permanente
      • Richmond, California, United States, 94801
        • Kaiser Permanente
      • San Francisco, California, United States, 94115
        • Kaiser Permanente, San Francisco Medical Center
      • San Jose, California, United States, 95119
        • Kaiser Permananete, San Jose Medical Center
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asthma Control Questionnaire
Time Frame: Baseline, 6- and 12-months
Baseline, 6- and 12-months

Secondary Outcome Measures

Outcome Measure
Time Frame
Lung function
Time Frame: Baseline, 6-, and 12-months
Baseline, 6-, and 12-months
Quality of Life
Time Frame: Baseline, 6- and 12-months
Baseline, 6- and 12-months
Symptom-free days
Time Frame: Baseline, 6- and 12-month
Baseline, 6- and 12-month
Asthma-related and total health care utilization
Time Frame: Baseline, 6- and 12-month
Baseline, 6- and 12-month
BMI, diet, and physical activity
Time Frame: Baseline, 6- and 12-months
Baseline, 6- and 12-months
Adverse Events
Time Frame: 6- and 12-months
6- and 12-months
Patient Satisfaction
Time Frame: Baseline and 12-month
Baseline and 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Medical Foundation

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Stanford University
Kaiser Permanente

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

May 12, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimate)

May 13, 2009

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01HL094466 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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