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OpenTrials
Completed

NCT Number: NCT00901095

Can Diet- and 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaiser Permananete, Fremont Medical Center, Fremont, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

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

Primary outcomes

  1. Asthma Control Questionnaire

    Time frame: Baseline, 6- and 12-months

Secondary outcomes

  1. Lung function

    Time frame: Baseline, 6-, and 12-months

  2. Quality of Life

    Time frame: Baseline, 6- and 12-months

  3. Symptom-free days

    Time frame: Baseline, 6- and 12-month

  4. Asthma-related and total health care utilization

    Time frame: Baseline, 6- and 12-month

  5. BMI, diet, and physical activity

    Time frame: Baseline, 6- and 12-months

  6. Adverse Events

    Time frame: 6- and 12-months

  7. Patient Satisfaction

    Time frame: Baseline and 12-month

Sponsors and collaborators

Lead sponsor

Palo Alto Medical Foundation

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
May 13, 2009
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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