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

Phase 2

Completed

• Conditions: Obesity; Asthma
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT00901095
• Lead Sponsor: Palo Alto Medical Foundation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Study Start: 2010-02
• Primary Completion: 2013-09
• Status Verified: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	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.

Primary Outcome Measures

Name	Time	Method
Asthma Control Questionnaire	Baseline, 6- and 12-months

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Kaiser Permanente; 🇺🇸 Santa Clara, California, United States

Kaiser Permananete, Novato Medical Center; 🇺🇸 Novato, California, United States

Kaiser Permananete, Hayward Medical Center; 🇺🇸 Hayward, California, United States

Kaiser Permananete, San Jose Medical Center; 🇺🇸 San Jose, California, United States

Kaiser Permananete, Fremont Medical Center; 🇺🇸 Fremont, California, United States

Kaiser Permanente, San Francisco Medical Center; 🇺🇸 San Francisco, California, United States