INSIGHT COPD

Principal Investigator: Boaz  Markewitz
Keywords: COPD , Obesity , Weight , Exercise , Chronic Obstructive Pulmonary Disease , Overweight , Pulmonary , Physical activity Department: Pulmonary
IRB Number: 00097990 Co Investigator: Cheryl  Pirozzi
Specialty: Pulmonary, Pulmonary, Pulmonary, Pulmonary, Pulmonary
Sub Specialties: Pulmonary Rehabilitation, Pulmonary Function, General Pulmonary, Pulmonary, Airway Disorders
Recruitment Status: Not yet recruiting

Contact Information

Guillermo Villegas
mvillegas@hsc.utah.edu
8015816496

Brief Summary

The overall goal is to produce first-ever evidence on the effectiveness of a proven pragmatic lifestyle intervention targeted at modest, clinically meaningful weight loss and increased physical activity in overweight or obese patients with spirometry-confirmed COPD. In the 18-month simple, pragmatic clinical trial (PCT), we efficiently focus on the intervention effects primarily on weight loss and exercise tolerance; and secondarily on dyspnea, generic health-related quality of life (HRQoL) and cardiovascular risk factors (CVRFs).

We will implement the E-LITE self-directed lifestyle intervention in a multicenter, patient-level randomized PCT of approximately 1000 overweight and obese patients with COPD. Our specific aims are to test whether, compared with usual care (UC) controls, intervention participants have better outcomes through 18 months of follow-up, including:

1. Primary measures: Greater weight loss and better exercise tolerance by the 6-Minute Walk Test (6MWT) at 12 months (intermediate endpoint) and 18 months (primary endpoint).

2. Secondary measures: Less dyspnea measured with the modified Borg scale, and more improvements in generic HRQoL by the SF-12v2 and major CVRFs (central obesity by waist circumference, Framingham Risk Score and blood pressure).

STUDY DESIGN

INSIGHT COPD is a simple, two-arm PCT in which approximately 1000 overweight and obese COPD patients, aged 40 years and older, will be randomized to UC or UC plus the self-directed lifestyle intervention for 12 months. Follow-up assessments will occur at 12 and 18 months. We hypothesize that intervention participants will have lower weight and better exercise tolerance at 18 months.

Detailed Description

The overall goal is to produce first-ever evidence on the effectiveness of a proven pragmatic lifestyle intervention targeted at modest, clinically meaningful weight loss and increased physical activity in overweight or obese patients with spirometry-confirmed COPD. In the 18-month simple, pragmatic clinical trial (PCT), we efficiently focus on the intervention effects primarily on weight loss and exercise tolerance; and secondarily on dyspnea, generic health-related quality of life (HRQoL) and cardiovascular risk factors (CVRFs). We will implement the E-LITE self-directed lifestyle intervention in a multicenter, patient-level randomized PCT of approximately 1000 overweight and obese patients with COPD. Our specific aims are to test whether, compared with usual care (UC) controls, intervention participants have better outcomes through 18 months of follow-up, including: 1. Primary measures: Greater weight loss and better exercise tolerance by the 6-Minute Walk Test (6MWT) at 12 months (intermediate endpoint) and 18 months (primary endpoint). 2. Secondary measures: Less dyspnea measured with the modified Borg scale, and more improvements in generic HRQoL by the SF-12v2 and major CVRFs (central obesity by waist circumference, Framingham Risk Score and blood pressure).

Inclusion Criteria

Inclusion

• 40 years or older at time of eligibility screening;

• Body mass index 25.0-44.9 kg/m2;

• Smoked at least 10 pack-years of cigarettes;

• Modified Medical Research Council dyspnea score of 2 or higher, i.e., “I walk slower than people…”;

• COPD, defined as an FEV1/FVC less than the lower limit of normal and FEV1% predicted greater than 40;

• Access to DVD player or internet in order to view the 12 GLB sessions;

• Consent to the study protocol/procedures including: o time and data collection requirements of the study;

o randomization to one of the two intervention arms;

o adherence to the recommendations of the study intervention as assigned;

o authorizing extraction of relevant information from their medical records.

 

Exclusion Criteria

Exclusion

• Inability to speak, read, or understand English;

• Active weight loss interventions including: o use of prescription weight-loss medications in the past 3 months,

o current participation in group or individual weight loss programs provided by trained personnel (attending peer support groups or following a self-help weight management book, "boot camp," or diet is not an exclusion),

o had bariatric surgery or plans to undergo bariatric surgery during the study period;

• Expected weight loss because of alternate explanations, such as from illness;

• Unable to ambulate to weight scale for weight measurement;

• Safety and/or adherence concerns due to severe physical or mental health issues or life expectancy <18 months;

• Pregnant, lactating, or planning to become pregnant during the study period;

• Participation in other intervention studies