Clinical trial NCT02634268: INtervention Study In overweiGHT Patients With COPD
Official title: INtervention Study In overweiGHT Patients With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Obesity
Weight Loss
Life Style
Overweight
Keywords: randomized controlled trial
diet
exercise
obesity
overweight
chronic obstructive pulmonary disease
lifestyle
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
name: University of Illinois at Chicago
First posted: 2015-12-18
Enrollment: 684
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. The investigators are trying to find out if a program proven to help people lose a modest amount of weight and increase their physical activity will improve COPD symptoms for those with a high BMI. The program uses a series of video sessions and self-study handouts focused on healthy eating and increasing physical activity, and encourages participants to monitor their weight, diet, and physical activity for one year. For those who want to, they will be able to work with a health coach to help meet weight and activity goals. We hope that the program will lead to improved exercise tolerance, body weight, dyspnea, generic health-related quality of life, and major cardiovascular risk factors (central obesity by waist circumference, Framingham Risk Score, and blood pressure) through 12 months of follow-up. To be in the study, participants will need to have COPD, high BMI, history of smoking, shortness of breath, and be at least 40 years old.


Eligibility criteria: Inclusion Criteria:

* 40 years or older at time of eligibility screening;
* Body mass index 25.0-44.9 kg/m2 (also see Figure 2);
* Smoked more than 10 pack-years of cigarettes;
* Shortness of breath;
* COPD;
* Able to participate fully in all study protocol/procedures including written informed consent process.

Exclusion Criteria:

* Inability to speak, read, or understand English;
* Active weight loss interventions;
* 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.

Primary outcomes:
measure: Six Minute Walk Test
timeFrame: 12 months
Secondary outcomes:
measure: Modified Borg Scale
timeFrame: 12 months
measure: Weight
timeFrame: 12 months
measure: Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
timeFrame: 12 months
measure: Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
timeFrame: 12-months
measure: Non-laboratory Framingham Risk Score
timeFrame: 12 months
measure: Waist Circumference
timeFrame: 12 months
measure: Systolic Blood Pressure
timeFrame: 12 months
measure: Body Mass Index (BMI)
timeFrame: 12 months
measure: St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
timeFrame: 12 months
measure: St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
timeFrame: 12 months
measure: St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
timeFrame: 12 months
measure: St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - UAB Lung Health Center
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: Universtiy of California, San Francisco
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Waterbury
country: United States
facility: Waterbury Pulmonary Associates
state: Connecticut
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University - Northwestern Medical Group - Pulmonology
state: Illinois
city: Chicago
country: United States
facility: University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: South Portland
country: United States
facility: Chest Medicine
state: Maine
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University - Pulmonary & Critical Care Medicine
state: Maryland
city: Boston
country: United States
facility: Boston VA Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Health
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Division of Pulmonary & Critical Care Medicine
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System - Pulmonology
state: Minnesota
city: Saint Paul
country: United States
facility: Minnesota Health Partners
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis VA
state: Missouri
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Buffalo
country: United States
facility: Buffalo VA Medical Center
state: New York
city: Mineola
country: United States
facility: NYU Winthrop
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University - Pulmonary, Critical Care & Sleep Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Case Western
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital - Temple Lung Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center - Kaufmann Building
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: BSW Research
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Katy
country: United States
facility: Grand Medical Clinic
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: White River Junction
country: United States
facility: White River Junction VA
state: Vermont
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: David H Au, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago - Institute for Health Research and Policy
name: Jun Ma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: