INtervention Study In overweiGHT Patients With COPD

Obesity Clinical Trial

— INSIGHT COPD  

Official title:

INtervention Study In overweiGHT Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02634268
• Other study ID #: 1U01HL128868
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: October 30, 2020

Study information

• Verified date: March 2022
• Source: Seattle Institute for Biomedical and Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Life Style
• Lung Diseases
• Obesity
• Overweight
• Pulmonary Disease, Chronic Obstructive
• Weight Loss

Intervention

Behavioral:
• Lifestyle Intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity

Locations

Country	Name	City	State
United States	Albany Medical College	Albany	New York
United States	University of Michigan - Division of Pulmonary & Critical Care Medicine	Ann Arbor	Michigan
United States	Johns Hopkins University - Pulmonary & Critical Care Medicine	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Birmingham VA Medical Center	Birmingham	Alabama
United States	University of Alabama at Birmingham - UAB Lung Health Center	Birmingham	Alabama
United States	Boston VA Medical Center	Boston	Massachusetts
United States	Buffalo VA Medical Center	Buffalo	New York
United States	University of Buffalo	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University - Northwestern Medical Group - Pulmonology	Chicago	Illinois
United States	University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy	Chicago	Illinois
United States	Case Western	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	BSW Research	Dallas	Texas
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	National Jewish Health	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	East Carolina University - Pulmonary, Critical Care & Sleep Medicine	Greenville	North Carolina
United States	Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine	Hershey	Pennsylvania
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Grand Medical Clinic	Katy	Texas
United States	University of California, Los Angeles	Los Angeles	California
United States	NYU Winthrop	Mineola	New York
United States	Minneapolis VA Health Care System - Pulmonology	Minneapolis	Minnesota
United States	Temple University Hospital - Temple Lung Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center - Kaufmann Building	Pittsburgh	Pennsylvania
United States	St. Louis VA	Saint Louis	Missouri
United States	Minnesota Health Partners	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Universtiy of California, San Francisco	San Francisco	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	Chest Medicine	South Portland	Maine
United States	Baystate Health	Springfield	Massachusetts
United States	University of Arizona	Tucson	Arizona
United States	Waterbury Pulmonary Associates	Waterbury	Connecticut
United States	White River Junction VA	White River Junction	Vermont

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Institute for Biomedical and Clinical Research	University of Illinois at Chicago, VA Puget Sound Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walk Test	distance walked in six minutes	12 months
Secondary	Modified Borg Scale	Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).	12 months
Secondary	Weight	body weight	12 months
Secondary	Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)	scores range from 0-100 with higher scores reflecting better health	12 months
Secondary	Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)	scores range from 0-100 with higher scores reflecting better health	12-months
Secondary	Non-laboratory Framingham Risk Score	This measure uses non-laboratory-based measures (sex, age, body mass index, systolic blood pressure, use of antihypertensive treatment, smoking status, and diabetes status) to yield a score (cardiovascular disease points) representing 10-year risk of having a cardiovascular problem. Low scores (minimum of -2 for women, -3 for men) indicate low risk. Scores of 21 or higher indicate high risk (30% risk or higher).	12 months
Secondary	Waist Circumference	cardiovascular disease risk	12 months
Secondary	Systolic Blood Pressure	indicator of cardiovascular disease risk; higher values indicate higher risk	12 months
Secondary	Body Mass Index (BMI)	cardiovascular disease risk	12 months
Secondary	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score	Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.	12 months
Secondary	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score	Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.	12 months
Secondary	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score	Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.	12 months
Secondary	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score	Designed to measure respiratory health quality of life in patients with COPD, providing a total score and three subscale scores assessing: (1) symptoms (frequency and severity), (2) activities that cause or are limited by breathlessness and (3) Impact (social functioning and psychological disturbances resulting from COPD). Each score ranges from 0-100, with higher scores indicating more limitations.	12 months