INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

• ClinicalTrials.gov Identifier: NCT02634268
• Recruitment Status: Completed
• First Posted: December 18, 2015
• Results First Posted: February 9, 2022
• Last Update Posted: April 7, 2022
• Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: VA Puget Sound Health Care System; University of Illinois at Chicago
• Information provided by (Responsible Party): Seattle Institute for Biomedical and Clinical Research

Tracking Information

• First Submitted Date: December 10, 2015
• First Posted Date: December 18, 2015
• Results First Submitted Date: December 7, 2021
• Results First Posted Date: February 9, 2022
• Last Update Posted Date: April 7, 2022
• Actual Study Start Date: May 12, 2017
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2022)

Six Minute Walk Test [ Time Frame: 12 months ]

distance walked in six minutes

Original Primary Outcome Measures (submitted: December 15, 2015)

• weight [ Time Frame: 24 months ]
  participants body weight
• Six minute walk test [ Time Frame: 24 months ]
  distance walked in six minutes

Current Secondary Outcome Measures (submitted: March 10, 2022)

• Modified Borg Scale [ Time Frame: 12 months ]
  Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
• Weight [ Time Frame: 12 months ]
  body weight
• Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) [ Time Frame: 12 months ]
  scores range from 0-100 with higher scores reflecting better health
• Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) [ Time Frame: 12-months ]
  scores range from 0-100 with higher scores reflecting better health
• Non-laboratory Framingham Risk Score [ Time Frame: 12 months ]
  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).
• Waist Circumference [ Time Frame: 12 months ]
  cardiovascular disease risk
• Systolic Blood Pressure [ Time Frame: 12 months ]
  indicator of cardiovascular disease risk; higher values indicate higher risk
• Body Mass Index (BMI) [ Time Frame: 12 months ]
  cardiovascular disease risk
• St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score [ Time Frame: 12 months ]
  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.
• St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score [ Time Frame: 12 months ]
  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.
• St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score [ Time Frame: 12 months ]
  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.
• St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score [ Time Frame: 12 months ]
  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.

Original Secondary Outcome Measures (submitted: December 15, 2015)

• Short Form 12 Health Survey (SF-12 [ Time Frame: 24 months ]
  general health status
• Framingham Risk score [ Time Frame: 24 months ]
  cardiovascular disease (CVD) risk
• waist circumference [ Time Frame: 24 months ]
  CVD risk
• blood pressure [ Time Frame: 24 months ]
  CVD risk
• St George's Respiratory Questionnaire [ Time Frame: 24 months ]
  self-report respiratory symptoms

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: INtervention Study In overweiGHT Patients With COPD
• Official Title: INtervention Study In overweiGHT Patients With COPD
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

Behavioral: Lifestyle Intervention

Behavioral lifestyle intervention focused on healthy eating and physical activity

Study Arms

• Active Comparator: Lifestyle intervention
  Behavioral lifestyle intervention focused on healthy eating and physical activity
  Intervention: Behavioral: Lifestyle Intervention
• No Intervention: Usual Care
  Participants continue with usual diet and exercise activities as they desire

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2020): 684
• Original Estimated Enrollment (submitted: December 15, 2015): 1000
• Actual Study Completion Date: October 30, 2020
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02634268
• Other Study ID Numbers: 1U01HL128868( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: A de-identified dataset will be shared with NHLBI's data repository, Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Summer 2022 and onward according to BioLINCC policy.
• Access Criteria: Researchers may submit a data request vis BioLINCC, including description of the research plan/protocol, and documentation of review from an Institutional Review Board (IRB) or Ethics Committee (EC). Once those requirements are met and the request is approved by the NHLBI, BioLINCC staff will provide a Research Materials Distribution Agreement (RMDA) to be signed by a designated Principal Investigator and an authorized business official from the receiving institution, prior to data release.
• URL: https://biolincc.nhlbi.nih.gov/home/

• Current Responsible Party: Seattle Institute for Biomedical and Clinical Research
• Original Responsible Party: Same as current
• Current Study Sponsor: Seattle Institute for Biomedical and Clinical Research
• Original Study Sponsor: Same as current

Collaborators

• VA Puget Sound Health Care System
• University of Illinois at Chicago

Investigators

• Principal Investigator: David H Au, MD, MS; VA Puget Sound Health Care System
• Principal Investigator: Jun Ma, MD, PhD; University of Illinois at Chicago - Institute for Health Research and Policy

• PRS Account: Seattle Institute for Biomedical and Clinical Research
• Verification Date: March 2022