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INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborators:
VA Puget Sound Health Care System
University of Illinois at Chicago
Information provided by (Responsible Party):
Seattle Institute for Biomedical and Clinical Research

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Obesity Weight Loss Life Style Overweight Behavioral: Lifestyle Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: INtervention Study In overweiGHT Patients With COPD
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : October 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Six Minute Walk Test [ Time Frame: 12 months ]
    distance walked in six minutes


Secondary Outcome Measures :
  1. Modified Borg Scale [ Time Frame: 12 months ]
    Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).

  2. Weight [ Time Frame: 12 months ]
    body weight

  3. 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

  4. 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

  5. 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).

  6. Waist Circumference [ Time Frame: 12 months ]
    cardiovascular disease risk

  7. Systolic Blood Pressure [ Time Frame: 12 months ]
    indicator of cardiovascular disease risk; higher values indicate higher risk

  8. Body Mass Index (BMI) [ Time Frame: 12 months ]
    cardiovascular disease risk

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634268


Locations
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Sponsors and Collaborators
Seattle Institute for Biomedical and Clinical Research
VA Puget Sound Health Care System
University of Illinois at Chicago
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Seattle Institute for Biomedical and Clinical Research:
Study Protocol and Statistical Analysis Plan  [PDF] February 18, 2021

More Information
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Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT02634268    
Other Study ID Numbers: 1U01HL128868 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2015    Key Record Dates
Results First Posted: February 9, 2022
Last Update Posted: April 7, 2022
Last Verified: March 2022
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seattle Institute for Biomedical and Clinical Research:
randomized controlled trial
diet
exercise
obesity
 overweight
chronic obstructive pulmonary disease
lifestyle
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Overweight
Weight Loss
Overnutrition
Nutrition Disorders
Body Weight
 Respiratory Tract Diseases
Body Weight Changes
Chronic Disease
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive