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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 : Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : August 21, 2019
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

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 digital video discs (DVD) sessions focused on healthy eating and physical activity, and encourages participants to monitor their weight, diet, and physical activity for two years. 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 weight loss, better exercise tolerance, and less shortness of breath. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 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
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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



Primary Outcome Measures :
  1. Six minute walk test [ Time Frame: 12 months ]
    distance walked in six minutes


Secondary Outcome Measures :
  1. Short Form 12 Health Survey (SF-12 [ Time Frame: 12 months ]
    general health status

  2. Framingham Risk score [ Time Frame: 12 months ]
    cardiovascular disease (CVD) risk

  3. waist circumference [ Time Frame: 12 months ]
    CVD risk

  4. blood pressure [ Time Frame: 12 months ]
    CVD risk

  5. St George's Respiratory Questionnaire [ Time Frame: 12 months ]
    self-report respiratory symptoms

  6. weight [ Time Frame: 12 months ]
    participants body weight



Information from the National Library of Medicine

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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 <24 months;
  • Pregnant, lactating, or planning to become pregnant during the study period;
  • Participation in other intervention studies.

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


  Show 34 Study Locations
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

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Responsible Party: Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier: NCT02634268     History of Changes
Other Study ID Numbers: 1U01HL128868 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Chronic Disease
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Body Weight Changes
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive