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INtervention Study In overweiGHT Patients With COPD (INSIGHT COPD)

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ClinicalTrials.gov Identifier: NCT02634268
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : May 10, 2018
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

December 10, 2015
December 18, 2015
May 10, 2018
May 12, 2017
August 2020   (Final data collection date for primary outcome measure)
  • weight [ Time Frame: 18 months ]
    participants body weight
  • Six minute walk test [ Time Frame: 18 months ]
    distance walked in six minutes
  • weight [ Time Frame: 24 months ]
    participants body weight
  • Six minute walk test [ Time Frame: 24 months ]
    distance walked in six minutes
Complete list of historical versions of study NCT02634268 on ClinicalTrials.gov Archive Site
  • Short Form 12 Health Survey (SF-12 [ Time Frame: 18 months ]
    general health status
  • Framingham Risk score [ Time Frame: 18 months ]
    cardiovascular disease (CVD) risk
  • waist circumference [ Time Frame: 18 months ]
    CVD risk
  • blood pressure [ Time Frame: 18 months ]
    CVD risk
  • St George's Respiratory Questionnaire [ Time Frame: 18 months ]
    self-report respiratory symptoms
  • 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
Not Provided
Not Provided
 
INtervention Study In overweiGHT Patients With COPD
INtervention Study In overweiGHT Patients With COPD
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Obesity
  • Weight Loss
  • Life Style
  • Overweight
Behavioral: Lifestyle Intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Same as current
August 2020
August 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact: Margaret P Collins, PhD 206-764-2085 margaret.collins@va.gov
Contact: Amber D. Lane, BS 206-277-4196 insight1@uw.edu
United States
 
 
NCT02634268
1U01HL128868( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Seattle Institute for Biomedical and Clinical Research
Seattle Institute for Biomedical and Clinical Research
  • VA Puget Sound Health Care System
  • University of Illinois at Chicago
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
Seattle Institute for Biomedical and Clinical Research
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP