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Completed

NCT Number: NCT02634268

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 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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Body Weight Body Weight Changes Chronic Disease Disease Attributes Life Style Lung Diseases Lung Diseases, Obstructive Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Weight Loss

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Center, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

Behavioral lifestyle intervention focused on healthy eating and physical activity

Primary outcomes

  1. Six Minute Walk Test

    Time frame: 12 months

    distance walked in six minutes

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seattle Institute for Biomedical and Clinical Research

Other

Collaborators

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

Registry information

Acronym: INSIGHT COPD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2015
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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