Life Style, Obesity, Overweight, Pulmonary Disease, Chronic Obstructive, Weight Loss
Conditions
Keywords
randomized controlled trial, diet, exercise, obesity, overweight, chronic obstructive pulmonary disease, lifestyle
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.
Interventions
BEHAVIORALLifestyle Intervention
Behavioral lifestyle intervention focused on healthy eating and physical activity
Sponsors
VA Puget Sound Health Care System
University of Illinois at Chicago
Seattle Institute for Biomedical and Clinical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six Minute Walk Test | 12 months | distance walked in six minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 12 months | body weight |
| Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) | 12 months | scores range from 0-100 with higher scores reflecting better health |
| Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) | 12-months | scores range from 0-100 with higher scores reflecting better health |
| Non-laboratory Framingham Risk Score | 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 | 12 months | cardiovascular disease risk |
| Modified Borg Scale | 12 months | Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe). |
| Body Mass Index (BMI) | 12 months | cardiovascular disease risk |
| St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score | 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 | 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 | 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 | 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. |
| Systolic Blood Pressure | 12 months | indicator of cardiovascular disease risk; higher values indicate higher risk |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 4/28/2017-8/16/2019 from 38 diverse settings across the United States, including rural, urban, and academic medical centers, and Department of Veteran Affairs Health Systems.
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Intervention Behavioral lifestyle intervention focused on healthy eating and physical activity
Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | 346 |
| Usual Care Participants continue with usual diet and exercise activities as they desire | 338 |
| Total | 684 |
Baseline characteristics
| Characteristic | Usual Care | Total | Lifestyle Intervention |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 7.7 | 67.0 years STANDARD_DEVIATION 8 | 67.0 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 9 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 333 Participants | 670 Participants | 337 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants | 136 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) White | 260 Participants | 527 Participants | 267 Participants |
| Sex: Female, Male Female | 140 Participants | 282 Participants | 142 Participants |
| Sex: Female, Male Male | 198 Participants | 402 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 346 | 9 / 338 |
| other Total, other adverse events | 95 / 346 | 90 / 338 |
| serious Total, serious adverse events | 78 / 346 | 75 / 338 |
Outcome results
Primary
Six Minute Walk Test
distance walked in six minutes
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Six Minute Walk Test | 1071.0 feet | Standard Deviation 354.1 |
| Usual Care | Six Minute Walk Test | 1005.9 feet | Standard Deviation 339 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month six minute walk test distance between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.0295% CI: [7.93, 76.6]Mixed Models Analysis
Secondary
Body Mass Index (BMI)
cardiovascular disease risk
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Body Mass Index (BMI) | 31.9 kg/m^2 | Standard Deviation 5 |
| Usual Care | Body Mass Index (BMI) | 32.7 kg/m^2 | Standard Deviation 4.8 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month BMI between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.00495% CI: [-0.85, -0.17]Mixed Models Analysis
Secondary
Modified Borg Scale
Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Modified Borg Scale | 2.7 units on a scale | Standard Deviation 1.9 |
| Usual Care | Modified Borg Scale | 3.2 units on a scale | Standard Deviation 1.9 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Modified Borg Scale score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.000895% CI: [-0.63, -0.09]Mixed Models Analysis
Secondary
Non-laboratory Framingham Risk Score
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).
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Non-laboratory Framingham Risk Score | 15.0 score on a scale | Standard Deviation 3 |
| Usual Care | Non-laboratory Framingham Risk Score | 15.4 score on a scale | Standard Deviation 3 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month Framingham Risk Score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.00995% CI: [-0.71, -0.1]Mixed Models Analysis
Secondary
Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
scores range from 0-100 with higher scores reflecting better health
Time frame: 12-months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) | 51.7 score on a scale | Standard Deviation 9.7 |
| Usual Care | Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) | 51.4 score on a scale | Standard Deviation 9.8 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 MCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.4595% CI: [-0.84, 1.89]Mixed Models Analysis
Secondary
Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
scores range from 0-100 with higher scores reflecting better health
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) | 39.7 score on a scale | Standard Deviation 8.5 |
| Usual Care | Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) | 37.5 score on a scale | Standard Deviation 8.8 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SF-12 PCS between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.0195% CI: [0.35, 2.6]Mixed Models Analysis
Secondary
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
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.
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score | 58.9 score on a scale | Standard Deviation 25.8 |
| Usual Care | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score | 63.3 score on a scale | Standard Deviation 25.3 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Activity score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.1295% CI: [-5.19, 0.56]Mixed Models Analysis
Secondary
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
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.
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score | 29.2 score on a scale | Standard Deviation 20.1 |
| Usual Care | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score | 32.8 score on a scale | Standard Deviation 21.5 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Impact score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.0395% CI: [-5.19, -0.25]Mixed Models Analysis
Secondary
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
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.
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score | 52.6 score on a scale | Standard Deviation 21.9 |
| Usual Care | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score | 54.9 score on a scale | Standard Deviation 20.8 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month SGRQ-C Symptom score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.0995% CI: [-4.87, 0.36]Mixed Models Analysis
Secondary
St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
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.
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score | 42.4 score on a scale | Standard Deviation 19.5 |
| Usual Care | St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score | 46.1 score on a scale | Standard Deviation 19.8 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month SGRQ-C Total score between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.0395% CI: [-4.55, -0.28]Mixed Models Analysis
Secondary
Systolic Blood Pressure
indicator of cardiovascular disease risk; higher values indicate higher risk
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Systolic Blood Pressure | 129.5 mmHg | Standard Deviation 17.2 |
| Usual Care | Systolic Blood Pressure | 128.8 mmHg | Standard Deviation 16.2 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month systolic blood pressure between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.6495% CI: [-3.02, 1.84]Mixed Models Analysis
Secondary
Waist Circumference
cardiovascular disease risk
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12-months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Waist Circumference | 111.3 centimeters | Standard Deviation 12.9 |
| Usual Care | Waist Circumference | 113.1 centimeters | Standard Deviation 13.5 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12 month waist circumference between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.1395% CI: [-2.12, 0.26]Mixed Models Analysis
Secondary
Weight
body weight
Time frame: 12 months
Population: We report here the unadjusted means at 12 months. The analysis population for adjusted between-group difference includes study participants with a measurement at baseline and/or 12 months; see Statistical Analysis 1 for those results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Weight | 91.0 kilograms | Standard Deviation 17.7 |
| Usual Care | Weight | 93.7 kilograms | Standard Deviation 17 |
Comparison: Linear mixed model analysis, including participants with a measurement at baseline and/or 12 months, comparing the average 12-month body weight between control and intervention groups. Our analysis controlled for smoking and before/during the COVID-19 pandemic with fixed effects, while random effects were used for multiple measurement on individuals and study sites.p-value: 0.000895% CI: [-2.33, -0.34]Mixed Models Analysis