INSIGHT COPD: INtervention Study In overweiGHT Patients With COPD

• Sponsor: Seattle Institute for Biomedical and Clinical Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02634268
• Collaborator: VA Puget Sound Health Care System (U.S. Fed), University of Illinois at Chicago (Other)
• Enrollment: 684
• Locations: 39
• Arms: 2
• Actual Duration (Months): 41.6
• Patients Per Site: 17.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Oct 30, 2020
• Actual Study Completion Date: Oct 30, 2020

Arms and Interventions

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

Primary Outcome Measures

1. Six Minute Walk Test [12 months]

   distance walked in six minutes

Secondary Outcome Measures

1. Modified Borg Scale [12 months]

   Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).

2. Weight [12 months]

   body weight

3. Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) [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) [12-months]

   scores range from 0-100 with higher scores reflecting better health

5. 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).

6. Waist Circumference [12 months]

   cardiovascular disease risk

7. Systolic Blood Pressure [12 months]

   indicator of cardiovascular disease risk; higher values indicate higher risk

8. Body Mass Index (BMI) [12 months]

   cardiovascular disease risk

9. 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.

10. 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.

11. 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.

12. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham VA Medical Center	Birmingham	Alabama	United States	35233
2	University of Alabama at Birmingham - UAB Lung Health Center	Birmingham	Alabama	United States	35294
3	University of Arizona	Tucson	Arizona	United States	85724
4	University of California, Los Angeles	Los Angeles	California	United States	90095
5	Universtiy of California, San Francisco	San Francisco	California	United States	94143
6	National Jewish Health	Denver	Colorado	United States	80206
7	Waterbury Pulmonary Associates	Waterbury	Connecticut	United States	06708
8	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
9	Northwestern University - Northwestern Medical Group - Pulmonology	Chicago	Illinois	United States	60611
10	University of Illinois, Chicago - Division of Pulmonay, Critical Care, Sleep & Allergy	Chicago	Illinois	United States	60612
11	University of Iowa	Iowa City	Iowa	United States	52242
12	Chest Medicine	South Portland	Maine	United States	04106
13	University of Maryland	Baltimore	Maryland	United States	21201
14	Johns Hopkins University - Pulmonary & Critical Care Medicine	Baltimore	Maryland	United States	21224
15	Boston VA Medical Center	Boston	Massachusetts	United States	02132
16	Baystate Health	Springfield	Massachusetts	United States	01199
17	University of Michigan - Division of Pulmonary & Critical Care Medicine	Ann Arbor	Michigan	United States	48109
18	Minneapolis VA Health Care System - Pulmonology	Minneapolis	Minnesota	United States	55417
19	Minnesota Health Partners	Saint Paul	Minnesota	United States	55101
20	St. Louis VA	Saint Louis	Missouri	United States	63106
21	Albany Medical College	Albany	New York	United States	12208
22	University of Buffalo	Buffalo	New York	United States	14203
23	Buffalo VA Medical Center	Buffalo	New York	United States	14215
24	NYU Winthrop	Mineola	New York	United States	11501
25	Duke University	Durham	North Carolina	United States	27705
26	East Carolina University - Pulmonary, Critical Care & Sleep Medicine	Greenville	North Carolina	United States	27834
27	Case Western	Cleveland	Ohio	United States	44016
28	Ohio State University	Columbus	Ohio	United States	43221
29	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
30	Penn State Milton S. Hershey Medical Center - Pulmonary, Allergy & Critical Care Medicine	Hershey	Pennsylvania	United States	17033
31	Temple University Hospital - Temple Lung Center	Philadelphia	Pennsylvania	United States	19140
32	University of Pittsburgh Medical Center - Kaufmann Building	Pittsburgh	Pennsylvania	United States	15213
33	Medical University of South Carolina	Charleston	South Carolina	United States	29425
34	BSW Research	Dallas	Texas	United States	75246
35	Baylor College of Medicine	Houston	Texas	United States	77505
36	Grand Medical Clinic	Katy	Texas	United States	77498
37	University of Utah	Salt Lake City	Utah	United States	84108
38	White River Junction VA	White River Junction	Vermont	United States	05009
39	VA Puget Sound Health Care System	Seattle	Washington	United States	98108

Sponsors and Collaborators

• Seattle Institute for Biomedical and Clinical Research
• VA Puget Sound Health Care System
• University of Illinois at Chicago

Investigators

• 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)

• Study Protocol and Statistical Analysis Plan - Feb 18, 2021

More Information

Publications

None provided.

• Responsible Party: Seattle Institute for Biomedical and Clinical Research
• ClinicalTrials.gov Identifier: NCT02634268
• Other Study ID Numbers: 1U01HL128868
• First Posted: Dec 18, 2015
• Last Update Posted: Apr 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Overweight; Weight Loss

Study Results

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.

Arm/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Period Title: Overall Study
STARTED	346	338
COMPLETED	287	291
NOT COMPLETED	59	47

Baseline Characteristics

Arm/Group Title	Lifestyle Intervention	Usual Care	Total
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire	Total of all reporting groups
Overall Participants	346	338	684
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.0 (8.2)	66.9 (7.7)	67.0 (8.0)
Sex: Female, Male (Count of Participants)
Female	142 41%	140 41.4%	282 41.2%
Male	204 59%	198 58.6%	402 58.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 1.2%	5 1.5%	9 1.3%
Not Hispanic or Latino	337 97.4%	333 98.5%	670 98%
Unknown or Not Reported	5 1.4%	0 0%	5 0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.9%	1 0.3%	4 0.6%
Asian	0 0%	1 0.3%	1 0.1%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.6%	2 0.3%
Black or African American	67 19.4%	69 20.4%	136 19.9%
White	267 77.2%	260 76.9%	527 77%
More than one race	4 1.2%	3 0.9%	7 1%
Unknown or Not Reported	5 1.4%	2 0.6%	7 1%

Outcome Measures

1. Primary Outcome

Title	Six Minute Walk Test
Description	distance walked in six minutes
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [feet]	1071.0 (354.1)	1005.9 (339.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average six minute walk test distance at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	42.3
	Confidence Interval	(2-Sided) 95%; 7.93 to 76.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

2. Secondary Outcome

Title	Modified Borg Scale
Description	Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [units on a scale]	2.7 (1.9)	3.2 (1.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.0008
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average Modified Borg Scale score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.36
	Confidence Interval	(2-Sided) 95%; -0.63 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

3. Secondary Outcome

Title	Weight
Description	body weight
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [kilograms]	91.0 (17.7)	93.7 (17.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0008
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average body weight at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.34
	Confidence Interval	(2-Sided) 95%; -2.33 to -0.34
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

4. Secondary Outcome

Title	Short Form 12 Health Survey (SF-12) Physical Component Score (PCS)
Description	scores range from 0-100 with higher scores reflecting better health
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	39.7 (8.5)	37.5 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SF-12 PCS at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.48
	Confidence Interval	(2-Sided) 95%; 0.35 to 2.60
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

5. Secondary Outcome

Title	Short Form 12 Health Survey (SF-12) Mental Component Score (MCS)
Description	scores range from 0-100 with higher scores reflecting better health
Time Frame	12-months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	51.7 (9.7)	51.4 (9.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SF-12 MCS at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.53
	Confidence Interval	(2-Sided) 95%; -0.84 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

6. Secondary Outcome

Title	Non-laboratory Framingham Risk Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	345	338
Mean (Standard Deviation) [score on a scale]	15.0 (3.0)	15.4 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average Framingham Risk Score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 95%; -0.71 to -0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Waist Circumference
Description	cardiovascular disease risk
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [centimeters]	111.3 (12.9)	113.1 (13.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average waist circumference at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.93
	Confidence Interval	(2-Sided) 95%; -2.12 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

8. Secondary Outcome

Title	Systolic Blood Pressure
Description	indicator of cardiovascular disease risk; higher values indicate higher risk
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [mmHg]	129.5 (17.2)	128.8 (16.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average 12 month systolic blood at 12 months between control and intervention groups
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -3.02 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

9. Secondary Outcome

Title	Body Mass Index (BMI)
Description	cardiovascular disease risk
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [kg/m^2]	31.9 (5.0)	32.7 (4.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average BMI at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.51
	Confidence Interval	(2-Sided) 95%; -0.85 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

10. Secondary Outcome

Title	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Symptom Component Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	52.6 (21.9)	54.9 (20.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SGRQ-C Symptom score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.25
	Confidence Interval	(2-Sided) 95%; -4.87 to 0.36
	Parameter Dispersion	Type: Value:
	Estimation Comments
Other Statistical Analysis		Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

11. Secondary Outcome

Title	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Activity Component Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	58.9 (25.8)	63.3 (25.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.12
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SGRQ-C Activity score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.31
	Confidence Interval	(2-Sided) 95%; -5.19 to 0.56
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

12. Secondary Outcome

Title	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Impact Component Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	29.2 (20.1)	32.8 (21.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SGRQ-C Impact score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.72
	Confidence Interval	(2-Sided) 95%; -5.19 to -0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

13. Secondary Outcome

Title	St George's Respiratory Questionnaire For COPD Patients (SGRQ-C) Total Score
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lifestyle Intervention	Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity	Participants continue with usual diet and exercise activities as they desire
Measure Participants	346	338
Mean (Standard Deviation) [score on a scale]	42.4 (19.5)	46.1 (19.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lifestyle Intervention, Usual Care
	Comments	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.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Mixed Models Analysis
	Comments	Difference in average SGRQ-C Total score at 12 months between control and intervention groups.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.42
	Confidence Interval	(2-Sided) 95%; -4.55 to -0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments	Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom.

Adverse Events

Time Frame	We systematically collected adverse events (AE) by body system at the 12-month visit. Lifestyle coaches also learned about AEs through their interaction with participants.
Adverse Event Reporting Description	Adverse events were monitored without regard to the specific Adverse Event Term.
Arm/Group Title	Lifestyle Intervention		Usual Care
Arm/Group Description	Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity		Participants continue with usual diet and exercise activities as they desire
All Cause Mortality
	Lifestyle Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/346 (1.2%)		9/338 (2.7%)
Serious Adverse Events
	Lifestyle Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	78/346 (22.5%)		75/338 (22.2%)
Blood and lymphatic system disorders
Hematological	2/346 (0.6%)	3	2/338 (0.6%)	2
Gastrointestinal disorders
Gastrointestinal	14/346 (4%)	16	7/338 (2.1%)	9
General disorders
Cardiovascular	22/346 (6.4%)	27	20/338 (5.9%)	27
Other	13/346 (3.8%)	14	14/338 (4.1%)	14
Hepatobiliary disorders
Hepatobiliary	4/346 (1.2%)	4	3/338 (0.9%)	3
Metabolism and nutrition disorders
Metabolic	2/346 (0.6%)	2	3/338 (0.9%)	4
Musculoskeletal and connective tissue disorders
Musculoskeletal	10/346 (2.9%)	10	7/338 (2.1%)	7
Nervous system disorders
Neurological	7/346 (2%)	7	7/338 (2.1%)	8
Psychiatric disorders
Psychological	2/346 (0.6%)	4	2/338 (0.6%)	2
Renal and urinary disorders
Renal/Urologic	7/346 (2%)	9	11/338 (3.3%)	11
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory	35/346 (10.1%)	42	35/338 (10.4%)	50
Skin and subcutaneous tissue disorders
Dermatological	2/346 (0.6%)	2	3/338 (0.9%)	5
Other (Not Including Serious) Adverse Events
	Lifestyle Intervention		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	95/346 (27.5%)		90/338 (26.6%)
Blood and lymphatic system disorders
Hematological	6/346 (1.7%)	6	1/338 (0.3%)	1
Gastrointestinal disorders
Gastrointestinal	6/346 (1.7%)	6	10/338 (3%)	13
General disorders
Cardiovascular	20/346 (5.8%)	21	14/338 (4.1%)	16
Other	16/346 (4.6%)	19	10/338 (3%)	11
Hepatobiliary disorders
Hepatobiliary	0/346 (0%)	0	2/338 (0.6%)	2
Metabolism and nutrition disorders
Metabolic	5/346 (1.4%)	5	4/338 (1.2%)	4
Musculoskeletal and connective tissue disorders
Musculoskeletal	30/346 (8.7%)	35	24/338 (7.1%)	29
Nervous system disorders
Neurological	7/346 (2%)	8	6/338 (1.8%)	7
Psychiatric disorders
Psychological	4/346 (1.2%)	5	3/338 (0.9%)	4
Renal and urinary disorders
Renal/Urologic	3/346 (0.9%)	4	5/338 (1.5%)	5
Respiratory, thoracic and mediastinal disorders
Pulmonary/Respiratory	38/346 (11%)	47	52/338 (15.4%)	67
Skin and subcutaneous tissue disorders
Dermatological	12/346 (3.5%)	15	11/338 (3.3%)	12

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.