| Primary | Six Minute Walk Test | distance walked in six minutes | 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. | Posted | | Mean | Standard Deviation | feet | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001071.0± 354.1
- OG0011005.9± 339.0
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Mixed Models Analysis | Difference in average six minute walk test distance at 12 months between control and intervention groups. | .02 | | Mean Difference (Final Values) | 42.3 | | | 2-Sided | 95 | 7.93 | 76.6 | | | Standard errors estimated using Kenward-Rogers adjustment for the denominator degrees of freedom. |
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| Secondary | Modified Borg Scale | Shortness of breath: scores range from 0 (nothing at all) to 10 (very, very severe). | 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. | Posted | | Mean | Standard Deviation | units on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Weight | | 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. | Posted | | Mean | Standard Deviation | kilograms | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Short Form 12 Health Survey (SF-12) Physical Component Score (PCS) | scores range from 0-100 with higher scores reflecting better health | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Short Form 12 Health Survey (SF-12) Mental Component Score (MCS) | scores range from 0-100 with higher scores reflecting better health | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12-months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Waist Circumference | cardiovascular disease risk | 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. | Posted | | Mean | Standard Deviation | centimeters | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Systolic Blood Pressure | indicator of cardiovascular disease risk; higher values indicate higher risk | 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. | Posted | | Mean | Standard Deviation | mmHg | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| Secondary | Body Mass Index (BMI) | cardiovascular disease risk | 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. | Posted | | Mean | Standard Deviation | kg/m^2 | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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| 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 12 months | | | | ID | Title | Description |
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| OG000 | Lifestyle Intervention | Behavioral lifestyle intervention focused on healthy eating and physical activity Lifestyle Intervention: Behavioral lifestyle intervention focused on healthy eating and physical activity | | OG001 | Usual Care | Participants continue with usual diet and exercise activities as they desire |
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