| Primary | Difference in Participant's Total Distance During 6-minute Walk | The 6-minute walk test (6MWT) will be used to measure cardiorespiratory fitness (CRF) during which individuals will be asked to walk continuously for six minutes on a flat, indoor surface around cones (separated by 100ft). The possible distance range is 400 meters to 650 meters. Higher scores reflect better outcomes (greater physical fitness). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Participants who completed assessments from home were unable to provide data on this measure (n=5 in walking group, n=9 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group, n=2 in Fitbit alone). | Posted | | Mean | Standard Deviation | meters | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG00012
- ParticipantsOG00111
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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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| Posttreatment - Baseline: 10 participants analyzed (had data at both time points) | | | | | Mean Difference (Net) | -13.470 | Standard Deviation | 48.09 | 2-Sided | | | | | | | | Other | Single group mean difference between baseline and post-treatment assessments. | | | |
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| Secondary | Mean Difference in Minutes Spent Walking | Mean difference in overall minutes spent walking per week from baseline to last study visit (up to 20 weeks). This information will be obtained from the participant's Fitbit. Higher scores reflect more minutes walking. | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Data was not available from all participants as it was dependent upon consistent daily wearing of Fitbit device. Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=2 in Fitbit alone). | Posted | | Mean | Standard Deviation | minutes/week | | Baseline and the last study visit (up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | |
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| Secondary | Mean Difference in Daily Steps | Mean difference in daily steps from baseline to last study visit (up to 20 weeks). This information will be obtained from the participants Fitbit. Higher scores reflect more daily steps. | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Data was not available from all participants as it was dependent upon consistent daily wearing of Fitbit device. Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=3 in walking group, n=2 in Fitbit alone). | Posted | | Mean | Standard Deviation | steps/day | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference Overall UCLA Loneliness Scale Score | Mean difference in overall score from baseline to last study visit (up to 20 weeks). The UCLA Loneliness scale is a 20 item scale. Answers are on a 4 point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=4 in Fitbit alone). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone |
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| Secondary | Mean Difference Overall PANSS Score | Mean difference in the overall score from baseline to last study visit (up to 20 weeks). The PANSS is a semi-structured interview using a 30-item scale to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. All 30 items are rated on a 7-point scale (1 = absent; 7 = extreme). Possible scores range from 30 to 210. Higher scores reflect worse outcomes (i.e. greater symptoms of psychosis). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=4 in Fitbit alone). | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 |
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| Secondary | Mean Difference in Body Mass Index (BMI) Change | Mean difference in BMI from baseline to last study visit (up to 20 weeks). Expected normal BMI ranges from 14 to 54. Higher scores reflect worse outcomes (i.e., greater body mass). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in walking group, n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in Fitbit alone). | Posted | | Mean | Standard Deviation | kg/m^2 | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference in Body Weight Change | Mean difference in body weight change from baseline to last study visit (up to 20 weeks). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone). | Posted | | Mean | Standard Deviation | lbs | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference in Waist Circumference | Mean difference in waist circumference from baseline to last study visit (up to 20 weeks). Higher scores reflect worse outcomes. | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=4 in walking group, n=7 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group, n=2 in Fitbit alone). | Posted | | Mean | Standard Deviation | cm | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference in Systolic Blood Pressure Change | Mean difference in systolic blood pressure change from baseline to last study visit (up to 20 weeks). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone). | Posted | | Mean | Standard Deviation | mmHg | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference in Diastolic Blood Pressure Change | Mean difference in diastolic blood pressure change from baseline to last study visit (up to 20 weeks). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=2 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=2 in walking group, n=3 in Fitbit alone). | Posted | | Mean | Standard Deviation | mmHg | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | Participants will be provided with a Fitbit wristband and instructed how to use it. Participants will also be given information on current recommended physical activity guidelines and told that study staff may be contacting them on a weekly basis if it looks like participants are not wearing their Fitbit for a certain number of days or to troubleshoot any issues. Exercise Intervention: Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking. |
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| Secondary | Mean Difference in Resting Heart Rate Change | Mean difference in resting heart rate change from baseline to last study visit (up to 20 weeks). Expected normal heart rate ranges from 40 to 120. Higher scores reflect worse outcomes (poorer heart condition). | Participants were only analyzed from cohorts 2 and 3 as cohort 1 was deemed not comparable (protocol changes & cancellation after 7 groups due to the onset of the COVID-19 pandemic). Some participants who completed assessments from home were unable to provide accurate data on this measure (n=1 in walking group, n=4 in fitbit alone). Post-treatment data are not available for participants who withdrew or were lost to follow-up (n=1 in walking group). | Posted | | Mean | Standard Deviation | beats per minute | | Baseline and the last study visit (Up to 20 weeks) | | | | ID | Title | Description |
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| OG000 | Walking Group | Participants will be walking two times a week in supervised virtual walking groups on a secure online platform (Zoom) and will also participate in independent walks done at a location of their own choosing outside group participation. PACE-Life: PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF. | | OG001 | Fitbit Alone | |
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| Other Pre-specified | Mean Difference in Composite Motivation Score on the Behavioral Regulation Exercise Questionnaire (BREQ-2) | Mean difference in composite motivation score from baseline to last study visit (up to 20 weeks). The BREQ-2 is a 19 item self-report scale. Answers are on a 5 point Likert scale ranging from 0 to 4. 0 corresponds to "not true for me" and 4 corresponds to "very true for me." Possible scores are averaged and range from 0-4. Higher scores reflect better outcomes (higher autonomous motivation to exercise). | | Not Posted | | | | | | Baseline and the last study visit (Up to 20 weeks) | | Participants | | | | |
| Other Pre-specified | Mean Difference in Composite Score on the Basic Psychological Needs in Exercise Scale (BPNES) | Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNE is an 11 item self-report scale. Answers are on a 5 point Likert scale ranging from "I don't agree at all" to "I completely agree." Possible scores are averaged and range from 1-5. Higher scores reflect better outcomes (i.e. more psychological needs being met through exercise). | | Not Posted | | | | | | Baseline and the last study visit (Up to 20 weeks) | | Participants | | | | |
| Other Pre-specified | Mean Difference in Composite Score on the Physical Activity Enjoyment Scale (PACES) | Mean difference in composite score from baseline to last study visit (up to 20 weeks). 2. The PACES is an 18 item self-report scale. Answers are on a 7-point scale. Possible scores are averaged and range from 1-7. Higher scores reflect better outcomes (greater enjoyment of physical activity). | | Not Posted | | | | | | Baseline and the last study visit (Up to 20 weeks) | | Participants | | | | |
| Other Pre-specified | Mean Difference in Composite Score on the Basic Psychological Needs Scale (BPNS) | Mean difference in composite score from baseline to last study visit (up to 20 weeks). The BPNS is a 21 item self-report scale. Answer are on a 7-point Likert scale ranging from "not at all true" to "very true." Possible scores on each subscale are averaged onto a scale of 1-7. Higher scores reflect better outcomes (better autonomy, competence, and relatedness). | | Not Posted | | | | | | Baseline and the last study visit (Up to 20 weeks) | | Participants | | | | |
| Other Pre-specified | Mean Difference in Composite Score on the Autonomy Support Scale | Mean difference in composite score from mid-treatment to last study visit (up to 20 weeks). The Autonomy Scale is a 6 item self-report scale. Answers are made using a 7-point scale. Possible scores range from 7 to 46. Higher scores reflect better outcomes (better relationship between research participant and staff. | | Not Posted | | | | | | Baseline and the last study visit (Up to 20 weeks) | | Participants | | | | |
| Other Pre-specified | End of Study Survey | Total score at Post treatment visit only (16 weeks). The End of Study survey measures participant's satisfaction and feedback with the PACE-Life trial. The survey is a 18 item self-report scale, consisting of both Likert scale and open-ended items. Answers are made using a 5-point Likert scale. Possible scores on each item range from 1-5. Higher scores reflect higher levels of satisfaction and enjoyment in the study. | | Not Posted | | | | | | Post treatment only (16 weeks) | | Participants | | | | |