Trial Outcomes & Findings for The Peer Assisted Lifestyle Intervention (NCT NCT03163264)

NCT ID: NCT03163264

Last Updated: 2024-11-19

Results Overview

Weight change in kg at 12 months

Recruitment status

COMPLETED

Study phase

Target enrollment

301 participants

Primary outcome timeframe

12 months

Results posted on

2024-11-19

Participant Flow

Randomization performed at provider level. Patients recruited from provider panels randomized to each arm (PAL or EUC).

Participant milestones

Participant milestones
Measure	PAL Intervention: Patients Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC): Patients Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	PAL Intervention: Providers Providers at Brooklyn VA with panel size \> 250, Received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change	Enhanced Usual Care (EUC): Providers Providers at Brooklyn VA with panel size \> 250
Overall Study STARTED	120	161	10	10
Overall Study COMPLETED	90	136	6	8
Overall Study NOT COMPLETED	30	25	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	PAL Intervention: Patients Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC): Patients Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	PAL Intervention: Providers Providers at Brooklyn VA with panel size \> 250, Received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change	Enhanced Usual Care (EUC): Providers Providers at Brooklyn VA with panel size \> 250
Overall Study Withdrawal by Subject	13	3	4	2
Overall Study Lost to Follow-up	17	20	0	0
Overall Study Death	0	2	0	0

Baseline Characteristics

Baseline data for providers were not collected except for sex

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PAL Intervention: Patients n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC): Patients n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	PAL Intervention: Providers n=10 Participants Providers at Brooklyn VA with panel size \> 250 Providers received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change.	Enhanced Usual Care (EUC): Providers n=10 Participants Providers at Brooklyn VA with panel size \> 250 Providers did not receive additional training.	Total n=301 Participants Total of all reporting groups
Age, Continuous	51.6 years STANDARD_DEVIATION 11.3 • n=120 Participants • Baseline data for providers were not collected except for sex	49.9 years STANDARD_DEVIATION 11.6 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	50.6 years STANDARD_DEVIATION 11.5 • n=281 Participants • Baseline data for providers were not collected except for sex
Sex: Female, Male Female	31 Participants n=120 Participants	29 Participants n=161 Participants	5 Participants n=10 Participants	6 Participants n=10 Participants	71 Participants n=301 Participants
Sex: Female, Male Male	89 Participants n=120 Participants	132 Participants n=161 Participants	5 Participants n=10 Participants	4 Participants n=10 Participants	230 Participants n=301 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=120 Participants • Baseline data for providers were not collected except for sex	3 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	5 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) Asian	3 Participants n=120 Participants • Baseline data for providers were not collected except for sex	2 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	5 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=120 Participants • Baseline data for providers were not collected except for sex	1 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	1 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) Black or African American	63 Participants n=120 Participants • Baseline data for providers were not collected except for sex	97 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	160 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) White	28 Participants n=120 Participants • Baseline data for providers were not collected except for sex	36 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	64 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) More than one race	6 Participants n=120 Participants • Baseline data for providers were not collected except for sex	5 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	11 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=120 Participants • Baseline data for providers were not collected except for sex	17 Participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	35 Participants n=281 Participants • Baseline data for providers were not collected except for sex
Region of Enrollment United States	120 participants n=120 Participants • Baseline data for providers were not collected except for sex	161 participants n=161 Participants • Baseline data for providers were not collected except for sex	—	—	281 participants n=281 Participants • Baseline data for providers were not collected except for sex
Height	171.5 centimeters STANDARD_DEVIATION 8.9 • n=120 Participants • Baseline data for providers were not collected except for sex	173.8 centimeters STANDARD_DEVIATION 8.5 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	172.8 centimeters STANDARD_DEVIATION 8.8 • n=281 Participants • Baseline data for providers were not collected except for sex
Weight	98.9 kg STANDARD_DEVIATION 20.4 • n=120 Participants • Baseline data for providers were not collected except for sex	100.8 kg STANDARD_DEVIATION 16.3 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	100.0 kg STANDARD_DEVIATION 18.2 • n=281 Participants • Baseline data for providers were not collected except for sex
Body Mass Index	33.5 kg/m^2 STANDARD_DEVIATION 5.6 • n=120 Participants • Baseline data for providers were not collected except for sex	33.3 kg/m^2 STANDARD_DEVIATION 4.7 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	33.4 kg/m^2 STANDARD_DEVIATION 5.1 • n=281 Participants • Baseline data for providers were not collected except for sex
Waist Circumference	42.9 inches (in) STANDARD_DEVIATION 6.2 • n=120 Participants • Baseline data for providers were not collected except for sex	42.7 inches (in) STANDARD_DEVIATION 4.7 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	42.8 inches (in) STANDARD_DEVIATION 5.4 • n=281 Participants • Baseline data for providers were not collected except for sex
Diastolic blood pressure	79.3 mmHg STANDARD_DEVIATION 28.0 • n=120 Participants • Baseline data for providers were not collected except for sex.	77.8 mmHg STANDARD_DEVIATION 10.5 • n=161 Participants • Baseline data for providers were not collected except for sex.	—	—	78.5 mmHg STANDARD_DEVIATION 19.9 • n=281 Participants • Baseline data for providers were not collected except for sex.
Systolic blood pressure	123.8 mmHg STANDARD_DEVIATION 14.4 • n=120 Participants • Baseline data for providers were not collected except for sex	126.9 mmHg STANDARD_DEVIATION 41.9 • n=161 Participants • Baseline data for providers were not collected except for sex	—	—	125.6 mmHg STANDARD_DEVIATION 33.1 • n=281 Participants • Baseline data for providers were not collected except for sex

PRIMARY outcome

Timeframe: 12 months

Weight change in kg at 12 months

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Mean Weight Change in Kg	-2.51 kilograms (kg) Standard Deviation 0.73	-0.79 kilograms (kg) Standard Deviation 0.48

PRIMARY outcome

Timeframe: 12 months

Mann-Whitney tests for continuous outcomes (e.g., weight change)

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Mean Percent Weight Change From Baseline to 12 Months	-2.32 percent change Standard Deviation 0.75	-0.69 percent change Standard Deviation 0.47

SECONDARY outcome

Timeframe: 6 months

Percent of people in each arm attaining \> or = to 5% weight loss

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Achievement of 5% Weight Loss	17 Percent of people	6 Percent of people

SECONDARY outcome

Timeframe: 12 months

Percent of people in each arm attaining \> or = to 5% weight loss

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Achievement of 5% Weight Loss	26 Percent of people	15 Percent of people

SECONDARY outcome

Timeframe: 6 and 12 months

Population: Data were not collected.

The investigators will extract HB A1C data from the electronic health record. Due to COVID, participants did not have their regular in-person doctor's appointments to test/collect their HB A1C. Due to a large amount of missing HB A1C data, data was not collected/extracted from the electronic health record and therefore changed in HB A1C was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 6 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Changes in Waist Circumference	-1.44 inches (in) Standard Deviation 0.31	-0.72 inches (in) Standard Deviation 0.23

SECONDARY outcome

Timeframe: 12 months

To determine whether patients had changes in waist circumference. Adjusted changes between baseline and 12 Months. Mean (SD) of adjusted outcomes in each treatment arm are provided.

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Changes in Waist Circumference	-1.82 inches (in) Standard Deviation 0.37	-1.40 inches (in) Standard Deviation 0.29

SECONDARY outcome

Timeframe: 6 and 12 months

Population: The investigators planned to use accelerometers, given out at each study visit, to measure physical activity for 7 days at baseline, 6 month, and 12 months. However, due to COVID-19, the investigators were unable to give out accelerometers at each visit to collect this data. Therefore, data collection was not completed and outcome will not be reported.

Measure duration and intensity using accelerometers. The ActiGraph Link (GT9X) accelerometer, worn on the wrist, was used to objectively measure PA for 7 days at Baseline, and at 6 and 12 months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Measure duration using the Paffenbarger questionnaire items. Difference in adjusted mean behavioral outcome between the treatment arms. Adjusted mean difference (95% Confidence Interval) \[p-value\] between the treatment arms (PAL - EUC) for each behavioral outcome at 6 months of follow-up.

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Moderate to Vigorous Physical Activity Difference (Minutes)	93.43 minutes Standard Deviation 57.88	101.78 minutes Standard Deviation 43.96

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Moderate to Vigorous Physical Activity Difference (Minutes)	13.32 minutes Standard Deviation 53.77	46.15 minutes Standard Deviation 45.34

SECONDARY outcome

Timeframe: 6 months

Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week	70 percent of people	80 percent of people

SECONDARY outcome

Timeframe: 12 months

Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items.

Outcome measures

Outcome measures
Measure	PAL Intervention n=120 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC) n=161 Participants Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.
Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week	29 percent of people	49 percent of people

Adverse Events

PAL Intervention: Patients

Serious events: 14 serious events

Other events: 36 other events

Deaths: 0 deaths

Enhanced Usual Care (EUC): Patients

Serious events: 17 serious events

Other events: 51 other events

Deaths: 2 deaths

PAL Intervention: Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care (EUC): Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Melanie Jay

VA New York Harbor Manhattan

Phone: 212-686-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PAL Intervention: Patients n=120 participants at risk Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC): Patients n=161 participants at risk Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	PAL Intervention: Providers Providers at Brooklyn VA with panel size \> 250, Received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change	Enhanced Usual Care (EUC): Providers Providers at Brooklyn VA with panel size \> 250
Injury, poisoning and procedural complications Shin bone fracture	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Cardiac disorders Chest pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Swollen nose	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Intestine infection	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Broken toe	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Broke vertebrae in neck	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Motor vehicle accident	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Metabolism and nutrition disorders Fainted	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Hernia	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Nervous system disorders Stroke	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Hip surgery	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Feeding tube	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Hernia surgery	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Gall bladder removal	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Back surgery	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Infection	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Wrist pain	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Psychiatric disorders Mental health check	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders Respiratory issue	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders COVID-19	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders Blood clot in lungs	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Knee replacement	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Fibroid removal	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Prostate surgery	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Surgery	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Surgical and medical procedures Shoulder surgery	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.

Measure	PAL Intervention: Patients n=120 participants at risk Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Receiving Peer Assisted Lifestyle intervention (PAL tool, health coaching at baseline, follow-up health coaching calls, potential support of goals from primary care provider) Peer Assisted Lifestyle: Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.	Enhanced Usual Care (EUC): Patients n=161 participants at risk Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity Enhanced Usual Care: Patients will be given information on "healthy living messages" that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling.	PAL Intervention: Providers Providers at Brooklyn VA with panel size \> 250, Received training on the overview of the 5As and the intervention components and practiced brief MI (using role playing) to support Veterans' weight management goals and address barriers to change	Enhanced Usual Care (EUC): Providers Providers at Brooklyn VA with panel size \> 250
Cardiac disorders Chest pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	1.9% 3/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Ear and labyrinth disorders Ear infection	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Gastrointestinal disorders Upset stomach	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Gastrointestinal disorders Couldn't swallow	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
General disorders Not feeling well	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Immune system disorders Allergic reaction	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Flu	1.7% 2/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Tonsillitis	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Sore throat	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Head infection	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Bronchitis	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Infection	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Ankle sprain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Work-related injury	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Motor vehicle accident	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Sprained wrist	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Cut on finger	1.7% 2/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Dog bite	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Metabolism and nutrition disorders Diabetes (blurred vision/high sugar)	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Back pain	3.3% 4/120 • 12 months Adverse events were not monitored for providers.	2.5% 4/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Hand dysfunction	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Hernia	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Knee issue	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Knee, groin pull, back pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Hip pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Pain and couldn't walk	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Sciatica pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Arm pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Right shoulder tear	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Gout	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Pain in sides	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Nervous system disorders Migraine	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Psychiatric disorders Depression	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Renal and urinary disorders Kidney pain/stones	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Renal and urinary disorders Blood in urine and pain	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders Breathing issues	1.7% 2/120 • 12 months Adverse events were not monitored for providers.	1.9% 3/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders Sinus infection	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	0.62% 1/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Vascular disorders Elevated blood pressure	1.7% 2/120 • 12 months Adverse events were not monitored for providers.	1.2% 2/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Cardiac disorders High pulse and temperature	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Eye disorders Blood vessel in eye	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
General disorders ED visit for medication	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Tendinitis	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Infections and infestations Laryngitis	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Excessive bleeding	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Eye injury	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Injury, poisoning and procedural complications Hand injury	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Shoulder pain	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Musculoskeletal and connective tissue disorders Neck issue	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Nervous system disorders Headaches	2.5% 3/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Nervous system disorders Vertigo	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Psychiatric disorders Eating disorder	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Renal and urinary disorders Urinary tract infection	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.
Skin and subcutaneous tissue disorders Skin issue	0.83% 1/120 • 12 months Adverse events were not monitored for providers.	0.00% 0/161 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.	— 0/0 • 12 months Adverse events were not monitored for providers.