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| ID | Type | Description | Link |
|---|---|---|---|
| 01607 | Other Grant/Funding Number | Veterans Administration |
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The PAL intervention uses a new software tool delivered on tablets to facilitate 5As-based weight management counseling with a peer health coach and the VA PACT healthcare team to promote goal-setting, behavior change, and weight loss in the primary care (PC) setting. The PAL intervention also includes 10-12 health-coaching calls to the patient over 12 months.
As part of a cluster-randomized controlled study, the investigators will randomize 17 primary care providers at the Brooklyn VA to receive either the PAL Intervention or an Enhanced Usual Care control. The primary aim of the study is to explore differences in feasibility, acceptability, and intermediate, behavioral, and weight loss outcomes at 6 and 12 months of 520 patients recruited from the randomized primary care providers.
Objective:
1) Explore the feasibility and impact of this intervention on intermediate, behavioral, and weight loss outcomes at 6 and 12 months post-intervention when compared to enhanced usual care.
Veterans shoulder a disproportionate burden of obesity and its co-morbidities, including diabetes, hypertension, and hyperlipidemia. Modest weight loss in obese patients through diet and exercise improves health and prevents chronic disease, but primary care providers (PCPs) often fail to adequately counsel patients about their weight due to lack of time and training. Thus, tools and brief interventions are needed to support providers' behavior change counseling. The VA currently offers the MOVE! program to treat overweight and obese patients, but only 9% of eligible patients attend. At the same time, Veterans on average see their PCPs 3.6 times per year, which supports the importance of developing primary care (PC)-based interventions. The United States Preventive Services Task force (USPSTF) recommends the use of the 5As framework (Assess, Advise, Agree, Assist, Arrange) for counseling patients about weight.
Interactive behavior change technologies utilizing expert system software programs are an innovative way to facilitate 5As counseling to promote behavior change in primary care. These programs perform computerized risk, lifestyle, and theory- based, behavioral assessment to provide computer-generated, tailored advice to patients. They also can provide information to healthcare teams. The MOVE!11 software is an expert system program for VA patients referred to MOVE!, but is not currently used in primary care by Patient-Aligned Care Teams (PACT).
Collaborative goal setting can be used to achieve behavior change in this intervention. This construct, a critical component of several behavior change theories and models and corresponding to "agree" in the 5As model, has been widely recommended for health promotion in primary care. The investigators' formative work (MIRB #01333) using key informant interviews with PACT teamlets and MOVE! staff and focus groups with Veterans demonstrated that goal setting is feasible and acceptable to patients and PACT teamlets and provided insight on barriers to goal setting, and ways to facilitate goal-setting conversations.
During the development phase of this project, the investigators developed a primary care-based intervention called MOVE! Toward Your Goals (MTG) to facilitate weight management within primary care and increase adoption of intensive VA programs such as MOVE!. The PAL intervention uses the MTG software tool (that the investigators developed) delivered on tablets to facilitate 5As-based weight management counseling with a health coach and healthcare team to promote goal-setting, behavior change, and weight loss in the primary care setting. The Veteran also receives follow up with 10-12 health coaching calls over 1 year.
As part of a clustered randomized control trial, the investigators will randomize 17 primary care providers to either Enhanced Usual Care or the PAL Intervention, recruiting 520 subjects.
STUDY OBJECTIVES
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAL Intervention | Experimental | 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) |
|
| Enhanced Usual Care (EUC) | Active Comparator | Body mass index of =30kg/m2 OR Body mass index of =25 kg/m2 with an obesity associated co-morbidity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Assisted Lifestyle | Behavioral | Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight Change in Kg | Weight change in kg at 12 months | 12 months |
| Mean Percent Weight Change From Baseline to 12 Months | Mann-Whitney tests for continuous outcomes (e.g., weight change) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of 5% Weight Loss | Percent of people in each arm attaining > or = to 5% weight loss | 6 months |
| Achievement of 5% Weight Loss | Percent of people in each arm attaining > or = to 5% weight loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie R. Jay, MD MS | Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33637544 | Result | Wittleder S, Smith S, Wang B, Beasley JM, Orstad SL, Sweat V, Squires A, Wong L, Fang Y, Doebrich P, Gutnick D, Tenner C, Sherman SE, Jay M. Peer-Assisted Lifestyle (PAL) intervention: a protocol of a cluster-randomised controlled trial of a health-coaching intervention delivered by veteran peers to improve obesity treatment in primary care. BMJ Open. 2021 Feb 26;11(2):e043013. doi: 10.1136/bmjopen-2020-043013. | |
| 40892413 |
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Randomization performed at provider level. Patients recruited from provider panels randomized to each arm (PAL or EUC).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| FG003 | Enhanced Usual Care (EUC): Providers | Providers at Brooklyn VA with panel size > 250 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients of Randomized Providers. If patients changed providers (due to attrition), then they were analyzed in the groups they were originally assigned. NOTE: Baseline data for providers were not collected except for sex.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline data for providers were not collected except for sex |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weight Change in Kg | Weight change in kg at 12 months | Posted | Mean | Standard Deviation | kilograms (kg) | 12 months |
|
12 months
Adverse events were not monitored for providers.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shin bone fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Shin bone fracture |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
The COVID-19 pandemic was a limitation that impacted recruitment and decreased our power to see significant differences.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melanie Jay | VA New York Harbor Manhattan | 212-686-7500 | 5097 | melanie.jay@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2023 | Jun 30, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Enhanced Usual Care | Behavioral | 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. |
|
|
| 12 months |
| Changes in HB A1C | 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. | 6 and 12 months |
| Changes in Waist Circumference | 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. | 6 months |
| Changes in Waist Circumference | 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. | 12 months |
| Changes in Physical Activity | 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. | 6 and 12 months |
| Moderate to Vigorous Physical Activity Difference (Minutes) | 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. | 6 months |
| Moderate to Vigorous Physical Activity Difference (Minutes) | 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 12 (primary) months of follow-up. | 12 months |
| Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items. | 6 months |
| Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items. | 12 months |
| Derived |
| Wittleder S, Wong L, Ruan AM, Illenberger N, Nicholson A, Portelli D, Cansler R, Tenner CT, Sherman SE, Aguilar AD, Sweat V, Orstad SL, Vandyousefi S, Fronshtein M, Smith S, Dixon A, Goldstein MG, Raffa SD, Wylie-Rosett J, Jay M. Peer Coaching to Support Weight Management in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2529136. doi: 10.1001/jamanetworkopen.2025.29136. |
| Lost to Follow-up |
|
| Death |
|
| BG001 | 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. |
| BG002 | PAL Intervention: Providers | 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. |
| BG003 | Enhanced Usual Care (EUC): Providers | Providers at Brooklyn VA with panel size > 250 Providers did not receive additional training. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline data for providers were not collected except for sex | Count of Participants | Participants |
|
| Region of Enrollment | Baseline data for providers were not collected except for sex | Number | participants |
|
| Height | Baseline data for providers were not collected except for sex | Mean | Standard Deviation | centimeters |
|
| Weight | Baseline data for providers were not collected except for sex | Mean | Standard Deviation | kg |
|
| Body Mass Index | Baseline data for providers were not collected except for sex | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Baseline data for providers were not collected except for sex | Mean | Standard Deviation | inches (in) |
|
| Diastolic blood pressure | Baseline data for providers were not collected except for sex. | Mean | Standard Deviation | mmHg |
|
| Systolic blood pressure | Baseline data for providers were not collected except for sex | Mean | Standard Deviation | mmHg |
|
|
|
|
| Primary | Mean Percent Weight Change From Baseline to 12 Months | Mann-Whitney tests for continuous outcomes (e.g., weight change) | Posted | Mean | Standard Deviation | percent change | 12 months |
|
|
|
|
| Secondary | Achievement of 5% Weight Loss | Percent of people in each arm attaining > or = to 5% weight loss | Posted | Number | Percent of people | 6 months |
|
|
|
|
| Secondary | Achievement of 5% Weight Loss | Percent of people in each arm attaining > or = to 5% weight loss | Posted | Number | Percent of people | 12 months |
|
|
|
|
| Secondary | Changes in HB A1C | 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. | Data were not collected. | Posted | 6 and 12 months |
|
|
| Secondary | Changes in Waist Circumference | 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. | Posted | Mean | Standard Deviation | inches (in) | 6 months |
|
|
|
|
| Secondary | Changes in Waist Circumference | 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. | Posted | Mean | Standard Deviation | inches (in) | 12 months |
|
|
|
|
| Secondary | Changes in Physical Activity | 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. | 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. | Posted | 6 and 12 months |
|
|
| Secondary | Moderate to Vigorous Physical Activity Difference (Minutes) | 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. | Posted | Mean | Standard Deviation | minutes | 6 months |
|
|
|
|
| Secondary | Moderate to Vigorous Physical Activity Difference (Minutes) | 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 12 (primary) months of follow-up. | Posted | Mean | Standard Deviation | minutes | 12 months |
|
|
|
|
| Secondary | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items. | Posted | Number | percent of people | 6 months |
|
|
|
|
| Secondary | Percent of People Achieving >150 Minutes of Vigorous to Moderate Physical Activity/Week | Adjusted mean percent of people achieving behavioral outcome in each treatment arms. Measured duration using IPAQ questionnaire items. | Posted | Number | percent of people | 12 months |
|
|
|
|
| 0 |
| 120 |
| 14 |
| 120 |
| 36 |
| 120 |
| EG001 | 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. | 2 | 161 | 17 | 161 | 51 | 161 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Enhanced Usual Care (EUC): Providers | Providers at Brooklyn VA with panel size > 250 | 0 | 0 | 0 | 0 | 0 | 0 |
|
| Chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Swollen nose | Infections and infestations | Non-systematic Assessment |
|
| Intestine infection | Infections and infestations | Non-systematic Assessment |
|
| Broken toe | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Broke vertebrae in neck | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Fainted | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Feeding tube | Surgical and medical procedures | Non-systematic Assessment |
|
| Hernia surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Gall bladder removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Back surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Wrist pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Mental health check | Psychiatric disorders | Non-systematic Assessment |
|
| Respiratory issue | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Blood clot in lungs | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Knee replacement | Surgical and medical procedures | Non-systematic Assessment |
|
| Fibroid removal | Surgical and medical procedures | Non-systematic Assessment |
|
| Prostate surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Shoulder surgery | Surgical and medical procedures | Non-systematic Assessment |
|
| Ear infection | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Upset stomach | Gastrointestinal disorders | Non-systematic Assessment |
|
| Couldn't swallow | Gastrointestinal disorders | Non-systematic Assessment |
|
| Not feeling well | General disorders | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
|
| Flu | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Sore throat | Infections and infestations | Non-systematic Assessment |
|
| Head infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Ankle sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Work-related injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Motor vehicle accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Sprained wrist | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Cut on finger | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dog bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Diabetes (blurred vision/high sugar) | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hand dysfunction | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee issue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Knee, groin pull, back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain and couldn't walk | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Sciatica pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arm pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Right shoulder tear | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in sides | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Kidney pain/stones | Renal and urinary disorders | Non-systematic Assessment |
|
| Blood in urine and pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Breathing issues | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Elevated blood pressure | Vascular disorders | Non-systematic Assessment |
|
| High pulse and temperature | Cardiac disorders | Non-systematic Assessment |
|
| Blood vessel in eye | Eye disorders | Non-systematic Assessment |
|
| ED visit for medication | General disorders | Non-systematic Assessment |
|
| Tendinitis | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Excessive bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hand injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck issue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | Non-systematic Assessment |
|
| Eating disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Skin issue | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Wilcoxon (Mann-Whitney) |
The investigators will also use repeated measures modeling based on mixed models using baseline and follow up data to adjust for characteristics |
| 0.028 |
Statistical test was 2 sided with p<0.05 indicating statistical significance. |
| Mean Difference (Final Values) |
| 1.53 |
| 2-Sided |
| 95 |
| 0.21 |
| 3.76 |
| Superiority |