Trial Outcomes & Findings for The GEM (Goals for Eating and Moving) Study (NCT NCT03006328)
NCT ID: NCT03006328
Last Updated: 2023-04-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
489 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2023-04-27
Participant Flow
Unit of analysis: Care Clusters
Participant milestones
| Measure |
Participants With Obesity + GEM
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
220 9
|
269 10
|
|
Overall Study
COMPLETED
|
220 9
|
269 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The GEM (Goals for Eating and Moving) Study
Baseline characteristics by cohort
| Measure |
Participants With Obesity + GEM
n=220 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
Total
n=489 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.2 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
49.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
99 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
116 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
96 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
80 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
220 participants
n=5 Participants
|
269 participants
n=7 Participants
|
489 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Outcome measures
| Measure |
Participants With Obesity + GEM
n=220 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Change in Weight From Baseline
|
-1.4 kilograms
Standard Deviation 0.8
|
-0.8 kilograms
Standard Deviation 0.9
|
PRIMARY outcome
Timeframe: Baseline, Month 12Outcome measures
| Measure |
Participants With Obesity + GEM
n=220 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Change in Waist Circumference From Baseline
|
-1.3 centimeters
Standard Deviation 0.5
|
-0.6 centimeters
Standard Deviation 0.6
|
PRIMARY outcome
Timeframe: Baseline, Month 12Outcome measures
| Measure |
Participants With Obesity + GEM
n=220 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP) From Baseline
|
1.8 mmHg
Standard Deviation 1.7
|
3.2 mmHg
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Baseline, Month 12Outcome measures
| Measure |
Participants With Obesity + GEM
n=220 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 Participants
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP) From Baseline
|
1.6 mmHg
Standard Deviation 1.4
|
3.2 mmHg
Standard Deviation 1.5
|
Adverse Events
Participants With Obesity + GEM
Serious events: 53 serious events
Other events: 36 other events
Deaths: 1 deaths
Participants With Obesity + Enhanced Usual Care
Serious events: 81 serious events
Other events: 43 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Participants With Obesity + GEM
n=220 participants at risk
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 participants at risk
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Leg fracture
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
1.4%
3/220 • 24 months
|
1.1%
3/269 • 24 months
|
|
Cardiac disorders
Cardiac heart catheterization
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Cardiac disorders
Chest Pain
|
1.8%
4/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Complications after biopsy
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Severe pain in feet
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Infections and infestations
COVID-19 infection
|
0.45%
1/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Wound requiring stitches
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.91%
2/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.91%
2/220 • 24 months
|
1.9%
5/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.45%
1/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Cardiac disorders
Heart and blood vessel issues
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Cardiac disorders
Heart Attack
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Injury, poisoning and procedural complications
Severe muscle strain
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Arm paralysis secondary to botox injection
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Renal and urinary disorders
Kidney pain/stones
|
0.91%
2/220 • 24 months
|
1.1%
3/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.45%
1/220 • 24 months
|
1.1%
3/269 • 24 months
|
|
Surgical and medical procedures
Knee surgery
|
0.45%
1/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar scoliosis
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Metal in eye, work injury
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Migraines
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Loss of consciousness/fainting
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Infections and infestations
Pneumonia
|
0.91%
2/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Wrist/hand injury
|
0.00%
0/220 • 24 months
|
1.9%
5/269 • 24 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Operation
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Eye disorders
Retina Surgery
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer removal
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small tumor found on kidney
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Surgical and medical procedures
Spinal operation
|
0.45%
1/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Cardiac disorders
Cardiac Arrythmia
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Nervous system disorders
Stroke
|
0.45%
1/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Surgical and medical procedures
Surgery for parathyroid removal
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Broken ribs
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Surgical and medical procedures
Urology surgery
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Vertigo
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Psychiatric disorders
Suicide attempt
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Injury, poisoning and procedural complications
Work accident
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Psychiatric disorders
Depression
|
1.4%
3/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
0.91%
2/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Surgical and medical procedures
Abdominal Surgery
|
1.8%
4/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Gastrointestinal disorders
Gallbladder Disease
|
0.00%
0/220 • 24 months
|
1.5%
4/269 • 24 months
|
|
Immune system disorders
Allergic Reaction
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Surgical and medical procedures
Appendix Removed
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Psychiatric disorders
Possible Panic Attack
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Pregnancy, puerperium and perinatal conditions
Scrotal Pain
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Immune system disorders
Autoimmune Disorder on Eye
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
3/220 • 24 months
|
1.5%
4/269 • 24 months
|
|
Infections and infestations
Sepsis
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biopsy resulted in needing catheterization
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Blood and lymphatic system disorders
Blood Transfusion
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Vascular disorders
hypertension
|
0.91%
2/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Surgery
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
Other adverse events
| Measure |
Participants With Obesity + GEM
n=220 participants at risk
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will be assigned to GEM Tool and a health coach.
GEM: Online program designed to support health coach and primary care team counseling. It assesses current behaviors, barriers, and facilitators to weight loss via a 16-item questionnaire, provides tailored advice, and guides patients to set weight loss (5-10%), diet, and physical activity (PA) goals. After completing the tool, participants will meet with a Health Coach. Participants will receive 12 telephone coaching calls by a health coach over 12 months.
|
Participants With Obesity + Enhanced Usual Care
n=269 participants at risk
Body mass index of ≥30kg/m2 OR Body mass index of ≥25 kg/m2 with an obesity associated co-morbidity. Will receive receive non-tailored weight management handouts by health coaches.
Enhanced Usual Care: Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.91%
2/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Skin and subcutaneous tissue disorders
Abcess
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Accident
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Acute muscle spasm
|
0.91%
2/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Immune system disorders
Allergic reaction
|
0.45%
1/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Skin and subcutaneous tissue disorders
Contact Dermatitis
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
4/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.91%
2/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Surgical and medical procedures
Catheter Adjusted Due to Discomfort
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Surgical and medical procedures
Catheter Removed
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Victim of assault
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Cardiac disorders
Chest pains
|
2.3%
5/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
General disorders
Headaches from sinus issues
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Infections and infestations
COVID-19 infection
|
0.00%
0/220 • 24 months
|
1.5%
4/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst in arm
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endoscopy and colonoscopy
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Reproductive system and breast disorders
Enlarged Prostate
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Plantar faciitis
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.91%
2/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.45%
1/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.45%
1/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Injury, poisoning and procedural complications
Wrist/hand injury
|
0.91%
2/220 • 24 months
|
1.1%
3/269 • 24 months
|
|
Renal and urinary disorders
Kidney pain/stones
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.45%
1/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Lightheaded, dizzy
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma in left abdomen
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Nervous system disorders
Migraines
|
0.00%
0/220 • 24 months
|
1.1%
3/269 • 24 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/220 • 24 months
|
0.74%
2/269 • 24 months
|
|
Injury, poisoning and procedural complications
Ankle pain due to injury
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Injury, poisoning and procedural complications
Injury requiring physical therapy
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Diffuse muscle pain
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Infections and infestations
Fever
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain/injury
|
1.4%
3/220 • 24 months
|
1.9%
5/269 • 24 months
|
|
Infections and infestations
Sinus infection
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Infections and infestations
Sore throat
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Infections and infestations
Staphylococcus aureus infection in leg
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Surgical and medical procedures
Tonsil Removal
|
0.45%
1/220 • 24 months
|
0.00%
0/269 • 24 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
|
Injury, poisoning and procedural complications
Foot sprain
|
0.00%
0/220 • 24 months
|
0.37%
1/269 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place