Trial Outcomes & Findings for Web-based Physical Activity Intervention to Promote Physical Activity (NCT NCT05803304)
NCT ID: NCT05803304
Last Updated: 2026-08-12
Results Overview
Participants wore a physical activity tracker, the ActiGraph GT3X+ accelerometer, around their waist for 7 days at Baseline and Month 6 to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.
COMPLETED
NA
89 participants
Baseline, Month 6
2026-08-12
Participant Flow
Participants were recruited through Emory University in Atlanta, Georgia, USA. Participant enrollment began October 16, 2023 and all follow-up assessments were completed by March 13, 2025.
Participant milestones
| Measure |
Physical Activity for The Heart (PATH) Intervention
Insufficiently active adults with obesity assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and physical activity (PA) habits to support long-term adherence to the minimum threshold 150 moderate and vigorous physical activity (MVPA) minutes per week. The health coach provides participants with access to the PATH website and a detailed orientation on how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA by about 10 minutes per week. The PA prescription process begins by identifying a suitable PATH level for each participant. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Physical activity tracker: Participants are asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: Diet quality and barriers to healthy eating are evaluated at baseline, and then all study participants are provided with educational materials that are curated to promote diet quality. Participants receive a monthly email with a brief PDF addressing a diet component focused on improving diet quality to reduce cardiovascular disease (CVD) risk and improve general health.
|
Attention Control Group
Insufficiently active adults with obesity assigned to the attention control group.
A health coach has a zoom meeting with each control group participant where they are provided with an electronic copy of the "Be Active Your Way" booklet, developed by the Centers for Disease Control and Prevention (CDC) to help individuals integrate PA into their daily lives. The coach orients the participant to the key strategies used in the booklet and encourages them to use it regularly and to self-monitor PA using the Fitbit during the entire course of the study. In addition, the group is introduced to www.health.com, a jargon free website that focuses on general health topics and latest medical news. At the end of the meeting, the participants are asked to provide a schedule for zoom meetings with the study team twice per month during the 6-month study.
Physical activity tracker: Participants are asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: Diet quality and barriers to healthy eating are evaluated at baseline, and then all study participants are provided with educational materials that are curated to promote diet quality. Participants receive a monthly email with a brief PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
45
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
8
|
Reasons for withdrawal
| Measure |
Physical Activity for The Heart (PATH) Intervention
Insufficiently active adults with obesity assigned to the PATH intervention.
The PATH intervention guides participants in making changes in their lifestyle and physical activity (PA) habits to support long-term adherence to the minimum threshold 150 moderate and vigorous physical activity (MVPA) minutes per week. The health coach provides participants with access to the PATH website and a detailed orientation on how to use the resources included in PATH. The health coach meets remotely with each participant twice per month to develop a tailored plan geared towards increasing MVPA by about 10 minutes per week. The PA prescription process begins by identifying a suitable PATH level for each participant. After assigning the PATH level, the health coach guides each participant in selecting their weekly PA goal and helps them start slowly with a plan to establish regular exercise frequencies of 3-5 days per week.
Physical activity tracker: Participants are asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: Diet quality and barriers to healthy eating are evaluated at baseline, and then all study participants are provided with educational materials that are curated to promote diet quality. Participants receive a monthly email with a brief PDF addressing a diet component focused on improving diet quality to reduce cardiovascular disease (CVD) risk and improve general health.
|
Attention Control Group
Insufficiently active adults with obesity assigned to the attention control group.
A health coach has a zoom meeting with each control group participant where they are provided with an electronic copy of the "Be Active Your Way" booklet, developed by the Centers for Disease Control and Prevention (CDC) to help individuals integrate PA into their daily lives. The coach orients the participant to the key strategies used in the booklet and encourages them to use it regularly and to self-monitor PA using the Fitbit during the entire course of the study. In addition, the group is introduced to www.health.com, a jargon free website that focuses on general health topics and latest medical news. At the end of the meeting, the participants are asked to provide a schedule for zoom meetings with the study team twice per month during the 6-month study.
Physical activity tracker: Participants are asked to wear Fitbit Charge 5 on their non-dominant hand for the entire duration of the study using a 24-hour wear protocol.
Dietary education: Diet quality and barriers to healthy eating are evaluated at baseline, and then all study participants are provided with educational materials that are curated to promote diet quality. Participants receive a monthly email with a brief PDF addressing a diet component focused on improving diet quality to reduce CVD risk and improve general health.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Web-based Physical Activity Intervention to Promote Physical Activity
Baseline characteristics by cohort
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
5 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
8 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=1 Participants
|
19 Participants
n=1 Participants
|
41 Participants
n=1 Participants
|
|
Age, Continuous
|
48.04 years
STANDARD_DEVIATION 12.84 • n=1 Participants
|
49.30 years
STANDARD_DEVIATION 11.56 • n=1 Participants
|
48.66 years
STANDARD_DEVIATION 12.17 • n=1 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=1 Participants
|
41 Participants
n=1 Participants
|
81 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
23 Participants
n=1 Participants
|
22 Participants
n=1 Participants
|
45 Participants
n=1 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
3 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
45 Participants
n=1 Participants
|
44 Participants
n=1 Participants
|
89 Participants
n=1 Participants
|
|
Weight loss medication use
|
1 Participants
n=1 Participants
|
4 Participants
n=1 Participants
|
5 Participants
n=1 Participants
|
|
Weight
|
247.31 pounds (lbs)
STANDARD_DEVIATION 50.75 • n=1 Participants
|
243.77 pounds (lbs)
STANDARD_DEVIATION 41.00 • n=1 Participants
|
245.56 pounds (lbs)
STANDARD_DEVIATION 45.96 • n=1 Participants
|
|
Meeting PA guidelines, measured by ActiGraph
|
19 Participants
n=1 Participants
|
20 Participants
n=1 Participants
|
39 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants who had physical activity measured with ActiGraph at both time points. Some participants did not complete this study assessment at the Month 6 time point.
Participants wore a physical activity tracker, the ActiGraph GT3X+ accelerometer, around their waist for 7 days at Baseline and Month 6 to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.
Outcome measures
| Measure |
PATH Intervention
n=33 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=26 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph
Baseline
|
155.76 minutes of MVPA/week
Standard Deviation 105.84
|
159.69 minutes of MVPA/week
Standard Deviation 111.51
|
|
Weekly Moderate-to-Vigorous Physical Activity Measured With ActiGraph
Month 6
|
166.94 minutes of MVPA/week
Standard Deviation 108.27
|
128.23 minutes of MVPA/week
Standard Deviation 83.85
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: All participants are included in analysis of this outcome measure. Data analysis followed intent-to-treat principles for this primary outcome measure.
Participants wore a FitBit physical activity tracker on their wrist to assess the number of minutes of moderate-to-vigorous physical activity (MVPA) per week.The FitBit wrist activity tracker was worn for at least 10 hours per day while awake.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Weekly Moderate-to-Vigorous Physical Activity Measured With FitBit
Baseline
|
118 minutes of MVPA/week
Interval 66.0 to 222.0
|
239 minutes of MVPA/week
Interval 113.0 to 441.0
|
|
Weekly Moderate-to-Vigorous Physical Activity Measured With FitBit
Month 6
|
148 minutes of MVPA/week
Interval 49.0 to 238.0
|
125 minutes of MVPA/week
Interval 24.0 to 368.0
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: All participants are included in analysis of this outcome measure. Data analysis followed intent-to-treat principles for this primary outcome measure.
Adherence to PA Guidelines is defined as achieving ≥150 minutes of moderate-to-vigorous physical activity (MVPA) per week. The number of participants adhering to ≥150 minutes of MVPA per week between the Baseline and Month 6 assessments were examined.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=43 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Number of Participants by Change in Physical Activity (PA) Guidelines Adherence
Lost adherence
|
6 Participants
|
13 Participants
|
|
Number of Participants by Change in Physical Activity (PA) Guidelines Adherence
No change
|
29 Participants
|
26 Participants
|
|
Number of Participants by Change in Physical Activity (PA) Guidelines Adherence
Gained adherence
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants who had step counts measured with a FitBit physical activity tracker at both time points.
Daily step count is measured with a FitBit physical activity tracker worn on the wrist for at least 10 hours per day while awake.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=43 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Step Count
Baseline
|
5437.42 steps per day
Standard Deviation 2661.27
|
5587.33 steps per day
Standard Deviation 2780.04
|
|
Step Count
Month 6
|
5118.98 steps per day
Standard Deviation 2268.13
|
4617.77 steps per day
Standard Deviation 2449.48
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Due to shipping delays samples were not received by the processing laboratory until 2-4 months after collection and the laboratory was unable to process DBS samples for blood lipids. As a result, total cholesterol and HDL cholesterol values were not obtained, and the ASCVD Risk Calculator Score could not be computed for any participant. No further analysis of these samples is planned, as the documented degradation from shipping delays render lipid values from these specific samples unreliable.
The algorithm provides sex and race-specific estimates for the first CVD event for black and white men and women. Scores are calculated using age, diabetes status (no or yes), sex, smoking status (no or yes), total cholesterol, HDL cholesterol, systolic blood pressure, and treatment for hypertension (no or yes). Dried blood spot (DBS) samples for total cholesterol and HDL cholesterol - the lipid values required to calculate the 2013 ASCVD Risk Calculator Score - were collected from participants at Baseline and Month 6. ASCVD scores range from 0-100% with higher scores representing poor cardiovascular health status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants completing this assessment at the indicated time point. Some participants did not complete all study assessments for the Month 6 time point.
Waist circumference is measured in inches.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Waist Circumference
Baseline
|
47.42 inches
Standard Deviation 6.17
|
47.46 inches
Standard Deviation 5.34
|
|
Waist Circumference
Month 6
|
46.29 inches
Standard Deviation 6.59
|
46.12 inches
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants who provided a weight measurement at both time points. Some participants did not complete all study assessments for the Month 6 time point.
Weight is measured in pounds (lbs). The change from Baseline to Month 6 was assessed for both study arms.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=42 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Change in Weight
|
-4.31 pounds (lbs)
Standard Deviation 16.50
|
-5.38 pounds (lbs)
Standard Deviation 10.61
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants providing a systolic blood pressure measurement for the indicated time point. Some participants did not complete all study assessments for the Month 6 time point.
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Normal systolic blood pressure as lower than 120 millimeters of mercury (mmHg).
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Systolic Blood Pressure
Baseline
|
138.7 mmHg
Standard Deviation 18.5
|
139.7 mmHg
Standard Deviation 20.3
|
|
Systolic Blood Pressure
Month 6
|
134.8 mmHg
Standard Deviation 16.0
|
129.7 mmHg
Standard Deviation 17.6
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: This analysis includes participants providing a diastolic blood pressure measurement for the indicated time point. Some participants did not complete all study assessments for the Month 6 time point.
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Normal diastolic blood pressure as lower than 80 mmHg.
Outcome measures
| Measure |
PATH Intervention
n=45 Participants
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 Participants
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Diastolic Blood Pressure
Month 6
|
83.3 mmHg
Standard Deviation 8.7
|
80.5 mmHg
Standard Deviation 11.2
|
|
Diastolic Blood Pressure
Baseline
|
86.8 mmHg
Standard Deviation 11.9
|
86.1 mmHg
Standard Deviation 12.3
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: The Life's Essential 8 score requires blood lipid and blood glucose/HbA1c values as two of its eight components. The dried blood spot (DBS) samples collected for these laboratory values could not be processed due to documented shipping delays (2-4 months post-collection). Because two of the eight required components could not be obtained, the composite Life's Essential 8 score could not be calculated for any participant. No further analysis is planned for the DBS samples.
Life's Essential 8 is a way to assess cardiovascular health developed by the American Heart Association. Life's Essential 8 has 8 components: diet, physical activity, exposure to nicotine, sleep, body mass index (BMI), blood lipids, blood glucose, and blood pressure. Each component is scored with an algorithm and scores range from 0 to 100. A composite score of overall cardiovascular health can be generated and it also ranges from 0 to 100. A score of 0 indicates a low health score, a score of 50 indicates moderate health, and a score of 100 is the highest health for each of the 8 components as well as the overall score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Due to documented shipping delays (2-4 months), the laboratory was unable to process the DBS for HbA1c. As a result, no HbA1c values were obtained. No further analysis is planned for these samples.
The hemoglobin A1c test result reflects average blood sugar level over the past three months. Specifically, the A1c test measures what percentage of hemoglobin is coated with sugar (glycated). Values below 5.7% are normal, values between 5.7% and 6.4% indicate prediabetes, and values of 6.5% and higher indicate diabetes. Dried blood spots (DBS) were collected for assessing HbA1c at Baseline and Month 6 per protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Adiponectin was a pre-specified secondary outcome but was not included in the multiplex immunoassay panel used for laboratory analyses in this study, as such, no adiponectin data are available for analysis. With shipping delays resulting pre-analytical degradation in other biomarkers analyzed from the same dried blood spots, a separate standalone adiponectin assay was not pursued as it would likely yield similarly uninterpretable results. No future adiponectin analysis is planned for this study.
Adiponectin is a hormone released by adipose tissue, and other body tissues, that assists with insulin sensitivity and reducing inflammation. Normal ranges vary depending on sex and BMI and in general lower levels are associated with health conditions of obesity, Type 2 diabetes, and atherosclerosis. In people with a BMI of less than 25, the normal range for males and females is 5 to 37 micrograms per milliliter (µg/mL). In those with a BMI of 25 to 30 the normal range for males is 5 to 28 µg/mL and the normal range for females is 4 to 20 µg/mL. In people with a BMI over 30 the normal range for males is 2 to 20 µg/mL and the normal range for females is 4 to 22 µg/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Due to shipping delays samples were not received by the laboratory until 2-4 months after collection and the laboratory was unable to process the DBS samples for blood lipids. As a result, no total cholesterol values were obtained. No further analysis of these samples is planned as the DBS samples received after extended shipping delays did not meet quality thresholds for reliable lipid quantification.
Cholesterol is waxy substance which is produced by the liver or comes from food that is consumed. Cholesterol concentrations are commonly used as a marker for cardiovascular disease risk. Healthy levels of total cholesterol are 125 to 200 milligrams (mg) per deciliter (dL). Dried blood spot (DBS) samples for total cholesterol were collected from participants per protocol at Baseline and Month 6.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Due to shipping delays samples were not received by the laboratory until 2-4 months after collection and the laboratory was unable to process the DBS samples for blood lipids. As a result, no LDL cholesterol values were obtained. No further analysis of these samples is planned as the DBS samples received after extended shipping delays did not meet quality thresholds for reliable lipid quantification.
Dried blood spot (DBS) samples for LDL cholesterol were collected from participants per protocol at Baseline and Month 6. Healthy levels of LDL cholesterol are below 100mg/dL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Due to shipping delays samples were not received by the laboratory until 2-4 months after collection and the laboratory was unable to process the DBS samples for blood lipids. As a result, no HDL cholesterol values were obtained. No further analysis of these samples is planned as the DBS samples received after extended shipping delays did not meet quality thresholds for reliable lipid quantification.
HDL cholesterol is the "good" cholesterol because it is a type of fat that removes cholesterol from blood, thereby preventing build up. Healthy levels for HDL cholesterol are 40mg/dL or higher in adult males and 50 mg/dL or higher in adult females. Dried blood spot (DBS) samples for HDL cholesterol were collected from participants per protocol at Baseline and Month 6.
Outcome measures
Outcome data not reported
Adverse Events
PATH Intervention
Attention Control Group
Serious adverse events
| Measure |
PATH Intervention
n=45 participants at risk
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 participants at risk
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Gastrointestinal disorders
Colon tear
|
2.2%
1/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
0.00%
0/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Hepatobiliary disorders
Emergency cholecystostomy
|
2.2%
1/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
0.00%
0/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization due to asthma
|
0.00%
0/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
2.3%
1/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
Other adverse events
| Measure |
PATH Intervention
n=45 participants at risk
Insufficiently active adults with obesity assigned to the PATH intervention.
|
Attention Control Group
n=44 participants at risk
Insufficiently active adults with obesity assigned to the attention control group.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash caused by wrist band
|
4.4%
2/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
6.8%
3/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Musculoskeletal and connective tissue disorders
Aggravation of existing knee pain while walking
|
0.00%
0/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
2.3%
1/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Nervous system disorders
Myasthenia gravis flare up
|
2.2%
1/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
0.00%
0/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Cardiac disorders
New atrial fibrillation (AFib) medication prescribed
|
2.2%
1/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
0.00%
0/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
General disorders
Emergency department visit for chest pain
|
2.2%
1/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
0.00%
0/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
General disorders
Allergic reaction of unknown cause
|
0.00%
0/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
2.3%
1/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Vascular disorders
New hypertension diagnosis
|
0.00%
0/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
4.5%
2/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
|
Musculoskeletal and connective tissue disorders
Knee replacement
|
0.00%
0/45 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
4.5%
2/44 • Information on adverse events was collected beginning at the time when individuals gave consent to participate in the study and continued through the final assessment (up to 6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place