Trial Outcomes & Findings for Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth (NCT NCT03223649)

NCT ID: NCT03223649

Last Updated: 2021-06-11

Results Overview

Insulin integrated area under the curve (iAUC) as a marker of glucose metabolism on OGTT during test day #6, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

test day 6

Results posted on

2021-06-11

Participant Flow

Participants were recruited via multiple methods: 1. Letters were mailed to local parents 2. Flyers were posted with permission. 3. Local community groups were asked to send the flyer to their listservs. 4. Schools, churches, pediatricians, and community centers were contacted. 5. Potential volunteers in ResearchMatch program were contacted.

Of the 129 participants who were evaluated with baseline screening, 20 were not studied further: * 12: Failed to meet inclusion criteria * 2: Impaired glucose tolerance * 1: Hepatic disease * 7: Failed picture vocabulary test * 2 Did not meet BMI criteria * 6: No longer interested * 1: Could not determine VO2 max or lactate threshold from exercise testing (insufficient effort) * 1: Withdrawn due to COVID pandemic restrictions

Participant milestones

Participant milestones
Measure
Sedentary
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Overall Study
STARTED
52
57
Overall Study
COMPLETED
42
51
Overall Study
NOT COMPLETED
10
6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Break It Up: A Study Evaluating Breaking Up Daily Sedentary Behavior in Youth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sedentary
n=42 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=51 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Total
n=93 Participants
Total of all reporting groups
Age, Continuous
10.4 years
STANDARD_DEVIATION 1.3 • n=5 Participants
10.0 years
STANDARD_DEVIATION 1.2 • n=7 Participants
10.2 years
STANDARD_DEVIATION 1.3 • n=5 Participants
Sex: Female, Male
Female
18 Participants
n=5 Participants
27 Participants
n=7 Participants
45 Participants
n=5 Participants
Sex: Female, Male
Male
24 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
36 Participants
n=5 Participants
43 Participants
n=7 Participants
79 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
9 Participants
n=5 Participants
5 Participants
n=7 Participants
14 Participants
n=5 Participants
Race (NIH/OMB)
White
27 Participants
n=5 Participants
38 Participants
n=7 Participants
65 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Region of Enrollment
United States
42 Participants
n=5 Participants
51 Participants
n=7 Participants
93 Participants
n=5 Participants
Fat Mass (kg)
16.2 kg
STANDARD_DEVIATION 12.4 • n=5 Participants
13.5 kg
STANDARD_DEVIATION 6.9 • n=7 Participants
14.7 kg
STANDARD_DEVIATION 9.8 • n=5 Participants
Lean Mass (kg)
28.9 kg
STANDARD_DEVIATION 7.9 • n=5 Participants
25.5 kg
STANDARD_DEVIATION 4.8 • n=7 Participants
27.0 kg
STANDARD_DEVIATION 6.6 • n=5 Participants
Height (cm)
146.0 cm
STANDARD_DEVIATION 9.8 • n=5 Participants
141.2 cm
STANDARD_DEVIATION 8.5 • n=7 Participants
143.4 cm
STANDARD_DEVIATION 9.4 • n=5 Participants
BMI (kg/m2)
21.2 kg/m2
STANDARD_DEVIATION 6.6 • n=5 Participants
19.9 kg/m2
STANDARD_DEVIATION 3.9 • n=7 Participants
20.5 kg/m2
STANDARD_DEVIATION 5.3 • n=5 Participants
BMI z-score
0.8 z-score
STANDARD_DEVIATION 1.2 • n=5 Participants
0.8 z-score
STANDARD_DEVIATION 0.9 • n=7 Participants
0.8 z-score
STANDARD_DEVIATION 1.0 • n=5 Participants
Fasting glucose (mg/dL)
87.6 mg/dL
STANDARD_DEVIATION 6.8 • n=5 Participants
87.9 mg/dL
STANDARD_DEVIATION 5.9 • n=7 Participants
87.8 mg/dL
STANDARD_DEVIATION 6.3 • n=5 Participants
Fasting insulin (mIU/ml)
11.1 mIU/mL
STANDARD_DEVIATION 9.8 • n=5 Participants
9.7 mIU/mL
STANDARD_DEVIATION 5.9 • n=7 Participants
10.4 mIU/mL
STANDARD_DEVIATION 7.4 • n=5 Participants
Peak VO2 (ml/kg/min)
38.3 ml/kg/min
STANDARD_DEVIATION 9.1 • n=5 Participants
38.5 ml/kg/min
STANDARD_DEVIATION 7.4 • n=7 Participants
38.4 ml/kg/min
STANDARD_DEVIATION 8.1 • n=5 Participants
IPAQ score
2.2 units on a scale (1-4)
STANDARD_DEVIATION 1.0 • n=5 Participants
2.2 units on a scale (1-4)
STANDARD_DEVIATION 1.1 • n=7 Participants
2.2 units on a scale (1-4)
STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: test day 6

Insulin integrated area under the curve (iAUC) as a marker of glucose metabolism on OGTT during test day #6, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Outcome measures

Outcome measures
Measure
Sedentary
n=42 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=51 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Insulin iAUC Obtained During the Oral Glucose Tolerance Test at the Final Experimental Visit.
13,698.60 mIU/dL∙min
Standard Deviation 9414.9
10,619.70 mIU/dL∙min
Standard Deviation 6,781.30

SECONDARY outcome

Timeframe: test day 6

Integrated area under the curve (iAUC) for glucose values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Outcome measures

Outcome measures
Measure
Sedentary
n=42 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=51 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Glucose iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.
22,247.90 mg/dL∙min
Standard Deviation 2,927.70
21,688.80 mg/dL∙min
Standard Deviation 2,473.70

SECONDARY outcome

Timeframe: test day 6

Integrated area under the curve (iAUC) for C-Peptide values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Outcome measures

Outcome measures
Measure
Sedentary
n=42 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=51 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
C-Peptide iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.
1,292.10 ng/dL∙min
Standard Deviation 449.8
1,160.10 ng/dL∙min
Standard Deviation 448.8

SECONDARY outcome

Timeframe: test day 6

Integrated area under the curve (iAUC) for Free Fatty Acid values during the oral glucose tolerance test, collected at 0, 30, 60, 90, 120, 150, and 180 minutes after oral dextrose ingestion

Outcome measures

Outcome measures
Measure
Sedentary
n=42 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=51 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Free Fatty Acid iAUC Obtained During the Oral Glucose Tolerance Test on Day # 6 of Intervention.
39.7 mmol/L∙min
Standard Deviation 9.8
38.5 mmol/L∙min
Standard Deviation 13.1

SECONDARY outcome

Timeframe: test days 1-6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from one participant randomized to the Walking Bouts condition.

Mean 3-dimensional activity during the 3 hours of intervention from all days (step counts per minute)

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=50 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Daily Physical Activity (Step Counts/Min) During Intervention.
5.4 step count per minute
Standard Deviation 1.9
11.2 step count per minute
Standard Deviation 3.0

SECONDARY outcome

Timeframe: test days 1-6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from one participant randomized to the Walking Bouts condition.

Mean total daily 3-dimensional activity counts during the 21 hours without intervention on days 1-6 (activity counts/21 hours) from triaxial write accelerometers worn at home. Note: these are not "step counts" but total 3D activity counts because motion of the wrist at times other than walking are also recorded. There is no simple way to convert these counts to step counts.

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=50 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Daily Physical Activity (3-dimensional Activity Counts/Day) Outside of the Intervention.
2.1 activity counts per 21 hours x 10^6
Standard Deviation 0.6
2.2 activity counts per 21 hours x 10^6
Standard Deviation 0.5

SECONDARY outcome

Timeframe: test day 6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition.

Total energy intake (kcal) during buffet meal immediately after the end of intervention

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=49 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Energy Intake at the Final Test Meal.
1,312.4 kcal
Standard Deviation 478.4
1,207.4 kcal
Standard Deviation 443.8

SECONDARY outcome

Timeframe: test day 6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition.

Percentage Energy intake from Fat during buffet meal immediately after the end of intervention

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=49 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Percentage Fat Intake at the Final Test Meal.
35.8 percentage of total energy intake (%)
Standard Deviation 7.0
36.2 percentage of total energy intake (%)
Standard Deviation 6.0

SECONDARY outcome

Timeframe: test day 6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition.

Percentage Energy intake from Carbohydrate during buffet meal immediately after the end of intervention

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=49 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Percentage Carbohydrate Intake at the Final Test Meal.
52.0 percentage of total energy intake (%)
Standard Deviation 9.0
51.8 percentage of total energy intake (%)
Standard Deviation 8.4

SECONDARY outcome

Timeframe: test day 6

Population: Data were unavailable from two participants randomized to the Sedentary condition and from two participants randomized to the Walking Bouts condition.

Percentage Energy intake from Protein during buffet meal immediately after the end of intervention

Outcome measures

Outcome measures
Measure
Sedentary
n=40 Participants
(Control intervention) Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration. Sedentary: (Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
Walking Bouts
n=49 Participants
Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory thresholdas determined during a V02max test. Walking Bouts: Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
Percentage Protein Intake at the Final Test Meal.
12.2 percentage of total energy intake (%)
Standard Error 3.6
12.0 percentage of total energy intake (%)
Standard Error 3.2

Adverse Events

Sedentary

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Walking Bouts

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jack A. Yanovski, MD, PhD

National Institutes of Health

Phone: 3014960858

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place