Trial Outcomes & Findings for Behavioral Economics for Activity Motivation in Adolescents (BEAM) (NCT NCT04874415)
NCT ID: NCT04874415
Last Updated: 2025-10-28
Results Overview
Effects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-10-28
Participant Flow
n=75 participants signed consent to participate in the study. n=74 completed the baseline study visit and 2-week run-in using Fitbit. Those with insufficient Fitbit data or more than 30 minutes of moderate-vigorous physical activity daily were excluded prior to randomization (n=7).
Participant milestones
| Measure |
1FLD
One text per day, fixed goal, loss incentive, daily weekly goal time period.
|
1FLW
One text per day, fixed goal, loss incentive, weekly goal time period.
|
1RLD
One text per day, ramped goal, loss incentive, daily goal time period
|
1RLW
One text per day, ramped goal, loss incentive, weekly goal time period.
|
1FGD
One text per day, fixed goal, gain incentive, daily goal time period.
|
1FGW
One text per day, fixed goal, gain incentive, weekly goal time period.
|
1RGD
One text per day, ramped goal, gain incentive, daily goal time period.
|
1RGW
One text per day, ramped goal, gain incentive, weekly goal time period.
|
2FLD
Two texts per day, fixed goal, loss incentive, daily goal time period.
|
2FLW
Two texts per day, fixed goal, loss incentive, weekly goal time period.
|
2RLD
Two texts per day, ramped goal, loss incentive, daily goal time period.
|
2RLW
Two texts per day, ramped goal, loss incentive, weekly goal time period.
|
2FGD
Two texts per day, fixed goal, gain incentive, daily goal time period.
|
2FGW
Two texts per day, fixed goal, gain incentive, weekly goal time period.
|
2RGD
Two texts per day, ramped goal, gain incentive, daily goal time period.
|
2RGW
Two texts per day, ramped goal, gain incentive, weekly goal time period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
4
|
5
|
4
|
3
|
3
|
4
|
4
|
5
|
5
|
4
|
4
|
4
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
2
|
2
|
2
|
2
|
0
|
2
|
3
|
3
|
3
|
3
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
2
|
1
|
1
|
2
|
4
|
3
|
2
|
1
|
1
|
1
|
4
|
1
|
Reasons for withdrawal
| Measure |
1FLD
One text per day, fixed goal, loss incentive, daily weekly goal time period.
|
1FLW
One text per day, fixed goal, loss incentive, weekly goal time period.
|
1RLD
One text per day, ramped goal, loss incentive, daily goal time period
|
1RLW
One text per day, ramped goal, loss incentive, weekly goal time period.
|
1FGD
One text per day, fixed goal, gain incentive, daily goal time period.
|
1FGW
One text per day, fixed goal, gain incentive, weekly goal time period.
|
1RGD
One text per day, ramped goal, gain incentive, daily goal time period.
|
1RGW
One text per day, ramped goal, gain incentive, weekly goal time period.
|
2FLD
Two texts per day, fixed goal, loss incentive, daily goal time period.
|
2FLW
Two texts per day, fixed goal, loss incentive, weekly goal time period.
|
2RLD
Two texts per day, ramped goal, loss incentive, daily goal time period.
|
2RLW
Two texts per day, ramped goal, loss incentive, weekly goal time period.
|
2FGD
Two texts per day, fixed goal, gain incentive, daily goal time period.
|
2FGW
Two texts per day, fixed goal, gain incentive, weekly goal time period.
|
2RGD
Two texts per day, ramped goal, gain incentive, daily goal time period.
|
2RGW
Two texts per day, ramped goal, gain incentive, weekly goal time period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Missing Fitbit data but not lost to follow up
|
1
|
1
|
1
|
1
|
1
|
1
|
0
|
1
|
4
|
0
|
1
|
0
|
0
|
1
|
4
|
0
|
|
Overall Study
Missing Fitbit data and lost to follow up
|
1
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
0
|
3
|
1
|
1
|
1
|
0
|
0
|
1
|
|
Overall Study
Did not attend final study visit but had Fitbit data
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Behavioral Economics for Activity Motivation in Adolescents (BEAM)
Baseline characteristics by cohort
| Measure |
1FLD
n=5 Participants
One text per day, fixed goal, loss incentive, daily weekly goal time period.
|
1FLW
n=4 Participants
One text per day, fixed goal, loss incentive, weekly goal time period.
|
1RLD
n=4 Participants
One text per day, ramped goal, loss incentive, daily goal time period
|
1RLW
n=5 Participants
One text per day, ramped goal, loss incentive, weekly goal time period.
|
1FGD
n=4 Participants
One text per day, fixed goal, gain incentive, daily goal time period.
|
1FGW
n=3 Participants
One text per day, fixed goal, gain incentive, weekly goal time period.
|
1RGD
n=3 Participants
One text per day, ramped goal, gain incentive, daily goal time period.
|
1RGW
n=4 Participants
One text per day, ramped goal, gain incentive, weekly goal time period.
|
2FLD
n=4 Participants
Two texts per day, fixed goal, loss incentive, daily goal time period.
|
2FLW
n=5 Participants
Two texts per day, fixed goal, loss incentive, weekly goal time period.
|
2RLD
n=5 Participants
Two texts per day, ramped goal, loss incentive, daily goal time period.
|
2RLW
n=4 Participants
Two texts per day, ramped goal, loss incentive, weekly goal time period.
|
2FGD
n=4 Participants
Two texts per day, fixed goal, gain incentive, daily goal time period.
|
2FGW
n=4 Participants
Two texts per day, fixed goal, gain incentive, weekly goal time period.
|
2RGD
n=5 Participants
Two texts per day, ramped goal, gain incentive, daily goal time period.
|
2RGW
n=4 Participants
Two texts per day, ramped goal, gain incentive, weekly goal time period.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
16.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
15.2 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
15.3 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 1.3 • n=4 Participants
|
15.9 years
STANDARD_DEVIATION 1.6 • n=21 Participants
|
15.2 years
STANDARD_DEVIATION 1.9 • n=8 Participants
|
16.7 years
STANDARD_DEVIATION 3.3 • n=8 Participants
|
17.0 years
STANDARD_DEVIATION 2.7 • n=24 Participants
|
17.5 years
STANDARD_DEVIATION 2.5 • n=42 Participants
|
16.3 years
STANDARD_DEVIATION 1.0 • n=42 Participants
|
17.7 years
STANDARD_DEVIATION 2.0 • n=42 Participants
|
17.2 years
STANDARD_DEVIATION 3.2 • n=42 Participants
|
16.0 years
STANDARD_DEVIATION 0.6 • n=36 Participants
|
14.1 years
STANDARD_DEVIATION 0.9 • n=36 Participants
|
16.1 years
STANDARD_DEVIATION 1.3 • n=24 Participants
|
15.8 years
STANDARD_DEVIATION 2.5 • n=135 Participants
|
16.1 years
STANDARD_DEVIATION 2.0 • n=136 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
45 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
22 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
22 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Native American/Alaskan Native/Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
31 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino/Latina
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
9 Participants
n=136 Participants
|
|
Body mass index
|
38.4 kg/m^2
n=5 Participants
|
43.6 kg/m^2
n=7 Participants
|
43.7 kg/m^2
n=5 Participants
|
34.9 kg/m^2
n=4 Participants
|
46.9 kg/m^2
n=21 Participants
|
38.3 kg/m^2
n=8 Participants
|
40.3 kg/m^2
n=8 Participants
|
42.1 kg/m^2
n=24 Participants
|
39.6 kg/m^2
n=42 Participants
|
34.7 kg/m^2
n=42 Participants
|
44.6 kg/m^2
n=42 Participants
|
40.2 kg/m^2
n=42 Participants
|
37.8 kg/m^2
n=36 Participants
|
35.5 kg/m^2
n=36 Participants
|
35.9 kg/m^2
n=24 Participants
|
34.5 kg/m^2
n=135 Participants
|
40 kg/m^2
n=136 Participants
|
PRIMARY outcome
Timeframe: 12 weeksEffects of time spent in MVPA was measured by assessing the change in weekly mean minutes in MVPA per day from baseline
Outcome measures
| Measure |
Once Daily Text Message
n=21 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=18 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=19 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=20 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=20 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=19 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=18 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=21 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Moderate to Vigorous Physical Activity (MVPA)
Change from baseline to 12 weeks
|
2.3 minutes per day
Interval -0.9 to 5.5
|
1.8 minutes per day
Interval -2.9 to 6.5
|
3.3 minutes per day
Interval -0.9 to 7.4
|
0.8 minutes per day
Interval -4.0 to 5.7
|
4.0 minutes per day
Interval -0.2 to 8.3
|
0.07 minutes per day
Interval -4.7 to 4.9
|
-0.2 minutes per day
Interval -3.1 to 2.8
|
4.3 minutes per day
Interval -0.5 to 9.0
|
|
Change in Moderate to Vigorous Physical Activity (MVPA)
Baseline
|
6.1 minutes per day
Interval 3.6 to 8.6
|
7.1 minutes per day
Interval 3.0 to 11.3
|
5.0 minutes per day
Interval 1.8 to 8.2
|
8.2 minutes per day
Interval 3.7 to 12.8
|
5.1 minutes per day
Interval 2.0 to 8.1
|
8.2 minutes per day
Interval 3.6 to 12.7
|
6.5 minutes per day
Interval 3.3 to 9.7
|
6.7 minutes per day
Interval 3.1 to 10.3
|
SECONDARY outcome
Timeframe: 12 weeksDaily step count will be measured by assessing the change in daily mean steps from baseline
Outcome measures
| Measure |
Once Daily Text Message
n=21 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=18 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=19 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=20 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=20 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=19 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=18 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=21 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Daily Step Count
|
962 steps
Interval -446.0 to 2369.0
|
276 steps
Interval -1486.0 to 2038.0
|
1789 steps
Interval 144.0 to 3433.0
|
-551 steps
Interval -2201.0 to 1099.0
|
1266 steps
Interval 53.0 to 2478.0
|
-28 steps
Interval -1852.0 to 1797.0
|
687 steps
Interval -959.0 to 2332.0
|
551 steps
Interval -973.0 to 2076.0
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). BMI Z-scores were not calculated for individuals older than 20 years (n=1)
Z-score calculated using "zanthro" package in Stata, according to U.S. CDC growth charts. The BMI Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched adolescents and young adults). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population. A Z-score of 0 represents the population mean. BMI Z-scores greater than 1.645 are consistent with pediatric obesity.
Outcome measures
| Measure |
Once Daily Text Message
n=26 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=24 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=26 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=24 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=25 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=25 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=26 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=24 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in BMI Z-score
|
-0.02 Z-score
Interval -0.05 to 0.01
|
-0.03 Z-score
Interval -0.06 to 0.01
|
-0.009 Z-score
Interval -0.04 to 0.02
|
-0.03 Z-score
Interval -0.07 to -0.005
|
-0.03 Z-score
Interval -0.06 to -0.001
|
-0.01 Z-score
Interval -0.04 to 0.02
|
-0.02 Z-score
Interval -0.05 to 0.007
|
-0.02 Z-score
Interval -0.05 to 0.007
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1). Due to sample processing errors, n=2 additional results were missing.
mg/dL; obtained fasting
Outcome measures
| Measure |
Once Daily Text Message
n=25 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=23 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=23 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=25 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=23 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=25 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=25 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=23 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Plasma Glucose
|
0.006 mg/dL
Interval -10.3 to 10.3
|
0.000000004 mg/dL
Interval -0.00001 to 0.00001
|
0.000002 mg/dL
Interval -0.004 to 0.004
|
0.00001 mg/dL
Interval -0.03 to 0.03
|
0.000000002 mg/dL
Interval -0.000007 to 0.000007
|
0.01 mg/dL
Interval -12.7 to 12.7
|
0.00002 mg/dL
Interval -0.04 to 0.04
|
0.000001 mg/dL
Interval -0.003 to 0.003
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=4 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
uIU/mL; obtained fasting
Outcome measures
| Measure |
Once Daily Text Message
n=23 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=23 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=23 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=23 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=22 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=24 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=23 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=23 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Insulin
|
0.00000002 uIU/mL
Interval -1.5 to 1.5
|
0.00003 uIU/mL
Interval -2313.0 to 2313.0
|
0.0000006 uIU/mL
Interval -46.0 to 46.0
|
0.000001 uIU/mL
Interval -74.0 to 74.0
|
0.005 uIU/mL
Interval -6.8 to 6.9
|
0.0000000001 uIU/mL
Interval -0.02 to 0.02
|
0.3 uIU/mL
Interval -125.0 to 126.0
|
0.000000000002 uIU/mL
Interval -0.0003 to 0.0003
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight- or glucose-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
Percent (%)
Outcome measures
| Measure |
Once Daily Text Message
n=25 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=24 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=25 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=24 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=24 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=25 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=25 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=24 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Hemoglobin A1c
|
0.003 % (HbA1c unit)
Interval -3.9 to 3.9
|
0.00000002 % (HbA1c unit)
Interval -0.00007 to 0.00007
|
0.00000003 % (HbA1c unit)
Interval -0.0001 to 0.0001
|
0.002 % (HbA1c unit)
Interval -2.6 to 2.6
|
0.00001 % (HbA1c unit)
Interval -0.03 to 0.03
|
0.000004 % (HbA1c unit)
Interval -0.009 to 0.009
|
0.02 % (HbA1c unit)
Interval -22.8 to 22.8
|
0.000000002 % (HbA1c unit)
Interval -0.000009 to 0.000009
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
mg/dL; obtained fasting
Outcome measures
| Measure |
Once Daily Text Message
n=26 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=22 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=24 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=24 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=24 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=24 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=25 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=23 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Triglycerides
|
0.03 mg/dL
Interval -38.2 to 38.3
|
0.00000005 mg/dL
Interval -0.0001 to 0.0001
|
0.00001 mg/dL
Interval -0.04 to 0.04
|
0.0001 mg/dL
Interval -0.3 to 0.3
|
0.0006 mg/dL
Interval -0.8 to 0.8
|
0.000002 mg/dL
Interval -0.006 to 0.006
|
0.0001 mg/dL
Interval -0.3 to 0.3
|
0.00001 mg/dL
Interval -0.04 to 0.04
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing. Participants who arrived to the second study visit non-fasting had fasting-sensitive laboratory measures censored (n=1).
mg/dL; obtained fasting
Outcome measures
| Measure |
Once Daily Text Message
n=26 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=22 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=24 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=24 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=24 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=24 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=25 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=23 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in Low-density Lipoprotein (LDL)
|
0.1 mg/dL
Interval -65.6 to 65.9
|
0.2 mg/dL
Interval -97.1 to 97.5
|
0.1 mg/dL
Interval -60.7 to 60.9
|
0.2 mg/dL
Interval -105.0 to 105.0
|
0.005 mg/dL
Interval -4.6 to 4.6
|
5.7 mg/dL
Interval -1.3 to 12.8
|
5.4 mg/dL
Interval -0.7 to 11.6
|
0.005 mg/dL
Interval -4.9 to 4.9
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
mg/dL; obtained fasting
Outcome measures
| Measure |
Once Daily Text Message
n=26 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=23 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=24 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=25 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=24 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=25 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=25 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=24 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in High-density Lipoprotein (HDL)
|
0.0008 mg/dL
Interval -1.0 to 1.0
|
0.002 mg/dL
Interval -3.2 to 3.2
|
0.002 mg/dL
Interval -2.1 to 2.1
|
0.001 mg/dL
Interval -1.6 to 1.6
|
0.0005 mg/dL
Interval -0.5 to 0.5
|
0.004 mg/dL
Interval -3.9 to 3.9
|
0.002 mg/dL
Interval -1.7 to 1.7
|
0.001 mg/dL
Interval -1.2 to 1.2
|
SECONDARY outcome
Timeframe: From baseline to follow-up in-person study visits, separated by 3 monthsPopulation: Participants were censored if they started weight- or glucose-altering medications, including glucagon-like peptide-1 receptor agonists, metformin, or insulin (n=4). Due to sample processing errors, n=2 additional results were missing.
U/L
Outcome measures
| Measure |
Once Daily Text Message
n=25 Participants
All participants assigned to once (versus twice) daily text messages, including 1FLD, 1FLW, 1RLD, 1RLW, 1FGD, 1FGW, 1RGD, 1RGW.
|
Twice Daily Text Message
n=24 Participants
All participants assigned to twice (versus once) daily text messages, including 2FLD, 2FLW, 2RLD, 2RLW, 2FGD, 2FGW, 2RGD, 2RGW.
|
Fixed Step Count Goal
n=24 Participants
All participants assigned to fixed (versus ramped) step count goal, including 1FLD, 1FLW, 1FGD, 1FGW, 2FLD, 2FLW, 2FGD, 2FGW,
|
Ramped Step Count Goal
n=25 Participants
All participants assigned to ramped (versus fixed) step count goal, including 1RLD, 1RLW, 1RGD, 1RGW, 2RLD, 2RLW, 2RGD, 2RGW,
|
Loss Framed Incentive
n=24 Participants
All participants assigned to loss (versus gain) framed incentive, including 1FLD, 1FLW, 1RLD, 1RLW, 2FLD, 2FLW, 2RLD, 2RLW
|
Gain Framed Incentive
n=25 Participants
All participants assigned to gain (versus loss) framed incentive, including 1FGD, 1FGW, 1RGD, 1RGW, 2FGD, 2FGW, 2RGD, 2RGW
|
Daily Step Count Goal
n=24 Participants
All participants assigned to daily (versus weekly) step count goal, including 1FLD, 1FGD, 1RLD, 1RGD, 2FLD, 2FGD, 2RLD, 2RGD
|
Weekly Step Count Goal
n=25 Participants
All participants assigned to weekly (versus daily) step count goal, including 1FLW, 1FGW, 1RLW, 1RGW, 2FLW, 2FGW, 2RLW, 2RGW
|
|---|---|---|---|---|---|---|---|---|
|
Change in ALT
|
0.000000004 U/L
Interval -0.000008 to 0.000008
|
0.00000002 U/L
Interval -0.00003 to 0.00003
|
0.00002 U/L
Interval -0.03 to 0.03
|
0 U/L
Interval 0.0 to 0.0
|
0 U/L
Interval 0.0 to 0.0
|
0.00002 U/L
Interval -0.03 to 0.03
|
0.000003 U/L
Interval -0.004 to 0.004
|
0 U/L
Interval 0.0 to 0.0
|
Adverse Events
1FLD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1FLW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1RLD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1RLW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1FGD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1FGW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1RGD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1RGW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2FLD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2FLW
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2RLD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2RLW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2FGD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2FGW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2RGD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2RGW
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1FLD
n=5 participants at risk
One text per day, fixed goal, loss incentive, daily weekly goal time period.
|
1FLW
n=4 participants at risk
One text per day, fixed goal, loss incentive, weekly goal time period.
|
1RLD
n=4 participants at risk
One text per day, ramped goal, loss incentive, daily goal time period
|
1RLW
n=5 participants at risk
One text per day, ramped goal, loss incentive, weekly goal time period.
|
1FGD
n=4 participants at risk
One text per day, fixed goal, gain incentive, daily goal time period.
|
1FGW
n=3 participants at risk
One text per day, fixed goal, gain incentive, weekly goal time period.
|
1RGD
n=3 participants at risk
One text per day, ramped goal, gain incentive, daily goal time period.
|
1RGW
n=4 participants at risk
One text per day, ramped goal, gain incentive, weekly goal time period.
|
2FLD
n=4 participants at risk
Two texts per day, fixed goal, loss incentive, daily goal time period.
|
2FLW
n=5 participants at risk
Two texts per day, fixed goal, loss incentive, weekly goal time period.
|
2RLD
n=5 participants at risk
Two texts per day, ramped goal, loss incentive, daily goal time period.
|
2RLW
n=4 participants at risk
Two texts per day, ramped goal, loss incentive, weekly goal time period.
|
2FGD
n=4 participants at risk
Two texts per day, fixed goal, gain incentive, daily goal time period.
|
2FGW
n=4 participants at risk
Two texts per day, fixed goal, gain incentive, weekly goal time period.
|
2RGD
n=5 participants at risk
Two texts per day, ramped goal, gain incentive, daily goal time period.
|
2RGW
n=4 participants at risk
Two texts per day, ramped goal, gain incentive, weekly goal time period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
20.0%
1/5 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Blood and lymphatic system disorders
Hypobetalipoproteinemia
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
20.0%
1/5 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Musculoskeletal and connective tissue disorders
stress fracture
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Skin and subcutaneous tissue disorders
Skin irritation or rash on wrist
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
20.0%
1/5 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
66.7%
2/3 • Number of events 2 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
50.0%
2/4 • Number of events 2 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Skin and subcutaneous tissue disorders
Skin irritation or rash, unspecified
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
|
Infections and infestations
Infection
|
20.0%
1/5 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/3 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
33.3%
1/3 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
25.0%
1/4 • Number of events 1 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/5 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
0.00%
0/4 • from enrollment until end of follow-up, up to 3 months
Adverse events were assessed at study visits using questionnaires.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place