Trial Outcomes & Findings for Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans (NCT NCT02360293)
NCT ID: NCT02360293
Last Updated: 2020-01-06
Results Overview
Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
465 participants
Primary outcome timeframe
Change from Baseline in objectively monitored physical activity at one year after randomization
Results posted on
2020-01-06
Participant Flow
Letters were mailed to potential participants. They used the information in the recruitment letter to accessed an online portal and respond to screening question. If eligible, they completed the consent documentation, baseline questionnaire, downloaded and registered the Stay Strong App. Recruitment period was from 10/1/2017 - 4/30/2018.
After consent and prior to randomization participants were to completed baseline survey, register app, and complete a baseline physical activity (PA) period for randomization. 56 participants were excluded due to failure to complete baseline survey or register app. 52 participants were excluded due to failure to provide baseline PA.
Participant milestones
| Measure |
Stay Strong w/Coaching
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
179
|
|
Overall Study
6month f/u Survey
|
110
|
105
|
|
Overall Study
6month Physical Activity
|
122
|
108
|
|
Overall Study
12month f/u Survey
|
102
|
83
|
|
Overall Study
12month Physical Activity
|
68
|
59
|
|
Overall Study
COMPLETED
|
102
|
83
|
|
Overall Study
NOT COMPLETED
|
76
|
96
|
Reasons for withdrawal
| Measure |
Stay Strong w/Coaching
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
73
|
95
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Excluded
|
1
|
0
|
Baseline Characteristics
Stay Strong: A Physical Activity Program for Afghanistan and Iraq Veterans
Baseline characteristics by cohort
| Measure |
Stay Strong w/Coaching
n=178 Participants
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=179 Participants
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
40.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
20 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
117 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
178 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
357 Participants
n=5 Participants
|
|
Fitbit-Captured Active Minutes/Week, Median
|
165 Active minutes/week
n=5 Participants
|
190 Active minutes/week
n=7 Participants
|
178 Active minutes/week
n=5 Participants
|
|
Fitbit-captured steps/day, mean
|
7571 Steps/day
STANDARD_DEVIATION 3464 • n=5 Participants
|
8163 Steps/day
STANDARD_DEVIATION 3978 • n=7 Participants
|
7867 Steps/day
STANDARD_DEVIATION 3737 • n=5 Participants
|
|
Depression scale (PHQ-8), Median
|
7 units on a scale
n=5 Participants
|
6 units on a scale
n=7 Participants
|
6.5 units on a scale
n=5 Participants
|
|
Pain Intensity >=4
|
80 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
PHQ-8 - Clinically Significant Depression
|
61 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline in objectively monitored physical activity at one year after randomizationPopulation: Population decreases with time, at 12-month follow-up: SS+coaching 68; SS 58.
Physical activity is measured as Active Minutes by a wearable Fitbit Charge 2 device; daily activity is averaged over a one week period for which at least 5 days of valid data are available.
Outcome measures
| Measure |
Stay Strong w/Coaching
n=178 Participants
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=177 Participants
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device
|
-67.1 Active minutes/week
Interval -141.5 to 7.35
|
-69.0 Active minutes/week
Interval -148.1 to 10.18
|
SECONDARY outcome
Timeframe: Change from Baseline in weight at one year after randomizationPopulation: Due to missing data from study provided scale, EHR weight was pulled for all patients, however, roughly half of the population lacked EHR weights within the time-frame of the study.
Weights were extracted from VHA's Corporate Data Warehouse, vital signs package due to the high number of missing weights from the study provided blue tooth scale.
Outcome measures
| Measure |
Stay Strong w/Coaching
n=32 Participants
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=33 Participants
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Change in Weight as Measured From VA Medical Record
|
-0.121 weight by pounds
Interval -7.25 to 7.01
|
4.902 weight by pounds
Interval -1.65 to 11.45
|
SECONDARY outcome
Timeframe: Change from Baseline Depression score at one year after randomizationPopulation: Population decreases with time, at 12-month follow-up: SS+coaching 96; SS 81.
The Personal Health Questionnaire Depression Scale (PHQ) will be administered via online survey. Personal Health Questionnaire (8 item version),Reporting Scores on a Scale Lower Scores Indicate a Better Outcome, Range: 0-24
Outcome measures
| Measure |
Stay Strong w/Coaching
n=170 Participants
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=168 Participants
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Change in Depression Score as Assessed by the Personal Health Questionnaire Depression Scale (PHQ-8)
|
-0.410 score on a scale
Interval -1.51 to 0.69
|
0.752 score on a scale
Interval -0.442 to 1.946
|
SECONDARY outcome
Timeframe: Change from Baseline in Pain measures at one year after randomizationPopulation: Population decreases with time, at 12-month follow-up: SS+coaching 101; SS 84.
Pain intensity will be elicited via online survey. Neuropathic Pain in Past Week Reporting Scores on a Scale, Lower Scores Indicate a Better Outcome, Range: 0-10
Outcome measures
| Measure |
Stay Strong w/Coaching
n=178 Participants
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=179 Participants
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Change in Pain Measures as Assessed by the VA Pain Intensity
|
0.212 units on a scale
Interval -0.215 to 0.639
|
0.557 units on a scale
Interval 0.097 to 1.018
|
Adverse Events
Stay Strong w/Coaching
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Stay Strong
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stay Strong w/Coaching
n=178 participants at risk
Participants in the Stay Strong w/coaching (Experimental) arm are provided a wearable device, scale, telephone coaching, tailored push notifications, personalized goals, and enhanced online/app support.
Stay Strong w/coaching: Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
|
Stay Strong
n=179 participants at risk
Participants in the Stay Strong (active comparison) arm will only be provided a wearable device with standard online/app support.
Stay Strong: Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Important Medical Event
|
0.56%
1/178 • Number of events 1 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
0.56%
1/179 • Number of events 1 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Important Medical Event
|
0.56%
1/178 • Number of events 1 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
0.00%
0/179 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
|
Investigations
Protocol Deviation
|
0.56%
1/178 • Number of events 1 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
0.00%
0/179 • Through study completion, an average of 1 year.
Adverse event information was collected from participants if they reported events at quarterly status update. Adverse event information was also collected from patients through contact with coach interventionist or if patient reported during 6 or 12 month reminder calls for outcome survey. Adverse events were monitored/assessed without regard to the specific adverse event terms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place