Trial Outcomes & Findings for Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors (NCT NCT03131440)
NCT ID: NCT03131440
Last Updated: 2023-03-10
Results Overview
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
280 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-03-10
Participant Flow
A total of 280 women signed informed consent and enrolled in the study. However, in order to be randomized, participants must complete all baseline assessments. This includes wearing the accelerometer for a minimum of 5 valid days and completing all online questionnaires. A total of 269 women met the criteria for randomization.
Participant milestones
| Measure |
Experimental Condition #1
core, support calls
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
|
Experimental Condition #2
core, support calls, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #3
core, support calls, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #4
core, support calls, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #5
core, support calls, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #6
core, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #7
core, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #8
core, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #9
core, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #10
core, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #11
core, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #12
core, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #13
core, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #14
core, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #15
core, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #16
core, support calls, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #17
core, support calls, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #18
core, support calls, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #19
core, support calls, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #20
core, support calls, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #21
core, support calls, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #22
core, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #23
core, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #24
core, support calls, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #25
core, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #26
core, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #27
core, support calls, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #28
core, support calls, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #29
core, support calls, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #30
core
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
|
Experimental Condition #31
core, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #32
core, support calls, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
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8
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9
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8
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Overall Study
COMPLETED
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7
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6
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8
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8
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8
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9
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7
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7
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9
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7
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7
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8
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Overall Study
NOT COMPLETED
|
1
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3
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0
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0
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1
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1
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0
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1
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1
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1
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0
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1
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1
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0
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1
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0
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0
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0
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1
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2
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2
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1
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2
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0
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1
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1
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0
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2
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0
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2
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1
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0
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Reasons for withdrawal
| Measure |
Experimental Condition #1
core, support calls
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
|
Experimental Condition #2
core, support calls, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #3
core, support calls, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #4
core, support calls, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #5
core, support calls, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #6
core, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #7
core, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #8
core, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #9
core, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #10
core, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #11
core, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #12
core, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #13
core, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #14
core, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #15
core, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #16
core, support calls, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #17
core, support calls, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #18
core, support calls, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #19
core, support calls, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #20
core, support calls, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #21
core, support calls, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #22
core, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #23
core, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #24
core, support calls, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #25
core, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #26
core, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #27
core, support calls, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #28
core, support calls, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #29
core, support calls, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #30
core
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
|
Experimental Condition #31
core, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #32
core, support calls, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
Withdrawal by Subject
|
1
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3
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0
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0
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1
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0
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0
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1
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1
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1
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0
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1
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1
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0
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1
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0
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0
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0
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1
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0
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1
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1
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1
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0
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0
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0
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0
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0
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0
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0
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1
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0
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Overall Study
Lost to Follow-up
|
0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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2
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1
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0
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1
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0
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1
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0
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0
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2
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0
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2
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0
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0
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Overall Study
Death
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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0
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0
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Baseline Characteristics
Optimization of Remotely Delivered Physical Activity Intervention for Breast Cancer Survivors
Baseline characteristics by cohort
| Measure |
Experimental Condition #1
n=8 Participants
core, support calls
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
|
Experimental Condition #2
n=9 Participants
core, support calls, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #3
n=8 Participants
core, support calls, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #4
n=8 Participants
core, support calls, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #5
n=9 Participants
core, support calls, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #6
n=9 Participants
core, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #7
n=9 Participants
core, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #8
n=9 Participants
core, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #9
n=9 Participants
core, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #10
n=8 Participants
core, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #11
n=8 Participants
core, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #12
n=8 Participants
core, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #13
n=8 Participants
core, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #14
n=8 Participants
core, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #15
n=8 Participants
core, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #16
n=8 Participants
core, support calls, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #17
n=8 Participants
core, support calls, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #18
n=8 Participants
core, support calls, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #19
n=8 Participants
core, support calls, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #20
n=9 Participants
core, support calls, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #21
n=8 Participants
core, support calls, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #22
n=8 Participants
core, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #23
n=9 Participants
core, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #24
n=8 Participants
core, support calls, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #25
n=9 Participants
core, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #26
n=8 Participants
core, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #27
n=9 Participants
core, support calls, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #28
n=9 Participants
core, support calls, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #29
n=8 Participants
core, support calls, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #30
n=9 Participants
core
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
|
Experimental Condition #31
n=9 Participants
core, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #32
n=8 Participants
core, support calls, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 10 • n=5 Participants
|
48.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
52.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
58 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
54.6 years
STANDARD_DEVIATION 9.4 • n=21 Participants
|
49 years
STANDARD_DEVIATION 7.9 • n=8 Participants
|
53.1 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
49.1 years
STANDARD_DEVIATION 7.3 • n=24 Participants
|
50.8 years
STANDARD_DEVIATION 5.8 • n=42 Participants
|
57.3 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
55.6 years
STANDARD_DEVIATION 12.7 • n=42 Participants
|
52.1 years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
48.9 years
STANDARD_DEVIATION 9.1 • n=36 Participants
|
51.3 years
STANDARD_DEVIATION 9.0 • n=36 Participants
|
53.6 years
STANDARD_DEVIATION 10.4 • n=24 Participants
|
53.6 years
STANDARD_DEVIATION 9.1 • n=135 Participants
|
60.4 years
STANDARD_DEVIATION 9.7 • n=136 Participants
|
54.5 years
STANDARD_DEVIATION 13.4 • n=44 Participants
|
55.7 years
STANDARD_DEVIATION 11.3 • n=667 Participants
|
55.1 years
STANDARD_DEVIATION 7.1 • n=12 Participants
|
54.5 years
STANDARD_DEVIATION 8.1 • n=12 Participants
|
49.5 years
STANDARD_DEVIATION 7.2 • n=12 Participants
|
46.9 years
STANDARD_DEVIATION 13.2 • n=12 Participants
|
60.3 years
STANDARD_DEVIATION 9.4 • n=11 Participants
|
50.2 years
STANDARD_DEVIATION 11.3 • n=6 Participants
|
53.1 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
53.8 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
49.4 years
STANDARD_DEVIATION 8.6 • n=408 Participants
|
53.1 years
STANDARD_DEVIATION 13.5 • n=206 Participants
|
52.9 years
STANDARD_DEVIATION 11 • n=16 Participants
|
50.8 years
STANDARD_DEVIATION 5.5 • n=252 Participants
|
42.4 years
STANDARD_DEVIATION 9.1 • n=8 Participants
|
52.9 years
STANDARD_DEVIATION 11.0 • n=269 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=408 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=16 Participants
|
9 Participants
n=252 Participants
|
8 Participants
n=8 Participants
|
269 Participants
n=269 Participants
|
|
Sex: Female, Male
Male
|
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
|
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
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
2 Participants
n=8 Participants
|
19 Participants
n=269 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
7 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=408 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=16 Participants
|
9 Participants
n=252 Participants
|
6 Participants
n=8 Participants
|
244 Participants
n=269 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=269 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=269 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 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
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=269 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
|
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
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=269 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 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
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=252 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=269 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
9 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
9 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=408 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=16 Participants
|
8 Participants
n=252 Participants
|
7 Participants
n=8 Participants
|
234 Participants
n=269 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 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
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=269 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=252 Participants
|
0 Participants
n=8 Participants
|
6 Participants
n=269 Participants
|
|
Number of Participants Randomized
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
8 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
8 Participants
n=11 Participants
|
9 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=408 Participants
|
8 Participants
n=206 Participants
|
9 Participants
n=16 Participants
|
9 Participants
n=252 Participants
|
8 Participants
n=8 Participants
|
269 Participants
n=269 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All participants randomized.
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
Participants receive motivational app notifications
|
Online Gym
Participants receive access to online exercise videos.
|
App+
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Adherence to a 12 Week Technology Supported Physical Activity Intervention
|
93.0 Percentage of Days Fitbit Worn
Standard Deviation 12.7
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPercentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\].
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
Participants receive motivational app notifications
|
Online Gym
Participants receive access to online exercise videos.
|
App+
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Participant Retention
|
93.3 Percentage of participants retained
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: BaselinePercentage of individuals randomized of those who were sent a study screening survey
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
Participants receive motivational app notifications
|
Online Gym
Participants receive access to online exercise videos.
|
App+
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Intervention Reach
|
50.8 Percentage of participants randomized
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Outcome measures
| Measure |
All Reporting Groups
n=268 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=268 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=268 Participants
Participants receive motivational app notifications
|
Online Gym
n=268 Participants
Participants receive access to online exercise videos.
|
App+
n=268 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=268 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
"On" Group Change
|
57.9 Minutes per week
Standard Error 9.4
|
55.5 Minutes per week
Standard Error 9.2
|
59.8 Minutes per week
Standard Error 9.6
|
49.3 Minutes per week
Standard Error 9.0
|
44.3 Minutes per week
Standard Error 8.6
|
53.6 Minutes per week
Standard Error 6.6
|
|
Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention
"Off" Group Change
|
49.3 Minutes per week
Standard Error 9.0
|
51.7 Minutes per week
Standard Error 9.2
|
47.6 Minutes per week
Standard Error 8.9
|
58.1 Minutes per week
Standard Error 35.0
|
63.5 Minutes per week
Standard Error 9.9
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020).
Outcome measures
| Measure |
All Reporting Groups
n=268 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=268 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=268 Participants
Participants receive motivational app notifications
|
Online Gym
n=268 Participants
Participants receive access to online exercise videos.
|
App+
n=268 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=268 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
"On" Group Change
|
28.5 Minutes per week
Standard Error 8.0
|
25.9 Minutes per week
Standard Error 7.9
|
25.3 Minutes per week
Standard Error 7.9
|
15.1 Minutes per week
Standard Error 7.3
|
15.8 Minutes per week
Standard Error 7.4
|
24.6 Minutes per week
Standard Error 5.7
|
|
Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up
"Off" Group Change
|
49.3 Minutes per week
Standard Error 9.0
|
23.4 Minutes per week
Standard Error 7.8
|
24.0 Minutes per week
Standard Error 7.8
|
58.1 Minutes per week
Standard Error 35.0
|
34.2 Minutes per week
Standard Error 8.4
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Fatigue From Before to After a 12-Week Intervention
"On" Group Change
|
-3.1 t-score on a scale
Standard Error 0.7
|
-3.3 t-score on a scale
Standard Error 0.7
|
-2.8 t-score on a scale
Standard Error 0.7
|
-2.2 t-score on a scale
Standard Error 0.7
|
-2.0 t-score on a scale
Standard Error 0.7
|
-2.7 t-score on a scale
Standard Error 0.5
|
|
Change in Fatigue From Before to After a 12-Week Intervention
"Off" Group Change
|
-2.3 t-score on a scale
Standard Error 0.7
|
-2.1 t-score on a scale
Standard Error 0.7
|
-2.6 t-score on a scale
Standard Error 0.7
|
-3.2 t-score on a scale
Standard Error 0.7
|
-3.3 t-score on a scale
Standard Error 0.7
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
"On" Group Change
|
-3.5 t-score on a scale
Standard Error 0.7
|
-4.0 t-score on a scale
Standard Error 0.7
|
-3.6 t-score on a scale
Standard Error 0.7
|
-3.3 t-score on a scale
Standard Error 0.7
|
-3.0 t-score on a scale
Standard Error 0.7
|
-3.6 t-score on a scale
Standard Error 0.5
|
|
Change in Fatigue From Pre-Intervention to 24-Week Follow-up
"Off" Group Change
|
-3.7 t-score on a scale
Standard Error 0.7
|
-3.2 t-score on a scale
Standard Error 0.7
|
-3.6 t-score on a scale
Standard Error 0.7
|
-3.9 t-score on a scale
Standard Error 0.7
|
-4.2 t-score on a scale
Standard Error 0.7
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Physical Function From Before to After a 12-Week Intervention
"On" Group Change
|
2.4 t-score on a scale
Standard Error 0.4
|
2.3 t-score on a scale
Standard Error 0.4
|
2.2 t-score on a scale
Standard Error 0.4
|
1.4 t-score on a scale
Standard Error 0.4
|
2.5 t-score on a scale
Standard Error 0.4
|
2.0 t-score on a scale
Standard Error 0.3
|
|
Change in Physical Function From Before to After a 12-Week Intervention
"Off" Group Change
|
1.6 t-score on a scale
Standard Error 0.4
|
1.7 t-score on a scale
Standard Error 0.4
|
1.8 t-score on a scale
Standard Error 0.4
|
2.6 t-score on a scale
Standard Error 0.4
|
1.5 t-score on a scale
Standard Error 0.4
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
"On" Group Change
|
2.2 t-score on a scale
Standard Error 0.5
|
2.4 t-score on a scale
Standard Error 0.5
|
2.4 t-score on a scale
Standard Error 0.5
|
2.0 t-score on a scale
Standard Error 0.5
|
2.7 t-score on a scale
Standard Error 0.5
|
2.2 t-score on a scale
Standard Error 0.3
|
|
Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up
"Off" Group Change
|
2.0 t-score on a scale
Standard Error 0.5
|
2.0 t-score on a scale
Standard Error 0.5
|
1.9 t-score on a scale
Standard Error 0.4
|
2.4 t-score on a scale
Standard Error 0.5
|
1.7 t-score on a scale
Standard Error 0.5
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Depression From Before to After a 12-Week Intervention
"On" Group Change
|
-2.2 t-score on a scale
Standard Error 0.6
|
-2.2 t-score on a scale
Standard Error 0.6
|
-2.6 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.6
|
-2.1 t-score on a scale
Standard Error 0.6
|
-2.2 t-score on a scale
Standard Error 0.4
|
|
Change in Depression From Before to After a 12-Week Intervention
"Off" Group Change
|
-2.1 t-score on a scale
Standard Error 0.6
|
-2.1 t-score on a scale
Standard Error 0.6
|
-1.7 t-score on a scale
Standard Error 0.6
|
-2.5 t-score on a scale
Standard Error 0.6
|
-2.2 t-score on a scale
Standard Error 0.6
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=269 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=269 Participants
Participants receive motivational app notifications
|
Online Gym
n=269 Participants
Participants receive access to online exercise videos.
|
App+
n=269 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=269 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Depression From Pre-Intervention to 24-week Follow-up
"On" Group Change
|
-1.7 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.6
|
-1.6 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.7
|
-1.8 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.4
|
|
Change in Depression From Pre-Intervention to 24-week Follow-up
"Off" Group Change
|
-1.9 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.6
|
-1.9 t-score on a scale
Standard Error 0.6
|
-1.9 t-score on a scale
Standard Error 0.6
|
-1.8 t-score on a scale
Standard Error 0.6
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized participants.
Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24.
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
Participants receive motivational app notifications
|
Online Gym
Participants receive access to online exercise videos.
|
App+
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Adherence to During the Full 24-Week Study Period
|
80.0 Percentage of days the Fitbit was worn
Standard Deviation 25.8
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All participants randomized
Percentage of participants retained at 24 weeks of those randomized
Outcome measures
| Measure |
All Reporting Groups
n=269 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
Participants receive motivational app notifications
|
Online Gym
Participants receive access to online exercise videos.
|
App+
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Participant Retention at 24 Week Follow-up
|
90 Percentage of participants retained
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
"On" Group Change
|
-0.07 pg/mL
Standard Error 0.10
|
-0.06 pg/mL
Standard Error 0.09
|
-0.05 pg/mL
Standard Error 0.09
|
-0.08 pg/mL
Standard Error 0.10
|
0.01 pg/mL
Standard Error 0.09
|
-0.02 pg/mL
Standard Error 0.06
|
|
Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)
"Off" Group Change
|
0.02 pg/mL
Standard Error 0.08
|
0.02 pg/mL
Standard Error 0.09
|
0.01 pg/mL
Standard Error 0.09
|
0.05 pg/mL
Standard Error 0.07
|
-0.06 pg/mL
Standard Error 0.09
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6.In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
0.14 pg/mL
Standard Error 0.10
|
0.13 pg/mL
Standard Error 0.10
|
0.09 pg/mL
Standard Error 0.10
|
0.06 pg/mL
Standard Error 0.11
|
0.17 pg/mL
Standard Error 0.10
|
0.14 pg/mL
Standard Error 0.07
|
|
Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
0.14 pg/mL
Standard Error 0.09
|
0.15 pg/mL
Standard Error 0.09
|
0.18 pg/mL
Standard Error 0.09
|
0.22 pg/mL
Standard Error 0.08
|
0.10 pg/mL
Standard Error 0.09
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
"On" Group Change
|
0.03 pg/mL
Standard Error 0.03
|
-0.01 pg/mL
Standard Error 0.03
|
-0.01 pg/mL
Standard Error 0.03
|
-0.02 pg/mL
Standard Error 0.04
|
0.03 pg/mL
Standard Error 0.03
|
0 pg/mL
Standard Error 0.02
|
|
Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)
"Off" Group Change
|
0.12 pg/mL
Standard Error 0.05
|
0.01 pg/mL
Standard Error 0.03
|
0 pg/mL
Standard Error 0.03
|
0.02 pg/mL
Standard Error 0.03
|
-0.03 pg/mL
Standard Error 0.03
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
0.11 pg/mL
Standard Error 0.04
|
0.04 pg/mL
Standard Error 0.03
|
0.06 pg/mL
Standard Error 0.04
|
0.06 pg/mL
Standard Error 0.04
|
0.08 pg/mL
Standard Error 0.04
|
0.05 pg/mL
Standard Error 0.02
|
|
Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
-0.01 pg/mL
Standard Error 0.03
|
0.07 pg/mL
Standard Error 0.03
|
0.05 pg/mL
Standard Error 0.04
|
0.04 pg/mL
Standard Error 0.03
|
0.02 pg/mL
Standard Error 0.03
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
"On" Group Change
|
0.22 pg/mL
Standard Error 0.17
|
-0.27 pg/mL
Standard Error 0.15
|
-0.11 pg/mL
Standard Error 0.16
|
-0.27 pg/mL
Standard Error 0.17
|
-0.17 pg/mL
Standard Error 0.17
|
-0.13 pg/mL
Standard Error 0.11
|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)
"Off" Group Change
|
-0.05 pg/mL
Standard Error 0.14
|
0.01 pg/mL
Standard Error 0.15
|
-0.15 pg/mL
Standard Error 0.15
|
0.01 pg/mL
Standard Error 0.13
|
-0.10 pg/mL
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better.
Outcome measures
| Measure |
All Reporting Groups
n=121 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=121 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=121 Participants
Participants receive motivational app notifications
|
Online Gym
n=121 Participants
Participants receive access to online exercise videos.
|
App+
n=121 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=121 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
0.22 pg/mL
Standard Error 0.17
|
0.14 pg/mL
Standard Error 0.16
|
0.07 pg/mL
Standard Error 0.17
|
-0.03 pg/mL
Standard Error 0.18
|
0.24 pg/mL
Standard Error 0.17
|
0.09 pg/mL
Standard Error 0.11
|
|
Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
-0.05 pg/mL
Standard Error 0.14
|
0.03 pg/mL
Standard Error 0.15
|
0.11 pg/mL
Standard Error 0.15
|
0.20 pg/mL
Standard Error 0.13
|
-0.07 pg/mL
Standard Error 0.14
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better.
Outcome measures
| Measure |
All Reporting Groups
n=199 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=199 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=199 Participants
Participants receive motivational app notifications
|
Online Gym
n=199 Participants
Participants receive access to online exercise videos.
|
App+
n=199 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=199 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
"On" Group Change
|
-0.04 mg/L
Standard Error 0.19
|
-0.14 mg/L
Standard Error 0.18
|
0.14 mg/L
Standard Error 0.18
|
0.22 mg/L
Standard Error 0.19
|
-0.02 mg/L
Standard Error 0.19
|
0.07 mg/L
Standard Error 0.13
|
|
Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)
"Off" Group Change
|
0.18 mg/L
Standard Error 0.18
|
0.28 mg/L
Standard Error 0.19
|
0 mg/L
Standard Error 0.19
|
-0.08 mg/L
Standard Error 0.18
|
0.16 mg/L
Standard Error 0.18
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better.
Outcome measures
| Measure |
All Reporting Groups
n=199 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=199 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=199 Participants
Participants receive motivational app notifications
|
Online Gym
n=199 Participants
Participants receive access to online exercise videos.
|
App+
n=199 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=199 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
0.05 mg/L
Standard Error 0.20
|
-0.09 mg/L
Standard Error 0.18
|
-0.06 mg/L
Standard Error 0.18
|
0.01 mg/L
Standard Error 0.26
|
-0.07 mg/L
Standard Error 0.19
|
-0.09 mg/L
Standard Error 0.13
|
|
Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
-0.22 mg/L
Standard Error 0.18
|
-0.09 mg/L
Standard Error 0.19
|
-0.12 mg/L
Standard Error 0.19
|
-0.21 mg/L
Standard Error 0.18
|
-0.10 mg/L
Standard Error 0.18
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Outcome measures
| Measure |
All Reporting Groups
n=146 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=146 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=146 Participants
Participants receive motivational app notifications
|
Online Gym
n=146 Participants
Participants receive access to online exercise videos.
|
App+
n=146 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=146 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
"On" Group Change
|
-17.35 mg/dL
Standard Error 23.23
|
6.63 mg/dL
Standard Error 20.99
|
-14.96 mg/dL
Standard Error 22.55
|
28.08 mg/dL
Standard Error 22.52
|
9.01 mg/dL
Standard Error 21.33
|
4.40 mg/dL
Standard Error 15.28
|
|
Change in Triglycerides From Before to After a 12 Week Intervention (Optional)
"Off" Group Change
|
25.43 mg/dL
Standard Error 19.72
|
1.45 mg/dL
Standard Error 21.97
|
23.04 mg/dL
Standard Error 20.63
|
-20.00 mg/dL
Standard Error 20.42
|
-0.93 mg/dL
Standard Error 21.46
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better.
Outcome measures
| Measure |
All Reporting Groups
n=146 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=146 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=146 Participants
Participants receive motivational app notifications
|
Online Gym
n=146 Participants
Participants receive access to online exercise videos.
|
App+
n=146 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=146 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
-10.81 mg/dL
Standard Error 23.82
|
5.15 mg/dL
Standard Error 21.59
|
3.60 mg/dL
Standard Error 24.16
|
17.12 mg/dL
Standard Error 23.82
|
20.99 mg/dL
Standard Error 22.32
|
16.10 mg/dL
Standard Error 15.80
|
|
Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
43.01 mg/dL
Standard Error 20.76
|
27.05 mg/dL
Standard Error 22.82
|
28.60 mg/dL
Standard Error 20.68
|
15.09 mg/dL
Standard Error 20.69
|
11.21 mg/dL
Standard Error 22.00
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Outcome measures
| Measure |
All Reporting Groups
n=162 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=162 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=162 Participants
Participants receive motivational app notifications
|
Online Gym
n=162 Participants
Participants receive access to online exercise videos.
|
App+
n=162 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=162 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
"On" Group Change
|
1.16 mg/dL
Standard Error 3.2
|
3.90 mg/dL
Standard Error 2.99
|
2.68 mg/dL
Standard Error 3.07
|
3.83 mg/dL
Standard Error 3.20
|
3.29 mg/dL
Standard Error 3.16
|
2.62 mg/dL
Standard Error 2.11
|
|
Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)
"Off" Group Change
|
4.06 mg/dL
Standard Error 2.76
|
1.34 mg/dL
Standard Error 3.05
|
2.56 mg/dL
Standard Error 2.93
|
1.40 mg/dL
Standard Error 2.79
|
1.94 mg/dL
Standard Error 2.84
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Outcome measures
| Measure |
All Reporting Groups
n=162 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=162 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=162 Participants
Participants receive motivational app notifications
|
Online Gym
n=162 Participants
Participants receive access to online exercise videos.
|
App+
n=162 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=162 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
"On" Group Change
|
-3.13 mg/dL
Standard Error 3.45
|
-3.03 mg/dL
Standard Error 3.19
|
-1.33 mg/dL
Standard Error 3.43
|
-1.20 mg/dL
Standard Error 3.53
|
0.38 mg/dL
Standard Error 3.38
|
-1.55 mg/dL
Standard Error 2.31
|
|
Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)
"Off" Group Change
|
0.04 mg/dL
Standard Error 3.03
|
-0.06 mg/dL
Standard Error 3.30
|
-1.76 mg/dL
Standard Error 3.06
|
-1.89 mg/dL
Standard Error 2.96
|
-3.47 mg/dL
Standard Error 3.11
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 12 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Outcome measures
| Measure |
All Reporting Groups
n=177 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=177 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=177 Participants
Participants receive motivational app notifications
|
Online Gym
n=177 Participants
Participants receive access to online exercise videos.
|
App+
n=177 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=177 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
"On" Group Change
|
0.37 mg/dL
Standard Error 4.20
|
3.43 mg/dL
Standard Error 3.87
|
5.19 mg/dL
Standard Error 3.98
|
1.18 mg/dL
Standard Error 4.11
|
3.91 mg/dL
Standard Error 4.05
|
0.31 mg/dL
Standard Error 2.78
|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)
"Off" Group Change
|
-1.00 mg/dL
Standard Error 3.67
|
-4.05 mg/dL
Standard Error 4.00
|
-5.82 mg/dL
Standard Error 3.87
|
0.55 mg/dL
Standard Error 3.74
|
-4.53 mg/dL
Standard Error 3.83
|
—
|
SECONDARY outcome
Timeframe: Change from baseline to 24 weeksPopulation: This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group.
High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol.
Outcome measures
| Measure |
All Reporting Groups
n=177 Participants
All participants randomized regardless of individual randomly assigned combination of On- or Off levels of all intervention factors.
|
Buddy
n=177 Participants
Participants choose a buddy to receive a Fitbit and support them during the intervention
|
App Notifications
n=177 Participants
Participants receive motivational app notifications
|
Online Gym
n=177 Participants
Participants receive access to online exercise videos.
|
App+
n=177 Participants
Participants receive "deluxe" version of smartphone app with additional features.
|
Core Intervention
n=177 Participants
Participants receive educational materials, access to a basic smartphone app and a Fitbit.
|
|---|---|---|---|---|---|---|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
"On" Group Change
|
2.72 mg/dL
Standard Error 4.25
|
0.59 mg/dL
Standard Error 3.91
|
2.01 mg/dL
Standard Error 4.27
|
0.51 mg/dL
Standard Error 4.37
|
4.50 mg/dL
Standard Error 4.28
|
0.57 mg/dL
Standard Error 2.91
|
|
Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)
"Off" Group Change
|
-1.58 mg/dL
Standard Error 3.94
|
0.55 mg/dL
Standard Error 4.29
|
-0.86 mg/dL
Standard Error 3.93
|
0.64 mg/dL
Standard Error 3.83
|
-3.36 mg/dL
Standard Error 3.92
|
—
|
Adverse Events
Experimental Condition #1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental Condition #3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Experimental Condition #7
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #9
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental Condition #10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #11
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #12
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #13
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #14
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #15
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #16
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #17
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #18
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #19
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #20
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental Condition #21
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #22
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #23
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #24
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental Condition #25
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #26
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Experimental Condition #27
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #28
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental Condition #29
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #30
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Condition #31
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Experimental Condition #32
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 |
Experimental Condition #1
n=8 participants at risk
core, support calls
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
|
Experimental Condition #2
n=9 participants at risk
core, support calls, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #3
n=8 participants at risk
core, support calls, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #4
n=8 participants at risk
core, support calls, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #5
n=9 participants at risk
core, support calls, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #6
n=9 participants at risk
core, app+
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
|
Experimental Condition #7
n=9 participants at risk
core, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #8
n=9 participants at risk
core, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #9
n=9 participants at risk
core, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #10
n=8 participants at risk
core, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #11
n=8 participants at risk
core, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #12
n=8 participants at risk
core, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #13
n=8 participants at risk
core, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #14
n=8 participants at risk
core, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #15
n=8 participants at risk
core, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #16
n=8 participants at risk
core, support calls, app+, buddy
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #17
n=8 participants at risk
core, support calls, app+, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
|
Experimental Condition #18
n=8 participants at risk
core, support calls, app+, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #19
n=8 participants at risk
core, support calls, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #20
n=9 participants at risk
core, support calls, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #21
n=8 participants at risk
core, support calls, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #22
n=8 participants at risk
core, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #23
n=9 participants at risk
core, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #24
n=8 participants at risk
core, support calls, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #25
n=9 participants at risk
core, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #26
n=8 participants at risk
core, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #27
n=9 participants at risk
core, support calls, app+, buddy, online gym
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #28
n=9 participants at risk
core, support calls, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #29
n=8 participants at risk
core, support calls, app+, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
|
Experimental Condition #30
n=9 participants at risk
core
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
|
Experimental Condition #31
n=9 participants at risk
core, app+, buddy, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
Experimental Condition #32
n=8 participants at risk
core, support calls, app+, buddy, online gym, app notifications
Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
Support Calls: Participants will receive 6 bi-weekly phone calls from study staff.
App+: Participants will receive "deluxe" version of smartphone app with additional features.
Online gym: Participants will receive access to online exercise videos.
App notifications: Participants will receive motivational app notifications
Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Sprain
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
25.0%
2/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Musculoskeletal and connective tissue disorders
Torn/Pulled Muscle
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Musculoskeletal and connective tissue disorders
Multiple Sclerosis Relapse
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Surgical and medical procedures
Breast reconstruction surgery
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
General disorders
Dizziness Spell
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Nervous system disorders
Concussion
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
General disorders
Dehydration
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Metastasis
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
11.1%
1/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
12.5%
1/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/9 • Adverse events were collected for the duration of the 24 week study period.
|
0.00%
0/8 • Adverse events were collected for the duration of the 24 week study period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place