Trial Outcomes & Findings for Congenital Heart Disease Physical Activity Lifestyle Study (NCT NCT03335475)
NCT ID: NCT03335475
Last Updated: 2023-05-03
Results Overview
Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
From baseline to follow-up (approximately 22 weeks).
Results posted on
2023-05-03
Participant Flow
Participant milestones
| Measure |
Fitbit Only
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Fitbit Only
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Overall Study
Did not wear accelerometer
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
One participant in the Fitbit Only group had missing data for VO2peak.
Baseline characteristics by cohort
| Measure |
Fitbit Only
n=29 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=31 Participants
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.9 years
STANDARD_DEVIATION 0.9 • n=29 Participants
|
16.7 years
STANDARD_DEVIATION 1.0 • n=31 Participants
|
16.3 years
STANDARD_DEVIATION 1.0 • n=60 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=29 Participants
|
13 Participants
n=31 Participants
|
28 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=29 Participants
|
18 Participants
n=31 Participants
|
32 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=29 Participants
|
30 Participants
n=31 Participants
|
58 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=29 Participants
|
28 Participants
n=31 Participants
|
52 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=60 Participants
|
|
MVPA
|
19.0 average minutes per day
STANDARD_DEVIATION 10.8 • n=29 Participants
|
20.5 average minutes per day
STANDARD_DEVIATION 13.9 • n=31 Participants
|
19.8 average minutes per day
STANDARD_DEVIATION 12.4 • n=60 Participants
|
|
Sedentary Behavior
|
557.7 average minutes per day
STANDARD_DEVIATION 106.0 • n=29 Participants
|
578.9 average minutes per day
STANDARD_DEVIATION 105.3 • n=31 Participants
|
568.7 average minutes per day
STANDARD_DEVIATION 105.3 • n=60 Participants
|
|
VO2Peak
|
37.7 mL/kg/min
STANDARD_DEVIATION 9.2 • n=28 Participants • One participant in the Fitbit Only group had missing data for VO2peak.
|
37.6 mL/kg/min
STANDARD_DEVIATION 10.0 • n=31 Participants • One participant in the Fitbit Only group had missing data for VO2peak.
|
37.6 mL/kg/min
STANDARD_DEVIATION 9.5 • n=59 Participants • One participant in the Fitbit Only group had missing data for VO2peak.
|
PRIMARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Baseline to follow-up change in number of minutes spent in moderate to vigorous physical activity as measured by an accelerometer
Outcome measures
| Measure |
Fitbit Only
n=25 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=30 Participants
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Moderate to Vigorous Physical Activity (MVPA)
|
-1.9 average minutes per day
Standard Deviation 12.4
|
3.4 average minutes per day
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Baseline to follow-up change in number of minutes spent being sedentary as measured by an accelerometer.
Outcome measures
| Measure |
Fitbit Only
n=25 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=30 Participants
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Sedentary Behavior
|
-7.2 average minutes per day
Standard Deviation 146.9
|
-33.6 average minutes per day
Standard Deviation 109.9
|
SECONDARY outcome
Timeframe: From baseline to follow-up (approximately 22 weeks).Baseline to follow-up change in maximal oxygen utilization during physical activity as measured by VO2peak during an exercise stress test.
Outcome measures
| Measure |
Fitbit Only
n=25 Participants
In the Fitbit Only arm, participants will receive their exercise prescription, as devised from their baseline exercise stress test results, and a Fitbit. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
Fitbit + Coaching Sessions
n=29 Participants
In the Fitbit + Coaching Sessions arm, participant will receive their exercise prescription, as devised from their baseline exercise stress test results, a Fitbit, and will have 8 sessions with a coach (interventionist) over the course of 20 weeks. They will undergo a 9 week (interim) and a 22 week assessment (follow-up).
Physical Activity Lifestyle Intervention: Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
Physical Activity Monitoring: A physical activity monitor (Fitbit) will be provided to both groups.
|
|---|---|---|
|
Exercise Tolerance
|
-1.72 mL/kg/min
Standard Deviation 3.23
|
-0.57 mL/kg/min
Standard Deviation 3.11
|
Adverse Events
Fitbit Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fitbit + Coaching Sessions
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place