Trial Outcomes & Findings for FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study (NCT NCT01394705)
NCT ID: NCT01394705
Last Updated: 2019-05-29
Results Overview
Total time (minutes) in Physical Activity in one week
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2019-05-29
Participant Flow
38 completed study, 21 randomized to each group, 2 lost to follow-up in each group with an N of 19 in each group.
Participant milestones
| Measure |
Standard of Care
BodyMedia: Accelerometer
|
Intervention
BodyMedia: Accelerometer
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Baseline characteristics by cohort
| Measure |
Standard of Care
n=19 Participants
BodyMedia: Accelerometer
|
Intervention
n=19 Participants
BodyMedia: Accelerometer
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
15.7 years
n=93 Participants
|
15.9 years
n=4 Participants
|
15.8 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
19 participants
n=4 Participants
|
38 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsTotal time (minutes) in Physical Activity in one week
Outcome measures
| Measure |
Standard of Care
n=19 Participants
office provider exercise counseling
|
Intervention
n=19 Participants
BodyMedia: Accelerometer wear
|
|---|---|---|
|
Physical Activity
Baseline
|
457 minutes per week
Interval 19.0 to 2343.0
|
443 minutes per week
Interval 71.0 to 1219.0
|
|
Physical Activity
Follow-up
|
364 minutes per week
Interval 0.0 to 2037.0
|
279 minutes per week
Interval 0.0 to 1266.0
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsSecondary hypotheses include greater improvement in body mass index (BMI) reported below.
Outcome measures
| Measure |
Standard of Care
n=19 Participants
office provider exercise counseling
|
Intervention
n=19 Participants
BodyMedia: Accelerometer wear
|
|---|---|---|
|
Body Mass Index
Baseline
|
30 BMI (kg/m2)
Interval 17.0 to 64.0
|
33 BMI (kg/m2)
Interval 19.0 to 49.0
|
|
Body Mass Index
Follow up
|
30 BMI (kg/m2)
Interval 16.0 to 67.0
|
32 BMI (kg/m2)
Interval 19.0 to 50.0
|
Adverse Events
Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention
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