Trial Outcomes & Findings for Mobile Device Biomonitoring to Prevent and Treat Obesity in Underserved Youth (NCT NCT02017223)

NCT ID: NCT02017223

Last Updated: 2019-05-15

Results Overview

Participants will wear an accelerometer on the waist for 3 days to gather baseline data on habitual physical activity, and then wear KNOWME for one weekend, along with an accelerometer - no more than two weeks after baseline. Outcome is the difference between baseline and KNOWME wear (differences in moderate to vigorous physical activity and sedentary time).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Pretest for one weekend (Friday-Sunday) and during KNOWME wear for one weekend (Friday-Sunday
• Results posted on: 2019-05-15

Participant Flow

Participant milestones

Measure	Pre-post Test Design 10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Pre-post Test Design 10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
Overall Study Algorithm problems	2

Baseline Characteristics

Mobile Device Biomonitoring to Prevent and Treat Obesity in Underserved Youth

Baseline characteristics by cohort

Measure	Pre-post Test Design n=10 Participants 10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.3 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
height	65.4 inches STANDARD_DEVIATION 2.7 • n=5 Participants
weight	215.2 pounds STANDARD_DEVIATION 42.8 • n=5 Participants
accelerometry	0.3 minutes of physical activity STANDARD_DEVIATION 0.6 • n=5 Participants

PRIMARY outcome

Timeframe: Pretest for one weekend (Friday-Sunday) and during KNOWME wear for one weekend (Friday-Sunday

Participants will wear an accelerometer on the waist for 3 days to gather baseline data on habitual physical activity, and then wear KNOWME for one weekend, along with an accelerometer - no more than two weeks after baseline. Outcome is the difference between baseline and KNOWME wear (differences in moderate to vigorous physical activity and sedentary time).

Outcome measures

Measure	Pre-post Test Design n=10 Participants 10 participants wore an accelerometer for a weekend. Within two weeks, the same 10 participants wore KNOWME sensors, carried the KNOWME phone and wore an accelerometer.
Objectively Measured Physical Activity From Accelerometer and KNOWME Network	1.8 minutes Standard Deviation 3.2

Adverse Events

Knowme Device Wear

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

Donna Spruijt-Metz, MFA PhD

University of Southern California

Phone: 310-577-6248

Email: dmetz@usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place