Trial Outcomes & Findings for NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes (NCT NCT01754467)

NCT ID: NCT01754467

Last Updated: 2017-04-28

Results Overview

How many participants would continue to use or use NEAT! in the future

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 1 month
• Results posted on: 2017-04-28

Participant Flow

Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.

Participant milestones

Measure	NEAT! Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	NEAT! Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Overall Study Lost to Follow-up	1

Baseline Characteristics

NEAT! Technology to Increase Breaks in Sedentary Behavior in Adults With Diabetes

Baseline characteristics by cohort

Measure	NEAT! n=9 Participants Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	53.1 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Body Mass Index	37.4 kg/m^2 STANDARD_DEVIATION 9.9 • n=5 Participants

PRIMARY outcome

Timeframe: 1 month

How many participants would continue to use or use NEAT! in the future

Outcome measures

Measure	NEAT! n=8 Participants Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Acceptability of NEAT!	7 Participants

SECONDARY outcome

Timeframe: 1 Month

NEAT usage (days/month)

Outcome measures

Measure	NEAT! n=8 Participants Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Adherence to NEAT!	21.9 days Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline and 1 month

Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month

Outcome measures

Measure	NEAT! n=8 Participants Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Breaks in Sedentary Behavior	67.6 breaks/day Standard Deviation 15.1

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: One individual outlier showed opposite changes as compared with the other participants and was 2.1 standard deviations above the mean for change in percent of day spent in sedentary behavior; thus this individual was excluded from this analysis.

Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month

Outcome measures

Measure	NEAT! n=7 Participants Participants will use the NEAT! smartphone application and accelerometer over a 1 month period. NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
Changes in Total Sedentary Time	-8.1 percentage of day spent sedentary Standard Deviation 4.5

Adverse Events

NEAT!

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

Christine Pellegrini, PhD

Northwestern University

Phone: 312-503-1395

Email: c-pellegrini@northwestern.edu

Results disclosure agreements

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