Diabetes Mellitus
Conditions
Brief summary
Sedentary behavior is associated with an increased risk of mortality and many health conditions including type 2 diabetes, obesity, cardiovascular disease, and metabolic syndrome, independent of the time spent in moderate-to-vigorous intensity physical activity (MVPA). Furthermore, independent of total sedentary time and MVPA, Healy et al. observed that individuals who had more breaks in sedentary time had lower 2-h plasma glucose. Recent experimental findings also suggests that breaking up prolonged bouts of sedentary behavior (≥ 20 minutes) with either light or moderate intensity activity for 2 minutes reduces postprandial glucose and insulin responses.10 Replacing sedentary time with light-intensity activity or nonexercise activity thermogenesis (NEAT) may help to reduce the health consequences of sedentary behavior. The purpose of this study is to develop a smartphone application (NEAT!) to encourage sedentary adults with diabetes to increase breaks in prolonged bouts of sedentary behavior objectively measured by an accelerometer. NEAT! will be refined by modifying technology created for the ENGAGED trial (RC1DK087126) and will work in conjunction with a Bluetooth enabled accelerometer that can detect bouts of sedentary behavior. When a sedentary bout (≥ 20 minutes) is detected, the smartphone application will trigger a reminder prompt to the user encouraging him/her to participate in NEAT for at least 2 minutes. Following the development, testing, and refining of the application, a sample of 10 sedentary adults with type 2 diabetes will be recruited to participate in a one month trial to examine the feasibility and acceptability of NEAT!. To our knowledge, this is the first study to design and examine the acceptability of a smartphone application that will target interrupting sedentary behavior with NEAT using objectively measured sedentary time in a diabetic population.
Interventions
BEHAVIORALNEAT!
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.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 21-70 years of age * have physician diagnosed type 2 diabetes that is currently being treated by dietary modification, oral agents, or insulin * currently and plan on having an Android smartphone for the next 2 months * be willing to wear an accelerometer and use the NEAT! application * spend the majority of the day sitting.
Exclusion criteria
* unable to ambulate without assistance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of NEAT! | 1 month | How many participants would continue to use or use NEAT! in the future |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to NEAT! | 1 Month | NEAT usage (days/month) |
| Breaks in Sedentary Behavior | Baseline and 1 month | Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month |
| Changes in Total Sedentary Time | Baseline and 1 month | Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month |
Countries
United States
Participant flow
Pre-assignment details
Participants were only excluded if they did not meet the eligibility criteria or were no longer interested in participating.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | NEAT! |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 53.1 years STANDARD_DEVIATION 10.7 |
| Body Mass Index | 37.4 kg/m^2 STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Acceptability of NEAT!
How many participants would continue to use or use NEAT! in the future
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| NEAT! | Acceptability of NEAT! | 7 Participants |
Secondary
Adherence to NEAT!
NEAT usage (days/month)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEAT! | Adherence to NEAT! | 21.9 days | Standard Deviation 8 |
Secondary
Breaks in Sedentary Behavior
Changes in the number of breaks in sedentary behavior will be assessed via accelerometry between baseline and 1 month
Time frame: Baseline and 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEAT! | Breaks in Sedentary Behavior | 67.6 breaks/day | Standard Deviation 15.1 |
Secondary
Changes in Total Sedentary Time
Changes in total sedentary behavior will be assessed via accelerometry between baseline and 1 month
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NEAT! | Changes in Total Sedentary Time | -8.1 percentage of day spent sedentary | Standard Deviation 4.5 |