Type 1 Diabetes
Conditions
Brief summary
The goal of this longitudinal cohort study is to learn about a mHealth intervention in Type 1 Diabetes (T1D) The main question\[s\] it aims to answer are: * Does the intervention increase the amount of text messages between the mHealth software and participants? * Do the text messages from the Nudge software increase moderate to vigorous physical activity (MVPA) in participants? * Does the MVPA encouraged by the Nudge software improve the HbA1c levels of participants? Participants will: * Receive text messages from the Nudge software * Report physical activity goals via the text messages to the Nudge software * Wear both an accelerometer and an actigraph for three weeks (spread out across the beginning, 30 days, and 90 days of participation) * Complete surveys at the beginning of participation * Complete daily surveys while wearing the devices * Complete surveys at the end of participation * Record physical activity in study surveys
Interventions
OTHERNUDGE
NUDGE is a brief mHealth text messaging intervention designed to promote activity in adolescents by allowing them to set, monitor, and receive feedback on daily PA goals through text message.
Sponsors
University of Kansas
Nemours Children's Clinic
Children's Mercy Hospital Kansas City
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Participants 12.00-21.99 years old * Participants with a physician confirmed T1D diagnosis. * T1D diagnosis was at least 6 months prior to study enrollment * Participants are on an intensive insulin regiment (either with an insulin pump or multiple daily injection) * Participants must be using a continuous glucose monitor (CGM) * Participants and parents/legally authorized representatives (LARS) of participants less than 18.00 speak/read English.
Exclusion criteria
* Participants with evidence of type 2 or monogenic diabetes. * Participants with a comorbid chronic condition (e.g., renal disease). * Participants with presence of severe psychiatric disorders. * Participants with a diagnosis of low vision (vision that cannot be corrected with contact lenses or eyeglasses). * Participants with limited mobility that would prevent participant from engaging in daily physical activity, self-assessed by participant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| %Daily Text Messages Exchanged Between Youth and the NUDGE Bot | Through study completion, an average of 3.5 months | percent of daily text messages exchanged between youth and the NUDGE bot |
| Moderate to Vigorous Physical Activity (MVPA) Levels | Day 1, 30 and 90 | Participants' MVPA levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| %Days That Youth Wear the Actigraph | Day 1, 30 and 90 | Percent of days that youth wear the actigraph |
| %Daily Physical Activity (PA) Schedules That Participants Complete | Day 1, 30 and 90 | percent of daily PA schedules that participants complete |
| Change in Participant HbA1c | Through study completion, an average of 3.5 months | Change in participant HbA1c |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Arm Main group of patients 13.00 to 21.99 with T1D | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Primary Arm |
|---|---|
| Age, Continuous | 17 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 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 | 0 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 | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
%Daily Text Messages Exchanged Between Youth and the NUDGE Bot
percent of daily text messages exchanged between youth and the NUDGE bot
Time frame: Through study completion, an average of 3.5 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.
Primary
Moderate to Vigorous Physical Activity (MVPA) Levels
Participants' MVPA levels
Time frame: Day 1, 30 and 90
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.
Secondary
Change in Participant HbA1c
Change in participant HbA1c
Time frame: Through study completion, an average of 3.5 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.
Secondary
%Daily Physical Activity (PA) Schedules That Participants Complete
percent of daily PA schedules that participants complete
Time frame: Day 1, 30 and 90
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.
Secondary
%Days That Youth Wear the Actigraph
Percent of days that youth wear the actigraph
Time frame: Day 1, 30 and 90
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed.