Pre Diabetes
Conditions
Brief summary
This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.
Detailed description
Using a mixed-methods design, this study will be completed in three phases. For Phase 3, we aim to conduct a randomized control trial with 400 patients with pre-diabetic, all of whom will be using the dDPP application. Half of enrolled patients will be randomized to the intervention group and receive automated targeted messaging.
Interventions
The digital diabetes prevention program is through the Noom app, and the three devices (Fitbit physical activity tracker, Fitbit weight scale, and self-check hemoglobin a1c kit). This is a one year diabetes prevention program where participants will be expected to participate in 5 to 7 interviews over a 18 month period.
OTHERAdapted dDPP-EHR tool
This is a product of Phase 1 and 2 of this study where participants will receive detailed text messaging regarding their engagement levels in Noom app.
Sponsors
NYU Langone Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years or older, BMI ≥ 25 kg/m2 (\> 22 kg/m2 if self-identified as Asian) * Must be a NYU Langone patient * A diagnosis of prediabetes (either diagnosis of prediabetes or an HbA1C level of 5.7%-6.4% in past 12 months) or diabetes risk factors (BMI ≥ 25 kg/m2 or \> 22 kg/m2 if self-identified as Asian * Safe to engage in moderate physical exercise (as determined by their PCP) * Sufficient English to be able to complete the enrollment process * Has app-capable device with data to use the dDPP application and receive text messages
Exclusion criteria
* Diagnosed with diabetes * Patients whose weight may vary considerably over the study's timeframe for reasons other than the intervention (e.g. cancer, pregnancy, ascites, severe CHF) * Patients with severe psychiatric disease or dementia * Active health condition that prevents them from engaging in moderate exercise
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol) | Baseline, Month 6 | Repeated measurements of participant HbA1c will be taken via HbA1C home test kit and electronic health records. Data will be collected at discrete time points: 0 month (at enrollment), 6 months, 12 months (study completion). Changes were assessed relative to baseline. |
| Change in Body Weight (Lbs) | Baseline, Month 6 | Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Changes were assessed relative to baseline. |
| Change in Body Mass Index (BMI) (Lbs/in^2) | Baseline, Month 6 | BMI was calculated using height (in) from electronic health records and weight (lbs) from remote Bluetooth-connected weight scales. Data was collected at discrete time points: 0 month (at enrollment), 3 months, 6 months, 9 months, 12 months (study completion). Changes were assessed relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement With the dDPP Platform | Month 6 | Engagement was defined as completion of the following Noom activities: submission of at least one weigh-in; reading one article per week; participation in socialization through either one group post per week or one message to a Noom coach; and meeting physical activity goals by achieving either 150 minutes of activity or the step target assigned by Noom. Outcome measure is assessed as as score on a scale, where 0=Fail, and 1=pass |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDevin Mann, MD
NYU Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 95 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants |
| Race (NIH/OMB) Black or African American | 104 Participants |
| Race (NIH/OMB) More than one race | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 137 Participants |
| Region of Enrollment United States | 284 participants |
| Sex/Gender, Customized Female | 100 Participants |
| Sex/Gender, Customized Male | 131 Participants |
| Sex/Gender, Customized Missing | 11 Participants |
| Sex/Gender, Customized Other | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 284 | 0 / 151 |
| other Total, other adverse events | 0 / 284 | 0 / 151 |
| serious Total, serious adverse events | 0 / 284 | 0 / 151 |
Outcome results
None listed