Trial Outcomes & Findings for Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program (NCT NCT04773834)
NCT ID: NCT04773834
Last Updated: 2026-03-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
551 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Experimental Group
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Overall Study
STARTED
|
354
|
197
|
|
Overall Study
COMPLETED
|
284
|
151
|
|
Overall Study
NOT COMPLETED
|
70
|
46
|
Reasons for withdrawal
| Measure |
Experimental Group
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Overall Study
UPID not claimed
|
29
|
5
|
|
Overall Study
Failed criteria for randomization
|
41
|
41
|
Baseline Characteristics
Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program
Baseline characteristics by cohort
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 11.2 • n=41 Participants
|
57.4 years
STANDARD_DEVIATION 11.2 • n=35 Participants
|
57.5 years
STANDARD_DEVIATION 11.9 • n=76 Participants
|
|
Sex/Gender, Customized
Female
|
188 Participants
n=41 Participants
|
100 Participants
n=35 Participants
|
288 Participants
n=76 Participants
|
|
Sex/Gender, Customized
Male
|
83 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
131 Participants
n=76 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=76 Participants
|
|
Sex/Gender, Customized
Missing
|
11 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
14 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
51 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
187 Participants
n=41 Participants
|
95 Participants
n=35 Participants
|
282 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
70 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
102 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
50 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
104 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
137 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
217 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
34 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
50 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
14 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
284 participants
n=41 Participants
|
151 participants
n=35 Participants
|
435 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations.
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.
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
|
0.02 mmol/mol
Standard Deviation 0.034
|
-0.03 mmol/mol
Standard Deviation 0.045
|
PRIMARY outcome
Timeframe: Baseline, Month 12Repeated 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.
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) Level (mmol/Mol)
|
0.01 mmol/mol
Standard Deviation 0.040
|
0.01 mmol/mol
Standard Deviation 0.043
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations.
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.
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Body Weight (Lbs)
|
-7.13 lbs
Standard Deviation 0.968
|
-7.02 lbs
Standard Deviation 1.200
|
PRIMARY outcome
Timeframe: Baseline, Month 12Repeated measurements of participant weight will be taken via remote Bluetooth-connected weight scales, measured in light clothing without shoes. Data will be 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.
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Body Weight (Lbs)
|
-7.42 lbs
Standard Deviation 0.993
|
-7.02 lbs
Standard Deviation 1.330
|
PRIMARY outcome
Timeframe: Baseline, Month 6Population: Only 163 participants in the experimental group and 94 participants in the control group were analyzed. The others were missing weight data at either 6 or 12 months and were excluded. This analysis was done separately from the other outcomes, which used multiple imputation to help fill in the missing data.
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.
Outcome measures
| Measure |
Experimental Group
n=163 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=94 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Body Mass Index (BMI) (Lbs/in^2)
|
-1.1792 lbs/in^2
Standard Deviation 0.150
|
-1.30 lbs/in^2
Standard Deviation 0.228
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Only 163 participants in the experimental group and 94 participants in the control group were analyzed. The others were missing weight data at either 6 or 12 months and were excluded. This analysis was done separately from the other outcomes, which used multiple imputation to help fill in the missing data.
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.
Outcome measures
| Measure |
Experimental Group
n=163 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=94 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Change in Body Mass Index (BMI) (Lbs/in^2)
|
1.2045 lbs/in^2
Standard Deviation 0.147
|
-1.16 lbs/in^2
Standard Deviation 0.218
|
SECONDARY outcome
Timeframe: Month 6Population: The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations.
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
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Engagement With the dDPP Platform
|
0.25 score on a scale
Standard Deviation 0.0206
|
0.15 score on a scale
Standard Deviation 0.029
|
SECONDARY outcome
Timeframe: Month 12Population: The number of participants included in this analysis reflects the use of multiple imputation to account for missing data. All available cases were incorporated into the imputed datasets, and estimates are based on pooled results across imputations.
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
Outcome measures
| Measure |
Experimental Group
n=284 Participants
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Digital diabetes prevention program (dDPP): 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.
Adapted 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.
|
Control Group
n=151 Participants
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team
Digital diabetes prevention program (dDPP): 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.
|
|---|---|---|
|
Engagement With the dDPP Platform
|
0.29 score on a scale
Standard Deviation 0.048
|
0.25 score on a scale
Standard Deviation 0.061
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place