Trial Outcomes & Findings for Diabetes Management Intervention For South Asians (NCT NCT03333044)
NCT ID: NCT03333044
Last Updated: 2025-09-24
Results Overview
Measured via complete lipoprotein panel.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
859 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2025-09-24
Participant Flow
Primary care providers (PCPs) were not considered enrolled in this study.
Unit of analysis: Clinics
Participant milestones
| Measure |
Waive 1 (10/2018-12/2019) Round 1 Jan-Jun 2019, Round 2 July-Dec 2019
All participants waitlisted during the Waive 1- Round 1 were randomized to the Waive 1 Wait-List Control group.
During the first round (Jan-Jun 2019), participants received standard of care. During the second round (July-Dec 2019), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 1 received the intervention from Jan-Jun 2019 for Round 1; Round 2 participants received the intervention from July-Dec 2019.
|
Waive 2 (10/2019-12/2020) Round 1 Jan-Jun 2020, Round 2 July-Dec 2020
All participants waitlisted during the Waive 2 - Round 1 were randomized to the Waive 2 Wait-List Control group.
During the first round (Jan-Jun 2020), participants received standard of care. During the second round (July-Dec 2020), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 2 received the intervention from Jan-Jun 2020 for Round 1; Round 2 participants received the intervention from July-Dec 2020.
|
Waive 3 (10/2020-12/2021) Round 1 Jan-Jun 2021, Round 2 July-Dec 2021
All participants waitlisted during the Waive 3 - Round 1 were randomized to the Waive 3 Wait-List Control group.
During the first round (Jan-Jun 2021), participants received standard of care. During the second round (July-Dec 2021), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 3 received the intervention from Jan-Jun 2021 for Round 1; Round 2 participants received the intervention from July-Dec 2021.
|
|---|---|---|---|
|
Overall Study
STARTED
|
293 7
|
314 7
|
252 5
|
|
Overall Study
Participants Started Wait-List Control Round 1, CHW Round 2
|
146 7
|
150 7
|
123 5
|
|
Overall Study
Participants Completed Wait-List Control Round 1, CHW Round 2
|
146 7
|
150 7
|
123 5
|
|
Overall Study
Participants Started CHW Round 1, CHW Round 2
|
147 7
|
164 7
|
129 5
|
|
Overall Study
Participants Completed CHW Round 1, CHW Round 2
|
146 7
|
150 7
|
123 5
|
|
Overall Study
COMPLETED
|
292 7
|
300 7
|
246 5
|
|
Overall Study
NOT COMPLETED
|
1 0
|
14 0
|
6 0
|
Reasons for withdrawal
| Measure |
Waive 1 (10/2018-12/2019) Round 1 Jan-Jun 2019, Round 2 July-Dec 2019
All participants waitlisted during the Waive 1- Round 1 were randomized to the Waive 1 Wait-List Control group.
During the first round (Jan-Jun 2019), participants received standard of care. During the second round (July-Dec 2019), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 1 received the intervention from Jan-Jun 2019 for Round 1; Round 2 participants received the intervention from July-Dec 2019.
|
Waive 2 (10/2019-12/2020) Round 1 Jan-Jun 2020, Round 2 July-Dec 2020
All participants waitlisted during the Waive 2 - Round 1 were randomized to the Waive 2 Wait-List Control group.
During the first round (Jan-Jun 2020), participants received standard of care. During the second round (July-Dec 2020), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 2 received the intervention from Jan-Jun 2020 for Round 1; Round 2 participants received the intervention from July-Dec 2020.
|
Waive 3 (10/2020-12/2021) Round 1 Jan-Jun 2021, Round 2 July-Dec 2021
All participants waitlisted during the Waive 3 - Round 1 were randomized to the Waive 3 Wait-List Control group.
During the first round (Jan-Jun 2021), participants received standard of care. During the second round (July-Dec 2021), all control participants were offered the full CHW group education sessions, though not for research purposes.
Participants randomized to receive the intervention in Waive 3 received the intervention from Jan-Jun 2021 for Round 1; Round 2 participants received the intervention from July-Dec 2021.
|
|---|---|---|---|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
14
|
6
|
Baseline Characteristics
Diabetes Management Intervention For South Asians
Baseline characteristics by cohort
| Measure |
Wait-List Control
n=419 Participants
Participants in the wait-list control group will be receive care as usual during the first round for data abstraction and offered CHW group education sessions during the second round as a point of service (i.e., not for research purposes).
|
CHW-Led Health Coaching
n=419 Participants
Participants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round.
Community Health Worker (CHW)-Led Health Coaching: CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
EHR-Embedded Alerts: An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.
|
Total
n=838 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
445 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
419 Participants
n=5 Participants
|
419 Participants
n=7 Participants
|
838 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
419 Participants
n=5 Participants
|
419 Participants
n=7 Participants
|
838 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
419 participants
n=5 Participants
|
419 participants
n=7 Participants
|
838 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Measured via complete lipoprotein panel.
Outcome measures
| Measure |
Wait-List Control
n=196 Participants
Participants in the wait-list control group will be receive care as usual during the first round for data abstraction and offered CHW group education sessions during the second round as a point of service (i.e., not for research purposes).
|
CHW-Led Health Coaching
n=219 Participants
Participants in the treatment group will be randomized to receive the CHW group education session intervention in either the first or second round.
Community Health Worker (CHW)-Led Health Coaching: CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to manage diabetes.
EHR-Embedded Alerts: An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to identify South Asian patients with uncontrolled diabetes.
|
|---|---|---|
|
Percentage of Participants Who Had at Least a 0.5% Reduction in HbA1c From Baseline 6 Months
|
32.1 Percentage of participants
|
35.2 Percentage of participants
|
Adverse Events
Wait-List Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CHW-Led Health Coaching
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