Trial Outcomes & Findings for Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes (NCT NCT03188094)
NCT ID: NCT03188094
Last Updated: 2025-09-24
Results Overview
Weight measured at baseline and 6 month survey via study scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
974 participants
Primary outcome timeframe
Baseline, Month 6
Results posted on
2025-09-24
Participant Flow
Primary care providers (PCPs) were not considered enrolled as participants 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
|
333 7
|
294 7
|
347 5
|
|
Overall Study
Participants Started Wait-List Control Round 1, CHW Round 2
|
164 7
|
147 7
|
165 5
|
|
Overall Study
Participants Completed Wait-List Control Round 1, CHW Round 2
|
164 7
|
147 7
|
165 5
|
|
Overall Study
Participants Started CHW Round 1, CHW Round 2
|
169 7
|
147 7
|
182 5
|
|
Overall Study
Participants Completed CHW Round 1, CHW Round 2
|
164 7
|
147 7
|
165 5
|
|
Overall Study
COMPLETED
|
328 7
|
294 7
|
330 5
|
|
Overall Study
NOT COMPLETED
|
5 0
|
0 0
|
17 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
Screen failure
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
3
|
0
|
0
|
|
Overall Study
Ineligible
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
17
|
Baseline Characteristics
Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Baseline characteristics by cohort
| Measure |
Usual Care - Wait-List Control
n=476 Participants
All participants waitlisted during the first round will be randomized to the control group. Control group participants will be offered the full CHW group education sessions during the second round. The control participants will receive usual care during the first round.
|
Alert + CHW-Led Coaching
n=476 Participants
Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.
CHW-Led Health Coaching: The CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to prevent diabetes.
EHR Alerts: Primary care providers (PCP) treating patients in the intervention group will receive embedded EHR alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI \>23 kg/m2 and registries to track outcomes.
|
Total
n=952 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
48.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
274 Participants
n=7 Participants
|
548 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
404 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
|
476 Participants
n=5 Participants
|
476 Participants
n=7 Participants
|
952 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
|
476 Participants
n=5 Participants
|
476 Participants
n=7 Participants
|
952 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
|
476 participants
n=5 Participants
|
476 participants
n=7 Participants
|
952 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 6Weight measured at baseline and 6 month survey via study scale.
Outcome measures
| Measure |
Usual Care - Wait-List Control
n=210 Participants
All participants waitlisted during the first round will be randomized to the control group. Control group participants will be offered the full CHW group education sessions during the second round. The control participants will receive usual care during the first round.
|
Alert + CHW-Led Coaching
n=457 Participants
Participants will receive an alert and registry-driven CHW-led coaching during either the first or second round.
CHW-Led Health Coaching: The CHW intervention includes a protocol that consists of 5 monthly 90-minute group health education sessions, providing the tools and strategies to prevent diabetes.
EHR Alerts: Primary care providers (PCP) treating patients in the intervention group will receive embedded EHR alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI \>23 kg/m2 and registries to track outcomes.
|
|---|---|---|
|
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6
|
11 Percentage of participants
|
19 Percentage of participants
|
Adverse Events
Usual Care - Wait-List Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alert + CHW-Led 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