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Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03188094
Enrollment
974
Registered
2017-06-15
Start date
2018-12-17
Completion date
2024-06-30
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre Diabetes, Weight Loss

Brief summary

The proposed study will inform efforts to prevent diabetes and promote weight loss in a high-risk population and generate a reproducible, scalable, and sustainable model for use with other insurer groups and clinical settings that work in immigrant populations with a high burden of chronic disease.

Detailed description

The study Integrated Community-Clinical Linkage Model to Promote Weight Loss among South Asians with Pre-Diabetes aims to test the effectiveness and assess the implementation process of an integrated intervention to support weight loss for South Asian patients at-risk for type-2 diabetes mellitus (T2DM) in primary care settings. The integrated intervention involves: 1. An electronic health record (EHR) intervention for primary care providers (PCPs) utilizing embedded alerts to increase screening and identification of South Asian patients at-risk for T2DM with BMI \>23 kg/m2 and registries to track outcomes: and 2. Registry-driven community health worker (CHW)-led health coaching for patients. Using a stepped-wedge design, we will implement the study in 25 New York City PCP sites enrolling 2,840 South Asian patients at- risk for T2DM. 3. Provider Surveys (n=40) to capture data on satisfaction with workflow before and after intervention, information sources for EHR-CHW initiatives before and after intervention, acceptability of and satisfaction with the integrated EHR-CHW intervention, and barriers and facilitators of point-of-care use of the tools. 4. Key Informant Interviews (n=35) with physician champions at each site and/or administrator of each site, Health first representatives, and CHWs. At baseline, the interviews will be incorporated into the workflow analysis to assess current satisfaction and usage of EHR and health coaching. At follow-up, the interviews will assess barriers and facilitators to the implementation and adoption process of the integrated EHR-CHW intervention, fidelity to the interventions, and to solicit recommendations for the replication and scalability of the intervention to other sites and insurer organizations.

Interventions

BEHAVIORALCHW-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.

OTHEREHR 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* self identify as South Asian; * are at least 21 years of age and younger than age 75, * had an appointment with a physician or mid-level clinician for routine non-emergent primary care in the last 12 months; * have a BMI of \>23; and * have incident pre-diabetes as determined by HbA1c test (last A1c test date in the last 12 months).

Exclusion criteria

* Patients under the age of 21 and older than 75 will be excluded. * Individuals with a diagnosis of diabetes or pre-diabetes during the 12 months prior to intervention implementation will be excluded. * Pregnant women and all visits with an obstetrician gynecologist are excluded. * No children or vulnerable subjects will be enrolled in this study.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6Baseline, Month 6Weight measured at baseline and 6 month survey via study scale.

Countries

United States

Participant flow

Pre-assignment details

Primary care providers (PCPs) were not considered enrolled as participants in this study.

Participants by arm

ArmCount
Usual Care - Wait-List Control
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.
476
Alert + CHW-Led Coaching
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.
476
Total952

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyIneligible100
Overall StudyLost to Follow-up0017
Overall StudyPregnancy300
Overall StudyScreen failure100

Baseline characteristics

CharacteristicUsual Care - Wait-List ControlTotalAlert + CHW-Led Coaching
Age, Continuous48.3 years
STANDARD_DEVIATION 11.2
48.3 years
STANDARD_DEVIATION 11.2
48.2 years
STANDARD_DEVIATION 11.2
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
476 Participants952 Participants476 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
476 Participants952 Participants476 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
476 participants952 participants476 participants
Sex: Female, Male
Female
274 Participants548 Participants274 Participants
Sex: Female, Male
Male
202 Participants404 Participants202 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 4760 / 498
other
Total, other adverse events
0 / 4760 / 498
serious
Total, serious adverse events
0 / 4760 / 498

Outcome results

Primary

Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6

Weight measured at baseline and 6 month survey via study scale.

Time frame: Baseline, Month 6

ArmMeasureValue (NUMBER)
Usual Care - Wait-List ControlPercentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 611 Percentage of participants
Alert + CHW-Led CoachingPercentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 619 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026