Pre Diabetes, Weight Loss
Conditions
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
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.
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6 | Baseline, Month 6 | Weight 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
| Arm | Count |
|---|---|
| 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 |
| Total | 952 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 17 |
| Overall Study | Pregnancy | 3 | 0 | 0 |
| Overall Study | Screen failure | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Usual Care - Wait-List Control | Total | Alert + CHW-Led Coaching |
|---|---|---|---|
| Age, Continuous | 48.3 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 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 476 Participants | 952 Participants | 476 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 476 Participants | 952 Participants | 476 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 476 participants | 952 participants | 476 participants |
| Sex: Female, Male Female | 274 Participants | 548 Participants | 274 Participants |
| Sex: Female, Male Male | 202 Participants | 404 Participants | 202 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 476 | 0 / 498 |
| other Total, other adverse events | 0 / 476 | 0 / 498 |
| serious Total, serious adverse events | 0 / 476 | 0 / 498 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care - Wait-List Control | Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6 | 11 Percentage of participants |
| Alert + CHW-Led Coaching | Percentage of Participants Who Lost at Least 5% of Body Weight Between Baseline and Month 6 | 19 Percentage of participants |