Clinical trial NCT03188094: Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Official title: Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre Diabetes
Weight Loss
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-15
Enrollment: 974
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants who lose at least 5% of body weight between baseline and month 6
timeFrame: Baseline, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nadia Islam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim S, Wyatt LC, Mammen S, Zanowiak JM, Mohaimin S, Goldfeld KS, Shelley D, Gold HT, Islam NS. The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes. Trials. 2019 Nov 21;20(1):635. doi: 10.1186/s13063-019-3711-y.