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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03188094
• Other study ID #: 17-00693
• Status: Active, not recruiting
• Start date: December 17, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 974
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Provider Assessment Surveys

• clinicians employed by independent primary care practice that are members of HealthFirst's network and have enrolled into the study.

Key Informant Interviews

• must be a provider, clinic manger, Healthfisrt staff, or community health worker.

Exclusion Criteria:

Provider Assessment Surveys

• Exclusion criteria include the following: participants who are unable to complete the survey in the English language.

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Glucose Intolerance
• Pre Diabetes
• Prediabetic State
• Weight Loss

Intervention

Other:
• community health worker (CHW)-led health coaching for patients
Using a stepped-wedge design, investigators will implement the study in 25 NYC PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	probability of eligible patients at a practice site to lose 5% or more of their body weight six months following the index office visit.		6 Months
Secondary	Average reduction in HbA1c		12 Months
Secondary	% sustained >5% weight loss at 12 months		12 Months
Secondary	improved lipids following the index office visit		6 Months, 12 Months
Secondary	improved blood pressure following the index office visit		6 Months, 12 Months