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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Weight Loss; Pre Diabetes
• Intervention / Treatment: Other: community health worker (CHW)-led health coaching for patients

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.

• Study Type: Observational
• Enrollment (Estimated): 974

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The overall number of subjects expected to participate in this study is 2,915. This includes a total of 2,840 participants in the EHR-CHW Intervention, 40 subjects who participate in the surveys and 35 particpants in the key informant interviews.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
South Asians with Prediabetes	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Average reduction in HbA1c	12 Months
% sustained >5% weight loss at 12 months	12 Months
improved lipids following the index office visit	6 Months, 12 Months
improved blood pressure following the index office visit	6 Months, 12 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Nadia Islam, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 13, 2017
• First Posted (Actual): June 15, 2017

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Hyperglycemia; Diabetes Mellitus; Weight Loss; Prediabetic State; Glucose Intolerance; Body Weight
• Other Study ID Numbers: 17-00693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No