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

Sponsor
NYU Langone Health (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03188094
Collaborator
(none)
960
1
48.5
19.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
960 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Integrated Community-Clinical Linkage Model to Promote Weight Loss Among South Asians With Pre-Diabetes
Actual Study Start Date :
Dec 17, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Average reduction in HbA1c [12 Months]

  2. % sustained >5% weight loss at 12 months [12 Months]

  3. improved lipids following the index office visit [6 Months, 12 Months]

  4. improved blood pressure following the index office visit [6 Months, 12 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Nadia Islam, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03188094
Other Study ID Numbers:
  • 17-00693
First Posted:
Jun 15, 2017
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 7, 2021