## Protocol Section
### Identification Module
**NCT ID:** NCT03530579

**Acronym:** RICE

**Brief Title:** Community Health Worker Diabetes Prevention Intervention

**Official Title:** Community Health Worker Diabetes Prevention Intervention

#### Organization Study ID Info
**ID:** 11-01416
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
### Status Module
#### Completion Date
**Date:** 2015-02-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2018-05-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-02-13

**Type:** ACTUAL

#### Start Date
**Date:** 2014-02-13

**Type:** ACTUAL

**Status Verified Date:** 2018-05

#### Study First Post Date
**Date:** 2018-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2018-05-08
**Study First Submit QC Date:** 2018-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City.

In particular, the specific aims of this study are:

1. To utilize community based participatory research (CBPR) methods to expand upon an existing campus-community partnership to develop and implement a CHW program among Korean and South Asian Americans that promotes diabetes prevention;
2. To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes prevention and access to care among NYC Koreans and South Asians.

### Conditions Module

**Conditions:**

- Diabetes Prevention

**Keywords:**

- Diabetes Prevention

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 954

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will receive 6 two and a half hour educational group trainings over the course of 6 months.

**Intervention Names:**

- Behavioral: Educational group trainings

**Label:** Group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** A community health worker will answer your questions about diabetes and refer participant if you need one.

**Intervention Names:**

- Behavioral: Community Health Care Worker

**Label:** Group 2

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1

**Description:** Participants will receive 6 two and a half hour educational group training's over the course of 6 months. These sessions will be led by a trained CHW in your language and will be held on a monthly basis in a community based location.

Session 1: What is Diabetes

* Why is Prevention Important

Session 2: Nutrition Session 3: Physical Activity Session 4: Cardiovascular Disease \& Diabetes Complication Session 5: Stress Management Session 6: Access to Service

**Name:** Educational group trainings

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Group 2

**Description:** A community health care worker answer your questions about diabetes and refer participant to a physician. Survey will be completed at the start of the study and during the 3rd, 6th and 12th months

**Name:** Community Health Care Worker

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in weight

**Time Frame:** 3 Months, 6 Months, 12 Months

**Measure:** Change in Body Mass Index

**Time Frame:** 3 Months, 6 Months, 12 Months

**Measure:** Change in hip-to-waist ratio measurements

**Time Frame:** 3 Months, 6 Months, 12 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* is a South Asian or Korean American immigrant;
* is identified as at-risk by a diabetes risk assessment
* is between 18-75 years of age; and
* is willing to be randomized to either treatment or control groups.

Exclusion Criteria:

* is a confirmed diabetic;
* is on renal dialysis;
* has an acute or terminal illness or serious mental illness;
* has a history of recent coronary event within the last 12 months;
* has a recent history of acute medical problem or admission to hospital;
* has any other severe medical conditions that might make it difficult to attend educational sessions;
* has poor short-term prognosis (expected death in \<2 years);
* is planning to travel for longer than 6 weeks during the 6-month intervention period; or
* is participating in another CVD study.

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Nadia Islam, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.

**PMID:** 36273386

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003920

- Term: Diabetes Mellitus

### Misc Info Module

- Version Holder: 2024-05-24
