A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

NCT03557697 | Completed Results

• 2 other identifiers: 18-006095R00MD012811-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Despite the well-documented T2D disparities in this minority group, limited work has been conducted to improve health outcomes in Chinese Americans. The goal of this Pathway to Independence Award (K99/R00) is to expedite the candidate's transition to an independent investigator who possesses focused expertise in development and evaluation of culturally and linguistically tailored and sustainable interventions to reduce T2D disparities in Chinese Americans. In the K99 phase of this award, the candidate will obtain critical training needed to accomplish this goal and will develop a short message service (SMS) intervention to improve T2D management in Chinese Americans. More specifically, the aims are to 1) characterize barriers and facilitators of glycemic control in Chinese Americans with T2D (Aim 1a); 2) develop culturally and linguistically tailored SMS intervention content (Aim 1b); and 3) assess the feasibility and acceptability of the SMS intervention in a pre-, post-test study (Aim 1c). In the R00 phase, the candidate will refine the SMS intervention based on the K99 pilot data and evaluate the proof-of-concept regarding its efficacy in a pilot randomized controlled trial among 66 Chinese Americans with T2D (Aim 2). Participants will be randomized to one of 2 arms (n=30 each): 1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard of care treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the SMS-based counseling videos. Measurements will be obtained at baseline, 3, and 6 months. The primary outcome is HbA1c and secondary outcomes include self-efficacy, diabetes self-management behaviors, dietary intake and physical activity behaviors. Linear mixed modeling will be used to examine the group and group by time interaction effects between the SMS intervention and wait-list control group. Findings from this R00 study will inform a larger full-scale R01 efficacy trial of the SMS intervention, and ultimately, establish the candidate's program of research focused on developing and testing sustainable interventions to reduce disparities in chronic disease outcomes in Chinese Americans. This project can serve as a program model for other chronic disease interventions in Chinese Americans that require lifestyle modification (e.g., prediabetes, hypertension), or for disparities research in other high-risk immigrant populations (e.g., South Asians, Hispanic Americans).

Conditions

Type2 Diabetes

Keywords

Chinese Americans; SMS intervention

Outcome Measures

Primary Outcomes (2)

• Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels

  HbA1c testing results abstracted from medical record.

  Baseline, Month 3

• Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels

  HbA1c testing results abstracted from medical record.

  Baseline, Month 6

Secondary Outcomes (32)

• Change in Stanford Diabetes Self-Efficacy Scale Score

  Baseline, Month 3

• Change in Stanford Diabetes Self-Efficacy Scale Score

  Baseline, Month 6

• Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score

  Baseline, Month 3

• Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score

  Baseline, Month 6

• Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score

  Baseline, Month 3

Study Arms (2)

wait-list control

ACTIVE COMPARATOR

3 measurement visits, baseline, 3, and 6 months

Behavioral: Standard of Care

SMS intervention

ACTIVE COMPARATOR

3 measurement visits, baseline, 3, and 6 months

Behavioral: SMS Intervention

Interventions

Standard of Care BEHAVIORAL

At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS

wait-list control

SMS Intervention BEHAVIORAL

Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content. In addition, participants will receive biweekly phone calls from study community health workers to review the video content and clarify questions, set goals, and problem-solve barriers to achieving the goals.

SMS intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• self-identify as Chinese Immigrant or Chinese American
• be able to speak and understand Mandarin
• self-report a diagnosis of T2D
• baseline HbA1c ≥ 7%
• be currently using WeChat or text messages• be willing to receive WeChat or text messages regarding T2D management
• express strong interest and confidence in finishing watching 2 diabetes videos each week for a total of 12 weeks
• express motivation to make lifestyle changes to control their diabetes
• be willing to wear ActiGraph for 8 days

You may not qualify if:

• unable or unwilling to provide informed consent
• unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)
• unwilling to accept randomization assignment
• pregnant, plans to becomes pregnant in the next 6 months, or who become pregnant during the study
• breastfeeding
• live in a facility or other health care setting where they have to control over diabetes self-management

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (3)

• Liu J, Cao J, Shi Y, Sevick MA, Islam N, Feldman N, Li H, Wang C, Zhao Y, Tamura K, Levy N, Jiang N, Zhu Z, Wang Y, Hong J, Hu L. A Culturally and Linguistically Tailored Intervention to Improve Diabetes-Related Outcomes in Chinese Americans With Type 2 Diabetes: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 27;13:e78036. doi: 10.2196/78036.

  PMID: 41144955 DERIVED

• Shi Y, Sevick MA, Tang H, Wang C, Zhao Y, Yoon S, Li H, Jiang Y, Bai Y, Ong IH, Yang X, Su L, Levy N, Tamura K, Hu L. Culturally Tailored Social Media Intervention Improves Health Outcomes in Chinese Americans with Type 2 Diabetes: Preliminary Evidence from a Pilot RCT. J Gen Intern Med. 2025 Jul;40(10):2319-2329. doi: 10.1007/s11606-025-09430-9. Epub 2025 Feb 27.

  PMID: 40016380 DERIVED

• Hu L, Islam N, Zhang Y, Shi Y, Li H, Wang C, Sevick MA. Leveraging Social Media to Increase Access to an Evidence-Based Diabetes Intervention Among Low-Income Chinese Immigrants: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 28;11(10):e42554. doi: 10.2196/42554.

  PMID: 36306161 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Lu Hu
• Organization: NYU Langone Health

lu.hu@nyulangone.org

646 501 3438

Study Officials

• Lu Hu, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 15, 2018
• Study Start: March 1, 2021
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: February 19, 2025
• Results First Posted: December 27, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Requests should be directed to Lu.Hu@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)