A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

NCT ID: NCT03557697

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-04-21

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

wait-list control

3 measurement visits, baseline, 3, and 6 months

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

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

SMS intervention

3 measurement visits, baseline, 3, and 6 months

Group Type: ACTIVE_COMPARATOR

SMS Intervention

Intervention Type: 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.

Interventions

Standard of Care

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

Intervention Type: BEHAVIORAL

SMS Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lu Hu, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 41144955 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40016380 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36306161 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R00MD012811-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-00609

Identifier Type: -

Identifier Source: org_study_id