Clinical trial NCT03557697: A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
Official title: A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Keywords: Chinese Americans
SMS intervention
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-06-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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

Primary outcomes:
measure: Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
timeFrame: Baseline, Month 3
measure: Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change in Stanford Diabetes Self-Efficacy Scale Score
timeFrame: Baseline, Month 3
measure: Change in Stanford Diabetes Self-Efficacy Scale Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
timeFrame: Baseline, Month 6
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
timeFrame: Baseline, Month 3
measure: Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Fruits
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Fruits
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Vegetables
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Vegetables
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Refined Grains
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Refined Grains
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Whole Wheat
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Whole Wheat
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Sugary Drinks
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Sugary Drinks
timeFrame: Baseline, Month 6
measure: Change in Starting The Conversation Scale: Starchy Foods
timeFrame: Baseline, Month 3
measure: Change in Starting The Conversation Scale: Starchy Foods
timeFrame: Baseline, Month 6
measure: Change in International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Baseline, Month 3
measure: Change in International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Baseline, Month 6
measure: Change in Belief in Self-Management Score
timeFrame: Baseline, Month 3
measure: Change in Belief in Self-Management Score
timeFrame: Baseline, Month 6
measure: Change in Diabetes Distress Scale Score
timeFrame: Baseline, Month 3
measure: Change in Diabetes Distress Scale Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Lu Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.