A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

Study Overview
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Brief Summary
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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).

Official Title
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A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Behavioral: Standard of Care
* Behavioral: SMS Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: wait-list control<br>3 measurement visits, baseline, 3, and 6 months | Behavioral: Standard of Care<br>* At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS<br>|
| Active Comparator: SMS intervention<br>3 measurement visits, baseline, 3, and 6 months | Behavioral: SMS Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stanford Diabetes Self-Efficacy Scale Score | 8-item questionnaire asking participants to rate their confidence level in performing specific Type 2 Diabetes self-management behaviors on 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Higher scores indicate higher levels of confidence in performing self-management behaviors. | Baseline | 
| Stanford Diabetes Self-Efficacy Scale Score | 8-item questionnaire asking participants to rate their confidence level in performing specific Type 2 Diabetes self-management behaviors on 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Higher scores indicate higher levels of confidence in performing self-management behaviors. | Month 3 | 
| Stanford Diabetes Self-Efficacy Scale Score | 8-item questionnaire asking participants to rate their confidence level in performing specific Type 2 Diabetes self-management behaviors on 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Higher scores indicate higher levels of confidence in performing self-management behaviors. | Month 6 | 
| Summary of Diabetes Self-Care Activities (SDSCA) Score | 13-item questionnaire asking patients to describe their diabetes self-care activities over the past 7 days. Higher scores indicate a greater amount of diabetes self-care activities. | Baseline | 
| Summary of Diabetes Self-Care Activities (SDSCA) Score | 13-item questionnaire asking patients to describe their diabetes self-care activities over the past 7 days. Higher scores indicate a greater amount of diabetes self-care activities. | Month 3 | 
| Summary of Diabetes Self-Care Activities (SDSCA) Score | 13-item questionnaire asking patients to describe their diabetes self-care activities over the past 7 days. Higher scores indicate a greater amount of diabetes self-care activities. | Month 6 | 
| Adapted Mediterranean Dietary Screener Score | 14-item questionnaire measuring participants' adherence to the Mediterranean diet. Adherence scores are classified as low (0-7 points), moderate (8-10 points) and high (11-17 points). | Baseline | 
| Adapted Mediterranean Dietary Screener Score | 14-item questionnaire measuring participants' adherence to the Mediterranean diet. Adherence scores are classified as low (0-7 points), moderate (8-10 points) and high (11-17 points). | Month 3 | 
| Adapted Mediterranean Dietary Screener Score | 14-item questionnaire measuring participants' adherence to the Mediterranean diet. Adherence scores are classified as low (0-7 points), moderate (8-10 points) and high (11-17 points). | Month 6 | 
| International Physical Activity Questionnaire (IPAQ) Score | 7-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity. | Baseline | 
| International Physical Activity Questionnaire (IPAQ) Score | 7-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity. | Month 3 | 
| International Physical Activity Questionnaire (IPAQ) Score | 7-item self-assessment providing an estimate of the number of minutes per week participants engage in three categories of physical activity: vigorous activity, moderate activity, and walking activity. Results are expressed in metabolic equivalent (MET) minutes per week. MET minutes represent the amount of energy expended carrying out physical activity. Higher scores indicate higher weekly levels of physical activity. | Month 6 | 
| Minutes of Physical Activity as Measured by ActiGraph Watch |  | Baseline | 
| Minutes of Physical Activity as Measured by ActiGraph Watch |  | Month 3 | 
| Minutes of Physical Activity as Measured by ActiGraph Watch |  | Month 6 | 
| Minutes of Sleep as Measured by ActiGraph Watch |  | Baseline | 
| Minutes of Sleep as Measured by ActiGraph Watch |  | Month 3 | 
| Minutes of Sleep as Measured by ActiGraph Watch |  | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese Americans, SMS intervention