A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Behavioral: Standard of Care; Behavioral: SMS Intervention

• Registration Number: NCT03557697
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-04
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Study Start: 2021-03-01
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Results First Submitted: 2024-11-20
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Results First Posted: 2024-12-27
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
wait-list control	Standard of Care	3 measurement visits, baseline, 3, and 6 months
SMS intervention	SMS Intervention	3 measurement visits, baseline, 3, and 6 months

Primary Outcome Measures

Name	Time	Method
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels	Baseline, Month 6	HbA1c testing results abstracted from medical record.

Secondary Outcome Measures

Name	Time	Method
Change in Starting The Conversation Scale: Refined Grains	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Refined Grains subscale comprises 1 item in which respondents indicate how many cups of refined grains, on average, they ate each day in the past 30 days. The total score is estimation of average cups of refined grains consumed per day.
Change in Starting The Conversation Scale: Whole Wheat	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Whole Wheat subscale comprises 1 item in which respondents indicate how many cups of whole wheat, on average, they ate each day in the past 30 days. The total score is estimation of average cups of whole wheat consumed per day.
Change in Starting The Conversation Scale: Sugary Drinks	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Sugary Drinks subscale comprises 1 item in which respondents indicate how many cans of sugary drinks, on average, they consumed each day in the past 30 days. The total score is estimation of average cans of sugary drinks consumed per day.
Change in Starting The Conversation Scale: Starchy Foods	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Starchy Foods subscale comprises 1 item in which respondents indicate how many cups of starchy foods, on average, they ate each day in the past 30 days. The total score is estimation of average cups of starchy foods consumed per day.
Change in International Physical Activity Questionnaire (IPAQ) Score	Baseline, Month 6	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.
Change in Stanford Diabetes Self-Efficacy Scale Score	Baseline, Month 6	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). The total score is the sum of responses and ranges from 8-80; higher scores indicate higher levels of confidence in performing self-management behaviors.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The General Diet subscale comprises 2 items rated on a scale from 0-7. The total General Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Specific Diet subscale comprises 2 items rated on a scale from 0-7. The total Specific Diet score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Exercise subscale comprises 2 items rated on a scale from 0-7. The total Exercise score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Blood-Glucose Testing subscale comprises 2 items rated on a scale from 0-7. The total Blood-Glucose Testing score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Foot Care subscale comprises 2 items rated on a scale from 0-7. The total Foot Care score is the mean of the item responses and ranges from 0-14, with higher scores indicating better compliance.
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score	Baseline, Month 6	The SDSCA measures the frequency of diabetes self-care activities over the previous week across five domains of self-care. The Medication Adherence subscale comprises 3 items rated on a scale from 0-7. The total Medication Adherence score is the mean of the item responses and ranges from 0-21, with higher scores indicating better compliance.
Change in Starting The Conversation Scale: Fruits	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Fruit subscale comprises 1 item in which respondents indicate how many cups of fruits, on average, they ate each day in the past 30 days. The total score is estimation of average cups of fruit consumed per day.
Change in Starting The Conversation Scale: Vegetables	Baseline, Month 6	The Starting The Conversation Scale contains 6 items and asks respondents about the types of food they consumed in the past 30 days. The Vegetables subscale comprises 1 item in which respondents indicate how many cups of vegetables, on average, they ate each day in the past 30 days. The total score is estimation of average cups of vegetables consumed per day.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States