A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

Type2 Diabetes Clinical Trial

Official title:

A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557697
• Other study ID #: 18-00609
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 21, 2023

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type2 Diabetes

Intervention

Behavioral:
• 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
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Average Plasma Glucose Concentration measured by Hemoglobin A1c (HbA1c) Levels	HbA1c testing results abstracted from medical record.	Baseline, Month 3
Primary	Change in Average Plasma Glucose Concentration measured by Hemoglobin A1c (HbA1c) Levels	HbA1c testing results abstracted from medical record.	Baseline, Month 6
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Minutes of Physical Activity as Measured by ActiGraph Watch		Baseline
Secondary	Minutes of Physical Activity as Measured by ActiGraph Watch		Month 3
Secondary	Minutes of Physical Activity as Measured by ActiGraph Watch		Month 6
Secondary	Minutes of Sleep as Measured by ActiGraph Watch		Baseline
Secondary	Minutes of Sleep as Measured by ActiGraph Watch		Month 3
Secondary	Minutes of Sleep as Measured by ActiGraph Watch		Month 6