Type2 DiabetesNCT03557697
A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
A study testing SMS Intervention in people with Type2 Diabetes, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- SMS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 21 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Standard of Care, SMS Intervention
- Keywords
- Chinese Americans, SMS intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
SMS InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| wait-list control | Active comparator | 3 measurement visits, baseline, 3, and 6 months Receives: Behavioral: Standard of Care |
| SMS intervention | Active comparator | 3 measurement visits, baseline, 3, and 6 months Receives: Behavioral: SMS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
HbA1c testing results abstracted from medical record.
Measured: Baseline, Month 3
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
HbA1c testing results abstracted from medical record.
Measured: Baseline, Month 6
Secondary outcomes (32)
Change in 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). 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.
Measured: Baseline, Month 3
Change in 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). 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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
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.
Measured: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
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.
Measured: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Fruits
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 fruit, on average, they ate each day in the past 30 days. The total score is estimation of average cups of fruit consumed per day.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Fruits
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Vegetables
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.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Vegetables
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Refined Grains
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.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Refined Grains
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Whole Wheat
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.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Whole Wheat
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Sugary Drinks
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.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Sugary Drinks
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.
Measured: Baseline, Month 6
Change in Starting The Conversation Scale: Starchy Foods
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.
Measured: Baseline, Month 3
Change in Starting The Conversation Scale: Starchy Foods
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.
Measured: Baseline, Month 6
Change in 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.
Measured: Baseline, Month 3
Change in 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.
Measured: Baseline, Month 6
Change in Belief in Self-Management Score
Participants rated the importance of five self-care behaviors related to diabetes self-care-following a diabetic diet, exercising, self-monitoring blood glucose, taking medication, and checking their feet. Each behavior was rated on a 5-point Likert scale, where 1 indicated "not important" and 5 indicated "very important." The total score is calculated as the mean of the item responses and ranges from 1-5, with higher scores indicating greater belief in the importance of diabetes self-management.
Measured: Baseline, Month 3
Change in Belief in Self-Management Score
Participants rated the importance of five self-care behaviors related to diabetes self-care-following a diabetic diet, exercising, self-monitoring blood glucose, taking medication, and checking their feet. Each behavior was rated on a 5-point Likert scale, where 1 indicated "not important" and 5 indicated "very important." The total score is calculated as the mean of the item responses and ranges from 1-5, with higher scores indicating greater belief in the importance of diabetes self-management.
Measured: Baseline, Month 6
Change in Diabetes Distress Scale Score
This 17-item scale required participants to rate the extent to which each item was problematic for them in the past month, using a 6-point Likert scale ranging from 1 (no problem) to 6 (serious problem). The total score is the mean of the item scores and ranges from 1-6, with higher scores indicating a greater level of distress.
Measured: Baseline, Month 3
Change in Diabetes Distress Scale Score
This 17-item scale required participants to rate the extent to which each item was problematic for them in the past month, using a 6-point Likert scale ranging from 1 (no problem) to 6 (serious problem). The total score is the mean of the item scores and ranges from 1-6, with higher scores indicating a greater level of distress.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Mar 2021
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Lu Hu, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557697
- Sponsor's protocol ID
- 18-00609
- Other IDs
- 5R00MD012811-05
- Status last verified
- Jan 2025
- First submitted
- 4 Jun 2018
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 41144955Shi 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.
PubMed 40016380Hu 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.
PubMed 36306161
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
- ClinicalTrials.gov ID
- NCT03557697
- Acronym / sponsor ID
- 18-00609
- Conditions
- Type2 Diabetes
- Keywords
- Chinese Americans, SMS intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wait-list control | Active comparator | Behavioral: Standard of Care3 measurement visits, baseline, 3, and 6 months |
| SMS intervention | Active comparator | Behavioral: SMS Intervention3 measurement visits, baseline, 3, and 6 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of CareAt the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS | Behavioural | wait-list control |
| SMS InterventionParticipants 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. | Behavioural | SMS intervention |
Primary outcome
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
Time frame: Baseline, Month 3
HbA1c testing results abstracted from medical record.
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels
Time frame: Baseline, Month 6
HbA1c testing results abstracted from medical record.
32 secondary outcomes
Change in Stanford Diabetes Self-Efficacy Scale Score
Time frame: Baseline, Month 3
Change in Stanford Diabetes Self-Efficacy Scale Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score
Time frame: Baseline, Month 6
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
Time frame: Baseline, Month 3
Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Fruits
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Fruits
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Vegetables
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Vegetables
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Refined Grains
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Refined Grains
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Whole Wheat
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Whole Wheat
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Sugary Drinks
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Sugary Drinks
Time frame: Baseline, Month 6
Change in Starting The Conversation Scale: Starchy Foods
Time frame: Baseline, Month 3
Change in Starting The Conversation Scale: Starchy Foods
Time frame: Baseline, Month 6
Change in International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Month 3
Change in International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Month 6
Change in Belief in Self-Management Score
Time frame: Baseline, Month 3
Change in Belief in Self-Management Score
Time frame: Baseline, Month 6
Change in Diabetes Distress Scale Score
Time frame: Baseline, Month 3
Change in Diabetes Distress Scale Score
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41144955Liu 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.
- Derived from this study: PubMed 40016380Shi 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.
- Derived from this study: PubMed 36306161Hu 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Hu, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Intervention in people with Type2 Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels (time frame: Baseline, Month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03557697, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.