A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans
Phase: NA
Conditions: Type2 Diabetes
Sponsor: NYU Langone Health

Official Title: 
A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese 
Americans  
NCT Number:
NCT03557697
Study Number:
18-00609 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
October 10, 2022 

CARE Study Version 9.29.2022
1 
A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans 
Principal Investigator:  
 
Lu Hu, PhD 
                                        
 
NYU School of Medicine                                         
                                        
 
Department of Population Health 
                                        
 
180 Madison Ave 
                                        
 
New York, NY 10016                                                                 
                                        
 
646-501-3438 
 
 
 
        
 
lu.hu@nyulangone.org
 
Protocol Number: 
 
 
s18-00609 
 
 
Version #:  
Version 9.29.2022 
 
 

CARE Study Version 9.29.2022
2 
TABLE OF CONTENTS
1. Abstract 3
2. Purpose of the Study and Background 
4 
2.1 
Background ..........................................................................................................................................4
2.2 
Aims ......................................................................................................................................................... 5
3. Methods 5 
3.1  
Study Design ......................................................................................................................................... 5
3.2 
Sites ......................................................................................................................................................... 6
3.3. 
Characteristics of the Research Population..............................................................................6
4. Procedures
7
4.1   Patient Recruitment ............................................................................................................................... 7
4.2   Patient Consent ........................................................................................................................................ 8
4.3  Study Procedures ...................................................................................................................................... 9
5. Risk/Benefit Assessment 
13
5.1 
Potential Risks .................................................................................................................................. 14
5.2 
Benefits ............................................................................................................................................... 14
6. Confidentiality and Data Storage 
14
7. Data Analysis and Data Monitoring 15
7.1 Data Analysis ............................................................................................................................................ 15
7.2 Data Monitoring ...................................................................................................................................... 16
8. Investigators Qualifications 17
9. Study Records Retention and Data Sharing
17
10. References
18
 

CARE Study Version 9.29.2022
3 
1.
ABSTRACT
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. In the R00 phase, the candidate will utilize acquired skills to 
conduct a pilot randomized controlled trial to examine the potential efficacy of the SMS 
intervention.  In the K99 phase, the candidate will also conduct pilot work to develop linguistically 
and culturally tailored SMS intervention content and to refine the intervention to be tested in the 
R00 phase. 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 60 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). 
In Year 4 of this K99/R00 award (Year 2022), PI Dr. Lu Hu received additional pilot 
funding from Rutgers University to expand the goal of this study. Accumulating evidence shows 
that patients with T2D are more likely to have mental health issues, including depression, anxiety, 
eating disorders, diabetes distress, and other mental health issues than those without the 
disease.1 These mental health issues were often linked to suboptimal adherence to diabetes self-
care behaviors and poor glycemic control.2,3 Thus, there are increasing calls from national 
organizations such as the American Diabetes Association and the Association of Diabetes Care 
and Education Specialists to screen for mental health issues and integrate mental health in 
diabetes care.4,5 Yet, there is a dearth of data on the mental health burden among Chinese 
Americans with T2D. To address these important gaps, the goal of this Rutgers pilot project is to 
characterize the mental health burden and understand barriers to seeking mental health services 
in Chinese Americans with T2D. We are going to contact and consent participants from PI Dr. Lu 
Hu’ prior and current studies (K99, R00 Protocol Number: s18-00609; FAMILY Protocol Number: 
s19-01275)to administer surveys related to mental health and conduct focus groups with 
participants to gain a deeper understanding of barriers. K99 phase includes 2 pilots, the first pilot 
is qualitative focus groups with 20 participants, and the second pilot is about quantitative pre-, 

CARE Study Version 9.29.2022
4 
post-test evaluation with 30 participants. R00 phase is pilot RCT and sample size is 60. FAMILY 
study is also a pilot RCT, there are 23 pairs of participants: 23 T2D patients and 23 corresponding 
family members. In total, our target sample size for this Rutgers pilot project is 133 (50 from K99 
phase, 60 from R00 phase and 23 from FAMILY study). 
 
2.  
PURPOSE OF THE STUDY AND BACKGROUND 
2.1  
Background 
Chinese Americans are one of the fastest growing immigrant groups in the United States.6–
8 Multiple studies show that, compared to non-Hispanic whites, Chinese Americans suffer 
disproportionately higher rates of type 2 diabetes (T2D),9–13 have poorer self-management and 
glycemic control,14–18 and are at elevated risk of developing renal complications.19 Lack of 
culturally and linguistically sensitive healthcare providers and programs are the most commonly 
cited reasons for disparities in T2D care and health outcomes in Chinese Americans.20–23 High 
rates of limited English proficiency, poor access to healthcare and patient-provider communication 
barriers have played a critical role in prevention and management of T2D for this population.20–23
Given the substantial and growing limited English proficient Chinese American population in the 
United States and the continued rising prevalence of T2D, there is an urgent need to develop, 
culturally-adapt, and test evidence-based interventions for diabetes control in this population.24
Diabetes self-management education and counseling programs have been widely 
recognized as effective strategies to promote diabetes self-management and improve glycemic 
control.25,26 However, these programs are usually labor-intensive and especially challenging to 
implement in real world settings, because T2D patients only have limited time (e.g., 10-15 mins) 
with their clinicians during scarce clinical encounters.27,28 When language and cultural barriers 
come into play for Chinese immigrants, the lifestyle counselling at clinical settings is even more 
difficult.20,22,23,29,30 Given high rates of mobile technology usage among Chinese American 
communities,31–33 an intervention program based on mobile technology has unprecedented 
advantages for engaging patients with lifestyle changes in real time and in their natural settings 
(e.g., at homes).34–36 Emerging evidence shows that a text message-based approach (e.g., SMS, 
short message service) is a potentially low-cost, sustainable, and scalable strategy to deliver 
targeted and consistent diabetes education and support.37–39 While evidence demonstrates 
effectiveness of SMS interventions in young or middle aged adults,40 their efficacy or effectiveness 
remains untested in Chinese Americans with T2D, who often are older (~60 years old)  and are 
limited English proficient.13 
This K99/R00 study provides a unique opportunity to address this knowledge gap. In the 
K99 phase, we will conduct qualitative interviews to characterize barriers and facilitators of 
glycemic control in Chinese Americans with T2D (Aim 1a). Findings from these interviews will 
inform the cultural tailoring of the intervention content. Then we will develop the SMS intervention, 
which includes brief lifestyle counseling videos sent to participants via SMS links (Aim 1b). We 
will assess the feasibility and acceptability of the SMS intervention in a 3-month, single group pre-, 
post-test study among 30 Chinese Americans with T2D (Aim 1c). In the R00 phase, we will refine 
the intervention based on the K99 pilot data and evaluate the proof-of-concept regarding its 
efficacy in a pilot randomized controlled trial among 60 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.   
For the Rutgers mental health pilot, we will leverage participants in the K99, R00 phase 
(s18-00609), and FAMILY (s19-01275) studies (N=133), and add some mental health-related 
questions to understand the mental health burden in Chinese immigrants with T2D. To understand 
barriers to accessing mental health services, we will conduct two focus groups (n=10-16) with 
Chinese immigrants with T2D to gain a deeper understanding of barriers to mental health services.   
 

CARE Study Version 9.29.2022
5 
2.2
Aims 
 
K99 phase
Primary Aim 1a: Characterize barriers and facilitators of glycemic control in Chinese Americans 
with T2D 
Primary Aim 1b: Develop culturally and linguistically tailored SMS intervention content  
Primary Aim 1c: Assess the feasibility and acceptability of the SMS intervention 
R00 phase 
Primary Aim 2a: Establish the proof-of-concept regarding the efficacy of the SMS intervention 
for glycemic control in Chinese Americans with T2D 
 
Exploratory Aim 2b:  Explore the potential effects of the SMS intervention on psychosocial and 
behavioral factors in glycemic control. 
Rutgers Mental Health Pilot  
Exploratory Aim 2c: Examine current mental health burden and psychosocial support and how 
they are related to diabetes self-care behaviors and glycemic control in Chinese Americans with 
T2D (via validated surveys) 
Exploratory Aim 2d: Characterize barriers to accessing mental health services and understand 
needs and preferences in Chinese Americans with T2D (via focus groups) 
3.     METHODS AND PROCEDURES 
3.1  
Study Design 
K99 Phase  
Qualitative focus groups/interviews (N=20): We will conduct focus groups/interviews to 
understand barriers and facilitators of glycemic control in Chinese Americans with T2D and to 
develop culturally and linguistically tailored SMS intervention content.  
 
Quantitative pre-, post-test evaluation (N=30): We will assess the feasibility and acceptability 
of the SMS intervention in a 3-month, single group pre-, post-test study among 30 Chinese 
Americans with T2D. 
 
R00 Phase
Pilot RCT (N=60): Participants will be randomized to one of 2 arms (n=30 each): 1) wait-list 
control; or 2) SMS intervention. We will evaluate changes in HbA1c at baseline, 3-, and 6-
months. In exploratory analyses, we will test mediators (e.g., self-efficacy, diabetes self-
management behaviors, diet intake, and physical activity). 
Rutgers Mental Health Pilot  
Cross-sectional quantitative survey (N=133): We will contact the participants from K99, R00 
phase (s18-00609), and FAMILY study (s19-01275) to ask whether they are interested in joining 
this mental health pilot and answering a few additional questions. Our target goal is 133. As of 
9/28/2022, all participants from K99, R00 and FAMILY completed their assessments, intervention 
and participation with us. We will administer this mental health survey once this pilot modification 
was approved by the IRB. This will be a one-time survey administration because the goal of the 
pilot was to get a snapshot of the mental health burden in Chinese Americans with T2D. We are 

CARE Study Version 9.29.2022
6 
not examining changes over time in mental health, thus, we will not repeat the survey at 3 or 6 
months.  
Qualitative focus groups (N=10-16): Guided by the NIMHD Research Framework,41 we will assess 
facilitators and barriers to accessing mental health services in Chinese Americans with T2D. We 
will explore factors on multiple levels, including individual, interpersonal, community, health 
system, and societal levels. We will select 10-15 participants based on their survey responses 
(who reported elevated stress, anxiety, or depressive symptoms) to join the focus groups (2 focus 
groups; 5-8 participants per group) to gain a deeper understanding of barriers to utilizing mental 
health services. We will also ask participants’ preferences for mental health support (e.g., 
individual vs. group-based, in-person vs. phone vs. video-based).
3.2 
Sites 
The study will be conducted at the Charles B. Wang Community Health Center (CBWCHC), a 
federally qualified health center located in both Manhattan Chinatown and Queens Flushing 
Chinatown. In 2015, it provided a total of 275,749 service visits to 50,008 underserved Asian 
Americans in Greater NYC. The majority of patients are Chinese. CBWCHC is one of the largest 
and leading community centers in NYC, having established a trusting relationship with the 
Chinese American community. In 2016, approximately 5,000 patients with T2D were seen at the 
CBWCHC; the vast majority of them are Chinese.  
CBWCHC will not be engaged in research activities and their role is to identify/refer patients and 
provide space for this study. All research related activities (e.g. recruitment, consenting, 
conducting study procedures) will be performed by NYU study staff. The letter of support has 
been uploaded in the attachment section.  
To maximize recruitment efforts, we will also identify potential private practices or community 
based organizations in Chinatown areas and work with them to recruit potential participants. In 
addition, we will identify and recruit participants into the study from NYU Langone Health. Similar 
to the procedures at CBWCHC, all of the research related activities (e.g. recruitment, 
consenting, conducting study procedures) will be performed by NYU study staff. The role 
of NYU Langone Health, these private practices or community-based organizations is to 
help to identify/refer patients and/or provide space for this study.  
 
3.3.  
Characteristics of the Research Population 
Phase 1: K99 Phase Feasibility Study Inclusion criteria: To be eligible for the study, 
participants must: 1) self-identify as Chinese Immigrant or Chinese American; 2) be 18-75 years 
old, 3) be able to speak and understand Mandarin; 4) self-report a diagnosis of T2D; 5) know how 
to do a finger stick blood sugar test;  6) be willing to do a finger stick blood glucose test for each 
study visit; 7) baseline HbA1c  7%; 8) be currently using WeChat; 9) be willing to receive WeChat 
messages regarding T2D management, 9 10) express strong interest and confidence in finishing 
watching 2 diabetes videos each week for a total of 12 weeks; 11) be motivated to make lifestyle 
changes to control their diabetes.  
Phase 1: K99 Phase Feasibility Study Exclusion criteria: Individuals will be excluded from 
participation if they meet any of the following:(1) unable or unwilling to provide informed consent; 
(2) unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing 
impairment); (3) unwilling to accept randomization assignment; (4) pregnant, plans to becomes 
pregnant in the next 6 months, or who become pregnant during the study, or (5) breastfeeding or 

CARE Study Version 9.29.2022
7 
(6) live in a facility or other health care setting where they have no control over diabetes self-
management. 
Phase 2 R00 Phase pilot RCT Inclusion criteria: To be eligible for the study, participants must: 
1) self-identify as Chinese Immigrant or Chinese American; 2) be 18-70 years old, 3) be able to 
speak and understand Mandarin; 4) self-report a diagnosis of T2D; 5) baseline HbA1c  7%; 6) 
be currently using WeChat or text messages; 7) be willing to receive WeChat or text messages 
regarding T2D management, 8) express strong interest and confidence in finishing watching 2 
diabetes videos each week for a total of 12 weeks; 9) be motivated to make lifestyle changes to 
control their diabetes; 10) be willing to wear ActiGraph for 8 days.  
Phase 2 R00 Phase pilot RCT Exclusion criteria: Individuals will be excluded from participation 
if they meet any of the following:(1) unable or unwilling to provide verbal consent; (2) unable to 
participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment); (3) 
unwilling to accept randomization assignment; (4) pregnant, plans to becomes pregnant in the 
next 6 months, or who become pregnant during the study, or (5) breastfeeding or (6) live in a 
facility or other health care setting where they have no control over diabetes self-management. 
Rutgers Mental Health Pilot: For the quantitative survey, because we will call K99, R00 phase 
(s18-00609), and FAMILY study (s19-01275)  participants, the inclusion and exclusion criteria will 
be the same as each parent study. In addition, participants are eligible to participate in this pilot if 
they are willing to answer additional mental health related questions. For the focus group 
participants, we will review the mental health survey responses from participants and invite those 
who reported elevated stress, anxiety or depressive symptoms to join the focus group discussion.  
 
4.    PROCEDURES 
4.1   Patient Recruitment 
Participants will be identified and recruited into the study from NYC health care facilities, 
including CBWCHC, private practices, community-based organizations, and NYU Langone 
Health and affiliated provider practices. 
 
We will recruit participants using the following methods:   
a.  Posters.  Posters will be placed in NYC health care facilities waiting and examination 
rooms.  Posters will list a contact telephone number that patients can call if interested in 
enrolling.  Patients who self-refer will be screened for eligibility. Posters will also be placed in 
Chinese community centers (e.g., senior centers) and distributed during Chinese community 
events. Posters will also be posted electronically on WeChat, which is a popular chatting 
smartphone application among Chinese Americans and Chinese Immigrants.  
b.  Direct referral by health care providers.  CBWCHC, NYU Langone Brooklyn site 
providers, and private practice health care providers will approach patients who are potentially 
eligible for the study, solicit their interest in the study. If patients express verbal interest in the 
study participation, their health care providers will share the patient’s contact information with 
the study staff, or patients will also be able to call (self-refer to) to the number provided in the 
recruitment flyer and speak with a study staff if they are interested in participating. Study staff 
will call the patient and with the patient’s verbal consent the staff will conduct a quick phone pre-
screening to confirm eligibility prior to study enrollment. Dr. Qiuqu Zhao is the medical director 
at NYU Brooklyn Family Health Center. We are collaborating with Dr. Zhao and her team at 
NYU Brooklyn. They would help refer potential study participants that are eligible and interested 
in our study. The initial referral list from health care providers will only include patient’s name 
and phone number for those verbally expressed interest in the study. After verbal consent is 
obtained and documented, the study staff will request the patient’s medical information from the 

CARE Study Version 9.29.2022
8 
medical record. 
c. Registry lists. From our previous study, we have created a registry list of potential 
participants who indicated interest in future studies from NYU School of Medicine. We will call 
participants from the registry list, explain the study, and assess the eligibility to participate.  
d. EPIC and DataCore. We will work with DataCore to generate a report to identify 
potentially eligible subjects across NYU Langone Manhattan, Brooklyn, and Long Island 
campuses. Using a query, search will be conducted in EPIC to identify Chinese patients aged 
18-70 and with type 2 diabetes whose most recent HbA1c value  7%. The report will also 
include demographics including patient name, gender/sex, date of birth, address, phone 
number, weight, height, BMI, name of primary care physician, most recent HbA1c value and 
date of measurement. Only the principal investigator and all members of the research team will 
have access to this report. The report will be generated prior to the recruitment process to help 
us find potential participants. The report will be kept on a secure electronic NYU research drive 
to ensure the confidentiality of health information and identifying information from potential 
participants. These patients will receive a mailing describing the study and letting them know 
how they can opt out of further contact. The study staff will call eligible patients who have not 
opted out to describe the study, complete the brief eligibility screener and offer enrollment. 
While screening potential participants by telephone, demographics and the most recent HbA1c 
value will be confirmed or updated.  
 
4.2   Patient Consent 
The NYU study staff will be recruiting and consenting the participant by reading the approved 
telephone verbal consent script to the participant. The study staff will first complete a brief 
phone screener to screen whether or not the participant is eligible. Once eligibility is confirmed, 
the study staff will discuss with the patient what active participation in this study means (review 
verbal consent, interviews, potential benefits, and risks of participations), the purpose and 
limitations of the study, and requirements of the study. If the patients verbally agree to 
participate, the patient’s primary care physician will also be notified that the patient is being 
enrolled in this study. The verbal consent process will be audiotaped with the patient’s 
permission. The verbal consent is an accommodation due to the rising COVID-19 infection rate 
in New York, and that the target population for this study is low-income aging immigrants with 
limited education and low digital literacy. All interventions will be conducted via phone or text 
message. A waiver of documentation of consent has been requested. 
The study team has requested a waiver of signed HIPAA authorization and all HIPAA 
information will be presented verbally. Under the HIPAA section, we will explain the potential 
risks of WeChat platforms. Participants can decide on their own whether they would like to 
continue to participate.  
 
An IRB-approved verbal consent script will be used and will include the HIPAA and audio 
recording information, the subject will verbalize comprehension of the consent form and study 
enrollment. The consent process will be recorded via audio the consent and the date of consent 
will be documented on the Enrolled Participants Log. The Enrolled Participants Log is the only 
record linking a participant’s name and Subject ID, this information will be kept on a secure 
electronic drive to ensure the confidentiality of health information and identifying information 
from participants. Only the principal investigator and all members of the research team will have 
access to this information and the audio recordings of their verbal consent.  
 
We will have the verbal consent script available in both English and Chinese. The participant 
can choose their own preferred language and our bilingual study staff will explain the study to 

CARE Study Version 9.29.2022
9 
the participant. The participant will be encouraged to ask any questions they may have before 
providing the verbal consent.  
After verbal consent is obtained, we will ask patients if we can send them via text message a copy 
of the key information sheet for their records before we collect any data from them. 
 
The Informed Consent is a continuous and dynamic process, all participants will be reminded at 
every phone call about the A/V recordings, study assessments and that they are free to withdraw 
at any time. 
For the Rutgers Mental Health Pilot study, we will use an IRB-approved verbal consent to ask 
whether the K99, R00 phase (s18-00609), and FAMILY study (s19-01275) participants are willing 
to join this pilot and answer a few additional questions about their mental health. The consent 
process will be recorded via audio.  
4.3  Study Procedures 
Our NYU study staff will be conducting ALL of the following study procedures.  
4.3.1 K99 Phase Patient Focus Groups/Interviews Procedures 
We will recruit a convenience sample of 20 Chinese Americans with T2D from the CBWCHC, and 
conduct 4-5 focus groups, with 4-5 participants per group. Focus groups will be held at a private 
and quiet location at the CBWCHC. Focus groups will be audio-recorded and transcribed. Using 
a semi-structured interview guide, a trained interviewer will use open-ended questions and follow-
up probes to understand barriers to and facilitators of diabetes self-care in their daily life. 
Patients will be paid $30 for participating in the focus groups. We will transcribe audio recordings 
verbatim. Transcriptions of audio recordings will be stored separately from signed consent and 
authorization forms.  
4.3.2  K99 Phase Pre-, Post-Test Evaluation Procedures 
We will conduct a 3-month, single group, pre-, post-test study to assess the feasibility and 
acceptability of the SMS-based diabetes video counseling. We will recruit a randomly selected 
sample of approximately 30 Chinese Americans with T2D from the CBWCHC or private practices 
or community centers.  
We will first conduct phone screening for the interested participants. After they pass the phone 
screening, we will schedule the first baseline visit. During the baseline visit, the study staff will first 
explain the study and consent form to the participants. After the consent form is signed, study 
staff will ask participants to perform a finger stick to check their HbA1c levels. If the A1c level is 
greater or equal to 7%, the study staff will continue with the study survey. Otherwise, study staff 
will thank participants for their interest and time and pay $30 for their time.  
For those who are eligible to continue to participant, they will be asked several survey questions 
and then subscribed to our diabetes videos. They will receive 1-2 SMS-based counseling videos 
every week for 12 weeks (each video is about 5-10 minutes in duration).  HbA1c will be assessed 
at baseline and again at 3 and 6 months. At the end of the 3-month intervention, we will conduct 
focus groups with participants to assess the feasibility and acceptability of SMS-based video 
sessions, perceived usefulness of the video sessions, and recommendations for improvement. 
All of the focus group interviews will be recorded and transcribed. Acceptability will also be 
assessed by a satisfaction questionnaire used in a prior study. Changes and refinements will be 
made to the preliminary intervention content and delivery based on the feedback, which will be 
tested in the R00 study. We will also help participant to set goals for their diabetes management 
and then have biweekly phone call follow-ups to check in their progress toward the goal and 

CARE Study Version 9.29.2022
10 
problem solve any raised questions/concerns. 
Patients will be paid $30 for completing baseline visit and $30 for completing 3-month and 6-
month follow-ups. At the end of 3-month intervention, we will host 2 focus group discussions to 
understand their experience with our study. One focus group will invite highly engaged 
participants, defined as who have watched at least 60% of the diabetes videos. The other focus 
group is with poorly engaged group, defined as participants who have watched less than 60% of 
the videos. For those participated in the focus group discussion, they will receive $30 for their 
time and participation.  
We will reimburse $5 each week to each participant for cell phone data usage if they finish viewing 
both of the sent videos for that week. Given that we will send videos over a total of 12 weeks, 
participants may expect to receive a range of $0-$60 (=$5*12) depending on the number of weeks 
they have completed the videos.   
Due to COVID-19, we will conduct the 3-month and 6-month survey over the phone. For the 3-
month weight measurement, we will ask participants to weigh themselves at home if they have a 
scale at home. For those who do not have scales at home, this will be treated as missing data.  
4.3.3  R00 Phase Pilot RCT Procedures 
The R00 phase study is a pilot randomized controlled trial (RCT) of 6 months duration. 
Participants will be randomized to one of 2 arms (n=30 each): 1) wait-list control; or 2) SMS 
intervention. The study will include 3 measurement visits, baseline, 3, and 6 months. Patients 
will be paid $30 for each measurement visit.  
 
Upon receiving the referral list (interested patient’s name and phone number) from the 
providers, the bilingual study staff will call the patient and provide more details about the study. 
If patients expressed interest in participation, the study staff will administer several screening 
questions over the phone. After eligibility is determined and verbal consent is obtained, we will 
collect baseline surveys over the phone and randomize them via a computer-generated 
randomization scheme with equal allocation to one of the 2 groups: 1) wait-list control; or 2) 
SMS.  
 
Independent variable: randomization arm
Wait-list control group: All participants will continue to receive the standard of usual care for
their T2D at their providers’ office during the course of our study. At the end of the study, the 
wait-list control group will be provided the opportunity to receive the counseling videos delivered 
to them via SMS links.   
 
SMS intervention: Participants in the intervention group will receive SMS-based video 
counseling, which include both educational and SCT-based behavioral content (see Table 1 
below for a tentative outline of the intervention content). Given the system and personal 
barriers, we believe this SMS-based approach will improve access to culturally and linguistically 
tailored diabetes counseling. Additionally, this approach will allow participants to review the 
videos later on or share with their loved ones who often want to be supportive but do not know 
how. We will send 2 videos each week for a total of 12 weeks with each video about 5-10 
minutes in duration. The videos will be sent via WeChat or regular text messages (SMS). We 
will contact participants mainly through phone calls from an NYU Langone Study 
Phone. WeChat will be only used to send the health education videos. No other communication 
will occur via WeChat. Our study team will remind participants at the beginning of the study and 

CARE Study Version 9.29.2022
11 
during the bi-weekly phone calls about not sending any Protected Health Information via 
WeChat. In addition, our education videos do not contain any Protected Health Information and 
it will teach participants about diet, exercise, and stress management in general. We will ask 
participants’ permission to use WeChat platform and advise that sending messages over an 
unsecured application like WeChat is an unsecure and unencrypted form of communication and 
there is a potential risk of disclosing information to an individual who is not authorized to receive 
it (unauthorized disclosure).   
 
We will also let participants know that they can still participate in the study if they decline to 
receive the health education videos on WeChat. As an alternative, we will send the education 
videos as regular text messages to their phones. They can decline at any time during the study 
to receive the videos on WeChat and then we will switch to regular text messages.  
 
We will also help participants to set goals for their diabetes management and then have 
biweekly phone call follow-ups to check in their progress toward the goal and problem solve any 
raised questions/concerns.  
 
Procedures: The study will include 3 measurement phone calls, baseline, 3, and 6 months. 
Patients will be paid $30 for each measurement call. Due to COVID-19, all data will be collected 
over the telephone. Each survey calls will include audio/Video recordings if verbal consent from 
the study participants was obtained.  For participants randomized to the SMS intervention 
group, we will reimburse $5 each week to each participant for cell phone data usage if they 
finish viewing both of the sent videos for that week. Given that we will send videos over a total 
of 12 weeks, participants may expect to receive a range of $0-$60 (=$5*12) depending on the 
number of weeks they have completed the videos. We will also provide $60 to control 
participants if they finish all study related procedures at 3 months assessment.  
Study Variables 
Table 1: Tentative Outline of the Intervention Content
Sess.
#
Education Materials 
Social Cognitive Theory-Based Behavioral Materials 
1
Overview of diabetes, self-management
Setting goals; Establishing the relevance of behavior change.
2 
T2D diet, healthy eating, portion control
Self-Reward. Turning goals into habits. 
3 
Glucose self-monitoring
Social support.  Developing and working your social support 
network
4
Medication management
Problem solving: Barriers and setbacks.  Problem solving model.
5
Exercise and diabetes; home exercise demo
Problem solving: Behavioral triggers and stimulus-control 
6
Attending doctor appointments 
Problem solving: Lapse and Relapse 
7
Chinese holidays and eating at restaurants
Problem solving: Coping with lapses and setting new goals
8
Stress and T2D
Problem solving: Stress management.  
9
Grocery shopping demo at Chinese grocery store
Problem solving: Cutting carbohydrates and finding replacements 
10
Healthy cooking demo for a Chinese diet
Problem solving: Eliminating negative self-talk
11
Navigating the US healthcare system
Problem solving: Cravings for white rice, noodle, bun, dumplings etc 
12
Review of lifestyle recommendations
Problem solving: Anticipating high-risk situations
covariates

CARE Study Version 9.29.2022
12 
Figure 1. Conceptual Model 
 
Primary & Exploratory Outcomes  
Primary outcome: HbA1c: As part of the usual care, patients with T2D receive a HbA1c blood 
test at their doctors’ office every 3-6 months. To minimize participants’ burden, we will not conduct 
additional blood tests for this study. Instead, we will abstract the HbA1c testing results from the 
medical record at the participant’s health care facility. Once we obtain the consent from 
participants,  we will contact their doctors’ offices for HbA1c results.  
 
Secondary outcomes: Consistent with our conceptual model (Fig. 1), we will also measure self-
efficacy, diabetes self-management behaviors, dietary intake, and physical activities at each time 
points (baseline, 3-, and 6-months). All of these scales have been used and validated in the 
Chinese population. 
1. Self-efficacy: We will use the well-validated Stanford Diabetes Self-Efficacy Scale42 to 
measure participants’ confidence to manage T2D. This instrument contains 8 items and asks 
participants to rate their confidence level in performing specific self-management behaviors, 
using 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident).  
2. Diabetes Self-Management Behaviors: We will administer the adapted Summary of 
Diabetes Self-Care Activities (SDSCA) measure43 to assess participants’ adherence to 
diabetes self-management behaviors. This scale consists of 13 items and asks participate to 
describe their diabetes self-care activities over the past 7 days.  
3. Dietary Intake: Informed by a previous study in Chinese Americans,44 we will use the adapted  
Mediterranean Dietary Screener45 to estimate dietary intake behaviors in our participants at 
baseline, 3- and 6-months.  
4. Physical Activity: We will use the International Physical Activity Questionnaire (IPAQ)46,47
short version to assess the frequency and duration of various physical activities undertaken 
by adults over the past 7 days. This scale will provide an estimate of the number of minutes 
per week participants engage in each category of physical activity (e.g., vigorous, moderate, 
and mild intensity). We will also use the ActiGraph to objectively measure physical activity and 
sleep. Our study staff will distribute and collect the device to participants once they are eligible 
for the study. Once we receive the device, we will download the data. 
 
 
Covariates: Sociodemographic, health characteristics, and acculturation. We will use a 
sociodemographic questionnaire to collect basic information about the participant such as age, 
gender, education, income, duration of residence in the US, health insurance, the diabetes 
medication regimen, duration of T2D, and medical history. Informed by prior literature, we will also 
include surveys to measure Health Beliefs, Diabetes Knowledge, Diabetes Distress, Social 
Support, Mental Health, the Impact of COVID-19, and memory test, which also play essential 
roles in diabetes management.  
Interventions: 
 
Wait-list control 
SMS
Behavioral changes
 
Diabetes self-management behaviors 
 
Dietary intake
Physical activity
Glycemic control
(HbA1c) 
Self-efficacy

CARE Study Version 9.29.2022
13 
Rutgers Pilot Mental Health and Psychosocial Related Surveys: Accumulating evidence 
shows that patients with T2D are more likely to have mental health issues, including depression, 
anxiety, diabetes distress, and other mental health issues than those without the disease. We will 
add several mental health and psychosocial related surveys and administer this survey to the 
study participants via telephone at one survey only.. This survey phone call will not be audio or 
video recorded but the consent process will be audio recorded.   We are going to use validated 
measures to assess general stress,48,49 acculturation,50 minority stress (discrimination),51
symptoms of depression,52,53 anxiety,54 loneliness,55social support,56,57 stigma towards mental 
health58, mindfulness59, 60, and mental health seeking behaviors. See Table 2 below. We will 
provide a $20 clincard incentive to participants who complete this survey with us.  
Rutgers Pilot Focus Groups (N=10-16): We will select 10-15 participants based on their mental 
health survey responses to join the focus groups (2 focus groups; 5-8 participants per group) to 
gain a deeper understanding of barriers to utilizing mental health services. Participants who 
reported elevated stress, anxiety or depressive symptoms will be invited for this focus group 
discussion. We will collect their AV consent to record the focus group discussion. We will also ask 
participants’ preferences for mental health support (e.g., individual vs. group-based, in-person vs. 
phone vs. video-based). Participants will receive additional $20 clincard incentive for their time. 
We will submit the interview guide as a modification later.  
 
Table 2. Mental health and psychosocial related surveys 
 
Variables
Surveys/Scales
Any Adaptations? 
General stress
Perceived Stress Scale
Validated scale
Acculturation  
Short Acculturation Scale for 
Hispanics 
Adapted from the Hispanics 
version. In the response 
options, we changed 
“Spanish” to “Chinese”. 
Minority stress 
Everyday Discrimination 
Scale
Validated scale 
Depressive symptoms
PHQ-9
Validated scale
Anxiety  
Hospital 
Anxiety 
and 
Depression Scale (HADS)
Validated scale 
Loneliness 
Revised UCLA Loneliness 
Scale
Validated scale 
Social support 
Social support Availability
Online social support 
Validated scales 
Stigma towards Mental Health Perceived Devaluation and 
Discrimination Scale
Validated scales 
Current and Past Mental 
Health Seeking Behaviors
Self-developed  
Investigator developed  
Mindfulness 
FFMQ-15
Validated scales 
5.         RISK/BENEFIT ASSESSMENT 

CARE Study Version 9.29.2022
14 
5.1
Potential Risks
Risks of participation in this study are minimal and unlikely to occur given the safeguards in 
place. Psychological risks include: 1) the possibility that some participants may perceive some 
questionnaire or background data assessment as intrusive or causing them to feel 
uncomfortable; 2) breach of confidentiality. The study involves an intervention designed to 
enhance adherence to standard diabetes care (e.g., adherence to the prescribed diabetes 
medication, healthy eating, and physical activity behaviors). If our intervention improves 
adherence to the medication regimen or if participants make lifestyle changes (e.g., increased 
physical activity), more episodes of hypoglycemia may result. We will advise participants of the 
importance of monitoring their blood sugar as suggested by their doctors, and to contact their 
doctors as soon as they experience low blood sugar. 
There is also a potential risk for breach of confidentiality on WeChat. To minimize the risk, we 
will remind participants that they should call our study phone number for any questions related 
to the study participation. WeChat will only be used to send education videos. No 
communication will occur via WeChat. Also, we will remind them at the beginning of the study 
and during the bi-weekly phone calls about not sending any Protected Health Information via 
WeChat. In addition, our education videos do not contain any Protected Health Information and 
it will teach participants about diet, exercise, and stress management in general. Based on our 
recent completed pilot study (a similar WeChat video study in 30 Chinese immigrants), we did 
not observe any breach of privacy or confidentiality. All of the study team members received 
sufficient training on protecting privacy and confidentiality and have extensive experience in 
working with this hard-to-reach immigrant population. The benefits of receiving these culturally 
and linguistically tailored education videos outweighed the risks.  
 
 
5.2 
Benefits 
We do not anticipate that participants will receive any direct benefit from participating. However, 
information learned during the study may produce benefits for future patients by improving their 
diabetes care.  
 
6.  CONFIDENTIALITY AND DATA STORAGE 
We will use the IRB recommended RedCap for data storage (openREDCap.nyumc.org). We will 
also work with MCIT to set up a NYU shared network drive which is HIPAA compliant (for offsite 
backup storage) specifically for our study. All study personnel have already taken the mandatory 
HIPAA and Patient Privacy/Confidentiality training modules required by our institutional IRBs, to 
ensure that they are aware of the importance of patient confidentiality and all appropriate laws 
regarding protection against privacy breaches. Procedures will be in place to ensure that all files 
containing subject information will be kept in locked filing cabinets or password-protected 
electronic databases on a secure server. The majority of study data and all interview transcripts 
will be maintained in electronic files with no patient identifiers other than a study ID number; 
there will be one file maintained separately with its own password protection that links study ID 
numbers to patient identifying information.  
No identifiable information about study participants will be disclosed to individuals outside those 
approved by the IRB to be on the study protocol. No publications that result from the study will 
identify individual participants. 
 

CARE Study Version 9.29.2022
15 
Transcript files will also be password-protected and user-restricted. We will delete potential 
identifiable information from transcripts and audio recordings one year after the study ends. We 
will also encourage participants to use pseudonyms during focus groups and/or interviews. 
During each focus group or interview session, the study PI will emphasize the importance of 
privacy and confidentiality of the discussion within the group. The text-message-based video 
counseling will be protected via password-enabled access. Only study participants will have 
access codes to open these videos. Others in the same household would not be able to open 
the video, unless participants choose to share the access code.  
7.
DATA ANALYSIS AND DATA MONITORING
7.1 Data Analysis 
K99-phase Aim 1: All focus groups will be audio-recorded and transcribed verbatim into Microsoft 
Word. Atlas will be used to store, organize, retrieve, and analyze the qualitative data. Thematic 
analysis will be used to analyze qualitative data.61 To establish coding reliability, the RA and PI 
will independently code up to 10% of the transcripts and identify kappa coefficient.62 We will meet 
weekly to review definitions and assignment of codes, and resolve differences through consensus. 
If no agreement can be made, the study team will be consulted. The RA and PI will read all 
transcripts and develop an open coding schema based on emergent theses. We will present 
coding schemes to study team, discuss emergent themes, refine codes, and develop a codebook 
that consists of a list of categories and topics. Once all data have been coded based on the 
codebook, codes most relevant to the research questions will be subject to further analysis. For 
the quantitative data, a paired t-test will be used to determine pre-post change in HbA1c. 
Descriptive statistics will be used to summarize participants’ satisfaction with the SMS intervention.  
R00-phase Aim 2: We will employ the “intent to treat” (ITT) approach in analyses. We will perform 
a detailed descriptive analysis of all the data collected in the study. These preliminary descriptive 
statistics will be used to 1) check accuracy and completeness of inputted data, 2) describe 
univariate distribution of each variable at baseline, and 3) examine the associations between 
variables. We will also explore features of the data (e.g., amount and pattern of missing data, 
outliers, excess zeros, departures from distributional assumptions) to determine whether special 
techniques are needed.  
Aim 2a: Establish the proof of concept regarding the efficacy of the SMS intervention for 
glycemic control in Chinese Americans with T2D. We will test whether the 2 groups are 
comparable on baseline sociodemographic, health characteristics, and levels of acculturation. If 
significant differences are found, we will include the variables as covariates in the models. 
Between group and group by time interaction effects will be examined graphically and via linear 
mixed modeling for HbA1c. Calculated effect sizes will be used for sample size estimation needed 
for a two-sided alpha of 0.05 and power of 0.80 for the larger scale R01 study. 
  
Exploratory Aim 2b: Explore the potential effects of the SMS intervention on psychosocial 
and behavioral factors in glycemic control. For continuous secondary outcome variables (self-
efficacy, adherence, and dietary data), linear mixed modeling will be used to examine the group 
and group by time interaction effects for each outcome at 3- and 6-months. For the physical 
activity data, we will use a GEE logistic model to examine whether there are group differences in 
the proportions of participants achieving 150 minutes/week of physical activity at any level of 
intensity and at a moderate- or greater intensity level.  
 
Rutgers Mental Health Pilot 
Aim 2c: Examine current mental health burden and psychosocial support and how they 
are related to diabetes self-care behaviors and glycemic control in Chinese Americans with 

CARE Study Version 9.29.2022
16 
T2D. We will use descriptive statistics to summarize mental health burden and psychosocial 
support in Chinese immigrants with T2D. We will describe the percent of the sample who has 
elevated stress, anxiety and depressive symptoms and the current social support and coping 
strategies. We will also use correlation to examine the relationships between the mental health 
burden and diabetes self-management behaviors and HbA1c (measured in R00 study).  
Aim 2d: Characterize barriers to accessing mental health services and understand needs 
and preferences in Chinese Americans with T2D. Similar to the analytic approach used in the 
K99 Aim 1 analyses, all focus groups will be audio-recorded and transcribed verbatim into 
Microsoft Word. Atlas will be used to store, organize, retrieve, and analyze the qualitative data. 
Thematic analysis will be used to analyze qualitative data.59
7.2 Data Monitoring  
The purpose of the data safety monitoring plan is to ensure the safety of subjects and the 
validity and integrity of the data. Data and safety monitoring will be the shared responsibility of 
all members of the research team. Personnel involved in monitoring activities will include:  
 
Dr. Mary Ann Sevick, ScD (co-ivestigator). Professor of Population Health at NYU 
School of Medicine (NYUSoM).  
 
Dr. Lu Hu, PhD, PI, Dr. Hu has worked as a graduate student researcher on several 
NIH-funded projects during her doctoral training and participated in the data and safety 
monitoring meetings. During her current postdoctoral training, she is also actively 
participating in Dr. Sevick’s project meetings, including data and safety monitoring 
meetings. Dr. Hu has received intensive training in human subjects research. Dr. Hu will 
be responsible for data safety monitoring of the overall study and Dr. Sevick will provide 
close oversight via weekly mentoring meeting.  
 
Data monitoring 
Ongoing quality control will include regular data verification and protocol compliance checks. An 
ongoing review of study procedures will be done to ensure that the privacy of subjects and 
confidentiality of data is not violated. Weekly meetings will be held between Dr. Hu and Dr. 
Sevick and other research staff involved in the project to review the progress of subjects 
enrolled in the study.  
 
Safety monitoring 
It is possible that our intervention might help participants better adhere to the medication 
regimen or make lifestyle changes (e.g., increased physical activity), which may result in the 
need for less diabetes medications and thus more episodes of hypoglycemia might happen. We 
will advise them to continue to monitor their blood sugar levels as suggested by their doctors, 
and contact their doctors if they experience any low blood sugar levels. This safety information 
will be emphasized at the beginning and end of each intervention video. 
 
Because the proposed study is minimal risk, we will not establish an independent Data Safety 
and Monitoring Board. The study team including several experts (Drs. Sevick, Hu) who have 
extensive experience in conducting clinical trials will perform date safety and monitoring. We will 
meet regularly to review inclusion and exclusion criteria, and develop a detailed safety protocol, 
plans for monitoring subjects for adverse events, and a protocol for protection of privacy and 
confidentiality of participants. The study PI (Dr. Hu) will hold weekly project meeting with the 
study staff and provide project updates to Dr. Sevick (primary mentor) via weekly mentoring 
one-on-one meetings. The study PI will provide updates on the study progress, recruitment, 

CARE Study Version 9.29.2022
17 
retention, data quality, safety, confidentiality, and the occurrence of adverse events to the whole 
mentoring team during bi-monthly check-in meetings. 
 
The whole team will provide oversight for the following study procedures: 
 
Monitoring the safety of the subjects (e.g., review the research protocol and plans for 
data and safety monitoring) 
 
Evaluate the progress of the clinical trial, including periodic assessments of data quality 
and timeliness, subject recruitment, accrual and retention, subjects risk versus benefit, 
performance of the recruitment site, and other factors that can affect study outcome 
 
Maintaining the confidentiality and integrity of the data 
 
Reports of critical or adverse events from research staff. The PI will receive these 
reports on an event-by-event basis and will inform the whole study team of all such 
reports 
 
Make recommendations to the IRB and investigators concerning continuation or 
conclusion of the trial.  
 
 
8.     INVESTIGATORS QUALIFICATIONS 
 
Mary Ann Sevick, ScD (diabetes mHealth behavioral expert) is a Professor at the NYU School of 
Medicine. Dr. Sevick has over 25 years of experience in conducting large, theory-based 
behavioral intervention trials. She has been the PI/Co-I on multiple NIH and foundational grants 
(R01-NR008792; R01-NR010135; K24- NR012226; HSR&D-IIR07154; AHA-17SFRN33590133). 
She is currently the PI of an R01 study examining technology-based behavioral interventions in 
patients with T2D and concurrent kidney disease. She is also the PI of an R21 study examining 
the use of video-based behavioral counseling interventions in hemodialysis patients and the PI of 
an American Heart Association (AHA) Obesity Network Center study investigating a novel, 
personalized dietary weight-loss approach in patients with prediabetes. Dr. Sevick has mentored 
10 junior faculty members and 18 postdoctoral fellows. Given her extensive expertise, she will 
serve as a content expert in T2D, theory-based behavioral intervention, mHealth, and academic 
career mentor.  
 
Lu Hu, PhD, is well poised to serve as the PI on the proposed study based on 1) her rigorous 
doctoral training in chronic disease management and postdoctoral and 2016 NIMHD Summer 
training in health disparity, 2) her current role as a co-investigator on an Aetna-funded study 
involving the use of a mHealth intervention (e.g., text messages) to remotely titrate the insulin 
regimen in underserved low-income patients with uncontrolled type 2 diabetes (T2D), 3) a strong 
publication record of about 20 published/accepted papers, and 4) several national and 
international awards and fellowships.  
 
All investigator’s CV and medical licenses are attached to the protocol submission.  
All investigators and staff involved in this project have completed training on the protection of 
human subjects in research through CITI training and HIPAA certification. 
 
9. STUDY RECORDS RETENTION AND DATA SHARING 
 
We are firmly committed to sharing data with the scientific community so that the data 
generated from this study can be fully utilized for research. Provided below is the proposed 
data-sharing plan: 
 

CARE Study Version 9.29.2022
18 
1.
We will publish the detailed methodology used for this study. Aggregated statistics will 
be provided to the broad scientific community via a journal’s website or to an individual 
investigator/team upon request.  
2. 
We will release the data generated from all study participants to qualified researchers 
who wish to collaborate with the investigators from our study. Investigators who wish to 
collaborate should submit a proposal that will be reviewed using criteria similar to those used by 
the NIH \for scientific merit and human subject protection. All data should be used for research 
only. No data will be provided that could potentially disclose the identities of study participants.   
NIH may release new policies regarding data sharing during the study period. We will be willing 
to discuss such policies with NIMHD program officers and modify the data-sharing plan detailed 
above. 
 
10. 
REFERENCES 
 
1.  
Powers MA, Bardsley JK, Cypress M, et al. Diabetes Self-management Education and 
Support in Adults With Type 2 Diabetes: A Consensus Report of the American Diabetes 
Association, the Association of Diabetes Care & Education Specialists, the Academy of 
Nutrition and Dietetics, the American Academy of Family Physicians, the American 
Academy of PAs, the American Association of Nurse Practitioners, and the American 
Pharmacists Association: https://doi.org/101177/0145721720930959. 2020;46(4):350-
369. doi:10.1177/0145721720930959 
2.  
Gonzalez JS, Safren SA, Cagliero E, et al. Depression, Self-Care, and Medication 
Adherence in Type 2 Diabetes: Relationships across the full range of symptom severity. 
Diabetes Care. 2007;30(9):2222-2227. doi:10.1002/cncr.29075.Familial 
3.  
Lerman I, Lozano L, Villa AR, et al. Psychosocial factors associated with poor diabetes 
self-care management in a specialized center in Mexico City. Biomed Pharmacother. 
2004;58(10):566-570. doi:10.1016/j.biopha.2004.09.003 
4.  
Ducat L, Rubenstein A, Philipson LH, Anderson BJ. A review of the mental health issues 
of diabetes conference. Diabetes Care. 2015;38(2):333-338. doi:10.2337/dc14-1383 
5.  
Gonzalvo JD, Hamm J, Eaves S, et al. A Practical Approach to Mental Health for the 
Diabetes Educator. AADE Pract. 2019;7(2):29-44. doi:10.1177/2325160319826929 
6.  
Zong J, Batalova J. Chinese Immigrants in the United States | migrationpolicy.org. 
Migration policy institute. http://www.migrationpolicy.org/article/chinese-immigrants-
united-states. Published 2017. Accessed May 30, 2017. 
7.  
Passel JS, Cohn D. U.S. Population Projections: 2005-2050 |. Pew Research Center. 
http://www.pewsocialtrends.org/2008/02/11/us-population-projections-2005-2050/. 
Published 2008. Accessed May 30, 2017. 
8.  
Hoeffel EM, Rastogi S, Kim MO, Shahid H. The Asian Population: 2010 2010 Census 
Briefs. 2012. https://www.census.gov/prod/cen2010/briefs/c2010br-11.pdf. Accessed May 
30, 2017. 
9.  
McNeely MJ, Boyko EJ. Type 2 diabetes prevalence in Asian Americans: results of a 
national health survey. Diabetes Care. 2004;27(1):66-69. 
http://www.ncbi.nlm.nih.gov/pubmed/14693968. Accessed May 30, 2017. 
10.  
Menke A, Casagrande S, Geiss L, Cowie CC. Prevalence of and Trends in Diabetes 

CARE Study Version 9.29.2022
19 
Among Adults in the United States, 1988-2012. JAMA. 2015;314(10):1021. 
doi:10.1001/jama.2015.10029 
11.  
Islam NS, Wyatt LC, Kapadia SB, Rey MJ, Trinh-Shevrin C, Kwon SC. Diabetes and 
associated risk factors among Asian American subgroups in New York City. Diabetes 
Care. 2013;36(1):2013. doi:10.2337/dc12-1252 
12.  
Thorpe LE, Upadhyay UD, Chamany S, et al. Prevalence and control of diabetes and 
impaired fasting glucose in New York City. Diabetes Care. 2009;32(1):57-62. 
doi:10.2337/dc08-0727 
13.  
Rajpathak SN, Wylie-Rosett J. High prevalence of diabetes and impaired fasting glucose 
among chinese immigrants in New York City. J Immigr Minor Heal. 2011;13(1):181-183. 
doi:10.1007/s10903-010-9356-2 
14.  
Ma RCW, Chan JCN. Type 2 diabetes in East Asians: similarities and differences with 
populations in Europe and the United States. Ann N Y Acad Sci. 2013;1281(1):64-91. 
doi:10.1111/nyas.12098 
15.  
Brown AF, Gregg EW, Stevens MR, et al. Race, ethnicity, socioeconomic position, and 
quality of care for adults with diabetes enrolled in managed care: the Translating 
Research Into Action for Diabetes (TRIAD) study. Diabetes Care. 2005;28(12):2864-
2870. doi:10.2337/DIACARE.28.12.2864 
16.  
Herman WH, Dungan KM, Wolffenbuttel BHR, et al. Racial and ethnic differences in 
mean plasma glucose, hemoglobin A1c, and 1,5-anhydroglucitol in over 2000 patients 
with type 2 diabetes. J Clin Endocrinol Metab. 2009;94(5):1689-1694. 
doi:10.1210/jc.2008-1940 
17.  
Xu Y, Pan W, Liu H. Self-management practices of Chinese Americans with type 2 
diabetes. Nurs Heal Sci. 2010;12(2):228-234. doi:10.1111/j.1442-2018.2010.00524.x 
18.  
Islam NS, Kwon SC, Wyatt LC, et al. Disparities in diabetes management in Asian 
Americans in New York City compared with other racial/ethnic minority groups. Am J 
Public Health. 2015;105:S443-S446. doi:10.2105/AJPH.2014.302523 
19.  
Lanting LC, Joung IMA, Mackenbach JP, Lamberts SWJ, Bootsma AH. Ethnic differences 
in mortality, end-stage complications, and quality of care among diabetic patients: a 
review. Diabetes Care. 2005;28(9):2280-2288. 
http://www.ncbi.nlm.nih.gov/pubmed/16123507. Accessed May 30, 2017. 
20.  
Tseng J, Halperin L, Ritholz MD, Hsu WC. Perceptions and management of psychosocial 
factors affecting type 2 diabetes mellitus in Chinese Americans. J Diabetes 
Complications. 2013;27(4):383-390. doi:10.1016/j.jdiacomp.2013.01.001 
21.  
Chun KM, Chesla CA, Kwan CML. “So We Adapt Step by Step”: Acculturation 
experiences affecting diabetes management and perceived health for Chinese American 
immigrants. Soc Sci Med. 2011;72(2):256-264. doi:10.1016/j.socscimed.2010.11.010 
22.  
Ho EY, Tran H, Chesla C a. Assessing the Cultural in Culturally Sensitive Printed Patient-
Education Materials for Chinese Americans With Type 2 Diabetes. Health Commun. 
2014;0236(February):37-41. doi:10.1080/10410236.2013.835216 
23.  
Chesla CA, Chun KM. Accommodating type 2 diabetes in the Chinese American family. 
Qual Health Res. 2005;15(2):240-255. doi:10.1177/1049732304272050 
24.  
King GL, Mcneely MJ, Thorpe LE, et al. Understanding and addressing unique needs of 
diabetes in Asian Americans, Native Hawaiians, and Pacific Islanders. Diabetes Care. 

CARE Study Version 9.29.2022
20 
2012;35(5):1181-1188. doi:10.2337/dc12-0210
25.  
Perez-Escamilla R, Damio G, Chhabra J, et al. Impact of a Community Health Workers – 
The DIALBEST Trial. Diabetes Care. 2015;38:197-205. doi:10.2337/dc14-0327 
26.  
Haas L, Maryniuk M, Beck J, et al. National standards for diabetes self-management 
education and support. Diabetes Care. 2012;35(11):2393-2401. doi:10.2337/dc12-1707 
27.  
Peyrot M, Rubin RR, Funnell MM, Siminerio LM. Access to Diabetes Self-management 
Education. Diabetes Educ. 2009;35(2):246-263. doi:10.1177/0145721708329546 
28.  
Hsu WC, Cheung S, Ong E, et al. Identification of linguistic barriers to diabetes 
knowledge and glycemic control in Chinese Americans with diabetes. Diabetes Care. 
2006;29(2):415-416. doi:10.1142/S0129054106003905 
29.  
Chun KM, Chesla CA. Cultural issues in disease management for chinese americans with 
type 2 diabetes. Psychol Health. 2004;19(6):767-785. 
doi:10.1080/08870440410001722958 
30.  
Ho EY, Chesla C a, Chun KM. Health communication with Chinese Americans about type 
2 diabetes. Diabetes Educ. 2012;38(1):67-76. doi:10.1177/0145721711428774 
31.  
Katigbak C, Zuo S, Chan P. Chinese immigrants’ views on exercise and using technology 
to enhance physical activity. Innov Aging. 2017;1(suppl_1):404-405. 
doi:10.1093/geroni/igx004.1459 
32.  
Juliana Reyes. Immigrants use mobile technology more than overall U.S. population, 
local study finds - Technical.ly Philly. https://technical.ly/philly/2013/01/28/immigrants-
use-mobile-technology-more-than-overall-u-s-population-local-study-finds/. Published 
2013. Accessed September 20, 2017. 
33.  
Hu L, Islam N, Langford A, Sevick MA. Mobile Technology for Health Management in 
Chinese Americans: Preliminary Findings from 2014 HINTS Data. In: Poster presentation 
at the 3rd Annual NYU Health Disparity Symposium; 2017. 
34.  
Free C, Phillips G, Galli L, et al. The effectiveness of mobile-health technology-based 
health behaviour change or disease management interventions for health care 
consumers: a systematic review. PLoS Med. 2013;10(1):e1001362. 
doi:10.1371/journal.pmed.1001362 
35.  
de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone 
messaging for facilitating self-management of long-term illnesses. Cochrane database 
Syst Rev. 2012;12(12):CD007459. doi:10.1002/14651858.CD007459.pub2.Copyright 
36.  
Free C, Phillips G, Felix L, Galli L, Patel V, Edwards P. The effectiveness of M-health 
technologies for improving health and health services: a systematic review protocol. BMC 
Res Notes. 2010;3(1):250. doi:10.1186/1756-0500-3-250 
37.  
Fortmann AL, Gallo LC, Garcia MI, et al. Dulce Digital: An mHealth SMS-Based 
Intervention Improves Glycemic Control in Hispanics With Type 2 Diabetes. Diabetes 
Care. 2017;40(10):1349-1355. doi:10.2337/dc17-0230 
38.  
Nundy S, Dick JJ, Chou C-H, Nocon RS, Chin MH, Peek ME. Mobile Phone Diabetes 
Project Led To Improved Glycemic Control And Net Savings For Chicago Plan 
Participants. Health Aff. 2014;33(2):265-272. doi:10.1377/hlthaff.2013.0589 
39.  
Dick JJ, Nundy S, Solomon MC, Bishop KN, Chin MH, Peek ME. Feasibility and usability 
of a text message-based program for diabetes self-management in an urban African-

CARE Study Version 9.29.2022
21 
American population. J Diabetes Sci Technol. 2011;5(5):1246-1254. 
doi:10.1177/193229681100500534 
40.  
Lyles CR, Ratanawongsa N, Bolen SD, Samal L. mHealth and Health Information 
Technology Tools for Diverse Patients with Diabetes. J Diabetes Res. 2017;2017:1-3. 
doi:10.1155/2017/1704917 
41.  
National Institute on Minority Health and Health Disparities. NIMHD Research 
Framework. https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-
framework.html. Published 2017. Accessed September 20, 2021. 
42.  
Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-
management: A randomized trial. Diabetes Educ. 2009;35(4):641-651. 
doi:10.1177/0145721709335006 
43.  
Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities 
measure: Results from 7 studies and a revised scale. Diabetes Care. 2000;23(7):943-
950. doi:10.2337/diacare.23.7.943 
44.  
Ho EY, Pak S, Leung G, et al. Pilot cluster randomized controlled trial of integrative 
nutritional counseling versus standard diabetes self-management education for Chinese 
americans with type 2 diabetes. Heal Equity. 2020;4(1):410-420. 
doi:10.1089/heq.2020.0002 
45.  
Panagiotakos DB, Pitsavos C, Stefanadis C. Dietary patterns: A Mediterranean diet score 
and its relation to clinical and biological markers of cardiovascular disease risk. Nutr 
Metab Cardiovasc Dis. 2006;16(8):559-568. doi:10.1016/j.numecd.2005.08.006 
46.  
Craig C, Marshall A, Sjöström M, et al. International Physical Activity Questionnaire: 12-
Country Reliability and Validity. Med Sci Sport Exerc. 2003;35(8):1381-1395. 
doi:10.1249/01.MSS.0000078924.61453.FB 
47.  
International physical activity questionnaire. 2002. 
http://uacc.arizona.edu/sites/default/files/ipaq_english_telephone_short.pdf. Accessed 
August 23, 2017. 
48.  
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc 
Behav. 1983;24(4):385-396. doi:10.2307/2136404 
49.  
Ezzati A, Jiang J, Katz MJ, Sliwinski MJ, Zimmerman ME, Lipton RB. Validation of the 
Perceived Stress Scale in a community sample of older adults. Int J Geriatr Psychiatry. 
2014;29(6):645-652. doi:10.1002/gps.4049 
50.  
Marin G, Sabogal F, Marin BV, Otero-Sabogal R, Perez-Stable EJ. Development of a 
Short Acculturation Scale for Hispanics: http://dx.doi.org/101177/07399863870092005. 
2016;9(2):183-205. doi:10.1177/07399863870092005 
51.  
Kim G, Sellbom M, Ford KL. Race/ethnicity and measurement equivalence of the 
Everyday Discrimination Scale. Psychol Assess. 2014;26(3):892-900. 
doi:10.1037/a0036431 
52.  
Li C, Friedman B, Conwell Y, Fiscella K. Validity of the Patient Health Questionnaire 2 
(PHQ-2) in identifying major depression in older people. J Am Geriatr Soc. 
2007;55(4):596-602. doi:10.1111/j.1532-5415.2007.01103.x 
53.  
Huang FY, Chung H, Kroenke K, Delucchi KL, Spitzer RL. Using the Patient Health 
Questionnaire-9 to measure depression among racially and ethnically diverse primary 
care patients. J Gen Intern Med. 2006;21(6):547-552. doi:10.1111/j.1525-

CARE Study Version 9.29.2022
22 
1497.2006.00409.x
54.  
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr 
Scand. 1983;67(6):361-370. doi:10.1111/J.1600-0447.1983.TB09716.X 
 
55.  
Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. 
J Pers Assess. 1996;66(1):20-40. doi:10.1207/S15327752JPA6601_2 
56.  
Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 
1991;32(6):705-714. doi:10.1016/0277-9536(91)90150-B 
57.  
Lubben J, Blozik E, Gillmann G, et al. Performance of an abbreviated version of the 
Lubben Social Network Scale among three European community-dwelling older adult 
populations. Gerontologist. 2006;46(4):503-513. doi:10.1093/GERONT/46.4.503 
58.     Link, B. G. (1987). Perceived Devaluation-Discrimination Scale [Database record]. APA 
PsycTests. https://doi.org/10.1037/t16562-00059.     Baer, R. A., Smith, G. T., Lykins, E., 
Button, D., Krietemeyer, J., Sauer, S., Walsh, E., Duggan, D. & Williams, J. M. G. (2008). 
Construct validity of the Five Facet Mindfulness Questionnaire in meditating and 
nonmeditating samples. Assessment, 15, 329–342. doi: 10.1177/107319110731300360.     
Gu, J., Strauss, C., Crane, C., Barnhofer, T., Karl, A., Cavanagh, K., & Kuyken, W. 
(2016). Examining the factor structure of the 39-item and 15-item versions of the Five-
Facet Mindfulness Questionnaire before and after MindfulnessBased Cognitive Therapy 
for people with recurrent depression. Psychological Assessment. doi: 
10.1037/pas0000263 
61.  
Fereday J, Muir-Cochrane E. Demonstrating Rigor Using Thematic Analysis: A Hybrid 
Approach of Inductive and Deductive Coding and Theme Development. Int J Qual 
Methods. 2006;5(1):80-92. doi:10.1177/160940690600500107 
62.  
Burla L, Knierim B, Barth J, Liewald K, Duetz M, Abel T. From Text to Codings. Nurs Res. 
2008;57(2):113-117. doi:10.1097/01.NNR.0000313482.33917.7d