Feasibility of a Family-oriented mHealth Intervention for Chinese Americans With Type 2 Diabetes
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: NYU Langone Health

 
 
Official Title: 
Feasibility of a Family-oriented mHealth Intervention for Chinese 
Americans With Type 2 Diabetes   
NCT Number: 
NCT04108299 
Study Number: 
19-01275 
Document Type:  
Study Protocol and Statistical Analysis Plan 
Date of the 
Document: 
• 
March 27, 2021 
 
 

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Feasibility of a Family-oriented mHealth Intervention for Chinese Americans with Type 2 
Diabetes  
 
Principal Investigator:  
 
Lu Hu, PhD 
                                        
 
NYU School of Medicine                                         
                                        
 
Department of Population Health 
                                        
 
180 Madison Ave 
                                        
 
New York, NY 10016                                                                 
                                        
 
646-501-3438 
 
 
 
        
 
Hu.Lu@nyulangone.org 
 
                                        
Protocol Number: 
 
 
s19-01275   
 
 
Version #:  
Version 3.26.2021 
 
 
 

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TABLE OF CONTENTS 
1. Abstract ................................................................................................................................ 3 
2. Purpose of the Study and Background .............................................................................. 3 
2.1  
Background .............................................................................................................. 3 
2.2 
Aims .......................................................................................................................... 4 
3. METHODS and procedures ................................................................................................. 5 
3.1  
Study Design............................................................................................................. 5 
3.2 
Sites ........................................................................................................................... 5 
3.3.  
Characteristics of the Research Population ........................................................... 5 
4. Procedures ........................................................................................................................... 6 
4.1   Patient Recruitment ..................................................................................................... 6 
4.2   Patient Consent ............................................................................................................ 7 
4.3  Study Procedures .......................................................................................................... 7 
5. Risk/Benefit Assessment ...................................................................................................10 
5.1 
Potential Risks .........................................................................................................10 
5.2 
Benefits ....................................................................................................................11 
6. Confidentiality .....................................................................................................................11 
7. Data Analysis and Data Monitoring ...................................................................................11 
7.1 Data Analysis .................................................................................................................11 
7.2 Data Monitoring .............................................................................................................12 
8. Investigators Qualifications ...............................................................................................13 
9. Study Records Retention and Data Sharing .....................................................................14 
10. References .........................................................................................................................15 
 
 
 

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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. 
Given the high economic and societal burden of T2D and rapid population growth in Chinese 
Americans, there is an urgent need for research to develop effective interventions to address T2D 
burden in this population. Recent evidence suggests the importance of involving and empowering 
family members in diabetes intervention and calls for family intervention. A mobile health 
approach such as short message service (SMS) might be a promising way to deliver such family-
oriented interventions to the target population given prior studies suggests that Chinese 
Americans often report challenges to attend in-person lifestyle counseling because of long 
working hours and lack of sick time from work. A SMS-based intervention provides the flexibility 
of allowing them to view the intervention at a time and place convenient to them. However, such 
intervention has not been developed for or tested in Chinese Americans with T2D. This study will 
serve as the first step to explore an alternative approach for managing T2D in this group. The 
goal of this pilot study is to examine the feasibility and acceptability of a family-oriented SMS 
intervention in 30 pairs of Chinese Americans with T2D and their family members. Participants 
will be randomized to one of 2 arms (n=15 pairs 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 counseling videos. Measurements will be 
obtained at baseline, 3, and 6 months. The primary outcome is feasibility and acceptability, and 
secondary outcomes include HbA1c, self-efficacy, and diabetes self-management behaviors. 
Findings from this pilot study will inform a larger full-scale R01 efficacy trial of the SMS intervention, 
and ultimately, an implementation study in the real-world setting. 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). 
   
2. PURPOSE OF THE STUDY AND BACKGROUND 
2.1  
Background 
Chinese Americans are one of the fastest growing immigrant groups in the United States.1–
3 Multiple studies show that, compared to non-Hispanic whites, Chinese Americans suffer 
disproportionately higher rates of type 2 diabetes (T2D),4–8 have poorer self-management and 
glycemic control,9–13 and are at elevated risk of developing renal complications.14 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.15–17 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.15–17 
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.18  
 
While the majority of current diabetes interventions only involved patients, there is a 
growing body of evidence demonstrating the importance of educating and empowering family 
members in this process.19–21 The success of diabetes management depends largely on the social 
and environment contexts in which patients live and perform diabetes self-care.20,22 When patients 
with T2D live in a supportive family context (e.g., the family embraces a lifestyle consistent with 
the needs of the patient), they are more likely to receive social and emotional support for self-

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management, adhere to diabetes self-care requirements, and achieve better glycemic control.23 
Patients with T2D living in non-supportive family environments (e.g., family members undermine 
the patient’s efforts, use negative communication strategies) have more difficulty initiating and 
sustaining recommended diabetes self-care behaviors, experience more diabetes-related 
distress, and report lower self-efficacy for self-management success.23,24 Disruptive family 
behaviors have been reported as major barriers to diabetes self-care in our recently completed 
mixed method study of 101 Chinese Americans with T2D.25  
 
Family interventions involving both patients with T2D and family members may be 
particularly useful for Chinese Americans given that the Asian culture places a strong emphasis 
on family ties.19,26,27 When one family member is affected by a disease, the other family members 
are often willing to provide help and support.27–29 Family members are well-positioned to provide 
the long-term support that sustains beyond an intervention study. 27–29 Yet, family members often 
feel frustrated because they wanted to be involved in their loved ones’ diabetes care but lacked 
knowledge and skills necessary to be more supportive or helpful.20,23 Despite the significant role 
of family members in diabetes self-management success, most interventions reported in the 
literature failed to include family members.19,30   
 
Mobile health (mHealth) such as using short message services (SMS) is a promising and 
practical strategy to deliver such a family intervention.31,32 A SMS-based family intervention is 
particularly relevant to Chinese Americans given that they often report long working hours and 
various challenges to attending in-person intervention sessions, which can be avoided using an 
mHealth approach.16,28,29 In addition, Chinese Americans are quite familiar with the SMS because 
of their social needs to connect with family and friends in the US and China.25 A SMS-based 
intervention has several advantages for educating and engaging patients in self-management and 
enhancing self-management support of their family members. In our recently completed mixed 
method study of 101 Chinese American patients with T2D, the idea of a SMS-based intervention 
was endorsed by the majority of participants.25  Participants also reported that their family 
members would be interested in receiving such an intervention.25 The efficacy of a family-based 
mHealth intervention involving both T2D patients and family members remains untested in 
Chinese Americans. To address this significant knowledge gap, the proposed study will leverage 
our current K99/R00 project, which aims to examine the potential efficacy of a patient-focused 
SMS intervention in Chinese Americans with T2D. This proposed study will adapt our K99/R00 
patient-focused SMS intervention to a family-oriented SMS intervention, and pilot test it in a 
cohort of 30 Chinese American families (30 T2D patients and 30 their corresponding family 
members). Similar to the approach in our K99/R00 project, the culturally and linguistically adapted 
family-oriented intervention will be delivered to participants via brief counseling videos 
sent to participants via SMS links (hereafter SMS intervention). Specifically, our aims are as 
follows: 
2.2 
Aims  
Primary Aim 1: Assess the feasibility and acceptability of the SMS intervention in Chinese 
Americans with T2D and their family members 
Primary Aim 2: Establish proof-of-concept regarding the potential efficacy of the SMS 
intervention for improving glycemic control  
Exploratory Aim: Explore mediators of the SMS intervention  
 
 
 
 

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3. METHODS AND PROCEDURES 
3.1  
Study Design 
The proposed study is a pilot randomized controlled trial (RCT) of 6 months duration, with 
measurements at baseline, 3, and 6 months. Participants will be randomized to one of 2 arms 
(n=15 pairs each): 1) wait-list control; or 2) SMS intervention. 
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 these private practices, NYU Langone Health, 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 
We will recruit 60 participants for this project, including 30 T2D Chinese patients and 30 
corresponding family members. Family member is broadly defined as any support person who 
the patient considers plays a vital role in their diabetes self-management and would be interested 
in receiving such interventions. This can be spouse, adult children, siblings, or friends. 
Inclusion criteria for patient participants: To be eligible for the study, patient participants must: 
1) self-identify as Chinese immigrant or Chinese American; 2) be between the ages of 18 and 70; 
3) be able to speak and understand Mandarin; 4) self-report a diagnosis of T2D; 5) baseline 
HbA1c ≥ 7%; 6) be currently using WeChat; 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; and 10) have a family member or friend be willing to participate in the study 
to learn about T2D to better support them.  
 
Inclusion criteria for family/friend participants: Family/friend participants must 1) self-identify 
as Chinese immigrant or Chinese American; 2) be between 18-70 years old; 3) be able to speak 
and understand Mandarin; 4) be currently using WeChat or text messages; 5) be willing to receive 
WeChat or text messages regarding T2D management and learn how to better support the patient 
with T2D; 6) express strong interest and confidence in finishing watching 2 diabetes videos each 
week for a total of 12 weeks; and 7) be motivated to support their family/friend to make lifestyle 
changes to control their diabetes.  

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Exclusion criteria for both patient and family/friend participants: 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, (5) breastfeeding, or 
(6) live in a facility or other health care setting where they have no control over diabetes self-
management. 
 
4. PROCEDURES 
4.1   Patient Recruitment 
Participants be identified and recruited into the study from NYC health care facilities, including 
CBWCHC, private practices, and NYU Langone Brooklyn 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 very popular chatting 
smartphone application among Chinese Americans and Chinese Immigrants. 
b.  Direct referral by NYC 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 to 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 screen for eligibility. Meanwhile, patients will be 
invited to call (self-refer to) the 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 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 
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 drive to ensure the 

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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 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 informed 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 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.  
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 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 both patients and family/friend participants 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. 
4.3  Study Procedures 
The proposed study is a pilot randomized controlled trial (RCT) of 6 months duration. 
Participants will be randomized to one of 2 arms (n=15 pairs each): 1) wait-list control; or 2) 
SMS intervention. The study will include 3 telephone-based measurement visits, baseline, 3, 
and 6 months. For patient participant, during each telephone visit, we will ask them some survey 
questionnaires. Once we receive their consent, we will also contact their doctors’ office to obtain 
HbA1c results. For family/friend participant, each telephone visit will only have some survey 

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questionnaires. At the end of the 3-month intervention, we will randomly select 10-20 patient 
and family member participants to join a focus group/interview study to understand their 
experience with our intervention. Both patient and their family member 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, we will ask patients to talk to their family 
members or friends about this study and confirmed their family/friends interests in participation. 
Once we received call back from patients confirming their own as well as their family 
members/friends’ interests’, we will schedule an appointment to obtain verbal consent from both 
and collect baseline data. The patient and family/friend pair will be randomized 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: For patient participants, they will continue to receive the standard of 
usual care for their T2D at the NYC health care facilities during the course of our study. For 
family/friend participants, they will continue to receive their routine care with their own doctors 
during the study. At the end of the study, the wait-list control group (both patient and 
family/friend participants) will be provided the opportunity to receive the counseling videos 
delivered to them via SMS links.   
 
SMS or WeChat intervention: We will send 2-3 diabetes videos every week for 12 weeks 
(each video about 5-10 minutes in duration) to both patients and their family members via 
WeChat or regular text messages (SMS). We will contact participants mainly through phone 
calls from 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 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.  
 
Patients and their family members will receive the same intervention videos, including basic 
information about T2D, importance of diabetes self-management at home, behavioral 
techniques, and family-oriented sessions. For participants who miss 3 consecutive videos, the 
study team will follow-up with a phone call to identify barriers to watching the video and remind 
them to review the video. We will also help patient 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. 
 

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Procedures: The study will include 3 measurement telephone visits, baseline, 3, and 6 months. 
Each session will include audio/Video recordings if verbal consent from the study participants 
was obtained.  Both patient and family/friend participants will be paid $30 for each telephone 
visit. All data will be collected during the telephone visit. For patient participants, each visit will 
involve completion of questionnaires.  After obtaining patients’ consent, we will contact their 
doctors’ office to obtain HbA1c results. For family/friend participants, each visit will only involve 
completion of questionnaires. For family/friend participants in the intervention group, we will 
send them diabetes education videos to help them obtain more information about diabetes, 
which allows them to better support patients in their disease management. 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.  
 
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 80% of the diabetes videos. The other focus group is with poorly 
engaged group, defined as participants who have watched less than 80% of the videos. Each 
participant will receive $30 for their participation in the focus group. If it is challenging to identify 
a time that works for everyone, we will offer individual interview to those who have limited 
availability. After finishing the interview, they will also receive $30 as incentives.  
 
Study Variables 
 
 
 
 
 
 
Figure 1. Conceptual Model 
 
Primary & Exploratory Outcomes  
 
Primary outcome: Feasibility: Feasibility will be examined by calculating the percent of videos 
sent that are watched. We will also assess the feasibility by determining whether we are able to 
meet our recruitment goal of 30 Chinese American families and reach 80% retention rate.  
Acceptability: Acceptability will be assessed using a satisfaction questionnaire adapted from a 
prior SMS intervention study.33,34 
 
Secondary outcomes: Consistent with our conceptual model (Fig. 1), we will also measure 
HbA1c, self-efficacy, and diabetes self-management behaviors at each time points (baseline, 3-, 
and 6-months). All of these scales have been used and validated in the Chinese population. 
 
1. 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. 
Interventions: 
• 
Wait-list control 
• 
SMS 
Behavioral changes 
• 
Diabetes self-management behaviors 
• 
Dietary intake 
• 
Physical activity 
Glycemic control 
(HbA1c) 
Self-efficacy 
covariates 

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2. Self-efficacy: We will use the well-validated Stanford Diabetes Self-Efficacy Scale36 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). 
3. Diabetes Self-Management Behaviors: We will administer the adapted Summary of 
Diabetes Self-Care Activities (SDSCA) measure37 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. 
4. Dietary Intake: Informed by a previous study in Chinese Americans,38 we will use the adapted  
Mediterranean Dietary Screener39 to estimate dietary intake behaviors in our participants at 
baseline, 3- and 6-months. 
5. Physical Activity: We will use the International Physical Activity Questionnaire (IPAQ)42,43 
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).  
 
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. 
 
5. RISK/BENEFIT ASSESSMENT 
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. For the confidentiality protection related to audio-
recording, we will store all the recordings on a password protected server. We will use a unique 
code number during the transcription. Once the transcription is done, all the audio recordings 
will be destroyed. 
 
There is 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.  

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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. 
 
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 
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. 
 
Transcript files will also be password-protected and user-restricted. We will delete potential 
identifiable information from transcripts and audio/video 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 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 
Data analysis for Aim 1. Feasibility and acceptability: Feasibility will be examined by 
calculating the percent of videos sent that are watched. We will also report the actual enrollment 
and retention rate.  Acceptability will be examined by calculating percent of participants who 
report satisfaction with our intervention using a questionnaire adapted from a prior SMS 
intervention study.33,34  

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Data analysis for 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 2: Proof of concept regarding the potential efficacy of the intervention for glycemic 
control. 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: Explore the mediators of the SMS intervention. Although underpowered, 
we will perform exploratory analyses of candidate mediators to evaluate the merit of further 
testing in a larger, adequately powered study. We will perform mediation analyses to determine 
whether self-efficacy and adherence to diabetes self-management explain significant variance in 
improvements in HbA1c. 
 
Focus group: 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.41 To establish coding reliability, the RA and PI 
will independently code up to 10% of the transcripts and identify kappa coefficient.42 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.  
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-investigator). 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 

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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, 
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.  

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Lu Hu, PhD, is well poised to serve as the co-investigator 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: 
 
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. 
 

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