Better Together: A Patient-centered Approach to Improve Diabetes Among Immigrant Communities
Phase: NA
Conditions: Type 2 Diabetes
Sponsor: Emory University

 
 
Better Together Study 
NCT05275231 
2.5.2025 

Protocol Title:  Better Together: A patient-centered approach to improve diabetes among 
immigrant communities
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Protocol Version: V. 3.2 2/5/2025
PROTOCOL TITLE: Better Together: A patient-centered approach to improve diabetes among 
immigrant communities
PRINCIPAL INVESTIGATOR: 
Name: Megha K. Shah, MD
Department: Family and Preventive Medicine
Telephone Number: 404-778-6944
Email Address: mkshah@emory.edu
EXTERNAL (NON-EMORY) COLLABORATORS                                                                   
None
VERSION:  3.2
FUNDING SOURCE:  NIMHD
REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
1
09/03/2020
Updated recruitment methods section (added phone script 
to attachments)
2
10/25/21
Updated to change form to telehealth instead of in-person 
sessions.  Updated financial tokens given to patients. 
3
11/9/21
Updates incentives to match consent form
4
3/1/23
Added qualitative interview guide to participant 
satisfaction evaluation
5
10/25/24
Updating the protocol to reflect COVID related 
modifications in the data collection
6
11/13/24
There is one missed update in the objectives section that 
needed to be updated.
7
1/24/25
The inclusion/exclusion criteria needed to be updated to 
include women as well, based on COVID-related 
modifications
8
1/24/25
Clarifying that the secondary outcomes are all exploratory 
outcomes and data will be reported on participants 
individually.
9
2/5/25
We were unable to recruit any West African participants 
for this study, so we have removed this language.

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Table of Contents
1.
Study Summary .......................................................................................................................4
2.
Objectives................................................................................................................................4
3.
Background .............................................................................................................................4
4.
Study Endpoints ......................................................................................................................4
5.
Study Intervention / Design ....................................................................................................4
6.
Procedures Involved................................................................................................................5
7.
Data and Specimen Banking....................................................................................................5
8.
Sharing of Results with Participants........................................................................................5
9.
Study Timelines .......................................................................................................................6
10.
Subject Population...............................................................................................................6
11.
Vulnerable Populations .......................................................................................................6
12.
Local Number of Participants ..............................................................................................6
13.
Recruitment Methods..........................................................................................................7
14.
Withdrawal of Participants..................................................................................................7
15.
Risks to Participants.............................................................................................................7
16.
Potential Benefits to Participants........................................................................................7
17.
Data Analysis, Management and Confidentiality.................................................................8
18.
Provisions to Monitor the Data to Ensure the Safety of Participants..................................8
19.
Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data.........................................................................................................9
20.
Economic Burden to Participants ........................................................................................9
21.
Consent Process...................................................................................................................9
22.
Setting................................................................................................................................12
23.
Resources Available...........................................................................................................12
24.
Multi-Site Research when Emory is the Lead Site .............................................................12
25.
References.........................................................................................................................13

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1. Study Summary
Study Title
Better Together: A patient-centered approach to 
improve diabetes among immigrant communities
Study Design
pre-post trial
Primary Objective
Feasibility and acceptability 
Exploratory Objective(s)
Change in Hemoglobin A1c, Weight, Blood Pressure
Research 
Intervention(s)/Interactions
Health education focused on weight loss
Study Population
Immigrants from South Asia
Sample Size
48
Study Duration for 
individual participants
6 months
Study Specific 
Abbreviations/ Definitions 
Funding Source (if any)
NIMHD
2. Objectives
There  has traditionally been very low uptake of diabetes education programs among immigrant 
men.  This may be in part due to a lack of engagement of these community’s social support 
networks.  To address this, we will test: 1) that a social network-focused SMA intervention 
based in primary care is feasible and acceptable among South Asians with prediabetes/type 2 
diabetes, and 2) that health behaviors will also improve among participants’ social networks. 
The aims of this project are to: 
Aim 1: Implementation: Evaluate the preference, feasibility, and acceptability of social network-
based (participant + social partner) versus individual-based (participant only) SMA ILI among SA 
immigrant participants with prediabetes/T2D through a 2-group pilot study.
Leveraging a pragmatic design approach, simulating a natural experiment, I will recruit 
participants with prediabetes/T2D (n=48 total) to join one of 2 kinds of 8-session/16-week SMA 
intervention groups at an Emory Family Medicine clinic: (1) dyads (patient + social partner; 
mixed gender) or (2) men-only 
Primary Outcomes: recruitment and retention (preference and feasibility) and satisfaction 
(acceptability) 
Exploratory Outcomes: pre-post changes in biometric measurements (body weight, blood 
pressure, plasma lipids, glycated hemoglobin), physical activity, and diet
Aim 2:  Broader reach through Social Networks: Assess the behavioral outcomes of the pilot 
intervention amongst members of participants’ social networks as potential spillover effects.
Conduct baseline and 6-month post-recruitment mapping of participants’ (from Aim 2) self-
identified social networks (n=5/participant) and assess the following: 
Primary outcomes: change in weight control practices (e.g. physical activity, calorie counting, 
etc.)

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Exploratory outcomes: change in weight from baseline to 6 months
3. Background
Diabetes is a major public health concern and challenging to address in current primary care 
practice. The burden of prediabetes and type II diabetes (T2D) in the US is growing rapidly, with 
1.5 million new cases of T2D annually and 84 million currently living with prediabetes.1  T2D 
now accounts for the largest portion of healthcare cost in the US, and is a major contributor to 
morbidity and mortality.2  T2D can lead to complications such as renal dysfunction, peripheral 
and autonomic neuropathy, vision problems, and cardiovascular disease.3  It is one of the top 
chronic conditions seen in primary care, accounting for over 15% of all outpatient primary care 
visits.4 Over 50% of these visits are associated with multiple diagnoses, making it challenging for 
health professionals to address evidence-based T2D care in allotted 15 minute visits.5 As such, 
preventing or delaying the onset of T2D and its related complications are major public health 
and health system priorities.  
South Asians and Africans are growing immigrant groups at high risk for diabetes in the US. 
South Asian (SA) (ancestry originating from India, Pakistan, Bangladesh and other parts of South 
Asia) and Sub-Saharan African immigrant groups make up two of the fastest growing immigrant 
groups in the US.6  SAs have higher rates of T2D and cardiovascular disease than whites.7–9 
Furthermore, SAs without diabetes have a high prevalence of T2D risk factors. Compared to 
whites, SAs have: higher rates of hypertension,74 dyslipidemia, and insulin resistance.10–12 SAs 
report low levels of physical activity, and the diet of the SA migrant population is low in fiber 
and is often high in fat and sugar.13–16 In a British study, compared to white Europeans, SAs with 
T2D have worse glycemic control over time, even when the processes of care are similar.17,18  
Cumulatively, these findings in SA immigrant communities challenge the well-accepted 
“healthy immigrant effect” phenomenon (that immigrants are on average healthier than native-
born persons), suggesting that more tailored T2D prevention and management strategies are 
greatly needed to narrow the disparities in outcomes between these and other US 
populations.25,26
Intensive lifestyle interventions (ILIs) can improve diabetes self-management and health 
outcomes. Six large trials showed that intensive lifestyle interventions (ILIs), group-based 
programs designed to promote weight loss through a combination of diet, activity, and 
behavior change, decrease T2D incidence in people with prediabetes and reduced 
complications among people with T2D.27–31 Two of these studies, the Diabetes Prevention 
Program (DPP) in the US and the Finnish DPP, showed a >50% reduction in T2D incidence in 
study participants in the ILI group compared to those in the control group.27,30 Additional 
analyses have shown that the effects of lifestyle interventions are long-lasting, even when 
participants gain back some of the weight lost during the program.27,29,30,32 The effects of the 
DPP intervention are also cost-effective.33–35 The LookAHEAD trial, a weight-loss intervention in 
patients with T2D, showed improved quality of life, glycemic and lipid control, blood pressure, 
and reduction in overall cost.36  Based on the findings of these and other studies, expert 
organizations, including the American Diabetes Association recommend lifestyle changes such 
as weight loss and increased physical activity for the prevention and treatment of T2D.37
Immigrant men face systems and societal barriers to engage in ILIs. While no sex differences 
have been found in treatment effect for intensive lifestyle interventions for T2D prevention, 

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uptake of men in such programs is low, ranging from 20-40%.27,38–40  Immigrant men in 
particular, may face additional barriers to access such programs due to poor healthcare access 
(lack of health insurance and no usual source of care), compared to immigrant women and US-
born men.41,42 Men are less likely than women to identify disease prevention strategies and 
lifestyle as influencing their health.43  
Preliminary data from my qualitative study in the SA Muslim immigrant community in 
Atlanta suggests that immigrant men do not prioritize lifestyle change, citing a lack of perceived 
control to make decisions about what is eaten in the home.  One male focus group participant 
remarked, “If my wife tells me to eat, I have to eat. I have no choice.”  At the same time, 
spouses and family members can provide motivation for healthy lifestyle choices.  Another 
male participant noted, “I think husband and wife it does [motivates] automatically. Like the 
other day I came home and my wife was walking outside in the subdivision and she told me, 
"Do you want to join me for half an hour?" So let me go and join. Part of the kinda bonding.” 
 Strategies to improve the reach of diabetes prevention and management programs for 
men, particularly immigrant men, are needed and our data suggest that engagement of social 
networks, particularly family and other household members is important.39  
Family and social networks could be an important factor to improve patient activation, 
especially for South Asian and African immigrant men. Social networks, defined as someone 
with social or family ties to an individual, affect health through myriad mechanisms including 
social support, social influence, social engagement, and access to resources.44  Previous work 
from my mentorship team shows, that spouses of people with newly diagnosed T2D have twice 
the annual incidence of T2D in the year after their partner’s diagnosis compared to the national 
average (16.4 vs 8.1 per 1000 persons from 2007-2011).45 Moreover, social networks, 
participation through social support, may be able to be leveraged to improve health behaviors. 
In a number of studies, participants with high levels of social support were more engaged in 
health behavior changes, and social support has been shown to improve patient activation for 
behavior change.46–50 In a sub analysis of untreated spouses of participants in the LookAHEAD 
ILI were more likely to lose >5% of their body weight and engage in positive dietary changes, 
when compared to control group untreated spouses.51
However, to date, most research, guidelines, and approaches to diabetes prevention 
and care have focused on individual self-management.  We have not explored the potential for 
“collateral health effects” of interventions–for example, people who are socially connected 
with each other.52  Interventions that ignore participant’s social structure may overlook the 
potentially valuable support created by one’s social context (e.g., helping reinforce positive 
behaviors). Not engaging with social connections might even increase the barriers to behavior 
change as social connections may influence unhealthy lifestyle choices. Family members and 
friends can potentially be negative influences, hindering a patient’s health goal.53,54 Targeting 
social network influencers in programs could harness their knowledge and motivation in such 
a way that they enhance behavior change in both participants and their social influencers and 
potentially sustain behaviors, given the ongoing relationships of participants and social 
influencers. 
Typical SA immigrant populations are culturally close-knit communities, with strong 
family and social ties.55,56  Several studies have identified cultural and family priorities as barriers 

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to health behaviors such as physical activity among SAs.57,58  Lawton et al report that among SA 
men, there is a pervasive belief that time outside of work should not be spent on leisure activities 
such as exercise, but used to help family members or spend time with children.57 In a qualitative 
study of perceptions of cardiovascular risk among SAs in California, participants noted that 
dietary practices were a central part of the family unit.  They felt that giving foods, particular high 
in butter and milk, were considered a nurturing act by a mother or wife.59  Furthermore, social 
gatherings are an integral part of cultural identity for SA diaspora, and these events often center 
on food, which is often high in sugar and oil and low in fiber.57,60 Similarly Sub-Saharan African 
immigrant communities have high levels of social cohesion, often relying on family support and 
social networks for health concerns.61 A qualitative study of African immigrants in Manitoba, 
Canada cites how more established immigrants who have lived abroad in Canada often serve as 
an important support system for new arrived immigrants.62 A study of African immigrant 
offspring, note that social and religious gatherings are central part of their culture, and foods, 
often high in oils and starches, are central to these celebrations.63 Thus, these cultural and social 
influences shared among SA and African immigrants may be better addressed in an ILI that 
targets participants and their social influencers.
Shared medical appointments (SMAs) may be a model to incorporate the power of social 
networks for intensive lifestyle education delivery.  Group-based clinic visits, such as SMAs are 
a promising, sustainable strategy to increase patient access by seeing a larger volume of patients 
in shorter a time frame and increase efficiency of the time health professionals spend with 
patients.  In this model, individuals with a similar medical condition participate in a longitudinal 
multidisciplinary group visit with a portion of the visit dedicated to personalized care.  The visits 
generally involves 12 to 16 patients in a 1 to 2 hour visit in which a portion of the visit is facilitated 
by a team (for example a physician/nurse/advanced practice provider/nutritionist) in a group 
setting and a portion is individualized for each patient.37  The rationale for the group format is 
that it provides additional support that improves patient activation to make changes, thus SMAs 
focus on educational interventions such as self-management, medication management, or 
nutrition.38-40  Interventions testing the SMA model have been shown to be feasible in several 
chronic health conditions, including heart failure and diabetes (T2D) self-care, and are associated 
with lower direct medical costs and higher guideline adherence in T2D care.5,41 Furthermore, 
these visits are reimbursed by all payers, creating a sustainable approach to deliver ILI curriculum. 
Yet, to date the SMA model does not incorporate patients’ health influencers, who may be critical 
in providing support to initiate and sustain behavior change and have not targeted the specific 
needs of immigrant men. 
Preliminary/Relevant Data
In our pilot study, we focused on a dyad-based group ILI with SA Muslims.  We 
successfully recruited 7 patients and their support partners in 5 days, using physician referrals 
and chart review, supporting feasibility of the proposed study.  For those that were called and 
declined participation, 30% reported that their support partner, typically a spouse, could not 
commit to attend the sessions. Of the 7 patients enrolled, 3 were men, and their support 
partners included 1 adult son and 2 wives.  Of the 4 female patients, support partners included 
3 husbands and 1 female friend.  Pilot data show high levels of male participation (43%), and in 
most dyads (6 of 7), both partners have prediabetes or T2D, and the mean age of participants is 

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51 (age range 23-72). Retention of participants is >80% retention at midpoint of the 16-week, 
bi-weekly intervention.  Survey data suggest high levels of satisfaction with the group-based 
format (5/5 on Likert-like scales) and engagement of the support partner (5/5).  
Supporting our choice to offer a male-only group, in a pilot translation study of the DPP 
for a predominantly African American group in New York City, in which participants in an all-
male group program lost a mean 4% of body weight, participants reported interest for both 
male-only or mixed gender groups.39,64 
Rationale for the proposed study
The literature regarding social network-focused interventions for T2D prevention and 
management is limited. To date, studies have tended to focus on involving family members 
when intervening to address chronic conditions in pediatric populations.65,66 Current standard 
of care is individual-focused T2D self-management and prevention education at the time of 
diagnosis, and few published studies have explicitly targeted adult participants and their 
social contacts.67 Systematic reviews of family interventions to address adult T2D note that 
many interventions do not involve communities and patients in their study design phase.67,68 
Understanding the cultural and family environment have been identified as key factors in 
considering how to tailor interventions for racial/ethnic minority populations.69,70 Our study 
addresses these gaps by focusing on SA and WA immigrant men as model populations to 
examine preferences, feasibility, and acceptability for an SMA intervention based in primary 
care and developed with user-driven input and changes in healthy lifestyle practices among 
participants’ social networks. The findings of this study should have relevance to other 
chronic conditions, such as hypertension and cardiovascular disease, and for other socially-
cohesive subpopulations (e.g., Latinos, Native Americans, and rural whites).
4. Study Endpoints 
This study has 2 aims, the first is a culturally tailored lifestyle intervention for South 
Asian immigrants in Atlanta.  The second aim examines spillover effects of the 
intervention among participants’ self-identified spillover effects.  The endpoints are as 
follows:
Aim 1: 
Primary Outcomes: I will examine outcomes in both patients (P) and social partner (SP) for 
those in the mixed gender arm of the intervention Specifically, I will report on:
1. Recruitment and retention (preferences and feasibility): preference by group of the 
study (e.g. which group of the study are participants choosing), rate of recruitment, 
number of sessions attended; for dyads, this would include sessions attended together 
and separately, over the 6 month study period
2. Participant perceptions of ILI (acceptability): questionnaires at conclusion of program to 
evaluate: (1) satisfaction with the program and (2) suggestions for program 
improvement 
Exploratory Outcomes: To evaluate changes in T2D-related risk behaviors in Ps, changes in the 
following at baseline (BL), 6 months (conclusion of ILI), and 6 months will be measured:

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1. Anthropometric measurements (body weight, body mass index (BMI), abdominal waist 
circumference): Weight will be measured in kilograms using a calibrated, standardized 
scale, and height will be measured using a standardized stadiometer. BMI will be 
calculated using the standard formula. Waist circumference will be measured by the 
World Health Organization recommended method.113 
2. Hemoglobin A1c (A1c): Point-of-care testing (POCT) with well-validated clinical 
instrument
3. Blood pressure: Blood pressure will be measured using standard procedures with a 
manual cuff
4. Plasma lipids: POCT with well-validated clinical instrument
5. Physical activity: Participants will be asked to keep daily activity logs (e.g. minutes of 
exercise and types of exercises performed daily)
6. Diet: Changes in diet will be measured using the Rapid Eating and Activity Assessment 
for Participants short version (REAP-S), a validated short food frequency questionnaire 
(FFQ).71(p) 
Aim 2: Assess the behavioral outcomes of the pilot intervention among participants’ 
social contacts as potential spillover effects.
Primary outcomes will include change from baseline to 6- months in weight control practices 
(e.g. physical activity, calorie counting, etc.), based on a 30-item questionnaire previously used 
in a similar intervention.51 
5. Study Intervention / Design 
Describe the study intervention that is being evaluated, and/or the nature of 
interactions proposed.
6. Procedures Involved
Aim 1:
3.1 Overview: To evaluate preferences, feasibility, and acceptability of a virtual SMA ILI for SA 
and WA immigrant men on health behaviors and glucose control in a pre-post pilot study.  
Participants with T2D or prediabetes will be given a choice of 1 of 2 groups of the study: (1) 
dyads (patient + support partner; mixed gender) or (2) men-only (no social partner). Groups will 
be stratified by ethnicity, thus a total of 4 groups.  
3.2 Study Design and Setting: This is a pragmatic, pre-post, pilot study.  Participants will meet in 
groups of 12 for the SMA intervention at the conference room at the Emory Family Medicine 
Center in Dunwoody, Georgia.  The group size of 12 is the recommended size for SMAs.37 
Leveraging a pragmatic, quasi-experimental design, simulating a natural experiment, the ILI will 
occur on a rolling basis, as recruitment is completed by group.  
3.3 Intervention Development: The intervention will be refined based on feedback from the 
qualitative data analyses from Aim 1.  Based on previous work by our team, the intervention 
was modified to be delivered in group telehealth sessions over 6 months. Each session will last 

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60-90 minutes, and participants will engage in a total of 6 televisit sessions.  Sessions will 
consist of a group-based program for all participants, followed by a personalized care plan, led 
by a physician, Dr. Shah, or an advanced practice provider. For those that choose the dyad-
based group, their social partner must commit to attend all in-person sessions. The sessions will 
take place at a time most convenient to participants and a time that can be integrated into the 
routine clinic schedule, likely a weekend morning or weekday evening. Based on my pilot study 
and previous work of my mentorship team, the sessions will be modeled on the Diabetes 
Prevention Program27,72,73 and will include:
•
Basic skills in healthy eating and physical activity, tailored for SA and WA immigrants
•
Coping skills and managing the external environment (e.g. social or family situations that 
are specific SA and WA immigrant groups)
•
Building social support so dyads/participants can learn effective ways to support one 
another to make and sustain health behaviors.
3.4 Recruitment: I and a research assistant will identify eligible participants through chart 
review and referrals from the Emory Family Medicine Center.  We will contact eligible adult 
patients via phone to confirm their diagnosis, explain details of the study, obtain verbal 
consent, and recruit the patient and social partner, if choosing the dyad group (we will suggest 
who to include, based on our qualitative work) to participate.  I anticipate screening 200 patient 
charts to identify a total of 48 eligible, consenting participants.
Eligibility (Inclusion and Exclusion Criteria): Based on reviews done at screening, men and 
women >18 years of age with a diagnosis of T2D or prediabetes will be invited to participate.
3.5 Enrollment: Individuals and their support person (if choosing the mixed gender arm) meeting 
eligibility criteria will receive detailed study information and be invited to participate. Informed 
consent forms will be available in English.  All subjects will be reassured that their participation is 
voluntary and they are free to withdraw at any time, without consequences to their existing care. 
Participants will receive $20 gift cards for each data collection survey, and a total fo $75 if they 
complete all surveys and attend all sessions as a token of appreciation.
The following additional protocol adds a qualitative element to Aim 1, primary outcome 2: 
Participant perceptions of ILI (acceptability): questionnaires at conclusion of program to 
evaluate: (1) satisfaction with the program and (2) suggestions for program improvement
We will employ a type of in-depth interviewing style known as semi-structured interviews. 
Semi-structured interviews and semi-structured interview guides allow some flexibility in the 
administration of the guide, as compared to a structured interview guide. This will allow for in-
depth data collection to generate valid data on this topic. 
The participant list will be pulled from the Better Together study and the community health 
workers from the Better Together study. Ten people from the Better Together study and their 
support person will be interviewed as dyads. The people selected for the interviews will be done 
purposively. We will aim to have balance in gender of the participant with diabetes – aiming for 
5 male participants and 5 female participants. Some questions in the attached interview guide 
pertain to the individual with diabetes, some will be directed at the support person, and some will 

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be answered by both. All three CHWs will be interviewed separately, totaling to 10 dyad 
interviews and 3 CHW interviews. 
We expect data saturation to be achieved with the 13 interviews and will then qualitatively 
analyze these data. Interviews will be transcribed using rev.com and a deductive coding process 
rooted in social support theory will be employed. A codebook will be developed with the initial 
set of codes matching the social support constructs. Inductive codes will be drawn from the 
emerging stories and themes from the interviews as needed. A second coder will independently 
code all transcripts. 
Aim 2: 
4.1 Overview:  To test the hypothesis that a social network-focused ILI SMA will have spillover 
effects among participants’ social networks I will prospectively assess the influence of 
behavioral weight loss treatment on participant’s self-identified social contacts who influence 
their lifestyle practices. I will conduct baseline and 6-month post-recruitment mapping of 
participants’ (from Aim 2) self-identified social contacts (n=5/participant). Based on the high 
rates of cardio-metabolic risk factors in SA and WA immigrant communities, we anticipate that 
participants’ social contacts will have elevated cardio-metabolic risk at baseline.59,61,74–76
4.2 Participants: We will utilize an egocentric approach. During enrollment of participants 
(egos) in Aim 2, we will use a name generator prompt to ask egos to identify social contacts 
who most influences their lifestyle behaviors (listing 5 alters).77  Alters will be asked to 
participate in surveys as baseline and at 6-months. Alters will be excluded if they lack 
proficiency in English, are < 18 years of age, or cannot provide written consent. 
4.3 Study Design: Paper surveys and weight assessments at baseline and at 6 months months 
will be conducted via home visits with alters (if geographically feasible). The alters will receive 
$20 for each assessment.  
7. Data and Specimen Banking
No specimens will be stored. •All hard copies of surveys and consent forms will be stored in a locked 
file cabinet in a locked cabinet at the Emory Family Medicine Clinic at Dunwoody.  
•
Electronic data will be stored on a password protected, Emory University laptop, in a password 
protected electronic file.
•
Every measure will be taken to prevent loss/theft of data, including limiting the number of 
people who have access to files and not allowing hard copies to of data to be taken from the 
clinic.
•
We will make the data of our work available through presentations of the results, including the 
methods, results, and plans for further investigation at regional, national, and international 
meetings and conferences for researchers and clinicians. We will also work with our community 
advisors to disseminate the results to local communities and other stakeholders with interest in 
our findings.
•
Publication of data shall occur during the project, if appropriate, or at the end of the project, 
consistent with standard scientific processes. We have budgeted for publication in open access 
journals to improve availability of our findings. Following NIH policy, the research data 
documenting, supporting, and validating research findings will be made available after the main 
findings from the final research data set have been accepted for publication via the procedure 
below. We will ensure adequate protections of the privacy of human subjects by removing all 

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personal identifiers and protected health information and ensuring IRB oversight of data 
sharing.
•
Participants will be informed during consent that completely de-identified data (i.e., free of all 
18 types of HIPAA identifiers) will be available to qualified researchers. Within 18 months of 
study completion, we will make datasets available to investigators who submit a written request 
to the PI. The only contingency on the use of the data will be ethical guidelines (e.g., 
requirement for completion of appropriate human subjects’ protection training courses, secure 
data storage). The NIH will be notified of any data transmissions.  De-identified data will be 
shared with requesting researchers via secure, electronic mail.
8. Sharing of Results with Participants
See above, study findings will be made available via community stakeholders, presentations, 
and publications.  Participants pre-post biometric results will be shared with individual 
participants at the end of study.
9. Study Timelines
The timeline of the proposed Study 2 and 3 (Aims 1 and 2) is summarized in the table below.  
The timeline begins after notice of award. Of note, there is a separate qualitative study (Study 
1) to culturally tailor all study related materials (this has been previously submitted to the IRB 
and is exempt).  Thus, the proposed aims in the protocol begin at month 12 after notice of 
award.
Overall Project
Expected completion post-award
Aim 1: Pragmatic Pilot Study
Finalized data collection protocol
Month 12
Finalized intervention protocol
Month 12
Approvals for Aim 2 consent forms
Month 13
IRB approval for Aim 2
Month 14
Registration on ClinicalTrials.gov
Within 1 month of IRB approval for Aim 2 
(Month 15)
Recruitment of research coordinators
Month 1
Completion of training of research 
coordinators 
Month 2
Recruitment of advance practice provider 
(APP)
Month 12
Completion of training of APP 
Month 14
Anticipated start of recruitment for trial 
participants
Month 15
Anticipate start of first group sessions
Month 16
Anticipated completion of 50% of group 
sessions 
Within 14 months of recruitment start 
(Month 30)

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Anticipated completion of 100% of groups 
sessions
Within 26 months of recruitment start 
(Month 42)
Follow up visit completion of 50% of group 
session participants 
Within 26 months of recruitment start 
(Month 42)
Follow up visit completion of 50% of group 
session participants
Within 38 months of recruitment start 
(Month 50)
Completion of primary endpoint and data 
analyses
Month 60
Final study report and manuscript submission
Over last 10 months of study, from Months 
50-60
Final results in ClinicalTrials.gov 
At time of manuscript acceptance
Aim 2: Social Network Analysis 
Finalized data collection protocol
Month 12
Approvals for Aim 3 informed consent forms
Month 13
IRB approval for Aim 3
Month 14
Anticipated start of recruitment for social 
network members (alters)
Month 16
Completion of data collection of alters
Approximately 6 months after last group 
session completed  (Month 50)
Completion of data analyses
Month 60
Manuscript submission
Over last 10 months of study, from Months 
50-60
10. Subject Population
Aim 1:
Based on reviews done at screening, men with a diagnosis of T2D or prediabetes will be invited 
to participate if they meet all of the following inclusion criteria: (1) age > 18 years; (2) 
confirmed diagnosis of prediabetes or T2D (documented A1c of ≥ 5.7% or FBG of >100); (3) a 
family member or peer willing to participate and attend all sessions as a social partner (if 
enrolling in dyad arm); and (4) proficiency in English(if in dyad, at least one member of each 
dyad), and (5) willingness to provide written consent.  Individuals will be excluded from 
participation if they have any of the following: (1) type 1 diabetes or diabetes secondary to other 
conditions (e.g. steroid-induced, pancreatic insufficiency, or chemotherapy-induced); (2) 
malignancy or life-threatening illness with life expectancy of <5 years; (3) end-stage disease or 
serious illness that prohibits participation (e.g. end-stage renal disease or class IV congestive 
heart failure); (4) inability to perform unsupervised physical activity; (5) pregnancy; (6) 
diagnosed cognitive deficits or limited decision-making capacity; (7) alcohol or substance abuse; 
or (8) homelessness or no fixed address.
Aim 2:
For the second aim, participants will be identified through participants in Aim 1.  The eligibility 
criteria are as follows:

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Proficient in English
Age greater than or equal to 18 years
11. Vulnerable Populations
•
NA
12. Local Number of Participants
For Aim 1, our goal is to recruit 48 participants.  We anticipate screening 200 patient charts to 
identify a total of 48 eligible, consenting participants.  For Aim 2, we anticipate that each 
participant will identify 4 social contacts (i.e. alters), and these will mostly consist of household 
members, based on a previous study.77 Of these, we conservatively expect 3 alters per 
participant to compete baseline and follow up surveys.  A previous study of SA’s in an urban 
setting in India reported a 97% response rate.77 This would provide a sample size of 140 (97% of 
48 participants x 3 alters/participant).
13. Recruitment Methods
All recruitment will be done via chart review of patients seen at the Emory Dunwoody Family 
practice, via chart review.  Patients who met eligibility criteria from chart review will be 
contacted by phone or email (See phone scripts). For Aim 2, participants will be identified from 
participants in Aim 1.
Incentives: For Aim 1: All subjects will be reassured that their participation is voluntary and they 
are free to withdraw at any time, without consequences to their existing care. Participants will 
receive $75 gift cards for completing all surveys and attending sessions.
For Aim 2: Paper surveys and weight assessments at baseline and at 6 months will be conducted 
via home visits with alters (if geographically feasible). Participants will receive $20 for each 
assessment.  
14. Withdrawal of Participants
Participants will be notified at the time of consent that they are free to withdraw from the 
study at any time. If during study participation, and participants develop conditions that do not 
allow participation in physical activity, such as unstable angina, stroke, or physical disability, 
they will be withdrawn from the study for their safety, without consent.  For those that 
withdraw or are asked to withdraw, data collected to that point will be included unless 
participants request their data be withdrawn as well.
15. Risks to Participants
This study has minimal risks.  There are no concerns for serious adverse events.  Other potential 
risks include pain with finger pricking for blood sample collection.  However, we are using 
standard clinical technique for point of care lab collection, thus this is an acceptable risk in the 
population.  There is a risk of loss of confidentiality of study data. We will, however, take 
measures to ensure that this does not happen by the following measures: storing data on a 
locked, password protected electronic file and using a study ID number in place of personal 
information when possible.

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16. Potential Benefits to Participants
The potential benefits to participants in Aim 1 include improved knowledge of diabetes 
management and prevention, better glycemic control, and improved weight management.  We 
hypothesize that participants in Aim 2 will also received some benefit from the intervention 
through contact with participants in Aim 1.  This will include improved weight control practices.
17. Data Analysis, Management and Confidentiality
Aim 1 Analysis: 
Power calculation: The sample size (12 participants per group) was chosen based on 
recommendations in the literature for optimal size for a SMA model.78,79  Given our primary 
outcomes are preferences, feasibility, and acceptability, we do not expect to be powered to 
find differences between groups, but rather to collect preliminary data to support a larger, 
more definitive pragmatic evaluation.  However, a lifestyle program to treat diabetes among SA 
immigrants in New York City provides a conservative power estimate for this study.80  They 
found a 0.5 percentage point difference in HbA1c.  Using this group as a known population with 
a baseline A1c of 7.8 with a standard deviation of 1.3, a fully powered study to detect a similar 
difference with an alpha (Type I error rate) of 0.05 and a beta (Type II error rate) of 0.20, would 
require 37 participants per group.  This is beyond the scope of this pilot study/training award. 
Instead, we will accept an alpha of 0.20 and a beta of 0.40, which defines a targeted 
recruitment of 11 participants per group (n=44); thus our target of 12 per group (n=48) would 
power us for these parameters. The Emory Family Medicine Clinic sees approximately 11,000 
unique patients annually.  We conservatively estimate that approximately 10% are of WA or SA 
origin and 30% of this population will have T2D or prediabetes, thus we would have 330 eligible 
participants from which to recruit 48.  This number is feasible as it would require enrollment of 
6 participants weekly for 8 weeks.   
Quantitative Data Analysis: De-identified, quantitative data will be entered into a Redcap 
database. Regular data audits will ensure the accuracy of the electronic data. Analyses will be 
conducted using the Stata 15 statistical software package. Descriptive analysis will be 
performed for all baseline variables, and outliers will be investigated for data errors. A 
probability of <0.05 will be considered statistically significant for all tests. All continuous 
variables will be tested for normality, and non-normal values will be categorized or 
transformed. Descriptive analysis will be performed for all variables and unadjusted pre-post 
comparisons will be made using t-tests or chi-square tests. Analyses will be intention to treat. 
When appropriate, hierarchical linear models will be created, to account for repeated measures 
in the same person and the clustering of participant into dyads, to look at pre- and post-
intervention changes (comparing baseline to 6-month follow up). However, modeling will be 
limited by the small sample size of the study. All data will be presented before and after 
adjustment for confounding and interaction (including, for example, age, gender, and 
education). Primary Outcome Analyses: Preferences will be assessed by quantifying number 
enrolled in each group.  Feasibility will be assessed by quantifying rate of enrollment, number 
of sessions attended by participants (for dyad arm, will assess P and SP individually and 
together).  Acceptability will be assessed by quantifying Likert-like scales of satisfaction with 
each session and overall intervention. Exploratory Analyses:  Participant anthropometric and 
biochemical markers will be assessed individually and modeled over time using hierarchical 

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modeling to account for clustering.  Changes in glycemic control and lipids from baseline to 6  
months for P will be done using similar methods as above to account for clustering; for dyad 
arm, if SP also has diabetes or prediabetes, their change in glycemic and lipid control will be 
assessed individually and compared to their baseline measure. This pilot data will be used to 
determine an effect size for sample size estimates for a larger, pragmatic, randomized trial.
Aim 3: 
Power calculation: We anticipate that each participant will identify 4 social contacts (i.e. alters), 
and these will mostly consist of household members, based on a previous study.77 Of these, we 
conservatively expect 3 alters per participant to compete baseline and follow up surveys.  A 
previous study of SA’s in an urban setting in India reported a 97% response rate.77 This would 
provide a sample size of 140 (97% of 48 participants x 3 alters/participant). Given, the small 
sample size of the intervention participants, we do not expect to be powered to find differences 
in weight loss practices among alters, however this data will provide a signal of spillover, pilot 
data, and necessary training for the PI for a larger fully powered study with a control group.
Analysis: After appropriate data checks (as described in section 3.8 above), descriptive analyses 
will be performed for all baseline variables, and outliers will be investigated for data errors. Chi 
squared tests will be used to assess pre-post differences in WCSS items.  Partial correlations, 
controlling for relevant baseline values from egos and alters will be used to examine 
associations between egos and alters in changes in weight and behaviors (as assessed by the 
WCSS items).  When appropriate, hierarchical linear models will be created, to account for 
repeated measures in the same person and the clustering of alters by household, to look at 
baseline to 6-month changes in weight management behaviors.
All patient-related data will be held in confidence by the investigator and if released will be 
identified only by a study ID number. Data will be stored and analyzed in a manner to preserve 
confidentiality; data will be de-identified and stored in a secured REDCap database with access 
limited to authorized personnel.  Source documents and paper documents will be stored in a 
locked drawer within another locked room; only authorized personnel will have access to these 
records.
This study will comply with Emory’s Data Security Policy 
(http://it.emory.edu/security/security_awareness/encrypt.html). All sensitive data and data 
that contains HIPAA identifiers will be stored on a hard drive, disk, or thumb drive that is 
encrypted, password-protected, and kept in a locked office. All data will be extracted and 
analyzed by the study team. Only aggregate data will be printed or published. Once the study is 
complete all data will be destroyed.
18. Provisions to Monitor the Data to Ensure the Safety of Participants
In Study 2 of this proposed project (Aim 1), the intervention is an educational behavior change 
program that is based on the successful lifestyle principles tested in the Diabetes Prevention 
Program (DPP) study and the Action for Health in Diabetes (Look AHEAD) study. Despite the 
very low potential for injury to research subjects, we will engage an independent data safety and 
monitoring board (DSMB) for assistance with oversight. 

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At each in-person session, participants will be asked about any potential adverse effects (e.g., 
injuries, chest pain associated with exercise) and report these to the study investigators. These 
adverse events will then be reported to the single institutional review board (IRB) and the 
DSMB. Detailed procedures for the notification of any abnormal findings of clinical relevance as 
well as non-emergency and emergency referrals will be developed and implemented. As part of 
the informed consent process, individuals will be informed of their rights regarding injury 
sustained during study procedures and if study-related injury does occur, participants will be 
offered treatment according to prevailing local health policies. 
DSMB – The PI will identify four independent scientists or clinicians who are not part of the 
mentorship team, to serve as a DSMB for the study. The DSMB will be charged with external 
oversight, monitoring conduct, data integrity, and patient safety. Prior to recruitment for Aim 1, 
the DSMB will review the protocol and monitoring plans. Following this, the DSMB will mainly 
monitor for adequate recruitment milestones, the occurrence of adverse events related to 
participation in the study, and for effectiveness (or lack thereof) of the intervention. 
The following adverse events will be monitored: death, dropout, clinical deterioration, 
hospitalizations related to cardiovascular disease, other major surgical procedures (e.g., 
amputation), development of serious substance abuse, and emergence of new medical diagnoses 
posing significant risk to subjects. 
The PI will convene DSMB meetings prior to recruitment and at 6-month intervals thereafter 
until the participants that were recruited last have completed their 6-month follow-up visits. The 
DSMB meetings will be via teleconference and the study has budgeted for honoraria for the 
DSMB members. At these meetings, the PI will present recruitment updates and data regarding 
patient safety and adverse events. Any events arising in the interim between DSMB meetings 
will be communicated to the DSMB electronically. Following DSMB meetings, the PI will 
compile the suggestions and discussion and share any concerns with the study investigators, the 
IRB, and the National Institutes of Health. 
In the unlikely event that we observe a high number of serious adverse events (e.g., heart attacks) 
that are deemed related to the intervention, premature discontinuation of the study may be 
recommended by the external DSMB or the IRB via consensus of the PI and mentorship team. 
Similarly, if an individual is hurt by the study, and the intervention is linked and decreases the 
likelihood of the participant completing the study, provisions will be made to remove him/her 
from the study.
Aim 2:
Participants in Study Record 3 (Aim 3) are not participating in an intervention, and are 
completing a pre-post paper survey and weight measurements.  There is no potential for side 
effects or injury. As such, a data safety and monitoring board (DSMB) is not applicable to this 
study aim.
19. Provisions to Protect the Privacy Interests of Participants and Confidentiality of 
Participants’ identifiable data

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All study personnel will have completed the mandatory CITI human subjects research training 
before commencing any study-related activities. 
The informed consent form for this study has been created by the Emory School of Medicine 
Office of Science and Research in accordance with Federal guidelines, including the Health 
Insurance Portability and Accountability Act (HIPAA).
We anticipate that all subjects will have the capacity to give informed consent.  
All patient-related data will be held in confidence by the investigator and if released will be 
identified only by a study ID number. Data will be stored and analyzed in a manner to preserve 
confidentiality; data will be de-identified and stored in a secured REDCap database with access 
limited to authorized personnel.  Source documents and paper documents will be stored in a 
locked drawer within another locked room; only authorized personnel will have access to these 
records.  All study related data will be destroyed within 3 years of study completion. 
Economic Burden to Participants
All study related costs are covered by the study, we do not anticipate economic burden to 
participants.  We will offer sessions during hours that are convenient to participants to avoid 
disruption of work schedules. 
20. Consent Process
• Informed consent will be obtained in person through review and written signature of our 
informed consent document; this will occur just prior to the focus group discussion.
• No waivers will be required
• No vulnerable populations are included
•We aim to ensure comprehension by reviewing and summarizing the informed consent in 
person with participants and allowing time to ask questions
Non-English-Speaking Participants  
•
Given the limited funding of this proposed study, all focus groups discussion will 
be conducted in English.  
•
English proficiency is included in the inclusion criteria.
21. Setting
For Aim 1, all research related activities will take place at Emory Family Medicine Clinic 
at Dunwoody.  For Aim 2, when geographically feasible, surveys and weight assessments 
will done via home visit.  If this is not feasible, this will be conducted remotely via phone 
or an approved video conference platform.
22. Resources Available

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•
Our research team has connections with the local South Asian immigrant 
populations.  In a previous pilot of South Asians in Atlanta, in a 5-day period, our 
team was able to recruit 14 eligible participants, thus our study is feasible.
•
The timeline is attached above.  We will have 48 months  to complete this study
•
The team has access to high-speed internet access with Dell docking station and 
laptop computer, each equipped with major word processing, citation manager 
(Endnote), Adobe professional, and statistical software (SPSS, Stata, matlab, 
MAXQDA, Microsoft Excel). All computers have connectivity to the Emory 
University secure network, which includes extensive access to online services, 
and medical journals.  The team also has access to 2 digital audio-recording 
devices.
•
All study team members must complete CITI training and will have access to all 
needed protocols and materials via a secure platform such as Emory Box.
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