Michigan Men's Diabetes Project (MenD) - Peer Leader Intervention
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sponsor: University of Michigan

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Michigan Men’s Diabetes Project (MenD) 
Diabetes Peer Leader Intervention IRB Protocol  
 
 
NCT04760444 
 
 
Document Date: 4/23/2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
1.0 PHASE II RESEARCH PLAN (PILOT RANDOMIZED CONTROL TRIAL, 3 
MONTHS) 
 
During Phase II we will be conducting a 3-month pilot randomized control trial (RCT) of 
virtual diabetes self-management education and support (DSMES) with peer leaders, 
(adapted in Phase I), to evaluate participant recruitment and retention rates, treatment 
and intervention satisfaction and estimate intervention effect sizes on our primary 
outcomes of self-management behaviors as well as on secondary outcomes such as 
glycemic control (HbA1c), diabetes social support, diabetes-related distress, and 
adherence to gender norms. This data will be collected at baseline and three months 
(treatment termination. Physiological data will be collected at St Patrick Senior Center or 
Ypsilanti Seventh Day Adventist Church and the self-report questionnaire data will be 
collected telephonically or virtually. Participants will be randomized to the virtual peer 
leader DSMES or a control group. All virtual DSMES sessions will be held on an online 
platform, Zoom Med. The baseline assessment and intervention period will consist of 16 
weeks. In the first 2 weeks participants will complete baseline questionnaires, 
interviews, and physiologic testing at St. Patrick’s or Ypsilanti Seventh Day Adventist 
Church, telephonically, or virtually. In weeks 3 to 8 participants will be simultaneously 
enrolled in 6 weekly virtual diabetes self-management education (DSME) classes with a 
certified diabetes care and education specialist (CDCES) and two peer leaders. In 
weeks 9 to 14 participants will be enrolled in diabetes-self management support 
(DSMS) sessions with two peer leaders (no CDCES). In weeks 15 and 16 of the 
intervention, participants will complete the post-treatment assessment battery (See 
Table 1). Each group will be invited to participate in the 3-month post-intervention 
assessment battery. Patients who do not complete the intervention phase will also be 
invited to participate in the 3-month assessment battery. The physiologic testing part of 
the assessment will be held at Ypsilanti Seventh Day Adventist Church or St. Patrick 
Senior Center, a non-profit that provides comprehensive services to a diverse 
population of more than 2,000 seniors living throughout metropolitan Detroit. Data 
analyses and dissemination of study findings are anticipated to be completed in months 
11-12 of the study funding period. We will also be conducting qualitative interviews to 
better understand the acceptability and sustainability of the intervention as routine 
practice in a community-based clinic. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Table 1. Detailed timeline of Phase I and Phase II 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TIMELINE 
Q1 
Q2 
Q3 
Q4 
Study Activities 
Dec 
20 
Jan 
21 
Feb 
21 
Mar2
1 
Apr 
21 
Jun 
21 
Jul 
21 
Aug 
21 
Sep 
21 
Oct 
21 
Nov 
21 
Dec 
21 
Phase I 
Focus Group 
Recruitment 
 
 
 
 
 
 
 
 
 
 
 
 
Hire & Train Research 
Staff 
 
 
 
 
 
 
 
 
 
 
 
 
Conduct Focus Groups  
 
 
 
 
 
 
 
 
 
 
 
Analyze Focus Group 
Data 
 
 
 
 
 
 
 
 
 
 
 
 
Adapt Intervention 
Materials 
 
 
 
 
 
 
 
 
 
 
 
 
Intervention Recruitment  
 
 
 
 
 
 
 
 
 
 
 
Phase II RCT 
Randomization 
 
 
 
 
 
 
 
 
 
 
 
 
T0 Baseline 
Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
T1 Post-Intervention 
Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
Phase III Data Analysis  
Interviews and Focus 
Groups (participants and 
practitioners) 
 
 
 
 
 
 
 
 
 
 
 
 
Analyze and 
disseminate data 
 
 
 
 
 
 
 
 
 
 
 
 

2.0 Background: 
Diabetes is the 6th leading cause of death in Detroit. 14,15 One-third of people living in the 
city over the age of 50 have diabetes or pre-diabetes.14,15 Michigan’s age-adjusted 
diabetes death rates in 2009 were 26.6 for White males, 19.1 for White females, 44.7 
for Black males, and 33.6 for Black females (deaths per 100,000 population).14,15 
Diabetes is highly prevalent in Black men and they are more likely to be diagnosed with 
T2D compared to non-Hispanic White men.16 In addition, they are disproportionately 
more likely to have uncontrolled blood glucose levels than their non-Hispanic White 
counterparts.17 
 
One factor that may account for diabetes health disparities is differences in 
diabetes management behaviors in Black men as compared to Whites.18 Studies 
suggest that Black men in general are less likely to adhere to diabetes self-
management regimens.19,20 Although studies of older Black men are more limited, those 
that exist suggest that they are even less likely to engage in diabetes self-management 
behaviors (e.g. checking blood glucose levels daily).7 Black men are also more likely to 
engage in behaviors that increase their risk for diabetes-related complications such as 
smoking and alcohol consumption than their non-Hispanic White peers.21 Black men 
may also face unique barriers that interfere with healthy behaviors including a lack of 
social support, negative patient-provider relationships, high medical fees and long work 
hours.22,23 While existing research clearly shows that older Black men are at elevated 
risk for poor diabetes management, they are also less likely to participate in 
interventions to improve diabetes management.12 Specifically, in our systematic review 
of T2D self-management interventions, the percentage of male participants was 
typically less than 15%. This is also consistent with the finding that men are more likely 
to drop out of diabetes self-management intervention trials.10,12, 24 
 
A growing body of literature demonstrates the critical role of gender in the 
management of health behaviors and shows that male gender norms can conflict with 
both healthy behaviors and healthcare engagement.25 Sex refers to biological 
differences (e.g. chromosomes and sex organs). Gender describes the characteristics 
that a society or culture delineates as masculine or feminine.25 Among Black men 
specifically, the need to exhibit toughness, confidence, suppression of emotions and 
independence/control served as barriers to both accepting advice from care providers 
and accepting social support offered by family and community networks.20 In a recent 
study, Black men reported encountering significant difficulty in accepting a caring 
environment, such as emotional support, as this was perceived as feminized behavior, 
which in turn served as a barrier to seeking care.19 Gender-related norms among Black 
men also include “superman syndrome” or the ability to maintain their health without the 
assistance of doctors.26 Recommendations for gender-specific programming have 
included using male interventionists to reduce stigma and embarrassment related to 
health care seeking, improve communication with health care providers and address 
specific beliefs that undermine health.27 Peer leaders have been defined as trained lay 
individuals used to improve diabetes self-management in minority communities through 
provision of diabetes education, assistance with goal setting, problem solving, and 
social and emotional support.28,29 In this context, peer leaders shared cultural identity 
and community ties are a critical component in improving diabetes management in 
minorities with T2D.30-32 However, despite studies showing that interventions using peer 

leader models have been successful in improving diabetes management (e.g. blood 
glucose monitoring) and clinical outcomes (e.g. HbA1c) among minority populations to 
date, these interventions have not been adapted to meet the needs of older Black 
men.  In addition to the lack of tailoring of content or adjustment of messaging, as noted 
earlier, the majority of peer leaders used in these studies have been female, and in 
general, women are the majority of participants in diabetes intervention studies.12 
Matching lay interventionists for the race and gender of patients may be one way to 
increase the likelihood that both intervention content and messaging are appropriate.12  
While there is a paucity of research using male peer leaders with Black men with 
T2D, male lay helpers have been used in other areas of health care to provide Black 
men with health education and support.33 These interventions have included prevention 
of chronic illness (e.g. screening for hypertension) in intervention venues such as 
barbershops.34 However, this research is limited and therefore additional work needs to 
be done to establish the efficacy of these approaches.33,34 In addition, as the behavioral 
targets of these programs were primarily health promotion and/or prevention behaviors 
such as increasing condom use and disease screening, and not management of a 
chronic disease, it is important to assess whether use of male peers as interventionists 
can improve health outcomes among men already living with a chronic illness. As 
previously noted, there is a dearth of efficacious diabetes management interventions for 
Black men. While the effectiveness of peer-led interventions delivering diabetes-related 
education and support for short-term clinical, psychosocial, and behavioral 
improvements is well-established, older Black men in particular are less likely to 
participate and are at a higher risk of drop-out from these studies. The proposed 
research is innovative because:  
1. interventions to date have not targeted older Black men, who are at highest risk 
for poor diabetes health; 
2. peer-led interventions have not matched peer leaders based on the gender of 
intervention participants nor have they;  
3. tailored the intervention content utilizing the perspectives of older Black men with 
T2D in the adaptation process to meet the specific needs of this understudied 
and at-risk population.  
We propose to develop training for our male peer leaders to specifically encourage 
conversations regarding beliefs that affect men’s health and to allow modeling of 
alternative views and perspectives that allow for successful disease management to be 
framed as competence and strength. Given that the life expectancy for Black men in the 
US is 71, we hypothesize that targeting men in earlier stages of T2D will assist greatly 
in facilitating healthy aging and improving diabetes-related health outcomes later in life. 
Based on our previous work, the long-term goal of our research is to determine the 
most effective, practical, and sustainable approach to provide diabetes self-
management education and support (DSMES) to older Black men. The objective of this 
proposal is to examine the relative effectiveness, feasibility, and acceptability of a peer-
leader intervention for Black men with T2D. To accomplish this objective, we will 
engage in a developmental phase and a validation phase [pilot randomized control trial 
(RCT)]. The RCT will be conducted with N=60 Black adult residents of metro Detroit, MI. 
Participants will be randomized to an enhanced usual care group or the tailored peer-
leader diabetes self-management support group (PLDSMS). We hypothesize that 1) 

participants in the PLDSMS group will have improved outcomes over the control group, 
and 2) an evaluation of measures will confirm efficacy of the intervention. Measures will 
be collected at baseline, 3-months and a 3-month follow-up. The primary outcome will 
be change in self-management behaviors measured through completion of the 
Perceived Diabetes Self-Management Scale and a self-report questionnaire measuring 
a broad range of diabetes self-management behaviors post intervention and at 3-month 
follow up. Secondary outcomes will be change in A1c, weight, blood pressure, quality of 
life, diabetes related-distress, diabetes social support, and adherence to gender norms. 
We hypothesize that 1) participants I the PLDSMS group will have improved outcomes 
over the control group, and that 2) participants in the PLDSMS will achieve DSMES 
skills at significantly higher levels than participants in the control group. 
 
3.0 Aims 
Aim 1 (Phase 1): Refine existing intervention components from a previous peer 
leader trial to allow it to be best tailored to the needs of older Black men with T2D 
by: 
- 
Conducting 10 interviews with older Black/African American men with T2D. 
 
Aim 2: Conduct a pilot randomized controlled trial for older Black men with T2D 
based on what we learn from Aim 1. Development, adaptation, and refinement will 
involve: 
- 
Developing a peer led diabetes self-management education and support 
intervention based on our interviews and previous research. 
- 
Conduct an open pilot study to determine feasibility and acceptability of the peer 
led diabetes self-management support and estimate intervention effect size on 
our primary outcome of diabetes self-management behaviors and changes in 
A1C, as well as on secondary outcomes of change in weight, blood pressure, 
quality of life, diabetes related-distress, diabetes social support, and adherence 
to gender norms. Data from the pilot trial will help refine recruitment strategies, 
training materials, and protocol to be used in a larger clinical study. 
 
Aim 3: Conduct a qualitative process evaluation of the implementation of peer led 
DSMS to determine feasibility and acceptability of the intervention by: 
- 
Recruiting 10-12 stakeholders (facilitators, participants, peer leaders, and 
certified diabetes care and education specialists) and complete post intervention 
interviews to identify barriers, perceptions and beliefs surrounding peer led 
DSMS targeting older Black male populations. 
 
Overall impact: Data from the pilot RCT will help refine recruitment strategies, training 
materials, and the study protocol to be used in a larger cluster RCT. Our study will also 
identify strategies to increase patient participation in intervention research and improve 
drop out rates. This goal is in line with the mission of NIDDK to disseminate science-
based information on diabetes, to improve people’s health and quality of life. 
4.0 Participants and Recruitment 
 

Participants will be 64 Black/African American men ages 55 years or older and meet the 
inclusion criteria listed below. During the Phase II pilot we will individually randomize 
each participant with a 50/50 randomization scheme to either the peer led DSMS or a 
control group. Four of the participants will attend 30- hours of training and function as 
peer leaders during the intervention DSMES. 
 
Inclusion: Inclusion criteria for the Phase II (intervention) will include males age 55 or 
older who are Black/African American, and who’ve had diagnosis of T2D for a six-month 
duration or longer.  
 
Exclusion: Exclusion criteria for Phase II will include: non-ambulatory, serious health 
conditions (morbid obesity and severe symptomatic heart disease, visual impairment, 
renal failure, and peripheral neuropathy), psychiatric illness (severity requiring 
hospitalization) or cognitive deficit (illness determined using the Montreal Cognitive 
Assessment tool) and serious diabetes complications (e.g. blindness) that would 
impede meaningful participation. We considered restricting eligibility to a higher-risk 
population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the 
proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with 
T2D allows us to cast a wide net for secondary prevention and public health impact. 
Persons who meet eligibility criteria will be invited to participate in the baseline 
screening assessment. While we have chosen the above eligibility criteria based on 
previous work, we will make adjustments to the future, larger trial, based on results and 
feedback from our proposed pilot. 
 
Participant Recruitment: We will put up flyers describing the study. The flyers will be 
posted at a Detroit-based senior center (St. Patrick’s), Ypsilanti Seventh Day Adventist 
Church, and Michigan Center for African American Aging Research Participant 
Resource Pool (MCUAAAR PRP) community-partners. The MCUAAAR PRP is a 
research volunteer registry can be accessed by scholars conducting research of Black 
males, 55 years of age and older who meet their study criteria. Men with T2DM 
identified with the help of the MCUAAAR PRP will be called by study staff and invited to 
participate in the intervention. Dr. Hawkins will also be working with the Dr. Linda Nyquist, 
the Human Subjects Assessment Core Leader. Dr. Nyquist will run a search in the MICHR 
DataDirect PHI system and identify potential participants that meet study eligibility criteria. 
Dr. Nyquist will provide the research team with the names, addresses, phone numbers, and 
emails of potential participants on a password protected document. Men with T2DM 
identified with the help of Dr, Nyquist will be mailed and emailed recruitment letters. Study 
staff will provide follow up phone calls after the letters are sent to ensure potential 
participants received the letter. Men interested in participating in the study will call a 
central office phone number or be identified on follow-up calls then they will be 
scheduled for screening.  
 
 
Peer Leader Participant Recruitment: Peer leaders will be recruited from the Phase 1 
Interviews, MICHR DataDirect, or identified by St. Patrick Center staff.  
5.0 PROCEDURES 
 

Screening Individuals that are interested in participating in the study will be asked to 
complete a phone screen with a study team member. During the phone screen, the 
research staff will read a brief recruitment script and ask if the participant is interested in 
participating. If the individual is interested and willing, they are asked to complete a 
phone screen. The phone screen can be scheduled for immediately following the 
recruitment script or at a time convenient for the potential participant. 
  
The phone screen will assess the following: basic demographic information and self-
identified T2D diagnosis. Individuals will be eligible for a baseline interview if they meet 
demographic criteria (self identified as African American/black, and 55 years or older), 
self report having Type 2 Diabetes.  
 
Upon completion of the phone screen, the study team member will inform the individual 
if they are eligible to complete the baseline interview. If the individual is eligible, a 
baseline assessment will be scheduled and details will be given to the individual. The 
purpose of this initial screen is to invite research candidates to additional eligibility 
screening (Baseline Assessment) having met initial criteria and for the research 
candidates to provide consent to answering questions at the in-person Baseline 
Assessment which involve Private Health Information, to be used for determining 
eligibility. 
 
Baseline Assessment (Assessment Battery) All individuals that meet initial phone 
screening criteria and agree to participate will complete a baseline assessment. The 
physiological testing portion of the baseline assessment will be held in person at either 
St. Patrick Senior Center or Ypsilanti Seventh Day Adventist Church and the self-report 
questionnaire will be completed by the participant virtually or over the phone with a 
study team member. During the assessment the participant will be asked to complete 
questionnaires and interviews to determine if the participant is eligible to participate 
based on inclusion and exclusion criteria. Baseline assessments will last about two 
hours total. The PI will train all research staff in standardized data collection. Trained 
research staff will take biometric data of participants including height, weight, blood 
pressure, and A1c. Participant A1c values will be analyzed on site using a DCA 
Vantage Analyzer. All participants, including peer leader participants, will be paid $20 
for completing the assessment and the same assessments at T0 (baseline) and T1 
(post-treatment). 
 
Randomization Participants will be randomized to the peer leader diabetes self-
management support (DSMS) group or a control group using a 50/50 randomization 
scheme. Participants will be aware if they are in the intervention group or the control 
group.  
Intervention (Peer Leader DSMS n=30) Participants randomized to the peer led DSMS 
group will receive 6 100-minute weekly sessions of diabetes self-management 
education (DSME) delivered by a certified diabetes care and education specialists 
(CDCES) and co-facilitated by a peer leader (PL) delivered via the Zoom for Health a U-
M service may be used for Protected Health Information (PHI, regulated by HIPPA). 
Next, participants will transition into 6 90-minute weekly PL led DSMS sessions 

intentionally designed for older Black men with T2D. The CDCES will provide oversight 
to the PL and be available by phone if any clinical questions arise during the session. 
 
Control Group (Control n=30) Participants randomized to the control group will receive 
6 sessions of group-delivered DSME provided by a CDCES; however they will not 
receive any DSMS or ongoing support from PLs and the PL will not participate in the 
DSME sessions. Based on several years of experience in Detroit, providing all 
participants with DSME and educational materials minimizes ethical concerns regarding 
assignment of underserved populations to receive a no-treatment control. To ensure 
treatment fidelity, three DSMS sessions will be selected at random and recorded and 
rated for fidelity by our research team. 
 
Peer Leaders (n=4) Participants recruited to be PLs for the intervention group will 
attend PL training (described below), co-facilitate DSME sessions with a CDCES, lead 
DSMS sessions, and complete the same battery of assessments as all other 
participants in the study.  
 
Peer Leader Training: The peer leader training curriculum will be based on materials 
used by Dr. Piatt and her research group. Thirty hours of training will be conducted over 
6 weeks. PLs will receive training in facilitation skills, coping strategies, and 
empowerment-based communication skills. As noted in Phase 1, training will be 
adapted to include a focus on men’s health issues. Training will be group-based and 
include both the knowledge and skills needed to implement empowerment-based 
DSMS. A CDCES who was involved in the development and implementation of the 
training curriculum in previous projects, will conduct the training. This training will 
support the PLs in developing communication, facilitation, and behavior change skills 
and opportunities to apply those skills in an experimental setting. To ensure that PLs 
are supported, 3-monthly meetings will be held with all PLs so that they may exchange 
information and support each other. As noted above, it is expected that this content will 
be adapted to include men’s health concerns based on Phase 1. PLs will be identified 
from interviews, based on recommendations from the senior center, and/or from the 
DataDirect participant pool. PLs will be compensated at $10/ hour for the duration of the 
study to defray the cost of their time and expenses. 
Follow-Ups The follow up assessment for both the peer led DSMS group and 
control group will occur at three months (post-treatment assessment). All 
participants, including peer leader participants, will return to the St. Patrick’s Senior 
Center or to Ypsilanti Seventh Day Adventist Church for physiological testing and 
complete the self-report questionnaire telephonically, or virtually. The same 
measurements and surveys will be completed. Participants will be compensated $20 
for completing this assessment. Data will be stored in REDCap, a secure, web-
based application hosted at UM. 
Maintenance of Samples Strategies will be used to encourage attendance of group 
sessions and to complete follow up interviews. Reminder emails, texts and/or calls 
will be sent before each session to remind participants by the study team. In 
addition, the study team will collect participant contact information from baseline to 

follow up phase. The study team will also ask participants to provide additional 
contact person(s) that the study team can contact if they cannot reach the 
participant. 
Participant Retention The following procedures will be used to minimize participant 
attrition: 1) Data collection sessions will be completed at the Senior Center site or 
the Ypsilanti Seventh Day Adventist Church in order to maximize the convenience of 
data collection for subjects, and 2) multiple techniques are used to increase the 
likelihood that participants will keep their data collection appointments, including 
advanced scheduling, multiple reminder letters, and phone reminders. Participants 
who withdraw will still be asked to participate in study data.  
Data Collection & Data Safety For Phase II (intervention), data will be collected 
through the following methods:  finger stick capillary blood samples, blood pressure 
measurements, weight, height, exit interviews regarding treatment satisfaction, 
surveys, audio recorded interviews and treatment sessions, and transcribed 
interviews and treatment session recordings. Data that are obtained specifically for 
research purposes will be collected only with informed consent. All data will be 
collected over the course of the award period. 
 
At the time of study enrollment, participants will be assigned a study identification 
number to be used in all study materials and data for the duration of the study. All 
identifying information will be separated from the data and laboratory values. A master 
list that contains participants names and study identification number will be kept in a 
locked filing cabinet within a locked office in the School of Social Work at the University 
of Michigan. Audiotapes of treatment sessions will be stored securely on a password 
protected computer only accessible to study personnel and will be destroyed upon study 
completion. We will use DropBox, a secure platform to share these recordings, 
transcriptions, and other study data between study team members.  
 
The principal investigator (Dr. Hawkins) and the research assistants will be the only 
persons who have access to the file linking study participant identification number to 
each subject, and this will be stored separately from study data. Participants will be 
assured that all data they provide to the study will be confidential to this study, unless it 
is necessary to “alert” the patient and possibly also their physician because of a 
laboratory value outside of the normal ranges that reflects a risk requiring immediate 
medical attention. All reports will use aggregate data. Subject names or other identifiers 
will not be reported. All quotes shared collected from the interviews will be de-identified 
for privacy. No persons from the recruitment sites will handle or have access to 
personal health information or participant survey data. 
 
Data will be stored in REDCap, a secure, web-based application hosted at the 
University of Michigan. Analyses will be conducted using Atlas.ti. This data will be used 
to conduct a final refinement of treatment content as needed. 
 
To ensure the proper monitoring of the safety of all participants and the quality of data 
collected, a Data Safety and Monitoring Board (DSMB) will be established that will 

follow techniques suggested in the literature (Damocles, et al, 2005). The board will 
consist of Drs. Hawkins, Piatt, and Alexander. In addition, five outside members, who 
are not involved with the study, will serve on the DSMB as voting members and will be 
identified at a later date. Voting members will consist of University professors with 
experience and expertise in clinical diabetes intervention research to ensure 
consistency and quality of input. 
6.0 GROUP LEADERS & TRAINING 
To ensure staff participation in data safety and monitoring activities, all members of the 
project team (research assistants and staff) will be trained on the specifics of the data 
safety and monitoring plan. Field staff will be trained on what constitutes an adverse 
event to a participant and instructed to report any adverse events immediately to the 
principal investigator, Dr. Jaclynn Hawkins.   
 
All questionnaires and instrumentations are standardized measures that have been 
used in our own trials and in other diabetes research and there are no significant risks 
anticipated related to the completion of them. However, breaks will be given as needed 
to reduce fatigue, or measures read to adolescents, and research assistants will be 
appropriately trained to obtain personal information in a sensitive fashion. Research 
staff will be trained in research ethics, confidentiality protection, and HIPAA prior to and 
throughout the study period. All CDCESs in this study are either a Registered Dietitian 
Nutritionist RDN) or Registered Nurse (RN) and are certified through the Certification 
Board for Diabetes Care and Education. The extensive CDCES certification process 
ensures health care professionals possess comprehensive knowledge and experience 
in prediabetes, diabetes prevention, and diabetes management. Katherine Kloss, RDN, 
CDCES has been working with people with diabetes for 6 years and a CDCES for 2 
years. Robin Nwankwo, MPH, RDN, CDCES has been working with people with 
diabetes for 28 years and a CDCES for 24 years. 
 
The PI will monitor adverse events throughout the clinical trial period. To ensure staff 
participation in data safety and monitoring activities, all members of the project team 
(research assistants and staff) will be trained on the specifics of the data safety and 
monitoring plan.  Field staff will be trained on what constitutes an adverse event to a 
participant and instructed to report any adverse events immediately to the principal 
investigator, Dr. Jaclynn Hawkins.   
 
The principal and co-investigators on the proposed study make up a trans-disciplinary, 
accomplished and collaborative team of community-based behavioral and clinical 
researchers. Together, our research team has a strong history of successfully 
implementing and publishing our work regarding diabetes interventions in high-risk 
communities. Most notably, Drs. Piatt and Herman of the Michigan Center for Diabetes 
Translational Research (MCDTR), collaborated on Praise I and II, T2D randomized 
controlled trials of the effectiveness of church-based diabetes self-management support 
being conducted with Black adults in Toledo, Flint, and Metro Detroit of which Dr. Piatt 
is PI. Dr. Hawkins is currently a co-investigator on Praise 2 (R01DK104733-02). Also, 
as part of the MCDTR, Dr. Hawkins is an early career trainee and Dr. Piatt served as 
Dr. Hawkins’ primary mentor for the last 3 years. All are members of BRIDGE. 

 
7.0 MEASURES 
Primary Outcome Measures 
Regimen adherence will be measured using the Perceived Diabetes Self-
Management Scale, a self-report questionnaire used to measure a broad range of 
management behaviors, such as insulin management, dietary management, blood 
glucose monitoring, symptom response, and parent assistance/supervision.  
Metabolic Control will be measured via hemoglobin A1c (HbA1c). HbA1c will be 
collected using the DCA 2000 point-of-care testing instrument.  
 
Secondary Outcome Measures 
Adherence to gender norms will be measured using the Male Role Norms Inventory-
Short Form. BMI will be calculated using height and weight. Height will be measured 
using a stadiometer. Weight will be measured on a high quality, calibrated digital 
scale. BP will be measured using a digital sphygmomanometer. 
Diabetes Social Support will be measured using the Diabetes Social Support 
Questionnaire. Diabetes-related Distress will be measured using Diabetes Distress 
Scale (SF-12) and lastly, a validated Diabetes Quality of Life will be used to measure 
quality of life. Participants will also complete questionnaires that assess socio-
demographic, behavioral, psychosocial, and health services utilization and are 
validated in diverse populations with diabetes. 
 
Specific Aim 1: Qualitative analyses will be conducted during the development phase 
and on the post-intervention focus groups and interviews.  First, we will develop codes 
utilizing a grounded theory approach and will start with the formulation of categories and 
definitions developed directly from the text. Content from transcripts will be coded for 
themes and patterns. Through this process a coding manual and definitions will be 
finalized. The refined manual will be used to guide ongoing coding and pairs of coders 
will read subsequent transcripts keeping codes that achieve 80% agreement on code 
application. Analyses will be conducted using Dedoose. This data will be used to 
conduct a final refinement of treatment content as needed. 
 
Specific Aim 2: The proposed study includes a sample size of 64 Black men, 30 in the 
intervention arm, 30 in the control arm and 4 trained as peer leaders for the intervention 
arm. We will assess the impact of the intervention on diabetes management and HbA1c 
(primary outcomes) and on secondary outcomes using multilevel modeling, with 
intervention group as a between-subjects factor (2 levels) and time as a within subjects 
factor (3 levels). HbA1c, diabetes self-management, and social support at baseline, 3 
and 6 months will be used as the dependent variables. Independent variables include 
intervention group, time of assessment, and interaction between time and intervention 

group. Random effects will be allowed for the intercept (to allow differences in baseline 
measurements) and the slope (to allow differences in the trajectories of change). 
Covariates e.g. length of time since diabetes diagnosis, age will be tested as predictors 
of the outcome and retained if significant at p < .10.  
 
Power Analysis: Assuming 20% attrition, we expect a final sample size of 48, 
approximately 12 per group (with 2 groups in the treatment arm). If we assume 
correlations of 0.25 between successive measurements of HbA1c, then this sample size 
will yield power of 0.8 to detect a difference of 0.6 standard deviation between average 
values of HbA1c in treatment and control groups. 
 
8.0 PROTECTION OF HUMAN PARTICIPANTS 
The protocol for this study will meet approval by the University of Michigan Institutional 
Review Board prior to initiating any of the described study activities. 
 
D 1. Human Participants Involvement And Characteristics Removing Participants From 
The Protocol.  
 
Respondents who meet eligibility criteria will be invited to participate in the baseline 
screening assessment. While we have chosen the above eligibility criteria based on 
previous work, we will make adjustments to the future, larger trial, based on the results 
and feedback from our proposed pilot. 
 
D 2. Sources Of Materials 
For Phase II (intervention), data will be collected through the following methods:  
finger stick capillary blood samples, blood pressure measurements, weight, and 
height. Data that are obtained specifically for research purposes will be collected 
only with informed consent. All data will be collected over the course of the award 
period. 
 
D 3. Potential Risks 
 
Participation in this study involves minimal foreseeable risks. Participants will be asked 
to provide finger stick capillary blood samples during assessments. Risks associated 
with finger stick capillary blood draws include: minor discomfort from obtaining the blood 
sample, minor pain, bruising, or bleeding at the puncture site similar to any other routine 
blood sample collections. With self-report surveys, there is also the small risk that 
prompting patients to review their diabetes care practices and providing them with 
feedback about their diabetes-related health outcomes (e.g., A1C, blood pressure) 
could cause some emotional discomfort or anxiety. Such discomfort would likely prime 
patients and their primary care physician or group facilitator to address any problems 
identified. Other risks include breach of confidentiality of study data. 
 
Protection Against Risk 

All questionnaires and instrumentations are standardized measures that have been 
used in our own trials and in other diabetes research and there are no significant risks 
anticipated related to the completion of them.  However, breaks will be given as needed 
to reduce fatigue, or measures read to adolescents, and research assistants will be 
appropriately trained to obtain personal information in a sensitive fashion.  Research 
staff will be trained in research ethics, confidentiality protection, and HIPAA prior to and 
throughout the study period.  All peer leaders must pass standardized training prior to 
providing service to participants and will also be trained in protection of participant 
confidentiality.   
 
At the time of study enrollment, participants will be assigned a study identification 
number to be used in all study materials and data for the duration of the study. All 
identifying information will be separated from the data and laboratory values.  A master 
list that contains participants names and study identification number will be kept in a 
locked filing cabinet in the School of Social Work. Audio/visual recordings of the 
intervention for fidelity purposes will also be stored securely on a password protected 
computer only accessible to study personnel and will be destroyed upon study 
completion. The principal investigator (Dr. Hawkins) and the research assistant will be 
the only persons who have access to the file linking study ID# to each subject.  
Participants will be assured that all data they provide to the study will be confidential, 
unless it is necessary to “alert” both the patient and their physician because of a 
laboratory value outside of the normal ranges that reflects a risk requiring immediate 
attention.  Participant’s physicians will receive a report of participant laboratory values 
after each assessment. All reports will use aggregate data.  Subject names or other 
identifiers will not be reported. No persons from the senior center, Ypsilanti Seventh 
Day Adventist Church, or other community based location will handle or have access to 
personal health information or participant survey data. 
 
D 6. Potential Benefits Of The Proposed Research To The Participant And Others 
Participants will have the potential to benefit from the study by receiving free diabetes 
self-management education and support from the intervention and also an opportunity 
to discuss barriers and facilitators to recruitment and retention of men and women in a 
large-scale intervention. There are also benefits to society from the research through its 
potential to improve diabetes self-management interventions for persons with Type 2 
diabetes. We feel the benefits of participating in this study significantly outweigh the 
risks. 
 
9. DATA AND SAFETY MONITORING PLAN 
Adverse Events:  The PI will monitor adverse events throughout the clinical trial period. 
To ensure staff participation in data safety and monitoring activities, all members of the 
project team (research assistants and staff) will be trained on the specifics of the data 
safety and monitoring plan.  Field staff will be trained on what constitutes an adverse 
event to a participant and instructed to report any adverse events immediately to the 
principal investigator, Dr. Jaclynn Hawkins.   
 

For the purposes of this study, adverse events will be considered any undesirable sign, 
symptom, or medical condition occurring during the study, whether or not related to the 
intervention. Adverse events include new events not present during the training period 
or events that were present during the training period but increased in severity over 
time. Each adverse event will be recorded and assessed for its date of onset, duration, 
severity, seriousness, and relationship to study treatment, and any action/treatment that 
is required. All adverse events will be collected, analyzed, and monitored using an 
adverse event form. Furthermore, the committee will establish “alert” values for A1C 
and blood pressure.  The PI will notify the subject and the subject’s physician whenever 
there are laboratory results above these values because of the clinical implications of a 
value substantially out of normal range.   
 
All serious medical events will be reported within one business day of their identification. 
All serious, fatal or life-threatening adverse events will be reported to UM IRB and the 
NIH within 24 hours of its identification. All causes of death are considered to be serious 
medical events. Unexpected moderate or severe adverse events will be reported in 
writing to the IRB and NIH. Serious medical events will be collected throughout the 
intervention phase of the study. The PI, along with the study physician, Bill Herman, 
and/or co-Investigator Gretchen Piatt, will adjudicate whether or not each serious 
adverse event may be attributable to study participation. Events that involve an 
unexpected adverse event and are possibly or probably related to participation in the 
study will be reported to the IRB at University of Michigan within one business day.  
Annual reporting of aggregate adverse events to the IRB and NIH will be performed. All 
research project personnel will complete training in the protection of human research 
participants. The PI and research assistant will verify appropriate reporting of adverse 
events, quality of data collection, and adherence to the study protocol. Participant 
dropout rate will also be monitored and reviewed for needs or trends based on specific 
participant characteristics. 
 
Data Safety & Monitoring Board: The DSMB will hold a minimum of two conference 
calls over the award period (approximately two hours per call) to discuss the progress of 
the intervention and review research results, if applicable.  At the first meeting, the 
board will elect a chair of the DSMB. To facilitate these conference calls, the principal 
investigator will prepare a report on the progress of the project to date. This report will 
be circulated well in advance of the conference call to allow all members ample time to 
read it. These calls will be scheduled and organized by the study coordinator and will be 
held at a time convenient for all members.  
 
The DSMB is responsible for assuring that study participants are not exposed to 
unnecessary or unreasonable risks and that the study is being conducted according to 
high scientific and ethical standards. Specifically, the DSMB will:  
 
1. Assess the performance of the study with respect to subject recruitment, retention 
and follow-up, protocol adherence, and data quality and completeness, in order to 
ensure the likelihood of successful and timely milestone completion.  
 

2. Monitor interim data regarding the safety of the study, including adverse events. The 
DSMB may, at its discretion, examine effectiveness data as well.  
 
3. Review abstract and publications of main findings prior to submission to ensure the 
study is being reported appropriately.  
 
4. Review and consider any protocol modifications or ancillary studies proposed by the 
study investigators after the main study begins to ensure that these do not negatively 
impact on the main trial.  
 
5. Advise the NIA and the study investigators as to whether a protocol should continue 
as scheduled or undergo a modification due to a finding from the monitoring process.  
 
6. Make recommendations to the NIDDK and principal investigator concerning 
continuation or conclusion of the trial. 
 
 
10.0 STUDY SITES 
Virtual empowerment-based DSME/S sessions: All DSME/S sessions will be held 
virtually via HIPPA compliant Zoom med. Baseline, post-treatment and follow-up 
assessment self-report questionnaire will take place telephonically or virtually and 
the physiological part of those assessments will take place at St. Patrick’s senior 
center, a non-profit that provides comprehensive services to a diverse population of 
more than 2,000 seniors living throughout metropolitan Detroit, or Ypsilanti Seventh 
Day Adventist Church. 
Elements Unique to this Site In each location, rooms with doors and telephones 
will be available to facilitate privacy, confidentiality, and safety of assessments.