Stories for Change: Digital Storytelling for Diabetes Self-Management Among Hispanic Adults
Phase: NA
Conditions: Type2 Diabetes
Sponsor: Mayo Clinic

Date: February 28, 2024 
 
 
 
 
WORKING PROTOCOL** 
 
Stories for Change: Digital Storytelling for Diabetes Self-Management among Hispanic Adults 
 
Funding: NIH NIDDK, R01 DK113999-01A1 
Clinical Trials.gov: 18-002998 
 
 
 
 
Study Personnel 
 
Principal Investigators 
Mark Wieland, MD, MPH, Mayo Clinic 
Irene Sia, M.D., MSc, Mayo Clinic 
 
Co-Investigators 
Christi A. Patten, PhD, Mayo Clinic 
Jane W. Njeru, MBChB, Mayo Clinic 
Jeff A. Sloan, PhD, Mayo Clinic 
 
Other personnel 
Paul Novotny, MS, Statistician 
Sheila Iteghete, Project Coordinator 
 
Consortium Study Personnel 
Hennepin Healthcare, MN 
Katherine Vickery, MD, MPH, Site PI/Co-Investigator 
Rachel Silva, MD, MPH, Co-Investigator 
Becky Ford, PhD, Project Manager 
Breidy Garcia, Research Assistant 
 
Mountain Park Health Center, AZ 
Davinder Singh, MD, Site PI/Co-Investigator 
Valentina Hernandez, Project Manager 
Crystal Ramos, Study Coordinator 
Sandra Bahena, Clinical Research Coordinator 
Elizabeth Hernandez, Research Assistant 
 
 
 
 
 
 
 
**The working protocol is a detailed description of how the funded grant will be implemented. 

Specific Aims  
     Hispanic adults are twice as likely to have type 2 diabetes mellitus (T2D) and 1.5 times more likely to die from 
the disease than non-Hispanic whites1,2. These disparities are mediated, in part, by less healthful levels of 
physical activity, dietary quality, medication adherence, and self-monitoring of blood glucose than non-Hispanic 
whites3-6. Innovative approaches that arise from affected communities are needed to address these health 
disparities. Community-based participatory research (CBPR) has been successful in targeting health issues 
among Hispanic and immigrant populations7-9; CBPR is an engaging and effective approach for addressing 
health behaviors in a sociocultural context10.  In 2004, our research team developed a CBPR partnership 
between immigrant communities and academic institutions in Rochester, Minnesota.  Since its inception, 
Rochester Healthy Community Partnership (RHCP) has matured, developed a community-based research 
infrastructure, and become productive and experienced at deploying data-driven programming and outcomes 
assessment among diverse immigrant populations in an effort to reduce health disparities11,12.   
 
     Storytelling or narrative-based interventions are designed to incorporate culture-centric health messaging to 
promote behavior change among vulnerable populations13,14. Previous research has shown that narrative based 
video interventions are more likely to elicit positive motivations for healthful behaviors than non-narrative video 
messaging for cancer screening15,16 and smoking cessation17 among viewers.  A single randomized trial has 
evaluated the impact of a narrative-based video intervention on chronic disease management, showing 
significant improvement in hypertension outcomes18. Digital storytelling interventions are narrative-based videos 
elicited through a CBPR approach to surface the authentic voices of individuals overcoming obstacles toward 
engaging in health promoting behaviors19 to shape positive health behaviors of viewers through influences on 
attitudes and beliefs20. 
 
     RHCP partners from Hispanic communities identified T2D as a priority area for intervention, and have co-
created each of the formative phases leading up to this proposal.  Narrative theory and social cognitive theory 
formed the conceptual basis for intervention development. Our study team conducted surveys21,22 and focus 
groups23 to derive the approach and personnel for building an authentic intervention that was created in a digital 
storytelling workshop where stories about diabetes self-management were captured, recorded, and edited to 
derive the final intervention products in video format23.  The respective digital storytelling videos were pilot tested 
with 25 patients across healthcare institutions in Minnesota and Arizona.  The intervention was rated as highly 
acceptable, culturally relevant, and perceived as efficacious for motivating behavioral change24.  
 
The overall objective of this application is therefore to assess the efficacy of a digital storytelling intervention 
derived through a CBPR approach on self-management of T2D among Hispanic adults.  
 
Specific Aim #1: Evaluate the efficacy of a community-derived digital storytelling intervention among 
Hispanic adults with poorly controlled T2D. 
 
Hypothesis 1: The digital storytelling intervention will significantly improve glycemic control and diabetes self-
management behaviors among Hispanic adults with poorly controlled T2D compared with controls.  
 
We will conduct a two-group randomized controlled trial in primary care clinical settings at two healthcare 
institutions among 455 Hispanic adults with poorly controlled T2D (hemoglobin A1c≥8%).  The intervention group 
will view the 12-minute digital storytelling video. The comparison group will receive usual clinical care. The 
primary outcome will be glycemic control as measured by hemoglobin A1c 3 months after intervention delivery. 
Secondary outcomes will include diabetes self-management behaviors, blood pressure, LDL-cholesterol, and 
body mass index.  The impact of concomitant covariates, including sex, age, and socio-economic status, on the 
sensitivity of the intervention effect will also be explored.   
 
Specific Aim #2: Explore the effect of the digital storytelling intervention on proposed theory-based 
mediators of change. 
 
Hypothesis 2: Digital storytelling intervention effects on diabetes outcomes will be mediated by social cognitive  
constructs (self-efficacy, outcome expectancy, social support) and narrative factor constructs (story identification 
and transportation).   

We will assess whether these theoretical factors impact the relationship between intervention effects on diabetes 
outcomes. A conceptual framework for potential mechanisms will be constructed to describe how digital 
storytelling may improve these outcomes.   
 
     This work is significant because it tests a scalable, low cost intervention targeting vulnerable populations 
implemented in primary care settings with the opportunity for rapid translation to practice. The innovation comes 
from utilizing a digital storytelling intervention created through a CBPR process for T2D management among 
Hispanic adults.  By using rigorous and transparent methods, we will establish a disseminable framework for 
community participation in digital storytelling production for chronic disease management, providing a model that 
may be applied to other communities and health priorities.  
 
 
RESEARCH STRATEGY 
1.  Significance 
Racial and ethnic minorities with type 2 diabetes mellitus (T2D) in the United States (U.S.) are more likely to 
develop complications and die from the disease than the general population25.  The Hispanic/Latino population 
is a heterogeneous mix of people born in and outside the U.S. who make up 17% of the population and who 
contributed to the majority of U.S. population growth (56%) over the last decade.  While there is significant 
variability between different Hispanic/Latino groups26, the age-adjusted prevalence of T2D among these 
populations as a whole was 22.6% in 2012, compared with 11.3% for non-Hispanic whites1. Likewise, Hispanic 
groups are less likely to achieve optimal glycemic control27 and have 1.5 times higher age-adjusted diabetes-
related mortality than non-Hispanic whites2.   
 
     Hispanic groups are less likely to achieve healthy levels of physical activity3, eat a healthful diet4, adhere with 
prescribed medications for T2D5 or achieve targets for self-monitoring of blood glucose6 than non-Hispanic 
whites, each of which are critical domains for the self-management of T2D that can delay complications 
associated with the disease28.  These behaviors are influenced, in part, by discrepancies in socioeconomic 
position, discrimination, access to healthcare, and access to health-promoting neighborhoods and 
environments29.  These structural factors interact with psychosocial constructs and health behaviors in complex 
ways through the life course30.  Higher levels of acculturation (however defined) among Hispanic groups are 
generally associated with improvements in some structural barriers to diabetes care (e.g., access to healthcare, 
education level), but significant worsening of diabetes risk and diabetes-related behaviors (e.g., dietary quality)31-
35.  Likewise, low health literacy is an important distal mediator of diabetes-related health disparities among 
Hispanic groups36. 
 
     This mechanistic complexity of diabetes-related health disparities highlights the difficulty in designing 
interventions to promote healthy behaviors among Hispanic and immigrant populations37,38.  Community-based 
participatory research (CBPR) is a means to collaboratively investigate healthy living interventions, whereby 
community members and academics partner in an equitable relationship through all phases of the research.39,40  
This is an approach to research that is well suited to intervention work that addresses the interplay between 
health behaviors and the social determinants of health, such that it empowers communities, promotes 
understanding of culturally pertinent issues, and targets the multi-faceted barriers to health. 
 
     Narrative-based (storytelling) interventions incorporate culture-centric health messaging to promote behavior 
change among vulnerable populations13,14.  Storytelling interventions for behavior change use narratives that 
resonate with target populations either through direct quotes from representative members or through story 
compositions inspired by culturally embedded informants15,41,42.  The ways in which stories elicit behavioral 
responses among target populations have been conceptualized as identification and transportation.  When 
narrative is drawn from within populations, identification with the storytellers is an important step for engagement, 
empowerment, and re-framing social norms of the listener43-47.  Transportation of the listener into the story is 
likewise important to generate persuasive effects for behavior change45,48-51.  For T2D, a group-based storytelling 
intervention in the United Kingdom demonstrated feasibility and acceptability of this approach among immigrants 
with T2D in face-to-face (workshop) settings.52 Indeed, storytelling interventions may be especially powerful 
among immigrants when communication barriers limit applicability of existing health education opportunities.53 
Furthermore, this approach is promising in populations with a strong oral tradition54, including those from Latin 
America55. 
 

     Narrative-based video interventions, where story components are incorporated into health communication 
media through a variety of ways, provide the opportunity for wide distribution and inclusion of consistent content 
to promote health behavior change.  It has been demonstrated that narrative-based video interventions are more 
likely to elicit positive motivations for healthful behaviors than non-narrative video messaging for cervical cancer 
screening14, breast cancer screening15,16, and smoking cessation17 among African American and Hispanic 
populations. Our review of the literature identified three published studies evaluating the impact of narrative-
based video interventions on health behaviors or other outcomes. Larkey and colleagues found that engagement 
with a storytelling video for colorectal cancer screening facilitated positive attitudes associated with behavior 
change, but no difference in screening rates when compared with a personal risk tool among low-income 
patients56.  In the first randomized trial of a storytelling video intervention for chronic disease management, 
Houston and colleagues demonstrated efficacy comparable to adding a medication for treatment of uncontrolled 
hypertension among African American women viewers.18 Finally, Campbell and colleagues established the 
promising role of storytelling videos in management of diabetes through a randomized trial among patients with 
T2D in Australia, which demonstrated significant improvements in self-reported diabetes self-management (diet, 
exercise, and glucose monitoring) among viewers57.   
 
     Digital storytelling interventions are narrative-based videos elicited through a CBPR approach to surface the 
authentic voices of participants overcoming obstacles to health promoting behaviors19.  They differ from other 
forms of narrative-based videos in that participants are central to the production of knowledge.  Through a group-
based digital storytelling workshop, storytellers build their own narrative, choose images and sounds that best 
represent their experiences, and are guided through hands-on computer editing.  Through a process of social 
construction, individuals and groups derive concepts and actions to co-create meaning. This differs from the 
communication paradigm where “experts” generalize an experience for a community, e.g., documentary story. 
Instead, participants construct their own experiences in a group setting of peers who, through reaction and 
feedback, contribute in turn to the shared understanding of the individuals’ experiences.  This process has been 
used to empower participants through personal reflection58-60 and as a tool for health advocacy61, but the resultant 
videos can also shape health behaviors of viewers through influences on attitudes and beliefs20.  Formative 
studies have demonstrated cultural acceptability and emotional engagement in response to a digital storytelling 
intervention derived through CBPR processes for cancer education among Alaskan natives54,62.  We are not 
aware of any published studies evaluating the impact of digital storytelling interventions on health outcomes of 
viewers.    
 
     With this study, we therefore propose to evaluate the impact of a digital storytelling intervention on health 
outcomes in Hispanic adults with T2D.   Only one of the studies cited above reported sex differences, finding 
that female sex was associated with positive behavior change after exposure to the narrative video intervention56.  
Therefore, we will explore the potential role of sex as a moderator of the effect of our proposed intervention.  
This study is significant because it will evaluate a scalable, low cost, high reach intervention targeting vulnerable 
populations whose health is critical to the future of this country.  Furthermore, this intervention will be 
implemented in primary care settings with the opportunity for rapid translation to practice.  Finally, this work will 
advance the science of participatory intervention development among Hispanic populations while providing a 
model (digital storytelling) that may be applied to other communities.   
 
2.  Innovation 
     The research proposed in this application is innovative because it focuses on digital storytelling to promote 
health behavior change in an underserved population.  Authors of a recent systematic review identified the need 
for more culturally tailored chronic disease management interventions that incorporate health technology63, but 
there are no published reports of interventions using narrative (storytelling) media for diabetes among minority 
or immigrant populations.  Moreover, community participation is a particularly powerful mechanism to maximize 
cultural and linguistic acceptability of the intervention, adding to the innovation. Furthermore, we have built a 
theoretical perspective within the context of the study design, extending beyond our pilot study assessment of 
social cognitive constructs to include storytelling factor measures to contribute knowledge on the psychosocial 
factors associated with behavior change.  Finally, by using rigorous and transparent methods, we will establish 
a disseminable framework for community participation in digital storytelling production for chronic disease 
management, providing a model that may be applied to other communities and health priorities.  
 
 
 
 

3.  Approach 
     This work builds on our thirteen years of experience with CBPR through Rochester Healthy Community 
Partnership (RHCP) http://rochesterhealthy.org/.  Past experience with CBPR interventions and partnership 
development has led us to collectively consider and derive an intervention to improve T2D management among 
Hispanic adults in our community through a CBPR approach using methods of digital storytelling. 
 
CBPR partnership experience and narrative 
In 2004, a community-academic partnership developed between Mayo Clinic and Hawthorne Education 
Center (HEC), an adult education center that serves approximately 2,500 immigrants per year.  This partnership 
has matured by formalizing operating norms, adopting CBPR principles, adding many dedicated partners, 
conducting community health assessments, and completing several CBPR projects.    The mission of RHCP is 
to promote health and well-being among the Rochester community through CBPR, education, and civic 
engagement to achieve health equity64.  The definition of community by RHCP has been delineated by individual 
ethnic/cultural groups (e.g., Hispanic/Latino) as well as a shared sense of experience of recent immigration, low 
English language and health literacy, and relatively low socioeconomic position among individuals from these 
heterogeneous groups.  Moreover, the partnership includes community-based organizations that work with 
members of these communities.  RHCP has developed an effective community-based research infrastructure 
that has facilitated human subjects protection training for community partners65; more than 30 community 
partners have completed our training in qualitative moderation and analysis66.    
 
RHCP has become productive and experienced at deploying data-driven programming and outcomes 
assessment among immigrant and populations11,12.  RHCP obtained extramural funding in 2008 through the NIH 
Partners in Research Program (R03 AI 82703) to strengthen the CBPR partnership through development of a 
culturally sensitive educational and health literacy infrastructure for immigrant populations. In 2011, RHCP 
received funding through the NIH Program Announcement for Community Participation in Research (R01 HL 
111407) to conduct a randomized controlled trial of a family-based behavioral lifestyle intervention.  Community 
and academic partners have conducted every phase of research and programming together, and disseminate 
research results jointly at community forums and academic meetings.  
 
Experience with conducting a randomized controlled trial among Hispanic populations.  RHCP community 
and academic partners recently co-created and tested a multi-component physical activity and nutrition 
intervention with Hispanic and Somali families through a CBPR approach.  Target enrollment was achieved (40 
families; 151 individuals) and randomization was successful12. All participating families assigned to the 
intervention group received 100% of the intervention with very high fidelity of the intervention67.  At 12 months, 
study retention was high (91% of families, 82% of individuals). We found statistically significant improvements in 
dietary quality among participants in the intervention group compared with wait list controls68.  
 
     Rationale for addressing T2D.  Previous community needs assessments including an open-ended survey 
among 175 immigrant adults at one of the community partner sites (HEC) and a survey of RHCP community 
leaders in 2010 revealed that T2D was among the top health priorities for Hispanic populations in our city.  Their 
other top concerns (physical activity, nutrition, obesity, hypertension) mirror national trends reflecting increasing 
obesity and associated co-morbidities among immigrants after arrival to the US69.  RHCP members reflected on 
the seemingly high impact of T2D on their communities and the overwhelming burden this disease leaves on 
individuals and their families as they strive and struggle to understand and manage the condition.  
  
     Rationale for digital storytelling.  During RHCP brainstorming sessions, community partners were clear that 
the current systems for T2D management among Hispanic adults do not address the social, linguistic, or cultural 
needs of their communities, and that these limitations negatively impact diabetes-related outcomes.   Further, 
low health literacy was implicated as a common pathway for sub-optimal T2D care.  The idea of storytelling arose 
from this paradigm as a means to mitigate these variables.  Indeed, there are data to suggest that storytelling is 
a promising approach for interventions to improve T2D management among immigrants52.  Finally, RHCP’s 
experience with the community-based qualitative work needed to build a foundation for storytelling70-73, and 
RHCP’s past experience with digital video production for health promotion among immigrant groups74 were seen 
as predictors of successful implementation of a digital storytelling intervention.    
     Rationale for focusing on Hispanic populations.  RHCP has a history of successful collaborative work between 
many different immigrant groups (and non-immigrant Latinos) towards common goals.  Our recent RHCP 

partnership evaluation highlighted the positive impact of this unique collaboration on community building, 
collective advocacy, and health outcomes75.  For this project, community leaders and community-based 
organizations from both Hispanic and Somali populations have taken leadership roles for intervention co-
creation.  Work with these two groups occurred both in parallel and in collaboration, such that best practices and 
learning opportunities have been shared throughout the process.  Likewise, RHCP academic partners have 
documented local diabetes-related disparities for both groups76-78.  For this grant application, community and 
clinical partners elected to focus on the Hispanic population because of the disproportionately large number of 
eligible patients within this group, and to reduce implementation complexity of the research procedures.  Because 
of the relatively low number of eligible Somali patients, we intend to test the intervention in this group on a smaller 
scale and through a different funding mechanism.       
 
     In summary, over the last 13 years, we have formalized a successful CBPR partnership, and matured into a 
broad network of dedicated partners uniquely suited to conduct the proposed study.   
 
Preliminary data  
     RHCP meeting minutes.  Based on a shared desire to address T2D, brainstorming sessions were conducted 
at monthly RHCP meetings.  These sessions drew on past partnership and personal experiences, and lessons 
learned to inform an intervention with the highest likelihood for success.  Digital storytelling was embraced as a 
framework.   Building on effective components of past strategies, a mixed community-academic RHCP grant 
writing sub-committee was established to prepare this grant proposal.  Community leaders inside and outside of 
the Alliance for Chicanos, Hispanics, and Latin Americans co-created this work.   
  
     Step 1: Diabetes survey.  Drawing from existing validated instruments, a diabetes survey was created by 
RHCP to assess diabetes attitudes, knowledge, and behaviors among community members with T2D.  The 
survey was adapted and pilot-tested to be culturally and linguistically appropriate through an RHCP-derived 
process for survey development and translation through a CBPR approach21. Survey administration was 
performed by community partners among 78 participants (39 Hispanic, 39 Somali) with T2D.  Respondents 
reported several barriers to optimal diabetes management for physical activity and glucose self-monitoring, as 
well as a high burden of disease and negative perceptions of diabetes. High participant engagement in disease 
management, self-efficacy, and social support were important assets22. 
 
     Step 2:  Diabetes focus groups.  We conducted three focus groups among a subset of Hispanic survey 
participants for a dual purpose: 1) to further inform the intervention as it related to four domains of diabetes self-
management (physical activity, healthful diet, medication management, self-monitoring of blood glucose); and, 
2) to identify persuasive storytellers for the intervention development.  Groups were led by language-congruent 
RHCP community partners trained in focus groups moderation66; the qualitative results achieved our study 
objectives23. Storytellers were selected by community partners on the basis of these focus groups data and 
consensus about who they wanted to represent them as having compelling stories. 
 
     Step 3: Digital storytelling intervention development:  Four gifted storytellers identified in the focus groups 
were recruited by RHCP community partners to participate in the story building process. In February 2015, these 
participants completed a 4.5-day story building workshop with RHCP staff and two facilitators from the Center 
for Digital Storytelling (CDS, www.storycenter.org).  CDS has more than 20 years of experience surfacing 
authentic voices around the world through participatory media creation. Through their Silence Speaks Initiative 
(www.silencespeaks.org), CDS has experience coordinating complex projects in public health that involve 
multiple stakeholders, working cross-culturally in multiple languages.   
 
     At the end of the workshop, all participants for this project had created powerful stories about their struggles 
and accomplishments related to four domains of diabetes self-management: physical activity, dietary quality, 
medication adherence, and self-monitoring of blood glucose.  Stories reflected on motivation and self-efficacy 
for management of these components. An important aspect of this method of digital story production is that all 
steps, from the initial consideration of what story to tell, scripting/storyboarding, visuals, music, compiling and 
editing are in the hands of the storytellers. Minor post-production editing was performed by CDS and RHCP 
staff/community partners, including the addition of a brief introduction and concluding educational message for 
the Spanish language videos23.  Participants provided written consent for dissemination of the final products.   
 

     Step 4:  Pilot testing of the intervention:   The 12-minute digital intervention package was viewed individually 
by 25 participants (52% female) with T2D in clinical settings at the institutions participating in the work described 
in this proposal (Hennepin County Medical Center, Minneapolis, MN and Mountain Park Health Center, Phoenix, 
AZ), as well as at clinical sites in Rochester, MN.  Eligible patients were identified through existing registries of 
primary care patients with T2D at each institution.  Recruitment and enrollment was conducted among sequential 
eligible patients before or after clinic visits at each site.  There were no screening failures (i.e., all patients 
identified as eligible in diabetes registries met inclusion criteria), and only one patient approached for the study 
declined participation.  The intervention was delivered in the clinical setting following a regularly scheduled visit 
to the patient’s primary care clinic.  Recruitment, enrollment, and intervention delivery was completed within one 
week at two institutions, and within four weeks at the other institutions. 
 
     After participating in the intervention, a cross-sectional face-to-face structured survey instrument, delivered 
by a language-congruent study staff, was utilized to assess intervention acceptability and motivational constructs 
consistent with our theoretical framework.  The evaluation assessed the degree to which the intervention 
motivated the patient to improve self-management of diabetes overall and across the four behavioral domains.  
The evaluation also assessed overall acceptability of the intervention and cultural relevance.  Items for this 
survey were adapted from a health communication assessment tool produced by the National Cancer Institute90.  
Results demonstrated high acceptability and cultural relevance, with 100% of participants reporting that the 
intervention got their attention, was interesting, and was useful.  In an open-ended question, participants reported 
a range of “main messages” coinciding with each of the behavior domains24.   
• 
25 (100%) participants reported that the video motivated them to change a specific behavior related to 
diabetes self-management.   
• 
24 (95%) participants reported that they were more confident about managing their diabetes (self-
efficacy) than before they watched the video.  
• 
25 (100%) of participants reported that they would show it to family members or friends with diabetes if 
made available. 
 
     We obtained follow-up clinical data from the electronic medical records for the subset of patients that viewed 
the intervention who were Hispanic/Latino and had a baseline hemoglobin A1c>7% (n=13).  
• 
There was a mean reduction in hemoglobin A1c of 1.5% from baseline to the first follow-up value at three 
to six months (p=0.03)24.   
 
     We then derived a control cohort of Hispanic patients (n=13) matched to each intervention patient by site and 
baseline hemoglobin A1c (+/- 0.5%).  We abstracted follow-up blood test results up to six months after baseline 
for all patients.  Patients in the intervention group had a hemoglobin A1c that was 37% times the standard 
deviation lower than the control group, a moderate effect size (Table 1)24.  Hence, the estimated effect size 
gleaned from this small, non-randomized pilot study suggests the possibility of a clinically relevant improvement 
in T2D outcomes as a result of intervention exposure. 
 
Table 1.  Pilot study of the digital storytelling intervention among Hispanic adults with poorly controlled T2D 
 
Intervention Group (n=13) 
Control Group (n=13) 
p-value 
Age, mean (SD) 
54.0 (12.7) 
56.8 (7.7) 
0.53 
Female sex, n 
6 
6 
1.00 
Baseline hemoglobin A1c, mean % (SD) 
10.3 (2.5) 
9.9 (2.1) 
0.84 
Change from baseline to first follow-up A1c, mean(SD) 
-1.5 (2.0) 
-0.8 (1.8) 
0.26 
       
 In conclusion, RHCP has spent the last three years developing and evaluating a digital storytelling 
intervention for T2D self-management among Hispanic adults through a CBPR approach.  We have engaged 
other clinical sites to participate in this project, and we have shown through pilot testing across these institutions 
that recruitment is feasible, that the storytelling video is acceptable, and that our study team has effective 
processes for site-specific recruitment and intervention delivery in primary care settings.  
 
 
Research Design 
     Overview of the general approach.  Our approach has followed established methods for behavioral therapy 
development research91,92.  The aim of this research is to evaluate the impact of a digital storytelling intervention 

derived through a CBPR approach on T2D outcomes among Hispanic adults with poorly controlled T2D in 
primary care settings through a randomized clinical trial. 
 
     Theoretical approach. The theoretical framework for this work is the application of Social Cognitive Theory 
(SCT)93 to Narrative Theory.13 SCT recognizes the interplay of individual factors, such as self-efficacy to become 
physically active and social environmental factors like social support, on health behavior.  Other key constructs 
of SCT are outcome expectations or the consequences that result from improved dietary quality (e.g., improved 
glycemic control). The SCT constructs of self-efficacy, social support, and outcome expectancy have been used 
successfully to explain self-cares for patients and populations with T2D.94  Furthermore, self-efficacy and social 
support are associated with diabetes self-management behaviors among Hispanic populations95-97.  Narrative 
Theory recognizes the critical role for narrative (stories) as strategies for navigating experience. In this case, the 
digital narrative will be used for behavior modeling to facilitate observational learning. Narratives incorporate 
information, communication and persuasion to encourage desired behavior change.13 The ways in which the 
narratives elicit behavioral responses among target populations have been conceptualized as identification with 
the storytellers43-47 and transportation of the listener into the story41-44 as described above.   
 
Our clinical trial will assess the potential effect of the proposed intervention on T2D outcomes (physiologic, 
behavioral, psychological); it will also identify the potential mechanisms of behavior change (i.e., how the 
intervention works).  Figure 1 provides a logic model framework with intervention strategies and outcomes that 
are consistent with the theoretical framework. 
 
Figure 1.  Logic model of intervention strategies and outcomes 
 
 
Design Overview  
     This study (Figure 2) will evaluate the intervention through a two-group, parallel randomized controlled trial 
in primary care clinical settings across two healthcare institutions among 455 Hispanic adults with poorly 
controlled T2D (hemoglobin A1c≥8%).  The intervention group will view the 12-minute digital storytelling 
intervention that has been previously pilot-tested, in addition to usual clinical care. The comparison group will 
receive usual clinical care. The primary outcome will be glycemic control as measured by hemoglobin A1c.  
Secondary outcomes will include diabetes self-management behaviors, blood pressure, LDL-cholesterol, body 
mass index, and diabetes process measures.  We will also measure covariates of treatment effect consistent 
with our theoretical framework. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Figure 2.  Study Design and Intervention Schedule 
 
 
 
Study Sites 
     Both clinical sites participated in the pilot testing of the intervention and in refinement of study procedures for 
the proposed trial. Our letters of support indicate strong investment and commitment to accomplish this study, 
and study personnel have been identified at both sites:  
• 
Hennepin Healthcare, Minneapolis, MN. Hennepin Healthcare is a large public academic healthcare 
institution that provides primary care to approximately 90,000 patients in Hennepin County, MN, a large 
proportion of whom are Hispanic.  Members of our study team have worked with HCMC investigators for 
the past three years on diabetes care for immigrant patients.   
• 
Mountain Park Health Center (MPHC), Phoenix, AZ.  MPHC is a community health center with more than 
30 years of experience. MPHC provides primary care for approximately 60,000 patients.  
Demographically, the vast majority of patients seen at MPHC are Hispanic.  MPHC has a long history of 
mission-driven research collaboration with Mayo Clinic.   
 
     Rationale for study site selection.  The study will take place at Hennepin Healthcare sites and MPHC because 
of their high volume of adult Hispanic patients with T2D, their strong history of research collaboration with Mayo 
Clinic, and because of a personal history of collaboration between the PIs and site-PIs (including pilot work for 
this application).  The intervention was initially created with RHCP community partners and Rochester, MN was 
included as a pilot site.  As in the pilot study, Mayo Clinic team members who have substantial expertise with 
clinical trial coordination and oversight will continue to perform this role (i.e., coordination and oversight) in the 
proposed study as described below.     
  
     Study coordination and oversight.  The Mayo Clinic PIs and project coordinator will provide central oversight 
for the project, including implementation of communication plans with both sites, data handling, data safety 
monitoring, and data analysis.  Mayo Clinic has significant experience and infrastructure as a coordinating center 
for multi-site trials, including the pilot phase of this study.  Study staff from both sites will conduct study 
procedures under direction of the site PIs (Drs. Vickery and Singh).  
 
     We will continue bi-weekly conference calls between Mayo Clinic and study teams at Hennepin Healthcare 
and MPHC that are on-going in the context of the pilot work and other collaborations.  If this proposal is funded, 
the PIs and project coordinator will meet with the Hennepin Healthcare and MPHC study teams separately for a 
kickoff retreat followed by quarterly face-to-face meetings. 
 
Study Participants  
     Eligibility criteria will include 1) self-identify as Hispanic or Latino, 2) age  18 to 70 years, 3) receive primary 
care at one of the participating clinical sites, 4) at least one office visit within the previous 12 months to the 
primary care site, 5) diagnosis of T2D in the medical record, 6) T2D diagnosis for six months or longer, 7) most 
recent hemoglobin A1c≥8%, and 8) intention to continue to receive medical care at the recruitment clinic for the 
next six months.  The value of 8% is higher than the goals established by the American Diabetes Association 
Guidelines (hemoglobin A1c<7%)98, but lower than the definition of poorly controlled T2D established by the 
Center for Medicare & Medicaid Services Core Quality Measures Collaborative (hemoglobin A1c>9%)99.  It is 
common practice to increase an individual patient’s goal hemoglobin A1c value in the context of clinical and 
social co-morbidities, but this goal value rarely exceeds 8%.  Furthermore, the Minnesota Department of Health 

has defined poorly controlled T2D as hemoglobin A1c≥8% for the purposes of mandatory reporting by clinical 
sites across the state100.  Therefore, we will use this value in keeping with common clinical practice to determine 
eligibility for the study.    
  
     The first step in screening for eligible participants is identification of Hispanic patients at both study sites with 
T2D.  Per state-wide reporting mandates, each site maintains registries of their primary care patients with 
diabetes and the most recent hemoglobin A1c value for each patient.  The second step in screening is to identify 
Hispanic adults within the subset of patients with the most recent hemoglobin A1c≥8% at both sites. Both sites 
have identified mechanisms for accurately identifying eligible patients (see letters of support).  In our pilot study, 
we identified 3,025 eligible patients across both sites. Based on our pilot data, we expect to recruit approximately 
50% women.  Children were not included because of perceived community need that resulted in an intervention 
created for adults, and because of the relatively higher prevalence of T2D among adults. 
 
Recruitment, Enrollment, Randomization, and Retention 
     Once eligible patients are identified from institutional registries, the next office appointment for any diabetes-
related indication (e.g., chronic disease management provider visit, diabetes educator visit, dietician visit, 
diabetes group class, etc.) will be recorded for each patient.  These patients will be contacted by telephone by a 
language-congruent study staff member to introduce them to the study and to assess preliminary interest in 
participation. Patients will be sequentially recruited at their next office visit until the target accrual is reached. 
Patients may also be recruited, consented and participate in study activities over the phone.   
 
     A language-congruent study staff member will confirm eligibility criteria with the patient and obtain written 
informed consent in an exam or private room before or immediately after their office appointment.  Study staff 
will then obtain a baseline survey and biometric assessment (see measures) followed by randomization 
procedures (stratified by gender) and delivery of the digital storytelling intervention (for the intervention group).  
Each site has developed slightly different protocols for effective recruitment and intervention implementation 
based on lessons learned from the pilot study.  Based on data from our pilot, we expect recruitment and 
enrollment to occur over a period of no more than 24 months across all sites with the following distribution: 
 
• 
Hennepin Healthcare:  N=240 participants enrolled. 
o Medicine Clinic 
o East Lake Clinic 
o Richfield Clinic 
• 
Mountain Park Health Center:  N=215 participants enrolled. 
 
Participant retention will be facilitated in five ways.  First, potential participants will confirm the eligibility 
criteria stating that they expect to receive medical care at the recruitment clinic for at least the next six months 
(above).  Second, appointment cards for both subsequent study visits will be provided to participants after they 
have completed enrollment.  Third, language-congruent study staff will contact patients by phone to remind them 
about upcoming study visits. Fourth, participants who do not return phone calls from study staff will be sent a 
letter asking them to call the study coordination to reschedule the appointment.  Fifth, participants will receive 
remuneration at enrollment and at the of the 3 month visit.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
Interventions  
     Digital storytelling intervention.  The digital intervention package, which is 12 minutes long, includes a brief 
introduction by an RHCP community partner, four stories with transitions, and a short closing educational 
message re-enforcing the four diabetes self-management behavioral goals (healthful diet, physical activity, 
medication adherence, glucose self-monitoring).  The storytellers include two women and two men; they reflect 
some of the heterogeneity among Hispanic/Latino subgroups (two Mexican, one Central American, and one 
South American) in the U.S.  After obtaining consent in the clinical setting or over the phone, study staff will 
deliver the intervention in the exam room,a separate private room or provide patient with a web address to view 
the video on YouTube from home.    
 
     Following the video exposure, study 
staff will ask these questions to each 
participant and record their answers: 1) 
What is your reaction to the video?, 2) 
What was the main message of the video, 
and 3) Does the video motivate you to 
make any changes to the way you manage 
your diabetes (probe positive responses)?  
These questions will confirm participant 
receipt of the intervention, which is an 
important fidelity construct to ensure that 
participants received and understood the 
intervention101.    
     Participants will be offered a copy of 
the video  as a portable storage device 
(i.e., “flash drive”) for viewing on a 
computer,  a DVD for viewing on a 
television, or a web address to watch the 
video on YouTube. Participants will also 
be provided access to the storytelling 
intervention as an application on their mobile phones and/or tablets.  In our pilot of the storytelling intervention, 
all participants cited the use of mobile smart phones.  Study staff will offer to assist participants in downloading 
this application during the baseline visit, and encourage participants to watch the video with family members or 
friends within their support network.  
 
     Rationale for implementation in the clinical setting.  The work proposed in this application is intentionally 
placed on the boundary of the efficacy-to-effectiveness transition102 in clinical trials.  We considered conducting 
a more traditional efficacy study, where participants would be invited to separate study visits for intervention 
delivery and measurements.  However, interventions that target improvements in diabetes self-management 
behaviors cannot be easily disarticulated from the clinical setting.  The hypothesized patient activation that may 
occur as a result of exposure to the digital storytelling intervention requires interaction with their healthcare home 
in order to translate that activation into improved outcomes.  Therefore, we pilot tested the intervention in primary 
care-based clinical settings.  We demonstrated feasibility of this approach while adapting intervention 
implementation for both sites. 
      
     Mobile short message service.  Mobile short message service, i.e., text messaging, has been shown to have 
some impact on diabetes self-care104 and cardiovascular-related lifestyle105 behaviors. Furthermore, a Cochrane 
review suggested moderate evidence for increasing self-efficacy for diabetes self-management using mobile 
phone messaging106.  Therefore, to increase the likelihood that participants will watch the storytelling video 
several times during the intervention interval, participants will receive a monthly automated text message (five 
total) that asks them to self-rate their motivational level and self-efficacy for managing their T2D (0 = no 
motivation/self-confidence to 10 = extremely motivated/confident), and will recommend that they watch the 
storytelling intervention if they score lower than a 7.        The rationale for the addition of mobile messages is 
that this intervention augmentation re-enforces concepts consistent with our theoretical framework.  It increases 
Figure 3. Still images from the existing digital storytelling 
intervention 

the potential treatment dose while maintaining an intervention package that is highly scalable.  As stated above, 
our pilot data indicate ubiquitous smart phone use among potential study participants.   
Control Condition 
     The control group will participate in the same usual clinical care for diabetes (e.g., visits with primary care 
physician, nurse, diabetes educator, dietician, etc.) as the intervention group.  We will control for study 
coordinator attention time throughout the enrollment and measurement activities.  The control group will be 
offered the digital storytelling intervention package after the study is completed. 
 
 
Measures 
Participant data will be collected at baseline, six weeks, three months, and six months in their preferred language.  
Biometric measurements will be obtained during clinic visits at baseline and 3 months. The 3 month visit can 
occur up to 2 weeks prior to the visit due date and up to 4 weeks after the visit due date, to accommodate 
scheduling limitations during the COVID-19 outbreak. Participants will complete a survey (administered by same 
language-congruent study staff) to obtain secondary outcomes and theory-based measures (Table 2) at clinic 
visits or by phone within 2 weeks following the clinic appointment, and during phone calls at 6 weeks and 6 
months. Surveys will be verbally administered to participants by bilingual research staff, and responses will be 
entered directly into an electronic database. Surveys are not printed and given directly to the participants to 
complete on their own. Participants will also receive appointment reminders (three total) prior to visits or calls. 
  Additional clinical data will be collected from the electronic medical records. Investigators and data analysts 
will remain blinded to group assignment throughout the study.   
 
Demographic, health status, acculturation, health literacy, and diabetes knowledge measures.  At baseline, 
study participants will report on the following demographic data: sex, age, ethnicity, country of birth, annual 
household income, education level, employment status and housing security.  Individuals will report on the 
following proxies for acculturation: time lived in the U.S., primary language spoken at home, and level of English 
language proficiency on a 5-point Likert scale107.  Health literacy will be measured with the Short Assessment of 
Health Literacy—Spanish and English108.  Diabetes knowledge will be measured using the Diabetes Knowledge 
Questionnaire, available in Spanish and English109. 
The following data will be obtained at baseline from manual abstraction of the electronic medical records:  
date of diabetes diagnosis, diabetes medications, diabetes microvascular complications (nephropathy, 
retinopathy, neuropathy), and presence or absence of provider-assigned diagnoses of coronary artery disease, 
cerebrovascular disease, peripheral arterial disease, and hypertension.  
 
     Primary outcome measure.  The primary outcome measure will be glycemic control as measured by 
hemoglobin A1c.  The rationale for use of hemoglobin A1c as an indicator of diabetes control is based on  national 
and regional data that demonstrate significant disparities in reaching hemoglobin A1c targets for Hispanic 
populations compared with non-Hispanic whites27,110.  The importance of glycemic control as part of the 
comprehensive management of diabetes is well documented, and hemoglobin A1c testing is a well-established 
strategy to monitor glycemic control in patients with diabetes111.  Hemoglobin A1c will be measured from whole 
blood samples obtained and analyzed in a blinded fashion by the clinical laboratories at Hennepin Healthcare 
and MPHC; both laboratories use methods certified by the National Glycohemoglobin Standardization Program.  
Both laboratories are certified by the College of American Pathologists. 
      
• 
Baseline hemoglobin A1c values will be drawn at the baseline study visit, abstracted from the electronic 
medical records, or reported from an self-check A1c test kit. A1c values drawn up to two weeks prior to the 
baseline visit date as part of usual clinical care may be used as the baseline A1c value. 
 
• 
Hemoglobin A1c values at 3 months (primary outcome) will be drawn at the 3 month study visit, or abstracted 
from the electronic medical records, or reported from an self-check A1c test kit. A1c values drawn up to two 
weeks prior or 4 weeks after the 3 month visit date as part of usual clinical care may be used as the baseline 
A1c value.       
 
• 
Hemoglobin A1c values at 6 months will be abstracted from the electronic medical records at both institutions.  
A1c levels drawn 5-7 months after the baseline value will be recorded.  
 

     Secondary outcome measures.  Diabetes self-management behaviors will be assessed with the Summary of 
Diabetes Self-Care Activities Measure (SDSCA)112.  This is a brief survey instrument to assess the following 
domains:  general diet, specific (diabetes) diet, physical activity, diabetes medication use, and blood glucose 
monitoring.  In a 2009 review of psychometric tools to assess diabetes self-management behaviors, the SDSCA 
was one of only three instruments to meet all appraisal criteria113.  The SDSCA is also the most commonly used 
instrument for these domains worldwide, with good validity evidence in several languages, including 
Spanish114,115.  Furthermore, we used this instrument with Hispanic/Latino patients during the early phase (Step 
1) for this project22.  The SDSCA will be administered by the same language-congruent study staff at each 
measure. 
 
     Seated blood pressure measurements (systolic and diastolic) will be made on the right arm using an 
automated BP Tru BPM-200 device after sitting quietly for five minutes116.  Blood pressure will be measured 
three times; the average of the second and third readings will be used in statistical analyses. Most recent values 
may also be abstracted from the electronic medical records.  
 
     Weight will be measured to the nearest 0.1 kg using a single portable scale (Seca 880 Digital Floor Scale).  
Height will be measured to the nearest 0.1 cm at baseline only using a stadiometer.  Participants will be asked 
to remove shoes prior to both measurements.  Body mass index (BMI) is calculated as weight (kg)/height squared 
(m2). Most recent values may also be abstracted from the electronic medical records.   
 
     Total cholesterol, HDL cholesterol, and triglycerides will be measured from the same blood sample used to 
derive the outcome measure. LDL-cholesterol will be calculated for each participant based on these values: LDL-
cholesterol=total cholesterol – HDL cholesterol – (triglycerides/5).   
• 
Baseline LDL-cholesterol values will be drawn at the baseline study visit. LDL-cholesterol values 
drawn up to two weeks prior to the baseline visit date as part of usual clinical care may be used as 
the baseline LDL-cholesterol value. Recent values recorded as part of usual clinical care within a 
week prior to the study visit may be abstracted from the electronic medical records. 
• 
Cholesterol values at 3 months will be drawn at the 3 month study visit. Recent values recorded as 
part of usual clinical care within two weeks prior to the visit may be abstracted from the electronic 
medical records.   
• 
Subsequent cholesterol levels will not be drawn or abstracted. 
   
     The total volume of whole blood drawn from each participant will be approximately 8 mL (3 mL for hemoglobin 
A1C testing and 5 mL for cholesterol testing) when visiting the lab. Over-the-counter A1c Test kits will be mailed 
to patients unable to visit the lab. Study staff with call patients to confirm reception of kit and go through the 
instructions.  
 
All study tasks can be completed in-person in the clinical setting, virtually, or a combination of both, to 
accommodate the growing interest of patients to perform tasks virtually, when possible. This flexibility is noted 
in the Study Tasks Table below.  
 
     The number of diabetes-related office visits will be abstracted from the electronic medical records and 
categorized as a visit with a primary care provider, endocrinologist, pharmacist, care manager, diabetes 
educator, dietician, community health worker or promotora. These visits will be recorded for the six-month interval 
before and after intervention (or control) delivery.      
 
     Theory-based measures.  We will measure diabetes-related self-efficacy with the Diabetes Self-Efficacy 
Scale (α=0.85)117, used in other studies with Spanish-speaking patients118, including one from our study team 
that we used to generate preliminary data for this proposal22.  We will measure diabetes-related outcome 
expectations with the Outcome Expectancies Questionnaire119, and social support for diabetes with items from 
the Diabetes Care Profile120, which we also used in our pilot study.   
     Story identification and transportation will be assessed through a 14-item scale developed by Larkey and 
colleagues that demonstrated very good construct validity among Hispanic, Spanish-speaking populations121,122, 
with initial predictive validity on the transportation (emotional engagement) scale84.  
 

     Intervention follow-up exposure.  During follow-up measures, we will assess the number of times each 
participant viewed the digital storytelling videos and whether they viewed it with friends or family.  This will provide 
an assessment of intervention dose for the intervention group following the supervised viewing at enrollment.   
Table 2.  Measures 
Data Collected 
Baseline 
6 weeks 
3 months 
6 months 
Demographics, health status, health literacy, and diabetes knowledge 
X 
 
 
 
Hemoglobin A1c 
X 
 
X 
X 
Diabetes self-management behaviors 
X 
X 
X 
X 
Systolic and diastolic blood pressure 
X 
 
X 
 
LDL-cholesterol 
X 
 
X 
 
Body mass index 
X 
 
X 
 
Diabetes-related healthcare utilization 
X 
 
X 
X 
Diabetes self-efficacy, outcome expectations, and social support 
X 
X 
X 
X 
Story identification and transportation 
X 
 
 
 
Intervention follow-up exposure 
 
X 
X 
X 
 
Study Coordinator Training and Quality Assurance 
The Mayo Clinic project coordinator will work with site investigators and study coordinators to oversee training 
of bilingual study staff at each site.  We have previously described our experience training study teams for 
intervention delivery among Hispanic populations67.  The project coordinator will monitor quality control of the 
data through review of participant forms and procedures every three months.  Moreover, the study statistician 
will perform monthly data checks (i.e., missing data, outliers).   
 
Treatment Fidelity 
     Because this work will be conducted in clinical settings, it is important to evaluate barriers and facilitators to 
implementation across the two primary care sites123.  We will evaluate subset domains of the intervention delivery 
construct as outlined by the recently reported NIH-sponsored framework for enhancing the value of research for 
dissemination and implementation124.       
     In the design and conduct of this study, we have incorporated recommendations from the Treatment Fidelity 
Workgroup125.  An intervention guide and checklist will be developed by the study team for each intervention and 
control component.  Likewise, a checklist will be derived for collection of follow-up measures.  Site principal 
investigators will randomly select and attend 5% of the patient visits.  Based on these observations, bi-weekly 
meetings will be held with the study staff at each site (via videoconference) to reinforce treatment fidelity, provide 
corrective feedback, and to conduct additional training if needed.    
  
     Implementation adaptation. There is increasing recognition of the need for transparent reporting on 
adaptations of intervention implementation to fit local contexts124,126.  The “core” component of the intervention 
for this study, i.e., viewing the video, will be standard across both sites.  However, during the pilot study, we 
learned that the timing of intervention delivery (e.g., before or after office visit), associated visit type (e.g., during 
diabetes classes versus during provider visits), and recruitment procedures will vary slightly between sites.  We 
will conduct semi-structured interviews with study staff and clinical staff at both sites to assess rationale for site-
specific adaptations across each of these domains, and to further elucidate generalizable best practices for 
implementation of this intervention. These various conditions (timing, visit type) as well as study site will be 
tracked and assessed for any moderating effects.  
           
     Intervention reach and adoption.  Intervention reach will be reported as the percentage of invited patients who 
choose to participate.  The differential demographic and disease-specific characteristics of these two groups will 
be reported and compared.  Intervention adoption will be reported as the percentage of eligible patients invited 
to participate at each site.  These groups will likewise be compared.  Site-specific differences in reach and 
adoption will be explored through interviews with staff at each site as described above.     
 
Sample size considerations  
     Our preliminary data suggest that we may expect a moderate effect size for the intervention (25%-50% times 
the standard deviation).  This is similar to two recent meta-analyses127,128 of related work that informs the effect 
size we can expect to observe in the proposed study. The first meta-analysis of 11 randomized trials examined 
the efficacy of diabetes self-management education added to usual care among Hispanic patients in primary 
care settings, which produced an average hemoglobin A1c reduction of 0.25 standard deviations127. The second 
meta-analysis of 20 randomized trials evaluated the efficacy of diabetes self-management education among 

racial/ethnic minority populations, which showed a similar hemoglobin A1c reduction of 0.31 standard 
deviations128.  While these effects sizes are smaller than that of our pilot study, we have picked the more 
conservative (lower) estimate of effect size to ensure ample sample size.  Hence, we can expect an effect likely 
to be between 0.25 and 0.31 standard deviation for the type of intervention proposed. Required sample sizes for 
an independent samples t-test to detect these two effect sizes, assuming 80% power, a two-tailed alternative 
and a 5% Type I error rate, are 252 and 145 patients per group, respectively.  With 200 patients per group, we 
will have 80% power to detect an effect size of 0.28 standard deviations via the independent samples t-test.  
Accounting for approximately 12% loss to follow-up, we intend to recruit 225 patients in each group, for a total 
sample size of 450 participants. 
 
Data analysis plan  
Aim #1: Evaluate the efficacy of a community-derived digital storytelling intervention among Hispanic 
adults with poorly controlled T2D. 
     The primary analysis will be an independent samples t-test between the group average hemoglobin A1c 
values at 3 months. A two-sided alternative with a 5% type I error rate will be employed. 
      
     Supplementary analysis for the primary endpoint. Repeated measures modeling of the individual time point 
A1c values (including chart abstracted values at approximately 6 months) will allow for a more detailed 
investigation to the timing of the impact of the intervention by including all time points (including baseline). Profile 
analysis (Srivastava) will further assess for difference in overall means, time point, and treatment by time 
interactions. Covariates indicated above including demographics and clinical covariates will be included in the 
repeated measures and profile analysis models to assess the sensitivity of the primary analysis conditional on 
these potential concomitant (mediating) influences. 
      
Secondary analyses. The analyses applied to the primary endpoint will also be applied to each of the secondary 
endpoints. The subscales from the SDSCA (general diet, diabetes diet, physical activity, diabetes medication 
use, blood glucose monitoring) and the physical measurements (blood pressure, LDL-cholesterol, BMI) will be 
compared between groups using t-tests and repeated measures monitoring similar to the primary endpoint. As 
we have a single variable primary endpoint defined, there will be no adjustment for comparison-wise Type I error 
rate.  Additional analyses will be performed to identify potential effect modifiers for the primary and secondary 
outcomes, i.e., sex, age, socioeconomic position, acculturation, health literacy, and diabetes knowledge. 
      
 
 
Aim #2:  Explore the effect of the digital storytelling intervention on proposed theory-based mediators 
of change. 
  We will examine the correlational structure of the covariates and their impact on the intervention effect size 
via repeated measures models. We will include procedures suggested by MacKinnon129,130 to assess mediation, 
fitting three general estimating equation models to the data.  We will first estimate the intervention effect 
separately for the dependent variable (with regression adjustment for covariates); that model provides an 
estimate of the total effect of the intervention.  Next, we will estimate the intervention effect for each mediator 
(with regression adjustment for covariates); that model provides an estimate of the effect of the intervention on 
the mediator.  Finally, we will estimate the mediated intervention effect for the dependent variable by adjusting 
for the mediator (and covariates); that model provides an estimate of the unmediated (i.e., direct) intervention 
effect, and the intervention-adjusted effect of the mediator on the dependent variable.  These analyses will be 
done for the primary endpoint and each of the secondary endpoints to identify any mediators of the study results. 
 
 
Table 3.  Study Timeline 
Tasks to be completed 
Year 1 
Year 2 
Year 3 
Year 4 
Recruitment, enrollment, and baseline measures 
 
 
 
 
 
 
Intervention  
 
 
 
 
 
 
Follow-up measurements 
 
 
 
 
 
Data analysis 
 
 
 
 
 
Dissemination and sustainability plan 
 
 
 
 
 
Dissemination and Sustainability Plan 

Consistent with CBPR principles10, dissemination of research findings will be a collaborative, multi-modal 
effort by both academic and community partners following the same process established with prior RHCP 
research efforts.  Dissemination will occur at RHCP meetings, community meeting places, at academic 
conferences, and in peer-reviewed publications.  Presentations and authorship will be shared by community, 
clinical and academic partners.   
 
     Sustainability of successful components of the program will be a high priority.  Consistent with previous RHCP 
efforts, sustainability planning will occur with community members.  Small group brainstorming sessions will 
commence even before data analysis is completed.  This will be an iterative process using results from 
brainstorming sessions to inform subsequent discussions until a collaborative plan is in place.  The intervention 
is intentionally designed to be sustainable and scalable.  The behavioral messages contained in the stories 
(dietary quality, physical activity, medication adherence, glucose self-monitoring) are unlikely to loose clinical 
relevance over time.  Once effectiveness is established, the intervention will be housed online in the public 
domain and available as a mobile application for use in clinical settings across the country.  Furthermore, the 
process of participatory digital storytelling intervention development contained in this work will provide a flexible 
template to address other health issues among diverse subset populations.  This template incorporates the digital 
storytelling CBPR process for message development and model factors to emphasize in selecting stories to 
share.  Furthermore, these products may be added to other evidence-based diabetes technologies to examine 
effectiveness of mobile applications for diabetes self-management among diverse populations.   
 
Potential Problems & Alternative Strategies 
     In addition to potential challenges elucidated above, it is expected to be challenging to implement the 
intervention and conduct follow-up measurements in busy clinical settings.  We have prepared for this challenge 
by pilot testing these processes in both of the sites that will participate in this study.  The pilot allowed us to adapt 
study implementation procedures at HCMC and MPHC.  We expect unforeseen site-specific implementation 
challenges to arise.  The communication scheme we have already developed between each of the sites will be 
used to brainstorm and adapt implementation strategies in the face of these new challenges. 
 
 
 
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