The National Diabetes Prevention Program in Rural Communities
Phase: NA
Conditions: PreDiabetes, Weight Loss, Lifestyle Risk Reduction
Sponsor: University of Kansas Medical Center

Official Title: The National Diabetes Prevention Program in Rural Communities 
NCT Number: 00146055 
Approval Date:  August 23, 2021
Document: Study Protocol with Statistical Analysis Plan 

Specific aims    
Approximately 72% of adults in the U.S. are overweight (39.8%) or obese (31.8%) of which 
9.5% have diagnosed type 2 diabetes (T2D) (1).  The prevalence of prediabetes, based on 
fasting glucose or hemoglobin A1C, is estimated to be 33.9% in U.S. adults age 18 yrs. and 
over, and 48.3% in those age 65 yrs. and above (2). Approximately 70% of those with 
prediabetes will eventually develop T2D (3).  The burden of diabetes disproportionately impacts 
the 60 million individuals living in rural areas (19.3% of the U.S. population) where the 
prevalence of T2D and obesity, a modifiable risk factor for T2D, are higher than their urban 
counterparts (4).  The proportion of the U.S. population age 65 yrs. and older, where the 
prevalence of prediabetes is extremely high, is greater in rural (17.5%) compared with urban 
areas (13.8%). Thus, interventions designed to improve weight loss and reduce the rate of 
conversion from prediabetes to T2D in rural adults would have a significant public health impact.   
The Centers for Disease Controls (CDC) Diabetes Prevention Program (DPP) is a 12-mo. 
lifestyle intervention (6 mos. weight loss -16 core sessions, 6 mos. maintenance- 6 sessions) 
designed to prevent the development of T2D in individuals with prediabetes. The DPP targets 
healthy eating, weight loss (5-7%) and increased physical activity (≥150 min./wk.) (5). Results 
from the multi-site DPP effectiveness trial (2002) indicated that adults (≥ 25 yrs.) and older 
adults (≥ 60 yrs.) with prediabetes who lost ≥ 5% of baseline body weight and achieved ≥ 150 
min./wk. of physical activity demonstrated 58% and 71% reductions in conversion to T2D, 
respectively (6). Subsequent to the publication of results from the original DPP trial, the DPP 
protocol has been modified for delivery to groups rather than individuals, and remote delivery 
using video conferencing, and text messages etc (7). To date, DPP has been effectively 
delivered by health educators, physicians, nurses, lay people, and pharmacists in a variety of 
settings such as hospitals, community centers, churches, schools, pharmacies, physician’s 
offices, and through the Cooperative Extension Service (CES) (7-9). However, a recent report 
found that DPP was available in 14.6% of rural, compared with 48.4% of urban counties (10). 
Currently the primary sites for the delivery of DPP in rural areas are hospitals/medical centers 
(6.5%) followed by health departments (3.5%), medical clinics (2.1%), and wellness centers 
(1.5%) (10).  
The effectiveness of the DPP protocol delivered in an individual or in-person group format, in 
predominately urban populations, has been well documented (11, 12). Although the CDC 
endorses remote delivery of DPP, limited information is available regarding the effectiveness of 
DPP in rural areas, or differences in effectiveness between DPP delivered in an on-site group or 
remotely delivered group format. Remote delivery eliminates the time and expense required to 
attend an on-site program and may be attractive to individuals in rural areas where income is 
low and public transportation is limited or non-existent (13). Additionally, the use of remote 
delivery could have a substantial impact on the reach and cost of delivery of DPP to 
underserved rural populations (14).  
The proposed 6-mo. pilot trial will compare the feasibility and effectiveness of DPP delivered 
through Facebook (DPP-FB) or group format delivered remotely by phone conference call 
(DPP-R) in 30 adults (age ≥ 18 yrs.) with prediabetes. Both interventions will be delivered 
through the CES, which serves as the community outreach arm of all land grant universities 
through over 2,900 offices across the U.S. The Kansas State Research and Extension (KSRE) 
(Kansas version of CES), is well positioned, but underutilized for the delivery of DPP in rural 
areas. Delivery of DPP by a well-recognized entity, such as the KSRE, may improve the 
probability of dissemination and long-term program sustainability. Two CES offices serving rural 
counties in Kansas will be randomized (1:1) to the DPP-FB or DPP-R arms.  Our research team 
will train 2 professional staff from KSRE (with backgrounds in nutrition programming and family 
consumer science) who will deliver the DPP intervention.   Outcomes will include body weight 

and moderate-vigorous physical activity assessed at baseline, 3 mos. and 6 mos., participant 
retention, i.e. weight assessed at 6 mos., program attendance (percentage of 16 sessions 
attended), and the fidelity of intervention delivery. i.e., the delivery of ≥ 80% of scheduled 
content as determined by reviewing audio recordings of all DPP sessions. This project will 
address the following aims: 
Primary aim:  Compare weight and MVPA between DPP-FB and DPP-R across 6 mos. We 
expect greater weight loss and MVPA in the DPP-R arm compared with the DPP-FB arm.   
Secondary aim:  Compare the feasibility of DPP-FB and DPP-R across 6 mos. based on 
participant retention and program attendance. We expect greater participant retention and 
program attendance in the DPP-R arm compared with the DPP-FB arm.   
This study will provide the pilot data necessary to apply for NIH funding to conduct a larger, 
adequately powered trial comparing the effectiveness of remote and Facebook group delivery of 
DPP through the KSRE to adults living in rural counties.  Compared with DPP delivered in-
person, Facebook or remote delivery of DPP eliminates the time and cost burdens of travel to 
attend behavioral sessions and may increase sessions attendance, which is strongly associated 
with weight loss success. Demonstrating that remote and Facebook delivery of DPP are at a 
minimum non-inferior to in-person, may be helpful in weight management providers ability to 
obtain reimbursement through the Centers for Medicare and Medicaid Services for remotely 
delivered DPP, which currently reimburses for in-person DPP programs only.  
 
BACKGROUND/SIGNIFICANCE 
Diabetes in rural residents. Approximately 72% of adults in the U.S. are overweight or obese 
of which 9.5% have diagnosed type 2 diabetes (T2D) (1).  The prevalence of prediabetes based 
on fasting glucose or hemoglobin A1C is estimated to be 33.9% in U.S. adults age 18 yrs. and 
over, and 48.3% in those age 65 yrs and above (2). Approximately 70% of those with 
prediabetes will eventually develop T2D (3).  The burden of diabetes disproportionately impacts 
the 60 million individuals (19.3% of the U.S. population) living in rural areas where the 
prevalence of T2D and obesity, a modifiable risk factor for T2D, are higher than their urban 
counterparts (4).  Rural residents experience higher rates of chronic disease included diabetes, 
metabolic syndrome, cardiovascular disease, have higher coronary heart disease and all-cause 
mortality and higher rates of disability compared to their urban counterparts (15-19). These 
health disparities may, in part be, associated with a higher prevalence of obesity in rural (~40%) 
compared to urban residents (~33%). The proportion of the U.S. population age 65 yrs. and 
older, where the prevalence of prediabetes is extremely high, is 17.5% in rural areas compared 
with 13.8% in urban areas. Effective prevention of T2D in rural adults would have a significant 
public health impact.  
Diabetes prevention program.  The Centers for Disease Controls (CDC) Diabetes Prevention 
Program (DPP) is a 12-mo. individually delivered lifestyle intervention (16 core sessions over 6 
mos., 6 maintenance sessions over 12 mos.) designed to prevent the development of T2D in 
individuals with prediabetes by targeting healthy eating, weight loss and increased physical 
activity (≥150 min./wk.). Results from the multi-site DPP effectiveness trial indicated that adults 
(≥ 25 yrs.) and older adults (≥ 60 yrs.) with prediabetes who lost ≥ 5% of baseline body weight 
and achieved ≥ 150 min./wk. of physical activity demonstrated 58% and 71% reductions in 
conversion to T2D, respectively (6). To date, DPP has been effectively delivered by health 

educators, physicians, nurses, lay people, and pharmacists in a variety of settings such as 
hospitals, community centers, churches, schools, pharmacies, physician’s offices, and through 
the CES (7-9).  However, information on the effectiveness of DPP in rural adults, and 
specifically DPP delivered through the CES or delivered remotely are limited or nonexistent.  
For example, Vadheim et al (20)  evaluated the feasibility of delivery of a group-based 
modification of the DPP protocol delivered in-person through a health care facility in a single 
group trial in 101 rural adults at high risk for diabetes and cardiovascular disease. Eighty-three 
percent of participants (n=84) completed the 16-session core program and 64% (n=65) attended 
one or more maintenance sessions. Following the core program 65% of participants met the 
150 min/wk. physical activity goal. Mean weight loss following the core program was 7.5% with 
78% of participants achieving ≥ 5% weight loss.  Based on the last recorded weight after 
completion of the core program a weight loss of ≥ 5% was observed in 66% of participants (20). 
The Vadheim group also compared a group-based modification of DPP delivered on-site (OS, 
n=256) or by telehealth (T, n=638) in a non-randomized trial rural adults (21).  No significant 
between group differences were noted in the number of core (OS=12.4, T=12.4) or maintenance 
sessions attended (OS=3.9, T=3.9), or percent achieving the 150 min/wk. physical activity 
(OS=47%, T=48%) or 7% weight loss goals (OS=38, T=41). Telehealth video conferencing has 
the potential to increase access for rural residents; however, telehealth still requires participants 
to travel a clinic site with telehealth capabilities, which may be a barrier for rural residents.  Perri 
et al (22), reported a mean 6 mo. weight loss (SE) of 10.0(0.4) kg in a sample of 234 obese 
(BMI=36.8 kg/m2), middle age/older women who completed a group-based modification of the 
DPP protocol delivered on-site through CES in 6 rural counties.  In summary, the limited 
available literature suggests feasibility and potential effectiveness of delivery of DPP in rural 
areas.  The feasibility and effectiveness of DPP delivered remotely to rural residents in their 
homes by the CES using group video conferencing or Facebook is unknown. 
Reimbursement of DPP.  The CDC maintains a registry of community organizations that have 
satisfied requirements for delivery of the DPP program. The CDC recognizes multiple delivery 
options for the DPP including: in-person, online, distance learning and a combination program. 
Recognized programs are eligible for cost reimbursement from the Centers for Medicare and 
Medicaid Services (CMMS); however, only in-person programs are currently eligible for 
reimbursement.  Additional research to evaluate the feasibility and effectiveness of alternative 
delivery methods such as group video conferencing and Facebook, as we have proposed, will 
contribute to the knowledge base required to obtain CMMS reimbursement in the future.   
INNOVATION 
Innovative aspects of this proposal include: 1) Targeting an under-served, at-risk group, i.e., 
rural residents at risk for T2D, 2) Partnering with Kansas State Research and Extension (KSRE) 
that is an established and a widely utilized community outreach arm across the state of Kansas, 
3) Using existing KSRE infrastructure for intervention delivery in rural communities which may 
increase the probability of perpetuation and reach of the intervention.  
APPROACH 
Design overview. The proposed 2-arm trial will compare the feasibility and effectiveness of 
Facebook or remote-delivery of the DPP in rural adults with prediabetes both delivered through 
the KSRE. The CES is a non-formal educational program, implemented in the U.S. through 
each state’s designated land grant university, to help people use research-based knowledge to 

improve their lives.  The KSRE maintains local units which are comprised of single counties or 
multi-county districts. Two KSRE local units serving rural counties will be identified by our 
partners at KSRE and randomized to the Facebook or remote delivery arms.  Members of the 
KUMC research team will recruit and consent participants and will train KSRE personnel to 
deliver the 30 core-sessions of the DPP protocol over 12 mos. Outcomes will be assessed by 
the research team at the local CES offices at baseline, 3 mos. 6 mos. and 12 mos. 
Participants/Recruitment: Men and women (n=15 per arm) who satisfy the inclusion/exclusion 
will be recruited through local physician’s offices, social media, KSRE offices, 
marketing/listservs, and local businesses. Interested potential participants will fill out an initial 
eligibility questionnaire via website or over the phone with a study team member. If they pass 
the screening, a consent session will be scheduled over the phone or over Zoom. The consent 
form will be emailed to participants prior to the consent session so ensure understanding of the 
study. The participant will have the option to sign the consent form and email it to the study 
coordinator or sign the consent form in REDCap.  
Inclusion/exclusion criteria. Inclusion: 1) Prediabetes as defined as A1C = 5.7-6.4%, fasting 
glucose = 100-125 mg/dl, (confirmed from physician/medical record in the previous year), 
history of gestation diabetes mellitus OR a positive result based on the CDC- DPP screener 
(see figure), 2) Age ≥18 yrs., 3) Willing to commit to participate on a weekly basis for the 6 
month intervention, 4) Living in the county of a rural KSRE local unit. Rural counties will be 
defined using the American Community Survey definition which categorizes a county as rural if 
the population is < 65,000 (23), 5) Internet access and capability to use Zoom, 6) Clearance 
from primary care physician and 7) Access to a scale. Exclusion. 1) Diagnosis of T2D, 2) 
Unable to participate in physical activity.    
Randomization: Two rural KSRE local units will be randomized in a 1:1 ratio to either DPP-FB or 
DPP-R.  
Intervention overview: The DPP is an evidenced based lifestyle intervention based on Social 
Cognitive Theory which includes topics on nutrition and physical activity in addition to behavior 
change strategies such as self-monitoring, environmental control, positive reinforcement and 
accountability (24). Six-month weight loss and physical activity goals, i.e. following completion of 
the 24-session core curriculum, are 5%-7% and ≥ 150 min/wk. of moderate intensity activity 
such as brisk walking, respectively.  The nutrition portion of the DPP curriculum focuses on 
reducing fat intake to reduce caloric intake. The physical activity portion of the curriculum 
focuses on incorporating physical activity throughout the day to reach the goal of 150 min/wk.  
Increasing lifestyle activities such as taking the stairs, stretching, gardening, and parking further 
away at the grocery store, etc. are encouraged.  At the baseline visit, participants in both 

intervention arms will receive a notebook which includes contact information for study 
personnel, instructions and guidelines for phone calls (DPP-R only), descriptions of the diet and 
physical activity protocols, handouts/worksheets/assignments specific to each meeting, and 
charts to self-monitor, weight, physical activity, and fruits and vegetables consumption. 
DPP-R intervention delivery.  Weekly 60 min. group meetings (12-15 participants) will be held 
by Zoom over 6 months followed by monthly 60 min. group meetings for the later 6 months.  
Approximately 5 min prior to the meeting time (typically early evening) participants will receive 
call in information to join the group meeting by video conferencing or phone. 
DPP-FB intervention delivery.  Formal meetings will not be scheduled. Logistics. Participants 
will be asked to join a secret, lifestyle coach moderated, Facebook® group. The content in a 
secret Facebook® groups is accessible only to invited members, and the existence of the page 
is hidden from the public. Participants with existing Facebook® accounts will be advised on 
adjusting privacy settings to control access by other members of their secret Facebook® group. 
Participants will access Facebook® with the iPad provided using Wi-Fi, thus participant’s 
personal data plans will not be impacted. The lifestyle coach will post new modules of the 
Prevent T2 curriculum to Facebook® weekly over months 1-6 (modules 1-24) and monthly over 
months 7-12 (modules 25-30). New modules will be posted prior to 9 a.m. on Mondays. De-
identified individual participant self-monitoring data (diet, PA, weight loss) and a brief comment 
from the lifestyle coach regarding the performance of the group will be posted on Tuesday 
a.m.  This allows participants to assess their progress relative to others in the group. Brief 
discussion points such as “what strategies to increase your level of PA will you try this week?” 
will be posted on Wednesday and Friday AM. These posts are designed to reinforce  the 
primary objectives of each module and to facilitate inter-participant discussion around these 
topics. Participants will be asked to comment on each of the discussion point posts. The lifestyle 
coach will monitor the responses to the discussion point posts daily and will answer questions 
and/or correct any misinformation that may be included in participant posts. The Friday morning 
post will include a reminder to sync self-monitoring devices by midnight on Sunday. New posts 
will be “pinned” to the top of the wall and included in the “announcements section”, to ensure the 
new posts  are easily identified. Participant engagement, which will be tracked across the 6-mo. 
trial, can take the form of  “liking” or “commenting” on the posts,  or contributing new posts. 
Lifestyle coaches will monitor the Facebook® group on the Monday following the posting of a 
new curriculum module to determine if the module has been accessed. This is analogous to 
attendance in the Zoom® group.  Lifestyle coaches will send  email reminders to participants 
who do not access 2 consecutive module postings. Participants will be encouraged to contact 
lifestyle coaches with any questions that arise during the intervention using Facebook® 
messenger, which automatically alerts lifestyle coaches that a message has been received. 
 
No data is downloaded from Facebook and transferred to KUMC servers. 
Self-monitoring.  Participants will be asked to self-monitor weight, minutes of physical activity, 
steps (Fitbit provided), and fruit and vegetable intake each week.  Participants in both 
intervention arms will be required to enter their data into REDCap, including weight (scale 
provided), diet and physical activity between weekly meetings. Self-report data will be used by 
lifestyle coaches to inform individual participant feedback.   
 
Attendance at group meetings and self-reported weights will be recorded weekly.  

 
Selection and training Lifestyle Coaches: Part of the translational nature of the DPP is that the 
lifestyle coaches can be ‘lay-persons’ without advances degrees in exercise physiology, 
behavioral psychology or health education. A primary lifestyle coach will be selected at the 
randomized KSRE offices in conjunction with our partners at KSRE (Dr. Proctor and Ms. Price). 
The study coordinator will be trained to ensure there is adequate coverage in the event of 
illness, job change, etc.  The study coordinator will provide a 1-day on-site training at each 
KSRE local unit prior to initiating the intervention. DPP-R training. Prior to the intervention 
lifestyle coaches at the DPP-R site will attend, four 1-hr training sessions via video chat. Audio 
recordings of previous group remote delivery recordings from our NIH trial (DK108732) will be 
utilized to demonstrate effective leadership and facilitation techniques in a group call setting. 
The 4 training sessions will be used to reinforce strategies taught during on-site training. Prior to 
initiating the intervention all lifestyle coaches will be required to successfully conduct 3 
simulated sessions over the phone with members of the research staff serving as participants. 
DPP-FB training. Lifestyle coaches at the DPP-FB site will also attend four 1-hr follow-up 
training sessions via video chat. Audio recordings of in-person group sessions from previous 
studies will be utilized. Prior to initiating the intervention, lifestyle coaches for the DPP-FB group 
will be required to successfully conduct 2 simulated discussions in a mock Facebook group 
conducted with CES or KUMC research staff as participants.  These sessions will be observed 
and evaluated by the study coordinator either via FaceTime or Zoom. A standardized checklist, 
which includes the important skills/strategies taught during training, will be used to assure that 
lifestyle coaches for both intervention arms demonstrate mastery of these skills.   
Intervention fidelity: To assure quality control and standardization of intervention delivery all 
DPP-R sessions will be audio recorded and compared with a standardized checklist of content 
to be delivered. For the DPP-FB group, the private group will also be audited to ensure quality 
control and standardized intervention delivery. Our study coordinator will randomly review 1 
session/mo. (total of 6 sessions for each intervention arm). Lifestyle coaches who fail to deliver 
at least 80% of the scheduled content will receive additional training with the study coordinator 
using video chat over Zoom. In the event the primary lifestyle coach is unable to lead a DPP 
session, the secondary lifestyle coach will be available as substitute or the study coordinator, 
thus assuring continuity of the intervention.  
Incentives: Participants will be compensated $20 for baseline, 3 mo. and 6 mo. outcome testing 
assessments.  
OUTCOME ASSESSMENTS   
All outcome assessments will be completed by KUMC research staff at the KSRE local unit at 
baseline, 3 mo. 6 mo. and 12 mo. KUMC research staff will follow all COVID procedures for 
testing that are outlined in the CPAWM COVID-19 Procedures- Off-Site attachment.  
Anthropometrics measurements. Body weight will be assessed to the nearest 0.1 kg with a 
calibrated scale (Belfour Inc., Model #PS6600, Saukville, WI). All participants will be weighed 
between the hours of 6 and 11 am following a 12 hr. fast in a standard hospital gown. Standing 
height will be assessed to the nearest cm with a stadiometer (Model PE-WM-60-84, Perspective 
Enterprises, Portage, MI). 
Physical activity. Physical activity will be assessed using an ActiGraph (wGT3x-BT) portable tri-
axial accelerometer (ArchiMed Co, Lyon, Auvergne-Rhone-Alpes, France) which has been 

shown to provide valid and reliable assessments of PA in adults. Participants will wear the 
ActiGraph on a belt over the non-dominant hip at the anterior axillary line during waking hours 
for 7 consecutive days, except for bathing, swimming, and contact sports. A 7-day monitoring 
period provides a reliable estimate of moderate-to-vigorous PA. ActiGraph data, aggregated 
over 1-min epochs, will be processed using the protocol used for adults in the 2003-2004 and 
2005-2006 cycles of NHANES using the following intensity cut-points: sedentary (< 1.0 METs ≤ 
100 counts/min), light (METs 1.1-2.99; 101-2019 counts/min.), moderate (METs 3.0-5.99; 2020-
5998 counts/min) and vigorous ( ≥ 6 METs; ≥ 5999 counts/min). ActiGraphs will be given to 
participants during outcomes testing with a prepaid envelope to mail back to the investigators 
after wearing for 7 days. Participant retention/program attendance.  Lifestyle coaches in both 
intervention arms will maintain records of participant retention and program attendance. 
Retention will be defined as attendance at 6 mo. and 12 mo. outcome testing. Program 
attendance will be defined as being present as the beginning and end of the class/call and 
reporting weekly data.   
 
End study survey. At the end of the 6 mo. intervention, a survey will be conducted to ask about 
your experience with the program.  
Focus group. At the end of the 6 mo. intervention, a recorded focus group will be conducted in 
all participants to gather information on the overall ease and enjoyment of the program. 
Questions on barriers to healthy eating and physical activity, time commitment, recommending 
the program to friends/family,  
Statistical analysis & Data management: Baseline measures and demographic characteristics 
will be summarized for the complete sample using means and standard deviations for 
continuous variables and frequencies and percentages for categorical variables. Weight loss will 
be calculated as the difference in body weight between baseline and 6 months. All analyses will 
be conducted using SAS 9.4 (SAS Institute, Cary, NC). We will compare change in body weight 
and MVPA between groups at 6 mos. and 12 mos. by using a two-sample t-test. Feasibility will 
be calculated as the percentage of participants who attended > 75% of the scheduled sessions. 
We will also conduct a qualitative analysis of focus group and end study surveys to gain insight 
on the acceptability and enjoyment of the program and suggestions for improvement. 
 
Online Safety 
A list of ground rules and code of conduct has been created for the DPP-FB group to follow 
while utilizing the group page and resources on Facebook. The study specific Facebook page 
will be available to study group members only. While on the study Facebook page, we will be 
monitoring their usage of the recordings and other posted materials as well as participant posts 
and comments on the feed to ensure the content is appropriate. We will not monitor whether or 
not they visit other pages within the Facebook platform. This risk is no different than the risk 
associated with having internet.  Facebook is free and has many public domains open to 
anyone who has a username and login.  Therefore, anyone who takes part in the study must 
agree to the disclaimer and limits of liability for Facebook. 
 
 
 
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