Reducing Cardiometabolic Risk and Promoting Functional Health in Community-based Elders With Obesity and Pre-diabetes: Evaluating Sustainable DPP Follow-up Strategies
Phase: NA
Conditions: Obesity, PreDiabetes, Aging
Sponsor: University of Pittsburgh

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
and pre-diabetes: evaluating sustainable follow-up strategies 
 
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Research Protocol 
 
Principal Investigator: 
 
Elizabeth M. Venditti, PhD, Associate Professor of Psychiatry and Epidemiology 
Director, Diabetes Prevention Support Center, University of Pittsburgh School of Medicine 
vendittiem@upmc.edu 
(412) 302-5228 
 
Co-Investigators: 
Marsha D. Marcus, PhD, Emeritus Professor of Psychiatry and Psychology,  
Anne B. Newman, MD, MPH, Distinguished Professor Epidemiology, Professor, Medicine and 
Clinical and Translational Science 
Steve Albert PhD, MA, MS, Philip B. Hallen Endowed Chair in Community Health and Social Justice 
Lan Yu, PhD, Associate Professor of Medicine, Psychiatry, and Clinical and Translational Science 
Kelly R. Williams, PhD, MPH, UPMC Center for High Value Health Care 
 
Study Location(s):  University of Pittsburgh (UPitt) 
 
Sponsor:  
National Institute on Diabetes, Digestive, and Kidney Diseases (NIDDK)  
Version: 
2 
Date: 
1-2-2024 
 
 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
and pre-diabetes: evaluating sustainable follow-up strategies 
 
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REVISION HISTORY 
 
Revision # 
Version 
Date 
Summary of Changes 
Consent 
Change? 
Version 2 
Effective 
1/5/2021 
Initial sessions during the 6-month base intervention 
protocol (in-person group sessions 1- 4, and one 
transition session to prepare for teleconference 
follow-up) were stopped as of April 2020 due to the 
Coronavirus disease (Covid-19) pandemic. All 
sessions were thereby implemented by group 
teleconference only. A session “0” was added for 
tele-orientation to the program. The learning content 
remained the same. 
Yes/approved 
 
 
 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
and pre-diabetes: evaluating sustainable follow-up strategies 
 
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Table of Contents 
1.0 
Study Summary ................................................................................................................................ 4 
2.0 
Objectives ........................................................................................................................................ 4 
3.0 
Background ...................................................................................................................................... 6 
4.0 
Study Endpoints ............................................................................................................................. 10 
5.0 
Study Intervention .......................................................................................................................... 10 
6.0 
Study Design/Timeline .................................................................................................................. 12 
7.0 
Inclusion and Exclusion Criteria .................................................................................................... 13 
8.0 
Vulnerable Populations .................................................................................................................. 14 
9.0 
Number of Subjects........................................................................................................................ 14 
10.0 Recruitment/Enrollment Methods .................................................................................................. 14 
11.0 Study Procedures ........................................................................................................................... 15 
12.0 Data and Specimen Banking .......................................................................................................... 17 
13.0 Sharing of Results with Subjects ................................................................................................... 17 
14.0 Withdrawal of Subjects .................................................................................................................. 18 
15.0 Risks to Subjects ............................................................................................................................ 18 
16.0 Potential Benefits to Subjects ........................................................................................................ 20 
17.0 Data Management and Confidentiality .......................................................................................... 20 
18.0 Data Analysis Plan ......................................................................................................................... 20 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .................................................. 22 
20.0 Provisions to Protect the Privacy Interests of Subjects .................................................................. 23 
21.0 Compensation for Research-Related Injury ................................................................................... 23 
22.0 Economic Burden to Subjects ........................................................................................................ 23 
23.0 Consent Process ............................................................................................................................. 23 
 
 
 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
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1.0 
Study Summary 
The confluence of obesity and pre-diabetes in older adults substantially increases the risk of 
diabetes, and accelerates functional decline, multimorbidity, disability, and death. More research is 
needed to refine and extend preventive interventions to reduce burden for elders and society. For over a 
decade efficacious 6- and 12-month Diabetes Prevention Program (DPP) based lifestyle interventions 
have been translated successfully and demonstrated positive impact. However, efforts to develop and 
evaluate more scalable programs conforming to current Medicare guidelines (MDPP) for longer term 
DPP interventions (up to 18- or 24-months) and help a greater proportion of enrollees achieve and 
sustain the recommended weight loss target of ≥ 5% are lacking. Our scientific premise is that the 
evaluation of translational DPP interventions, which has centered largely on strategies for weight loss 
induction, must be extended to include longer-term interventions that clearly demonstrate durable 
weight, cardiometabolic and functional health benefits for vulnerable elders in community-based 
settings. Our previous DPP-adapted research has documented the utility of group telephone follow-up 
after a 6-month DPP weight loss induction and shown that 63% of a 65–80-year-old volunteer sample 
with obesity and other risk factors were able to sustain ≥ 5% weight loss at 12-months.  
Despite good evidence that longer duration lifestyle interventions yield better outcomes (reflected in 
recent Medicare rulings) translational studies of 24-month long DPP interventions with older adults are 
scarce. This study utilizes community-based settings to examine whether we can sustain the impact of an 
elder-focused DPP approach using potentially scalable telehealth treatment components over a 24-month 
period. We will recruit and enroll 65–80-year-old adults with obesity and pre-diabetes (N = 360) through 
networks of senior community centers that provide aging services and utilizing other older adult targeted 
database resources. The intervention program sequencing will be aligned with current Medicare (MDPP) 
policy. First, from 0-6 months, experienced lifestyle coaches will offer a DPP-video intervention 
anchored by group telephone coaching for all participants, at least 25% from ethnic/racial minority 
groups. Next, participants, will be randomized (up to N = 180 per arm; stratified by weight loss of < or ≥ 
5%) to one of two 18-month follow-up conditions conducted between 6-24 months. We will compare 
the effects of (1) DPP-Behaviorally Intensive 30-Minute Groups or DPP-BI and (2) DPP Minimal 
Support 15-Minute Groups or DPP-MIN on measures of weight/adiposity (the primary outcome) at 12, 
18, and 24 months. In addition, we will collect cardiometabolic, physical activity, physical function, 
psychosocial, behavioral, and other age-sensitive quality of life measures at these same intervals. 
Medicare claims data will be examined for a proportion of the sample, regarding types of medical 
utilization.  If successful, this work will have immediate potential for MDPP lifestyle interventions, 
involving telehealth delivery, which are consistent with a chronic care model, and will benefit 
vulnerable aging individuals and society. 
 
2.0 
Objectives 
Obesity in adults ≥ 65 years is prevalent14 and elevates risk for diabetes,15 multimorbidity,16 
functional decline17 and healthcare burden.18-20 The Diabetes Prevention Program (DPP) intensive 
lifestyle intervention21-24 has been translated successfully by our group5,25-28 and others29-31 using 
primarily 6- or 12- month in-person programs, but translational studies have been hampered by lack of 
scientific rigor, incomplete reporting, inadequate focus on behavioral intensification for participants not 
meeting goals, and lack of scalable, longer duration interventions.31 Because there is good evidence that 
achieving and sustaining clinically meaningful weight loss of ≥ 5% 32-34 over time is critical for durable 
health benefits, especially for vulnerable elders with obesity and pre-diabetes,23,35,36 longer term tests of 
DPP-based behavioral self-management interventions are needed. These findings could have immediate 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
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impact for the increasing number of state and national DPP programs being designed to meet the chronic 
healthcare needs of the Medicare population.1,37  
Our central scientific premise is that DPP programs and associated benchmarks have been well-
established for the 6 month weight loss induction intervention, but that the most effective strategies for 
conducting longer duration DPP interventions with vulnerable older adults in the community are 
lacking.31,38 Our research group is well-qualified to develop and evaluate such an approach. We have 
shown that a 12-session, face-to-face, DPP intervention for elder volunteers followed by 6 months of 
modest interactive group phone support (one 30-minute contact/month) was associated with significant 
weight loss28 (7.5 ± 5.5% and 63% achieving ≥ 5%) and associated health improvements at 12 months. 
Now we propose to extend our previous work to senior community center settings and test more scalable 
intervention strategies, in a two-arm trial, designed to achieve and sustain weight losses of ≥5% and 
produce cardiometabolic, physical function, and other health benefits over 24 months. 
The proposed translational effectiveness study will commence with a non-randomized, video-
delivered DPP intervention (our Group Lifestyle Balance-DVD)4,25 anchored by telephonic group 
contact as a lower-cost model for achieving the primary weight loss induction of ≥ 5%, followed by 
randomization to either DPP-BI or DPP-MS (both telephonic coaching interventions, both aligned with a 
Medicare delivery schedule) for the next 18 months.  After the 6-month induction period, participants 
will be stratified by weight loss achievement (< or ≥ 5%) and those assigned to DPP-BI will receive 
continued MDPP-prescribed behavioral group sessions (remotely) plus additional individualized activity 
coaching. Activity is critical at any age, but for elders with obesity and pre-diabetes, especially those 
who have not reached DPP weight targets by 6-months, it may enhance cardiometabolic and functional 
health outcomes compared to minimal contact alone.7,39  Between 12-24 months the DPP-BI group will 
continue with group phone coaching sessions that are designed to integrate DPP weight management 
strategies with those aimed at critical self-care/healthcare behaviors for healthy aging (“5-keys”)8,10. In 
contrast, those assigned to DPP-MS (control) will rely on brief group phone contacts alone as the 
minimum scalable modality for lifestyle behavior change accountability over this period.  
We plan to recruit and enroll ambulatory adults, 65 years of age and older (up to N = 360) with BMI 
≥ 27 kg/m2 and pre-diabetes (FPG >100 and <125 mg/dl, or HbA1c >5.7 and <6.4% mg/dl) from senior 
community settings and using other database resources. Between 0-6 months, a base DPP intervention of 
self-directed lifestyle change videos, activity videos, and weekly group phone contact (16 sessions) will 
be provided to all enrolled. Between 6-12 months, individuals randomized to DPP-BI, will receive DPP 
sustained DPP-BI 30-minute group calls (6 sessions) and ≤ 2 individual physical activity consults. 
Between 12-24 months sessions reduce to one every two months (6 sessions). Those assigned to DPP-
MS, will participate in brief unstructured group support phone contacts according to the same schedule.  
Participants, 25% from ethnic/racial minority groups (primarily African American), will be assessed at 
baseline, 6, 12, 18, and 24 months to determine the following specific aims: 
Aim 1: Document the impact of DPP-BI compared to DPP-MS on weight at 12, 18, and 24 months.  
Hypothesis 1: Overall, DPP-BI compared to DPP-MS will result in more favorable weight loss (average 
change and the proportion reaching ≥ 5%) at 12, 18, and 24 months. 
Aim 2: Document the impact of DPP-BI compared to DPP-MS on cardiometabolic, physical 
activity/function, secondary outcomes, and behavioral adherence measures at 12, 18 and 24 months. 
Hypothesis 2: Overall, DPP-BI compared to DPP-MS will result in more favorable cardiometabolic, 
physical activity/function, secondary outcomes, and behavioral adherence measures at 12, 18, and 24 
months. 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
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Exploratory Aim:  We will examine differences in intervention response (weight, cardiometabolic, and 
function) by race (African American, Caucasian). For a proportion of the sample, we will explore 
Medicare data for group differences in medical utilization (medications, outpatient, inpatient, emergency 
visits) and participation in activity programs.  
Evaluating incremental refinements to standard DPP approaches through community centers 
providing aging services, in alignment with MDPP1,37 and other Medicare subsidized activity benefits, 
will improve our understanding of the most effective and potentially sustainable long term approaches 
for weight control and health maintenance in vulnerable older adults. A successful demonstration of 12-, 
18- and 24-month interventions using video- and telephone-coaching strategies to sustain weight loss 
self-management and enhance behavioral activation for cardiometabolic control and functional health 
outcomes would have significant individual and public health benefit.  
 
3.0 
Background 
Expanding on our previous work, we argue for employing an elder focused, behaviorally robust 24-
month DPP37 lifestyle intervention. With Medicare reimbursement for group lifestyle intervention now 
available, including virtual delivery options, but scant data regarding the most effective, sustainable 
weight-loss maintenance strategies, we conclude that refining and evaluating longer term healthy 
lifestyle maintenance programs for elders in the context of existing senior services can propel advances 
in preventive healthcare and potentially decrease medical burden for older adults and society. 
  Obesity is prevalent in the aging population and associated with cardiometabolic risk.  By 2030 
over 20% of the residents of the United States (US) will be over the age of 6540 and obesity in this group 
is likely to have critical implications for 21st century population health. Increases in obesity (BMI ≥ 30 
kg/m2) among adults in all age groups have neither slowed nor stopped.14 According to the US Centers 
for Disease Control and Prevention (CDC) National Health and Nutrition Examination Survey 
(NHANES) reports 41-43 more than one-third of men and women ≥ 60 years have obesity. Women 
compared to men, aged 65-74, have the highest obesity prevalence rate among older adults at 44.2%. 
Obesity prevalence rates have been shown to fall by roughly 10% after age 75, although black women 
and individuals in rural communities44 continue to demonstrate high rates of obesity well into late life. 
Moreover, many cross sectional and prospective studies of elders have shown the adverse health 
consequences of excess adiposity for metabolic, cardiovascular and general health outcomes (e.g., 
hyperglycemia, metabolic syndrome, insulin resistance, diabetes, inflammation, plasma lipids, arterial 
blood pressure, and other downstream physiologic abnormalities).45-48  Uncontrolled hypertension, 
dyslipidemia, and cardiovascular disease have decreased over the last few decades in all BMI categories, 
including among obese adults, however diabetes has not.49,50 Epidemiologic studies, such as the 
prospective Cardiovascular Health Study, have provided compelling evidence51 that high BMI, central 
adiposity or weight gain during the period of ages 65-74 years is associated with increased diabetes 
risk.15,52  The problem of obesity and diabetes is increasing throughout the lifespan in the US, but 
absolute prevalence rates of diabetes remain highest among adults aged 65-79 years53 owing to 
increasing incidence and decreasing mortality.54 Thus, this is a critical period for weight management 
and health promotion activities. 
  Obesity and diabetes in aging individuals accelerate risk for functional health decline.  In 
addition to its association with cardiometabolic risk, obesity is consistently shown to be one of the top 2-
3 modifiable risk factors for osteoarthritis and mobility disability in older adults.17,55-57 Data from 
NHANES and Medicare research have shown that obese older adults are more likely than their normal 
weight counterparts to report problems with walking, using stairs, and lifting.58 Although some 
investigators have argued that obesity is inversely associated with morbidity and mortality in elders (i.e., 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
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the “obesity paradox”),59,60 the CDC and many medical and scientific organizations61 have 
recommended that older individuals with obesity be identified, evaluated and treated with prudent 
lifestyle intervention strategies given the burden of comorbidities and accelerated functional decline 
likely to negatively impact life expectancy and quality of life.45,62-64 In addition, normative age-related 
physiologic changes are associated with a progressive loss of lean muscle mass and function known as 
“sarcopenia” with prevalence estimates ranging from 25-50% of adults ≥ 65 years showing problems 
with body strength and endurance.65 The term “sarcopenic obesity” has been coined to describe the 
problematic interplay of excessive fat mass and low muscle function.  Functional decrements may 
operate through biomechanical pathways (e.g., lower extremity stress and pain) or through cardio-
metabolic and pro-inflammatory pathways, all of which contribute to poor health outcomes. Although 
some have argued that weight loss among older adults may result in further loss of lean mass and 
compromise functional health,66 several intervention studies have shown that sustained modest weight 
loss, particularly when combined with regular physical activity, is highly beneficial.3,67,68 Additional 
research that indicates it is the confluence of obesity and diabetes that accelerates the physical function 
impairment and reduced quality of life seen in aging individuals, is especially pertinent to the current 
proposal.45,62,63,69,70 Unless feasible and sustainable prevention efforts are mounted 3,63,64 an increasing 
number of aging adults will be living longer with obesity and the progressive burden of chronic 
conditions and mobility impairment.   
  Obesity, diabetes, and mobility disability accelerates loss of independent living. It has been 
documented that the average age of nursing home residents with obesity is 74, compared to age 80 for 
normal-weight residents71. Although serious deficits in activities of daily living and disability (e.g., 
getting in and out of bed, eating, and dressing independently) have decreased during the last decades of 
the 20th century overall, they have increased by 43% for those living with obesity58. A large prospective 
study72 of community dwelling elders, aged 65-74 at baseline, examined the odds of nursing home 
admission over 2 decades and found that obesity increased the risk of admission by roughly 30%; 
obesity plus one additional risk factor (diabetes, hypertension, or smoking) doubled the odds. 
Maintaining functional independence is certainly paramount to older adults, caregivers, and the 
healthcare system. Thus, mitigating obesity and diabetes risk during this period seems particularly 
crucial for delaying the onset of more costly and restrictive levels of care. 
  Older adults respond well to diet and activity interventions but have been underrepresented in 
major clinical trials and community-based studies. Elders typically comprise <20% of the enrolled 
sample in major multicenter weight loss trials, but available data indicates they are very responsive to 
the behavioral regimens provided.23,36,73  This was striking in the DPP trial, with individuals ≥ 60 years 
attending more sessions (including supervised group activity), self-monitoring more consistently, 
achieving weight loss of ≥7% 74 and increasing physical activity36 at higher rates than younger 
participants. This observed outcome was associated with a decrease in incident diabetes of 71% over an 
average 34 months of active follow-up compared to the average decrease of 59% (ages 45-59) and 48% 
(ages 25-44) in the younger age groups. Figure 1a and 1b suggest that the long period of sustained 
weight loss (left, bottom line) among older adults was critical to diabetes prevention/delay (right, bottom 
line) compared to the metformin (middle line) and placebo (upper line) groups. However, older adults 
have not been the focus of most translational studies of DPP interventions and other cardiovascular risk 
intervention trials75 and Medicare coverage decisions have often been extrapolated from younger 
persons. A translation study by West et al76 delivered in senior centers by lay health workers compared a 
12-session DPP intervention to an attention control program and found significant differences between 
groups, but weight loss did not reach 5% on average. More community studies evaluating longer 
duration programs are needed to document the full potential for meaningful weight and health outcomes.  

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  Weight management and other evidence-based lifestyle interventions such as “10- Keys™ to 
Healthy Aging” have potential to mitigate multiple chronic conditions in aging adults. 
Epidemiologic data show that older adults who maintain ≥ 4 healthy lifestyle habits (e.g., faster walking 
pace, more leisure physical activity, modest alcohol intake, BMI <30 kg/m2 and not smoking) have 45% 
lower odds of incident heart failure.77 Several large randomized trials of intensive diet and activity 
interventions demonstrate that weight loss in the 65+ age group with obesity also results in enhanced 
health related quality of life, vitality and physical function.64,68,78,79 Moreover, in addition to 
cardiometabolic and musculoskeletal impact, obesity has been associated with an approximate 25% 
increase in odds of mood and anxiety disorders, including among adults ≥ age 6080. A community 
intervention study81 of racially diverse older adults found that either a brief evidence-based problem 
solving therapy directed at mood regulation, or an individual nutrition coaching program directed at 
healthy lifestyle, performed equally well in reducing symptoms of depression over 24 months among 
elders with elevated depressive symptoms at baseline. Our GLB intervention (mean age 72) also 
demonstrated a “two-for-one” (weight loss and mood) benefit in the short term28.  Therefore, our 
scientific premise is that older adults, at ever increasing risk for multiple chronic conditions,16,18,82 may 
benefit from comprehensive behavioral lifestyle interventions that reinforce common self-management 
behaviors (i.e., goal-setting, self-monitoring, problem-solving) with capacity to address multiple risk 
factors. Indeed, this is the theoretical rationale for the development of elder-focused approaches such as 
“10- Keys to Healthy Aging”,8 and is wholly consistent with DPP intervention goals regarding the 
importance of maintaining a healthier weight for cardio-metabolic and functional health benefit. With 
the proposed study of longer duration maintenance interventions, we reason that integrating DPP-based 
weight maintenance and a “multimorbidity prevention” approach is synergistic, with potential to amplify 
motivation for self-care among elders. 
  Few DPP translational studies have documented longer term maintenance outcomes or 
moderators of success beyond 12-months.  We know from clinical trials, overall, that continued 
contact,83 self-monitoring,74 self-weighing,84 problem solving,85-87 and adherence to physical activity are 
all implicated in the maintenance of long term weight loss and associated cardiometabolic and physical 
function benefits88. However, a recent meta-analysis of 44 DPP-based translation/dissemination studies 
demonstrated that a gap exists between that which has been demonstrated by obesity treatment efficacy 
research and DPP translational findings. Although short-term cardiometabolic benefits are evident, this 
systematic literature review found that the average number of program contacts in the first six months of 
DPP translational studies was 11 sessions and only 60% included a continued contact program of any 
kind. Moreover, translational programs that have offered follow-up interventions have reported that in-
person attendance wanes significantly during the second six months of programming and may not be 
cost-efficient.89 Thus, it appears critical that future studies address the feasibility and effectiveness of 
different strategies and formats for retaining participants to longer duration interventions, particularly 
after the initial period of weight loss induction to mitigate the likelihood of weight regain and loss of 
health benefits. Primary care based DPP translations have begun to examine the use of web-based90 and 
telephonic support91 to promote maintenance of weight loss and cardiometabolic improvements but 
these approaches have not been examined long term with elders, nor has the study of elder-focused 
physical activity programming and guidance been integrated or evaluated. 
     Enrollment/participation in community-based activity programs is a potentially promising 
approach for enhancing weight loss maintenance and functional health in elders. King and 
Guralnik92 have argued that the best way to maintain functional health in an aging population is to 
increase their physical activity and social engagement; providing behavioral guidance for community-
based activity program participation may offer a means to both ends. To date, most DPP interventions 

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have focused on self-monitoring and awareness of activity minutes or steps but not necessarily the 
merits of enrolling in structured or supervised activity programs. Increasing behavioral support for 
appropriate activity programs has potential to improve the weight and health of elders with 
cardiometabolic risk, such programs are often part of the services provided at senior centers and fitness 
facilities but are underutilized. Importantly, prospective research has shown that adjusted Medicare costs 
decreased in the two years subsequent to joining these types of activity programs (e.g., Healthways 
Silver Sneakers®, Silver&Fit®, EnhanceFitness®)93. Other data suggests that program participation of ≥ 
1 time per week is related to lower adjusted health care costs at 12 and 24-months post enrollment,94,95 
compared to controls. However, less is known about the factors associated with joining or adhering to 
Medicare subsidized physical activity programs. Focus group data from a large health maintenance 
organization has suggested that non-users, compared to users, have more physical limitations due to 
health conditions and aging and want more professional guidance on how to adapt physical activity 
regimens.6 Facilitators of enrollment included motivation to maintain physical strength, independence, 
and mental health, engaging and knowledgeable instructors, and the social camaraderie of certain 
programs and gyms. No studies, to our knowledge, have examined the impact of these types of elder-
focused activity programs when combined with a structured weight loss/weight maintenance component. 
     Our own initial internal review of Silver and Fit™ data, the subsidized activity program for elders 
that is part of the UPMC Health Plan, indicated that in 2015 only about 12.5% of those enrolled in 
Medicare Advantage chose to participate in this activity benefit. For those who did elect to participate, 
most attended classes < 3 times per month. Undoubtedly, there will be considerable variability in the 
activity needs, preferences, and outlets that best serve a 65–80-year-old cohort with obesity, pre-diabetes 
and emerging chronic conditions. However, we argue that comparing the effectiveness of a weight loss 
maintenance intervention that incorporates physical activity program guidance, compared to a minimal 
contact control, has potential to advance our understanding of effective lifestyle weight management 
strategies and outcomes.  
     Lifestyle interventions for older adults with obesity and pre-diabetes have potential to reduce 
medical utilization and contain costs. Of particular relevance to the current proposal are studies that 
have documented accelerations in health care utilization that are associated with pre-diabetes in the 1 to 
8 year interval prior to diabetes onset.96-98 Nearly 1 in 4 older adults are estimated to fall within the 
glucose range that precedes frank diabetes, suggesting that even modest decreases in glucose impairment 
and health care usage could decrease economic burden. When comparing a pre-diabetes group to a 
reference group (without diabetes diagnosis or never glucose tested) adjusted rate ratios showed that the 
pre-diabetes group had 34% more ambulatory visits per year. Additional medical visits associated with 
pre-diabetes have been estimated to range from 9% more for serious cardiovascular and peripheral 
vascular disease to 92% more for hypertension for age and sex-matched controls.96,97 Although the 
proposed investigation does not have sufficient follow-up duration to conduct formal cost-effectiveness 
analyses, our scientific premise remains that by exploring parameters such as medication use and 
medical utilization over the 24 month protocol period, we may be able to observe differences in the 
proxies of health economic burden between our two intervention conditions. With our UPMC Health 
Plan partners we are well situated to examine actual claims data and compare whether a more intensive, 
compared to minimal, 18-month maintenance intervention mitigates expected outcomes. Our shared 
partnership goal is to collect pilot data with potential to impact strategic care initiatives for Medicare 
services provision and propose longer and larger studies. 
     Summary. If successful, our study findings could have significant public health impact for late life 
individuals by documenting longer duration yet scalable strategies for improving cardiometabolic and 
functional health. In addition, our partnerships with established senior community service networks and 

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a large regional health insurer have potential to directly influence the design of preventive health 
intervention initiatives including the MDPP expansion opportunities currently proposed. Our findings 
will also have implications for a range of elder focused health services and add to our understanding of 
safe and effective lifestyle intervention weight management and preventive chronic care strategies for 
individuals aged 60+. 
 
4.0 
Study Endpoints 
The Sustain study primary endpoint is 24-months, and important secondary endpoints are examined at 
18, 12, and 6-months. All study endpoints are indexed from baseline assessment; however, 
randomization does not occur until the six-month assessment.  
 
5.0 
Study Intervention 
 
Session 0 
added 
4/1/20 
(when 
sessions 1-
4 in-person 
meetings 
were 
stopped)  
 
DPP Base Intervention Sequence: All Participants 
Distribute Core Sessions Workbook and Self-Monitoring Materials  
(45-60 minutes, weekly) 
0-Be a Good Phone Group Member 
1-Welcome to the Sustain-DPP Study  
2-Be a Calorie Detective 
3-Healthy Eating 
4-Move Those Muscles 
5-Tip the Calorie Balance  
6-Take Charge of What’s Around You 
7-Problem Solving 
8-Four Keys to Healthy Eating Out 
9-Slippery Slope of Lifestyle Change 
10-Step Up Your Activity Plan 
11-Make Social Cues Work for You 
12-Ways to Stay Motivated 
13-Strengthen Your Physical Activity 
14-Manage Your Stress 
15-Mindful Choices, Mindful Eating, Mindful Movement 
16-Take Charge of Your Lifestyle 
 
Randomization to Follow-up Conditions 
6 Months 
A. Active Comparator 
DPP Behaviorally Intensive (DPP-BI):  
30-45 Minute Calls (monthly) 
B. Placebo Comparator 
DPP Minimal Support (DPP-MIN):  
15-Minute Calls (monthly) 
 
New workbook and self-monitoring 
materials distributed. 
 
17- A New Balancing Act 
No workbook or self-monitoring materials. 
Two standard prompts per call: 
  
(1) Discuss past month lifestyle successes 
and challenges (2) Share strategies and 
positive ideas for healthy lifestyle 
maintenance 
 
18- Stay Active for Life  
 

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(plus 1 to 2 one-on-one PA telephone 
consults; delivered by Session 20) 
 
19- Build Your Own Eating Pattern 
 
 
20- Take Care of Your Heart 
 
 
21- Stay Positive 
 
 
22- Look Back and Look Forward 
 
12 Months 
DPP-BI Healthy Aging: 30-Minute Calls  
(every 2 months) 
DPP-MIN: 15-Minute Calls 
(every 2 months) 
 
New workbook distributed. 
 
22-Stay Vital Longer 
No workbook.  
Two standard prompts per call:  
(1) Discuss past month lifestyle successes 
and challenges (2) Share strategies and 
positive ideas for healthy lifestyle 
maintenance 
 
23-Keep Bones, Joints, Muscles Healthy 
 
 
24-Care for Mind Body Health 
 
18 Months 
DPP-BI Healthy Aging: 30-Minute Calls  
(every 2 months) 
DPP MIN: 15-Minute Calls  
(every 2 months) 
 
New workbook distributed: 
 
25- Know Your Numbers 
Two standard prompts per call:  
(1) Discuss past month lifestyle successes 
and challenges (2) Share strategies and 
positive ideas for healthy lifestyle 
maintenance 
 
26-Stay Socially Connected 
 
 
27-Live Healthier Longer 
 
24 Months 
End of study 
End of study 
Table 1: Overview of 24 Month Intervention Sequence by Randomized Follow-up Group 
Videos + Teleconference Coaching (0-6 months).  The 24-month intervention (Table 1) commences 
with a 16-session program administered to all enrolled. Participants receive both hard copy DVDs (DPP 
sessions 1-12 only) and instructions for how to access session videos on a password-protected website. 
Participants are directed to watch session videos independently (15-20 minutes per each) and follow 
along with the intervention workbook when participating in groups either in-person or by phone. 
Because the first several weeks of weight change have been shown to be highly predictive of long term 
intervention response106 we elected to provide in-person groups for the first 4 sessions to enhance 
commitment, group cohesion, and behavioral accountability for self-weighing and self-monitoring. As 
of 4/1/20 when in-person meetings ceased due to the Covid-19 pandemic, ALL intervention delivery 
converted to teleconference. Participants were asked to self-report their weekly weights for the first five 
weeks on a dedicated phone line as a proxy for in-person weighing. A preliminary Session 0 was added 
to orient the group to the phone conferencing procedures and “good virtual group etiquette” at the 
outset. Participants received materials to complete the base 16-session intervention (workbook, DVDs, 
Calorie King ® Calorie Counter; Food and Activity Diaries) by pick-up or mail delivery. An Accusplit 
Eagle activity monitor was distributed at the baseline assessment with instructions on how to complete 
the step assessment and mail-back a step-tracking post-card before Session 2. Participants also received 
Go4Life (NIA) activity videos and other web-linked resources featuring older adults doing aerobic, 
strength, balance, and flexibility exercises with instruction on safe progression. 

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Continued Group Teleconference Coaching for the Active Comparator and the Placebo Comparator 
(6-24 months). Following the six-month assessment visit, randomization to one of the two 18-month 
continued contact conditions followed stratification by weight loss achievement of < or ≥ 3.5%, and also 
incorporated age, sex, and race as balancing variables. The two conditions are: (Active Comparator) 
DPP Behaviorally Intensive or DPP-BI:30-Minute Calls (monthly) and (Placebo Comparator) DPP 
Minimal Support or DPP-MIN:15-Minute Calls (monthly). Both group conditions have the same follow-
up dose/frequency (total of 18 group contacts) and each cohort meets with the same lifestyle coach as 
they did during their base sequence.  
 
The DPP-BI condition was designed to be behaviorally intensive and aligned with principles of 
MDPP implementation.  Structured workbooks were used to guide all DPP-BI sessions. In addition, 
those assigned to this arm were offered up to 2 additional one-on-one phone consultations with a 
Masters-level physical activity specialist for tailored guidance and feedback on their activity goals 
between Sessions 18 and Session 20. Subsequent DPP-BI sessions incorporated concepts from the “5-
Keys to Healthy Aging” and integrated self-care/healthcare for blood pressure, blood glucose, LDL 
cholesterol, healthy bones, muscles and joints, and mood (depression).  Such health maintenance and 
weight loss maintenance health goals were mutually reinforced during this phase. Lifestyle coaches 
followed a standardized leader guide and session scripts. Phone sessions were designed to last about 30 
minutes and the protocol dictated not to exceed 45 minutes.  
The DPP-MIN condition was designed to provide brief, unstructured phone contacts that rely on the 
group members sharing and discussing their successes and challenges of the past month with minimal 
input from the Health Coach. There are no workbooks, or self-monitoring materials provided. Each 
session lasts about 15 minutes.  Lifestyle coaches did not present new intervention material, nor did they 
follow a standardized script for delivering session content. They used group facilitation prompts such as 
noted in Table 1. 
Interventionists. This study utilized lifestyle coaches with backgrounds like those typically hired as 
health and wellness coaching staff by large healthcare plans, or by community agencies that maintain 
healthy aging programs with permanent staff. We selected individuals with Master’s level preparation 
and demonstrated experience in DPP implementation and/or group lifestyle coaching. All 
interventionists received standardized 16-hour DPP-GLB training at the start of the study, 2-hours of 
booster training annually, and protocol and procedure updates monthly.  
Interventionist fidelity to the protocol intervention was measured for each of two conditions. We 
modelled our session-by-session fidelity checklists on those used in prior DPP-GLB studies107. We 
audio-recorded 10% of interventionist phone sessions for future independent coding.  
Intervention Fidelity Assurance/Session Monitoring. We used standardized intervention materials to 
promote rigor and reproducibility. A study investigator supervised the intervention delivery monthly  
and an independent rater listened to and rated 10% of session recordings to ensure that health coaches 
followed the intervention manual and delivered intervention content as intended. Feedback was 
provided. 
 
6.0 
Study Design/Timeline  
Study design.  This single-site study used an individually randomized, 2-arm, 24-month, translational 
effectiveness design.  We aimed to enroll N = 360 participants (180 per condition).  To meet total 
enrollment targets for the study (Table 2), we estimated a need of 6 waves of recruitment with the first 
wave commencing in the final two quarters of Year 1, two waves per year in each of Years 2 and 3, and 
a final wave in Year 4.  Because group telephone interaction constituted a large proportion of the core 
and follow-up intervention, we limited initial group size to approximately N = 8-10 participants. As 

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such, we aimed conduct 2-6 intervention groups, per each recruitment wave, over the course of the 
study. Anticipated recruitment was Year 1 (N = 62), Year 2 (N = 124), Year 3 (N=124), and Year 4 (N = 
50).  Outcome assessments were conducted at 0, 6, 12, 18, and 24 months for all participants in the two-
arm study. However, due to various Covid pandemic shutdowns and re-openings at both the University 
and community level, we extended our recruitment, enrollment, and intervention timeline through Year 
4 and into Year 5 of the study necessarily ending intervention and assessment at 18 months for the Wave 
6 cohort. 
 
 
 
7.0 
Inclusion and Exclusion Criteria 
To maximize generalizability and potential for broad dissemination, eligibility requirements were 
designed to be minimal.  Inclusion criteria were as follows: (1) Age 65+ years at baseline with no upper 
age limit, acknowledging that other exclusionary criteria would be present for the oldest old, (2) BMI ≥ 
27 kg/m2 confirmed at a screening/baseline visit, (3) Fasting plasma glucose >100-125 mg/dl or HbA1c 
>5.7-6.4% mg/dl confirmed at screening/baseline visit, (4) Medical clearance and approval for 
participation in the intervention protocol was required from all enrolled. If, for any reason, the provider 
believed that participation in a 24-month diet, activity and weight loss program was not safe or feasible, 
the candidate was excluded. Those without a primary healthcare provider were referred to low-cost 
community resources.  
 
Exclusion criteria were as follows: (1) Prior diagnosis of diabetes or currently using medications to treat 
diabetes, (2) permanently confined to a wheelchair (other assistive devices were deemed acceptable), (3) 
unable or unwilling to give informed consent (4) Unable or unwilling to self-monitor food, activity, and 
weight as indicated in the intervention orientation, (5) Significant dementia or hearing loss that would 
preclude group participation (6) Significant psychiatric impairment that would preclude group 
participation under normal circumstances in the community, (7) Currently using weight loss 
medications, (8) Weight loss of 4.5 kg or more in the last six months, (9) Bariatric surgery within the 
last two years (those who were greater than 2 years post-surgery were considered if they had not lost 4.5 
kg or more in the last six months) (10) Plans to leave the community permanently within the next 12 
months, plans for extended travel or other demands that would result in less than 50% attendance to the 
Table 2. Study Design and  Timeline of Protocol and Procedures 
 
YEAR 1 
YEAR 2 
YEAR 3 
YEAR 4 
YEAR 5 
 
Q1-2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
Protocol start-up 
 
Wave 1 recruit 
N=64 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assess 
 
0 
 
6 
 
12 
 
18 
 
24 
 
 
 
 
 
 
 
 
 
intervene 
 
 
C 
C 
P 
P 
P 
P 
P 
P 
 
 
 
 
 
 
 
 
 
Wave 2 recruit 
 
 
N=64 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assess 
 
 
 
0 
 
6 
 
12 
 
18 
 
24 
 
 
 
 
 
 
 
intervene 
 
 
 
 
C 
C 
P 
P 
P 
P 
P 
P 
 
 
 
 
 
 
 
Wave 3 recruit 
 
 
 
 
N=64 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
assess 
 
 
 
 
 
0 
 
6 
 
12 
 
18 
 
24 
 
 
 
 
 
intervene 
 
 
 
 
 
 
C 
C 
P 
P 
P 
P 
P 
P 
 
 
 
 
 
Wave 4 recruit 
 
 
 
 
 
 
N=64 
 
 
 
 
 
 
 
 
 
 
 
 
assess 
 
 
 
 
 
 
 
0 
 
6 
 
12 
 
18 
 
24 
 
 
 
intervene 
 
 
 
 
 
 
 
 
C 
C 
P 
P 
P 
P 
P 
P 
 
 
 
Wave 5 recruit 
 
 
 
 
 
 
 
 
N=64 
 
 
 
 
 
 
 
 
 
 
assess 
 
 
 
 
 
 
 
 
 
0 
 
6 
 
12 
 
18 
 
24 
 
intervene 
 
 
 
 
 
 
 
 
 
 
C 
C 
P 
P 
P 
P 
P 
P 
 
Wave 6 recruit 
 
 
 
 
 
 
 
 
 
 
N=40 
 
 
 
 
 
 
 
 
assess 
 
 
 
 
 
 
 
 
 
 
 
0 
 
6 
 
12 
 
18 
* 
intervene 
 
 
 
 
 
 
 
 
 
 
 
 
C 
C 
P 
P 
P 
P 
P 
 
 
 
Study Assessments (Blue); Core Program 0 to 6 Months (Green); Phone Follow-Up 6 to 18 Months (Pink) 
Manuscripts, Meetings, Partner Follow-Up and Planning Activities (Purple) 
Note: * for Wave 6 (N = 40)  the 24 month assessment will occur Q1, Year 6 

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intervention (in some instances patients are encouraged to pursue future baseline cycles of recruitment). 
In addition, those with diabetes and other exclusions were referred to other healthcare resources as 
needed. 
 
8.0 
Vulnerable Populations 
The following special populations were not targeted for recruitment: prisoners, institutionalized 
individuals, or others who may be considered vulnerable. Fetuses, neonates, children <18 years, and 
pregnant or lactating women were excluded based on our inclusion and exclusion criteria. 
 
9.0 
Number of Subjects 
We projected that at least 1620 subjects would need to provide verbal consent to undergo phone 
screening procedures prior to consent and enrollment to reach a target N = 360 subjects for the Sustain 
study. 
 
10.0 
Recruitment/Enrollment Methods 
 
Recruitment methods included contacts with members of senior centers, senior housing facilities, 
hospital-based community foundations, research data registries, and other entities providing services 
(and research opportunities) to older adults. Outreach to potential participants included in-person talks, 
electronic and postal mailings, posters and brochures, and paid advertising in senior-focused magazines 
and minority-focused newspapers. Participant recruitment activities commenced with the cooperation of 
the administrative directors and support staff of such organizations. The study was presented as an 
obesity management/diabetes prevention research program tailored to aging adults that could be 
complimentary to the health care or senior services they were already receiving. Using this natural 
infrastructure as a platform for lifestyle intervention/healthy aging dissemination efforts was intended to 
enhance sustainability and magnify public health impact. The PI and staff were available for follow-up 
questions, and it was made clear that choosing whether or not to participate would have no bearing on 
their community center activities or their medical care. We emphasized that the study duration (and 
expected commitment) was 24-months, and up to five assessment visits, but that they were free to 
withdraw at any time, even after signing informed consent. Staff used a uniform script to respond to 
individuals who voluntarily contacted a dedicated study line within 1-14 days to begin this process. 
 
The Sustain study employed a multi-step screening and enrollment process as follows:  
(1) Verbal Consent was given to make an initial determination for inclusion/exclusion based upon self-
reported demographic information, medical history, interest in the intervention study, ability and 
willingness to participate, 2) Written informed consent was obtained at the Field Screening where 
trained study staff collected a Cholestech finger-stick blood sample to measure HbA1c levels to provide 
confirmation of pre-diabetes status (i.e., 5.7-6.4%) and a height/weight measure to ascertain minimum 
BMI of 27 kg/m2. (3) Subjects were informed immediately at this screening step whether they were 
eligible to continue to the baseline visit and it was scheduled within one-two weeks, on average.  Prior to 
April 2020, the Field Screening was conducted in the community, proximal to where participants lived, 
but post-Covid these locations were slower to resume business and all in person research activities were 
conducted at the University-based offices of the Sustain study. 
 

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Participant Compensation. Participants received payment for research assessments in the amount of $25 
each for visits conducted at study months 0 (baseline), 6, 12, 18.  
 
11.0 
Study Procedures 
Assessments at 0 (baseline), 6, 12, 18 and 24-months  
 
All the following assessments occurred either in the community (pre-Covid) or in the University clinic 
offices. Standard assessment duration was about 1.5 hours. 
 
Weight and Height: was taken twice using a standardized protocol. Weight was measured to the nearest 
0.1 kg at all screening/assessment points using a digital scale (SECA 880) placed on a hard, flat surface. 
Height was measured at all screening/assessment points in street clothes, without shoes, using a portable 
stadiometer and rounded to the nearest 0.1 cm.  
 
BMI: was calculated as average weight divided by average height squared (kg/m2). 
 
Fasting HbA1c, Glucose, Insulin and Lipids (total, HDL and LDL cholesterol, and triglycerides): were 
collected via standard venipuncture procedures for all assessments at 0, 6, 12, 18 and 24 months, after at 
least an 8 hour fast (last food/drink consumption will be documented prior to collection of sample) or 
through a fingerstick assessment when venipuncture was not possible. The sample collected was no 
more than one teaspoon for a fingerstick sample and no more than one tablespoon, or 120 ul 
(microliters) for venipuncture. Procedures were performed by skilled phlebotomists with experience 
working with older adults. Until March 2020 samples were processed through the Northwest Lipid 
Research Laboratories at the University of Washington. When this lab closed in June 2020, specimens 
were processed at the Advanced Research and Diagnostic Laboratory (ARDL) at the University of 
Minnesota in Minneapolis.  
 
Waist Circumference: was measured as an index of truncal fat using a standardized protocol. A Gulick 
tape was placed around the bare abdomen horizontally at the midpoint between the highest point of the 
iliac crest and the lowest part of the costral margin in the mid-axillary line. Measurements were taken 
three times and averaged. 
 
Blood Pressure: was measured using an automatic inflatable digital blood pressure monitor (OMRON 
HEM90HXC) with appropriate cuff size according to a standardized protocol. 
 
International Physical Activity Questionnaire (Older Adult Version): is a 4-item questionnaire that asks 
participants to describe their usual physical activity during a typical day and a typical week, in each of 
the following categories --time spent sitting, walking, doing moderate physical activities, doing vigorous 
physical activities. 
 
Objective Physical Activity Measurement: Participants used a hip-worn pedometer to assess physical 
activity. They self-reported daily step counts, and the primary measure calculated was average daily step 
count over a 7-day recording period. 
 
Objective Short Physical Performance Battery (SPPB): Evaluation of physical functional ability was 
assessed with four short tests (about 3-5 minutes each) including (1) a 4-meter walk test (gait speed); (2) 

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standing balance (feet together, semi-tandem, full tandem); (3) a chair stand test (rise from chair five 
times); and (4) grip strength test using a Jamar dynamometer. 
 
Falls History: an interviewer administered survey documented number of falls, serious falls, and fear of 
falls experienced during the past year 
 
Prescribed Medication List: Participants were asked at each visit to update a list of all their currently 
prescribed medications (and dosages) taken regularly. 
 
Montreal Cognitive Assessment (MOCA): a widely used interviewer administered screening instrument 
for mild cognitive dysfunction, was used to assess several mental function domains. 
 
All of the following were sent to participants to be completed at home and brought back to the clinic at 
the time of each major assessment visit, or mailed back. Clinic staff checked all of these measures for 
completeness and phone participants if there were missing items. 
 
Center for Epidemiologic Studies-Depression Scale (CES-D): This 20-item scale is a self-administered 
instrument for assessing depressive symptoms. 
 
SF-12v2 Health Survey: Quality Metric's SF-12v2 is a self-administered shorter version of the SF-36v2 
(used to reduce burden). We used this extensively norm-referenced measure of functional health and 
well-being, which captures the same eight health domains and produces a physical component (PCS) 
and mental component (MCS) summary score that may be compared to the longer version. 
 
Patient Activation Measure: PAM is a self-administered 22-item scale measuring knowledge, skill and 
confidence for self-managing health and healthcare. 
 
Weight and Activity Lifestyle Questionnaire: is a self-administered 13-item scale to measure participant 
beliefs and expectations about self-managing eating and activity behaviors in the face of certain 
emotions, social situations and environments. 
 
Mediterranean Diet Assessment Tool: This 14-item self-administered index was used because it has 
been shown to be sensitive to shifts in dietary quality related to interventions, both in the presence and 
absence of significant weight loss. 
 
Rate Your Plate: We used the Rate Your Plate-Heart 2010 version, a 24-item, self-administered 
questionnaire that assesses the degree to which eating patterns are consistent with heart healthy dietary 
guidelines.  
 
CHAMPS Physical Activity Questionnaire: is a 41-item self-administered instrument, which measures 
the weekly frequency and duration of various physical activities commonly done by older adults. MET-
weighted variables are readily coded, and the measure is sensitive to changes following activity 
interventions in persons aged 65-90. 
 

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Self-Reported Medical Conditions: The Duke Comorbidity Index is a self-administered inventory that 
asks, "Has your doctor ever told you that you have or have had" (any of 19 specific medical conditions 
that can be categorized into 8 health domains). 
 
Family History of Diabetes and CVD: Research participants were asked to provide information about 
whether there is a family history of type 2 diabetes or other cardiovascular disease in a first degree 
relative. 
 
Self-Reported Medical Utilization Outcomes: 
Medical Utilization was measured by 4 questions from the Stanford Chronic Disease Self-Management 
Program evaluation protocol. This protocol measures the number of times, in the previous six months, 
an individual has visited a physician/health care provider (outpatient), a hospital emergency room, the 
total number of separate hospital admissions, and the total number of nights spend in the hospital. 
 
Sustain DPP Satisfaction and Acceptability Survey: was collected for qualitative assessment of 
participant satisfaction. This post-intervention survey contained Likert scale items and 5 open ended 
questions. 
 
Complementary and Integrative Research Lab (CAIR) Pandemic Impact Survey: As of 9/30/20 we 
added one 19-item survey with the approval of our NIH/NIDDK sponsor and IRB. The survey asks 
several questions about the psychosocial impact of COVID-19 and how it has affected either the study 
participant or someone close to them. We hypothesized that the primary study aims (and the pre-
specified outcomes of weight change, physical activity, physical function and other measures) had the 
potential to be influenced (negatively and positively) by the pandemic.  
 
UPMC Health Plan Medicare Metrics:  
We obtained de-identified descriptive statistics for medical claims for consenting Sustain DPP study 
participants who were also UPMC Health Plan Medicare Advantage members. This was done to 
compare the two randomized intervention groups (using UPMC Health Plan aggregate data only) on the 
following claims-based information: categories and number of prescription claims, number of 
outpatient, inpatient and emergency room visits, percentage of participants utilizing physical activity 
benefits (i.e. Silver and Fit). 
 
12.0 
Data and Specimen Banking 
There is no a priori data sharing plan for data or specimens. Blood specimens were centrally analyzed by 
both the Northwest Lipid Research Laboratory (University of Washington, Seattle) until they closed in 
July of 2020, and then by Advanced Research Diagnostics Laboratory (ARDL) (University of 
Minnesota, Minneapolis).  No stored samples were banked. An investigator with interest in the data files 
for this study would need to contact the PI at vendittiem@upmc.edu. 
 
13.0 
Sharing of Results with Subjects 
The data collected in this study are specific to the research and are not designed to assess medical 
conditions. The investigators are not responsible for failure to find existing abnormalities. In the unlikely 
event that a participant’s data (e.g., bloodwork biometrics) show a possible abnormality, the PI or Co-I 
(Study MD) contacts the participant and advises medical follow-up for the problem, including a referral 

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to a primary care provider (PCP). For participants who already have a PCP, and provide verbal 
permission, the study doctor may inform the PCP of the finding and determine if follow-up is advisable. 
The decision as to whether to proceed with further examination and/or treatment lies solely with a 
participant and their PCP. The study does not cover the costs of any follow-up actions.  
 
End of study information provided: Participants will be mailed a letter from the PI describing the results 
of the study, including a copy of the main outcomes paper when available. 
 
14.0 
Withdrawal of Subjects 
Participants may be withdrawn from the research without their consent under the following 
circumstances: 
• the investigator decides that continuation can be harmful to the participant, 
• participant develops a new condition or undergoes treatment that will make their subsequent 
follow-up data in the study unusable, 
• the study is cancelled, or there are other administrative reasons. 
 
In the event a participant withdraws or is asked to leave the study, they will still be compensated for the 
study activities they have completed. 
 
15.0 
Risks to Subjects 
This is a minimal risk study with prudent measures in place to protect the health and well-being of 
research participants and their privacy and confidentiality. Risks associated with participation in this 
study include the following:   
(1) Potential risks associated with reduced caloric intake and increased physical activity, such as 
musculoskeletal injuries. 
(2) Patient privacy and confidentiality breach. 
(3) Inconvenience associated with data collection.  
 
These risks are mostly associated with the characteristics of the target patient population and the 
procedures involved in the research. The risks are reasonable in relation to the anticipated benefits and 
will be minimized by using sound clinical research procedures and risk mitigation strategies. Although 
we cannot guarantee that risks will not occur, we will implement the following measures to minimize 
potential risks to participants in the study. 
 
Protection against Risks Associated with Weight Loss Strategies. The premise of the study is that 
prudent yet comprehensive lifestyle interventions, which include evidence-based strategies for dietary 
modification, physical activity and behavior change, are necessary to meet the targets set forth in 
national guidelines for managing obesity and obesity-related cardiometabolic and other comorbidities. 
By managing BMI according to these evidence-based guidelines for intensive behavior therapy, 
intervention participants may be exposed to risks associated with caloric reduction and physical activity 
not experienced in routine care. 
 
The interventions to be tested in this clinical trial promote a balanced, calorie-controlled diet approach 
and recommend against very low-calorie diets (<1200 kcal/day) or losing weight too rapidly (> 2 lbs. 

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per week). Participants will be advised to avoid crash or fad diets that promise marked, rapid weight 
loss. Instead, they will be advised to adopt a moderate caloric reduction by 500-1000 kcal/day through 
healthy substitutions and portion control, rather than omission or elimination of specific foods or food 
groups. Given the average age anticipated in this participant sample, the intervention will encourage 
consumption of plant-based and lean-meat proteins and low-fat or fat-free dairies at most meals. The 
selection of low-calorie, nutrient-dense foods in accordance with USDA-recommended healthy dietary 
patterns will be emphasized. Participants who wish to lose additional weight after reaching the 
program’s weight loss goal (5-10% of baseline weight) will be encouraged to do so only insofar as they 
maintain a normal BMI and the rate of weight loss does not exceed 2 lb/week.  
 
To minimize risks associated with increased physical activity, consistent with the current public health 
physical activity recommendations for Americans, the study interventions promote achieving 150 
minutes or more per week of moderate-intensity physical activity in a gradual manner. If participants 
reach the 150-minute goal but are not achieving the weight loss goal, they can gradually increase to 60-
90 minutes/day of moderate physical activity, as tolerated. We will also recommend resistance training 
activities 2 times per week, consistent with NIA public health guidelines. Moderate-intensity physical 
activity is deemed feasible for adults with chronic conditions or functional limitations, and the benefits 
are believed to outweigh the risks. We will emphasize brisk walking—a physical activity recommended 
as being safe for most adults—as the preferred mode of exercise. Participants will receive information 
about how to be active safely considering their conditioning, interest, context, and environment. 
 
Protection against Breaches of Participant Privacy and Confidentiality. All information to be 
obtained during the study will be considered strictly confidential and only used and disclosed as 
permitted under the HIPAA regulations. All eligible patients must sign the HIPAA authorization as a 
part of the informed consent to participate. Only aggregate data will be included in scientific 
presentations and publications resulting from this study; the identity of individual participants will not 
be revealed. In addition, the following measures will be taken during the conduct of the study to ensure 
adequate protection of participant privacy and confidentiality: 
• All investigators and staff will be adequately trained to protect participant privacy and sign an 
agreement to do so. 
• Personal identifiable information (PII) and protected health information (PHI) collected for the 
purpose of the research study will be assigned a unique anonymous study ID number. The study 
IDs will be used on all study forms and for data storage, tracking and reporting. 
• Both the anonymized health information and the information linking the study ID numbers to 
participants’ identities will be stored in a password protected database on a secure network fitted 
for protection of such information, which will be accessible only to the research personnel who 
have a need to know. 
• The information linking the study ID numbers to participants’ identities will be stored separately 
from the anonymized health information. 
• We will follow the latest industry standards for data encryption, server authentication, and client 
authentication to ensure secure data transmissions at all times. 
• No participant data, even if de-identified, shall be saved onto any portable devices, such as 
laptop computers or USB drives. 
Protection against Risks Associated with Data Collection. All study measures are either objectively 
measured by trained research staff, or self-measured or self-reported by participants. There are no 
greater risks associated with completing the required measurements in this study than those ordinarily 

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associated with such measurements in routine health care. For surveys and questionnaires, participants 
are reminded at each assessment that they do not have to answer any question they do not wish to 
answer.  
 
16.0 
Potential Benefits to Subjects 
Although several potential benefits may be expected from participating in this study, we cannot guarantee 
that any individual participant will experience these benefits. All participants, including the Placebo 
Comparator, will receive an evidence-based lifestyle intervention aligned with the MDPP. The 
interventions to be tested promote modest weight loss through healthy eating, increased physical activity, 
and behavioral self-management. These healthy lifestyle factors have known health benefits, including 
but not limited to, lowering the risk of type 2 diabetes for those at high risk as well as prevention and 
control of hypertension and hyperlipidemia. Improvements in these lifestyle factors and health outcomes 
may in turn lead to better quality of life. All the benefits are likely to be long-term and outweigh any 
possible short-term risks. 
 
17.0 
Data Management and Confidentiality 
Data Management.  
 
Data security.  
 
18.0 
Data Analysis Plan 
All analyses are conducted in consultation with the study biostatisticians, using SAS 9.4 (SAS Institute, 
Inc., Cary NC). Descriptive analyses and graphic displays are used to identify outliers, missing data, and 
patterns of attrition. Demographic variables and baseline measures are contrasted between the Active 
Comparator: DPP-Behaviorally Intensive 30-Minute Groups (DPP-BI) and the Placebo Comparator: 
DPP Minimal 15-minute Calls (DPP-MIN) conditions. In all outcome analyses we will use an intent-to-
treat (ITT) approach in which participants remain in the study arm to which they are randomized 
regardless of attrition. The primary analytic strategy is a linear or generalized mixed-effect models 
approach in which treatment group, time, and time by group interaction are treated as fixed effects, and 
subject is treated as a random effect to account for individual subject variability. Hypothesis tests are 
two-sided, and significance will be set at the 0.05 level. Mixed models are applicable to longitudinal 
datasets that contain missing observations, with the assumption that the data are missing at random. Our 
prior intervention studies suggest that we can anticipate 90% retention at 6 months and greater than 80% 
retention over the 18-month extended intervention period (at 24 months) with no differential attrition 
between arms. Those who drop out or are lost to follow-up are compared to those who have completed 
intervention for research assessments using standard parametric and non-parametric methods, as 
appropriate. We will examine the patterns of missingness and, if necessary, account for missingness in 
outcome analysis (e.g., the covariate approach). Regression modeling will be conducted to adjust for 
covariates such as race, sex, age, socio-demographic factors, and other designated baseline clinical 
variables.  
Research Questions  

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Analysis Plan for Hypotheses 1 and 2: We will apply mixed effect models to evaluate differential 
changes in weight measures at 6, 12, 18, and 24 months from baseline, with fixed terms of group (DPP-
BI vs. DPP-Min), time as a factor (6,12,18, and 24 months), and the group by time interaction. We 
employed the following steps as the pre-randomization balancing logic: (1) group subjects by weight 
loss status (≤ 3.5 vs. > 3.5 percent at 6-months) and age (≤ 70 vs. > 70 years at baseline), (2) group 
subjects by sex (male vs. female) and race (Black/African American or Black/Mixed/Other vs. 
White/Caucasian), (3) group subjects using all 4 factors (based on 2x2 frequency table) and (4) 
randomly assign the subjects in the same cell into 2 conditions (DPP Plus vs. DPP Minimal). Subject 
was included as a random term. To test the differential treatment effect, evaluated the coefficients that 
are associated with the group and the group by time interaction by using an F test.  Planned contrasts 
will be set up from the mixed models to compare the improvement in weight from baseline to Months 
12, 18 and 24 between the two conditions (DPP-BI vs. DPP-Min). In addition, a generalized mixed-
effect model was fit to the binary outcome of achieving ≥ 5% weight loss at 6, 12, 18, and 24 months, 
with the logit link, which includes similar fixed and random terms as above. Average percent weight 
loss and the proportions achieving ≥ 5% weight loss are compared between the two groups at 12, 18 and 
24 months. Similar analyses were performed for fasting glucose, HbA1c, and insulin (and other 
biometric measures), physical activity/function, and other secondary outcomes at subsequent assessment 
points.  
 
The planned contrasts were set up to compare differential changes from baseline to Months 12, 18, and 
24. Benjamini-Hochberg’s method was used to control for the overall type I error for multiple secondary 
outcomes. More intensive modeling is performed to account for factors that are known to affect the 
outcomes as well as those that have been found to differ between treatment conditions at baseline and at 
Month 6 (the timepoint at which participants are stratified by < or ≥ 3.5% weight loss and other factors 
and randomly assigned to the two 18-month conditions). We also perform analyses in which we restrict 
our linear and generalized mixed-effect analyses to those who did not reach ≥ 5% weight loss at 6 
months and set up the contrasts to compare DPP-BI with DPP-MIN, on average, and the proportion 
reaching ≥ 5% at 12 months and 18 months from baseline.  
 
Exploratory Aim. We examine available Medicare data for those insured by a large regional payer to 
assess group and time from baseline differences in medical utilization metrics (e.g., type of outpatient, 
inpatient, or emergency visits) and participation in activity programs, for a proportion of the sample.  
We will extract Medicare data on numbers of outpatient, inpatient and emergency visits, and number of 
subjects participating in activity programs, and compare the numbers between the two conditions using 
linear and generalized regression models.  We will explore the potential moderation effects of sex and 
race. We will include the interaction of sex by group or race by group in the mixed-effect models, as 
well as the three-way interaction of sex, group and time or race, group and time, if the group by time 
interaction is significant in the original model.  
 

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Power and Sample Size Considerations. We powered this study on the main comparisons between the 
Active Comparator: DPP-BI and the Placebo Comparator: DPP-MIN on average weight loss at 12 
months from baseline (24-month data is not readily available). With 180 subjects per arm and projected 
90% attrition at Month 12, we would have 80% power to detect effect sizes of 0.31, using two-sided t 
tests at the 0.05 level. Our prior Pitt Retiree study observed approximately 7.5 % weight reduction at 12 
months among those subjects who received active intervention for 12 months, and 5.5% reduction at 12 
months among those in the placebo comparator group. Assuming similar effects and similar standard 
deviation of 5.8% as observed in the Pitt Retiree study, we expect to see a standardized group difference 
ranging 0.34 at Months 12 between DPP-BI and DPP-MIN. Hence we anticipate that our projected. 
sample size will enable us to detect group differences with power greater than 0.8 for our primary 
weight outcome. 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
In this minimal risk Sustain study, we utilized a Data and Safety Monitoring Plan (DSMP) to ensure the 
safety of study participants and the validity and integrity of data in compliance with NIH/NIDDK and 
our local IRB.  The DSMP was reviewed annually by a single data safety monitoring officer via written 
report and teleconference. 
 
An AE is defined as any untoward medical or psychological event experienced by a subject during or as 
a result of his/her participation in the study that represents a new symptom or an exacerbation of an 
existing condition whether or not considered study-related based on appropriate medical judgment.  
SAEs are any adverse experience that results in any of the following outcomes:  
• Death 
• Imminently life-threatening event/illness 
• Inpatient hospitalization or prolongation of existing hospitalization 
• Persistent or significant disability/incapacity 
• Pregnancy resulting in a congenital anomaly/birth defect 
• Any event requiring medical or surgical intervention to prevent permanent impairment or 
damage. In this study, this is defined as physician confirmed diagnosis of any of the following: 
angina pectoris, heart attack, stroke, transient ischemic attack, heart failure, coronary angioplasty 
or bypass surgery, peripheral vascular disease, incident diabetes, serious musculoskeletal injuries 
(e.g., fractures, ruptured ligaments), liver failure, kidney failure, and cancer (except for non-
melanoma skin cancer).  
 
Non-SAEs are all adverse events that do not meet the above criteria for “serious.”   
 
Blinded Reporting.  Safety information for this study is reported to the Safety Officer by masked 
treatment group (i.e., without revealing the treatment assignment of each group). With each report, 
summaries of the numbers and rates of all AEs by masked treatment group are provided.  
 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
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Page 23 of 30 
 
Expedited reporting. All unexpected SAEs must be reported to the safety officer within 5 business days 
of discovery, regardless of any judgment of their relatedness to the study treatment. The safety officer 
may require a conference call to review relevant information (and the site study physician’s 
determination of whether there was any possible relevance to the study) and discuss and approve the 
investigators’ Corrective and Preventive Action Plan, if warranted.   
 
Data quality monitoring.  The safety officer receives an annual report on data quality and 
completeness. At a minimum, this report will include the following: (1) participant accrual and follow-
up completion/retention by site in relation to goals and timeline; (2) the randomization process and 
group comparability on the balancing variables; (3) data completeness for primary and secondary 
outcome measures; and (4) protocol exemptions, deviations and violations. Follow-up data will be 
reported for all participants, irrespective of random assignment, during the course of the study.  
 
Study Stopping Rules. Formal stopping rules for safety, efficacy, and futility are not proposed given 
that this is a minimal risk clinical trial as the behavioral intervention to be tested are based on prior 
research in different populations without major harms (e.g., mortality or serious medical complications). 
Second, while we hypothesize that the intervention will lead to significant and clinically meaningful 
improvements in weight loss and other outcomes of interest, we expect the probability of major health 
benefits (e.g., reduced incidence of disease or reduced mortality) that would trigger early stopping for 
efficacy to be negligible over a 24-month follow-up period.  
 
20.0 
Provisions to Protect the Privacy Interests of Subjects 
21.0 
Compensation for Research-Related Injury 
There are no plans for the study to provide free medical care or to pay for research-related illnesses or 
injuries, or to provide other forms of compensation (such as lost wages or pain and suffering) to 
participant for research related illnesses or injuries. As part of the informed consent process participants 
are advised to contact the site PI to report any illness or injury experienced from taking part in the 
Sustain study.  
 
22.0 
Economic Burden to Subjects 
There are no costs to participants for intervention.  
 
23.0 
Consent Process 
 
Multi-Stage Informed Consent. All study participants involved in the Sustain study must provide 
written informed consent before baseline assessment. Study personnel obtaining informed consent are 
experienced in obtaining informed consent and have receive standardized training in trial-specific 
protocols as well as mandatory trainings in good clinical research practice.  For Sustain, there will be an 

Reducing cardiometabolic risk and promoting functional health in community-based elders with obesity 
and pre-diabetes: evaluating sustainable follow-up strategies 
 
Page 24 of 30 
 
initial screening consent (verbal authorization for phone or field screening) and subsequently written 
informed consent. We allow sufficient time and resources to meet the ethical obligations to research 
participants and to foster a progressively increasing understanding of the research as well as the 
development of rapport between subjects and research staff.  
 
Informed Consent Process Training. We will conduct effective and efficient informed consent to 
ensure that participants understand the following: (1) that the study is for research purposes and in no 
circumstances does it supplant medical care provided by their health care provider(s), (2) the risks and 
benefits of the study, (3) the available alternatives, and (4) that their voluntary decision to participate or 
to not participant in this research will be accepted without penalty (i.e. without jeopardizing their 
medical care or relationship with their clinical sites). In reaching a decision about participation, it is 
essential for the potential subject to demonstrate an ability to use this information in a rational manner. 
Thus, in considering the risks, benefits, and available alternatives, subjects must show that they 
understand the aspects of these factors that are unique to them as individuals.   
 
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