Dissemination of a Diabetes Prevention Program Among Medicare Eligible Older Adults
Phase: NA
Conditions: Obesity, Cardiovascular Risk Factor, Eating Behavior, Diet Modification, Physical Activity, Quality of Life, Mobility Limitation
Sponsor: University of Pittsburgh

Cover Page: Study Protocol and Statistical Analysis Plan 
 
 
Official Title: Dissemination of a Diabetes Prevention Program for Medicare Eligible Older 
Adults 
ClinicalTrials.gov Identifier:  NCT03192475 (first posted 6/20/17) 
Document Date (approved):  5/24/12 
 

Section: Section 1 - Objective, Aims, Background and Significance
     [reviewer notes¬] 
1.1
Objective: What is the overall purpose of this research study?  (Limit response to 1-
2 sentences.) 
We propose to disseminate a novel, yet practical, diabetes prevention program among
Medicare eligible adults. This study will provide baseline, 4, 12, and 24 month data to help
determine whether a continued contact telephone intervention is feasible and effective
(compared to a newsletter control condition) in enhancing health outcomes and physical
functional ability in adults aged 65-80. 
1.2
Specific Aims: List the goals of the proposed study (e.g., describe the relevant
hypotheses or the specific problems or issues that will be addressed by the
study). 
Several dissemination studies have shown that DPP-adapted interventions (including the
Group Lifestyle Balance program) are feasible in diverse community settings with initial
body weight reductions of 5-7% that are accompanied by cardio-metabolic improvements.
However, the goal of establishing a prevention program infrastructure in managed health
care remains elusive. This application seeks to address three important dissemination
challenges. First, although effective treatments are available to mitigate diabetes risk
among older adults, resources have been directed much more frequently to younger,
employed individuals. Second, traditional medical settings alone have not been equipped to
provide the screening and behavioral support required to implement prevention programs
and innovative approaches to screening and intervention delivery platforms are needed.
Finally, although we know from obesity research that longer treatment duration (beyond an
initial 4-6 months) appears critical to enhance weight loss and prevent weight regain,
dissemination studies have not systematically examined the role of continued contacts in
sustaining longer term weight loss, and improving cardio-metabolic risk factors and physical
functional ability among older individuals.  
The proposed project is based on the premise that the annual Medicare enrollment period in
an institutional context presents an ideal opportunity to reach eligible, high-risk elders.
Retired adults, considering their future health care coverage needs, may be particularly
receptive to the proposed intervention and employers and insurers providing such benefits
may be more likely to offer programs that have been demonstrated to be effective and
sustainable. Thus, we propose to implement the GLB 12-session intervention (GLB-12) as
part of the annual health benefit package offered to high-risk retirees at a large public
university. Participants will be 320 non-diabetic adults, aged 65-80, with a BMI ≥ 27 and at
least one additional cardio-metabolic risk factor. First, we will evaluate the feasibility of
recruiting for and implementing an in-person group program (GLB-12) within this
infrastructure. Next, we will conduct a randomized, controlled comparison of two follow up
protocols for the remainder of one year of intervention, 8-sessions of continued small group
contact by telephone (GLB+8TC; N = 160) or a 2-newsletter control condition (GLB + NC;
N = 160). The primary aims are to: 
Aim 1: Document that the GLB-12 intervention is feasible and effective when implemented
with Medicare enrolled retirees. 
Hypothesis 1 (feasibility): We will enroll 107 participants per year, they will complete 65%
of sessions, return 50% of self-monitoring records and report above average program
satisfaction at the month 4.  
Hypothesis 2 (effectiveness): Participants will achieve 5% weight loss and 150 minutes of
self reported physical activity per week, and show corresponding waist, glucose, blood
pressure and lipid improvements (adjusted for medication use) at month 4. 
Aim 2: Evaluate the effects of continued small group contact by telephone (GLB+8TC)
compared to a newsletter control condition (GLB+NC) on anthropometric, cardio-metabolic,
physical function and health related quality of life (HRQL) measures at 12- and 24-months
follow up. 
Hypothesis 3: GLB+8TC will be associated with more favorable weight, waist, glucose, lipid,
blood pressure gait speed, grip strength, balance and HRQL at month 12 and 24
assessments.  
An exploratory aim will be to evaluate direct program costs and self reported health care
utilization. 

Section: Section 1 - Objective, Aims, Background and Significance
1.3
Background: Briefly describe previous findings or observations that provide the
background leading to this proposal.  
We have assembled a team of investigators with extensive background experience in
screening, assessing and delivering behavior modification interventions for obesity and the
reduction of diabetes risk. Our training manuals, protocols and procedures have been used
to translate evidence based intervention programs to a variety of community settings. The
original individually administered DPP Lifestyle Balance© intervention (copyright 1996;
2011) was developed at the University of Pittsburgh by Dr. Venditti and colleagues for the
DPP Research Group under the leadership of Dr. Rena Wing. Dr. Venditti continues as
Director of the Lifestyle Resource Core for the Diabetes Prevention Program Outcomes
Study (DPPOS) and oversees content development for all intervention materials as well as
the training of a wide array of clinical staff for this longitudinal follow up study. Between
2004 and the present, Dr. Venditti and several original members of the DPP team in
Pittsburgh established the Diabetes Prevention Support Center (DPSC) with the express
purpose of conducting dissemination research. With Department of Defense funding,
several primary prevention projects were delivered in underserved urban and rural areas of
Western Pennsylvania and, in parallel, to the military community through the United States
Air Force (USAF). 
To date, we have accomplished the following: 1) updated and consolidated the individually
administered 16-session DPP intervention to the Group Lifestyle BalanceTM (GLB) program
with available content for 12 core treatment sessions and 10 continued contact sessions; 2)
we have created a DVD version of the first 12 sessions using multi-ethnic professional
actors filmed “as if” they were participating in a group using a script that mirrors the
written participant materials, and; 3) we have developed a 2–day GLB training workshop
for health professionals (all disciplines) that includes continuing education hours for nurses
and registered dietitians. All manuals and materials have been made publicly available for
downloading and adaptation, and we have established additional procedures for licensing
the GLB program for research modification, education and/or commercial use nationally and
internationally. Our DPSC group has offered over 25 training workshops and trained over
900 people. Thus, this application reflects the cumulative experience of Dr. Venditti and her
colleagues at the University of Pittsburgh in creating, adapting and disseminating evidence-
based lifestyle intervention programs to reduce obesity and diabetes risk in multiple
community environments. If effective, the GLB program proposed in the current application
could be available immediately for employers, managed healthcare systems and older
Americans. 
Although Dr. Venditti and her colleagues have demonstrated their ability to train and
translate the GLB 12-session intervention in a number of community based settings it has
most often been in the context of primary healthcare. They have demonstrated feasibility
and effectiveness but not necessarily sustainability. Thus, the current application will focus
on a novel adaptation of the Group Lifestyle Balance intervention as disseminated in an
alternative institutional setting that provides health benefits to Medicare eligible retirees.
Our findings will clarify the role of an additive, scalable treatment model that is directly
applicable to the managed health care environment. 
1.4
Significance: Why is it important that this research be conducted? What gaps in
existing information or knowledge is this research intended to fill?  
There is great urgency to intervene with diabetes risk factors as the population ages. The
provision of lifestyle intervention to prevent or delay diabetes and associated co-morbidities
in older adults has critical implications for decreasing the total burden of diabetes care in
the U.S. during the next decades. Adults ≥ 65 account for approximately 12 percent of the
total population and this number will approach 20% during the years 2010-2030
(http://2010.census.gov/2010census). Epidemiologic evidence has provided strong support
for focusing diabetes prevention efforts on older adults. About 70% of US men and women
over age 60 are overweight or obese.  
Although diabetes is increasing throughout the lifespan, the US incidence remains highest
among adults aged 65-79 years. In 2009, the percentage of diagnosed diabetes among
people aged 65–74 (19.9%) was over 11 times that of people younger than 45 years of age
(1.7%). A recent ten-year prospective study of Medicare eligible adults sought to clarify the
relationship between adiposity and diabetes risk in this age group and demonstrated that
those individuals whose activity, diet, smoking and alcohol habits remained in the lowest
risk category had an 82% lower incidence of diabetes compared to other participants; lower
BMI and central adiposity were associated with additional decreases in diabetes risk. The
newly established Center for Medicare and Medicaid Innovation has mandated that
community-based coordination for screening individuals at risk and providing affordable

Section: Section 1 - Objective, Aims, Background and Significance
preventive services are a top national priority. 
There have been several prior demonstrations of community based diabetes prevention
programs, but important translation questions remain regarding sustainable screening and
enrollment strategies, intervention platform, continued contact and scalable delivery
methods for older individuals in managed care. The original DPP lifestyle intervention was
labor intensive and consisted, on average, of 50 individually administered, in person
sessions over 2.8 years –an implementation dose that is not feasible in real world practice. 
We also know that older adults are particularly responsive to structured diet and activity
programs. Adults over age 60 randomized to the lifestyle intervention group sustained ≥ 5
kg of weight loss for more than 5 years and at each time point their weight losses were
significantly greater than that of their younger counterparts. The data confirm that
participants ≥ age 60 were more likely to attend sessions, complete self monitoring
records, report a lower percentage of calories from fat and meet the 150 minute weekly
exercise goal compared to younger individuals. Interventions in this high risk, but relatively
healthy group clearly are worthy of translation efforts, but such opportunities have not been
exploited systematically. Careful examination of the most feasible and effective continued
contact methods to sustain modest weight loss and associated physiologic risk reductions or
enhance physical function and quality of life in older adults is warranted.

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.1
Does this research study involve the use or evaluation of a drug, biological, or
nutritional (e.g., herbal or dietary) supplement?
* No
    [reviewer notes¬] 
2.2
Will this research use or evaluate the safety and/or effectiveness of one or
more devices?
* No
    [reviewer notes¬] 
2.3
Summarize the general classification (e.g., descriptive, experimental) and
methodological design (e.g., observational, cross-sectional, longitudinal,
randomized, open-label single-blind, double-blind, placebo-controlled, active
treatment controlled, parallel arm, cross-over arm) of the proposed research
study, as applicable.
The current research can be classified as a feasibility/effectiveness design . First we will
document the feasibility of community based implementation of an evidence-based 12-
session Group Lifestyle Balance (GLB-12) intervention among retirees and/or their
dependent spouses/partners who have enrolled or are about to enroll in Medicare benefits
through the University of Pittsburgh. We will also recruit from other community locations.
Following implementation of the non-randomized GLB-12, participants will be assigned by a
stratified block randomization scheme to continued telephone contact (GLB + 8TC; N = 160)
or to newsletter control (GLB + NC; N = 160) for the remainder of the one year
intervention. Stratification will be based on the category of percent weight loss achieved
during the first phase of intervention (<3.5 % and >3.5%). Major outcome assessments will
be conducted at 0, 4, 12 and 24 months.
2.3.1
Does this research study involve a placebo-controlled arm?
* No
    [reviewer notes¬] 
2.4
Will any research subjects be withdrawn from known effective therapy for the
purpose of participating in this research study?
* No

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.5
Will screening procedures (i.e., procedures to determine research subject
eligibility) be performed specifically for the purpose of this research study?
* Yes
2.5.1
List the screening procedures that will be performed for the purpose of this
research study.  Do NOT include the inclusion/exclusion criteria in this section as
they will be addressed in section 3; questions 3.13 and 3.14.
Two staff members, using a dedicated phone line, will respond to individuals expressing
interest during regular office hours and complete a participant intervention eligibility
checklist (see below). An alternate scenario is that these same screening activities will be
performed at Medicare benefits fairs. Screeners will complete daily logs to document their
phone, or other in-person screening activities. 
Potential participants with self-reported eligibility will be invited to an orientation/information
session which includes a weight and a height measurement to confirm a minimum BMI of
27. They will also be asked to have a physician (or other primary health care provider)
referral form completed, including approval for moderate physical activity during the GLB
intervention. Because of the age of this cohort (65-80), only those individuals who can
provide a medical referral form will be included. This is not anticipated to be a problem
since, by definition, University of Pittsburgh retirees are provided with the Medicare benefit
and any other screening activities will be for those who are signing up for Medicare benefits.
However, those individuals who have not yet established a primary care provider relationship
and are interest in participation will be helped to do so, if possible. 
     [reviewer notes¬] 
2.6
Provide a detailed description of all research activities (e.g., all drugs or devices;
psychosocial interventions or measures) that will be performed for the purpose of
this research study.  
This description of activities should be complete and of sufficient detail to permit
an assessment of associated risks. 
At a minimum the description should include:
all research activities
personnel (by role) performing the procedures
location of procedures
duration of procedures
timeline of study procedures
Study Timeline 
There will be at least three annual waves of recruitment. Baseline and annual assessments
will be conducted in the period between January and March of each year; additional
recruitment may occur between May and July of each year. Waves of intervention will
commence within 8-12 weeks of screening and enrollment. Prior experience in our
community based GLB projects indicates that these are optimal times to initiate programs.
It will also allow for some groups to start in early Spring to accommodate older adults who
travel during the winter months. If recruitement targets are lagging, there may be an
additional wave of recruitment and intervention commencing in May/June annually---all
procedures will be identical. 
Training and Supervision. 
The GLB-12 intervention will be administered in groups of approximately 15-20 participants

Section: Section 2 - Research Design and Methods
by three part-time lifestyle coaches, with Bachelor’s degree training at minimum, and
previous experience in health promotion, health education or lifestyle interventions. They
will be trained by the Diabetes Prevention Support Center staff in a two-day workshop
conducted by a nurse diabetes educator (CDE), registered dietitian, exercise specialist and
a behavioral scientist. These individuals will be available for specialty consultation as
needed. Each coach will conduct 3-10 groups (GLB-12) per year and be responsible for all
associated follow up protocols. Drs. Venditti and Marcus will provide additional monitoring
and supervision for the telephonic continued contact coaching protocol and each lifestyle
coach will be required to audiotape 10% of their telephone contact sessions. Independent
reviewers will complete a session content checklist of these recordings as an intervention
fidelity check. If necessary, lifestyle coaches will be trained at remote campus locations to
implement the GLB-12.  
Description of GLB-12 session intervention. 
The instructional content of the original individually administered DPP 16-session curriculum
was consolidated into 12-sessions designed to be administered weekly over 3-4 months.
Other modifications to this content include 1) broad behavioral focus on the principles for
making healthy food choices, meal planning and the plate model as opposed to the earlier
USDA food pyramid, 2) instructions to monitor calories and fat beginning in Session 1, and
3) inclusion of the pedometer to help increase self-awareness and motivation for increasing
overall movement. As in the DPP, the goals of the GLB intervention are to achieve and
maintain a 7% weight loss, and safely and progressively increase to 150 minutes per week
of moderately intense physical activity similar to a brisk walk. Participants will receive
standard tools to complete the program: 1 –GLB participant notebook for weekly session
handouts; 1- Calorie King ® Calorie Counter; GLB Food Activity and Weight Diaries. Those
who miss group meetings will be mailed the GLB-DVD for that session and asked to watch
prior to the next meeting. There will be no additional phone support offered during the GLB-
12 session program. Participants will be weighed at each in-person treatment contact
(research weight measures will be conducted by independent assessors), diaries will be
collected weekly and data-entered, and attendance recorded. 
Randomized Intervention condition-GLB followed by Telephone Coaching (GLB + 8TC).
Following GLB-12, group telephone sessions will be the delivery format for the remaining
one year of intervention. The content, structure and sequence of these sessions is similar to
those conducted in person; however, a group phone coaching script and a participant
handout will be developed that details norms and procedures for phone interactions. As
with face-to-face intervention, the phone coaching sessions amplify core diabetes
prevention and cardiovascular health messages and allow for continued weight, diet, and
activity monitoring and accountability. Prior studies have shown that this method of
coaching has been employed successfully both for initial standard (core) as well as
maintenance interventions with older rural women (44, 45). All participants will be asked to
call into a toll-free conference line, and to treat the weekly call time as a standing
appointment for which they need to be in a private location free from distractions.
Participants will be asked to dedicate a maximum of 45 minutes for actual phone call time,
and to utilize15 minutes post-call time to review home assignments on their own. In the
GLB + 8TC condition, the first of the eight continued contact sessions be delivered face to
face to orient those randomized to telephone continued care to the specific protocol and
procedures, provide a new participant manual and other materials necessary to complete
the remainder of the program. Because problem solving strategies will be a dominant focus
of these continued contact sessions, we will limit participation on each group phone call to
approximately 5-7 individuals. In addition, because of the critical importance of
transitioning from face-to-face weekly sessions to home-based self-monitoring during the
follow up phase, all GLB +8TC participants will be provided with a digital bathroom scale
and a set of post-cards with instructions to mail in (or phone in) their weekly weights and
physical activity minutes for the duration of the intervention.  
During these group phone consultations the participants will be encouraged to discuss their
major barriers to achieving their dietary and physical activity goals and share the kinds of
approaches/strategies that they have been attempting to use during the prior month, since
the last contact. The specific information that is discussed/shared in these group
interactions is at the discretion of each individual participant; the nature of these
interactions is expected to be very similar to the types of discussions that occur in the live
group interaction. Participants will not be asked to report their current weight or weekly
physical activity minutes over the phone during the group interaction, although they will be
asked to phone or mail this specific information in to their lifestyle coach monthly . 
GLB followed by Newsletter only (GLB+ NC). Following GLB-12, four newsletter packets
containing information related to general health and well being (as opposed to specific
behavioral diet, weight loss and activity messages) will be mailed to participants at month 6

Section: Section 2 - Research Design and Methods
and month 11 from baseline. The packets will also include reminders about pending
assessments, and colorful, professional quality pamphlets and brochures from the National
Institute on Aging (NIA) that pertain to the self-management of sleep, stress, arthritis and
osteoporosis. 
2.6.1
Will blood samples be obtained as part of this research study?
* Yes
*If submitting a protocol for expedited review, it should be clear that the planned blood
draws are within the parameters described here:
http://www.hhs.gov/ohrp/policy/expedited98.html  (see Expedited Research Category #2)
If Yes, address the frequency, volume per withdrawal, the total volume per visit, and the
qualifications of the individual performing the procedure: 
Fasting Glucose and Lipids (total, HDL and LDL cholesterol, and triglycerides): will be
collected via finger stick sampling after at least an 8 hour fast (last food/drink consumption
will be documented prior to collection of sample). We will use the Cholestech LDX® System,
with results available immediately, and adhere to all quality control measures published by
the Cholestech Company. Each procedure requires no more than one or two drops of blood
or 40 ul (microliters) or less than one teaspoon maximum. The person completing the
procedure will be either a trained phlebotomist or other medical technician.
Study Flow Chart: 
Name
Modified Date

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.7
Will follow-up procedures be performed specifically for research purposes? 
Follow-up procedures may include phone calls, interviews, biomedical tests or
other monitoring procedures. 
* Yes
Detailed procedures listed in the textbox below:
Randomized Intervention condition-GLB followed by Telephone Coaching (GLB + 8TC). 
Following GLB-12, group telephone sessions will be the delivery format for the remaining
one year of intervention. The content, structure and sequence of these sessions is similar to
those conducted in person; however, a group phone coaching script and a participant
handout will be developed that details norms and procedures for phone interactions. As with
face-to-face intervention, the phone coaching sessions amplify core diabetes prevention and
cardiovascular health messages and allow for continued weight, diet, and activity monitoring
and accountability. Prior studies have shown that this method of coaching has been
employed successfully both for initial standard (core) as well as maintenance interventions
with older rural women (44, 45). All participants will be asked to call into a toll-free
conference line, and to treat the weekly call time as a standing appointment for which they
need to be in a private location free from distractions. Participants will be asked to dedicate
a maximum of 45 minutes for actual phone call time, and to utilize15 minutes post-call time
to review home assignments on their own. In the GLB + 8TC condition, the first of the eight
continued contact sessions be delivered face to face to orient those randomized to telephone
continued care to the specific protocol and procedures, provide a new participant manual
and other materials necessary to complete the remainder of the program. Because problem
solving strategies will be a dominant focus of these continued contact sessions, we will limit
participation on each group phone call to approximately 5-7 individuals. In addition, because
of the critical importance of transitioning from face-to-face weekly sessions to home-based
self-monitoring during the follow up phase, all GLB +8TC participants will be provided with a
digital bathroom scale and a set of post-cards with instructions to mail in (or phone in) their
weekly weights and physical activity minutes for the duration of the intervention. Session
content for the telephonic continued contact phase is described in Appendix B.  
GLB followed by Newsletter only (GLB+ NC).  
Following GLB-12, four newsletter packets containing information related to general health
and well being (as opposed to specific behavioral diet, weight loss and activity messages)
will be mailed to participants at month 6 and month 11 from baseline. The packets will also
include reminders about pending assessments, and colorful, professional quality pamphlets
and brochures from the National Institute on Aging (NIA) that pertain to the self-
management of sleep, stress, arthritis and osteoporosis. 

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.8
Does this research study involve the use of any questionnaires, interview or
survey instruments? 
* Yes
Upload a copy of all materials except for the SCID or KSADS which are on file at
the IRB.  The use of all instruments must be addressed in question 2.6 and/or
question 2.7 (except for an exempt submission where they should be addressed
on the appropriate uploaded exempt form). 
Name
Modified Date
Well Being (CES-D).docx
1/18/2013 11:07
AM
Falls History Screening - PRS Form A70.docx
1/18/2013 11:08
AM
Past Month Activity Questions
1/9/2014 6:24 PM
Clinical Data Collection Form - PRS A50.docx
1/18/2013 11:08
AM
Weight and Activity Questions
1/9/2014 6:25 PM
Demographic, Family & Personal History Data Input Form - PRS Form
A20.docx
1/18/2013 11:06
AM
SF-12v2.pdf
1/18/2013 11:13
AM
Short Physical Performance Battery - PRS Form A60.docx
1/18/2013 11:07
AM
GLB Satisfaction Survey - 4mos
1/9/2014 6:22 PM
Use of Medical Services Data Input Form - PRS Form A15.docx
1/18/2013 11:05
AM
Emergency and Physician Contact List - PRS Form A30.docx
1/18/2013 11:04
AM
Medication List - PRS Form A25.docx
1/18/2013 11:05
AM
Food Frequency Questions
1/9/2014 6:21 PM
CHAMPS Activity Questionnaire for Older Adults
1/18/2013 11:02
AM
Social Problem Solving Inventory-Revised (Instructions)
1/9/2014 6:25 PM
GLB Postcore Phone and Newsletter Satisfaction
1/9/2014 6:23 PM
Screening Data Input Form - PRS Form S02.docx
1/18/2013 11:03
AM
Duke Index - A40.doc
1/18/2013 11:06
AM
Mediterranean Diet Questions
1/9/2014 6:20 PM
Previously the name and publisher for commercially available materials
were listed in the textbox below but effective 9/1/2015, all materials (except for
the SCID and KSADS) must be uploaded using the Add button above. 

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.9
If subjects are also patients, will any clinical procedures that are being used for
their conventional medical care also be used for research purposes? 
* yes
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be
used for research purposes:  
Only for purposes of physician documentation of additional risk factors for diabetes based
on the physician referral. No new tests or procedures will be requested from the medical
provider for research purposes. 
2.10
The blood sample question was moved to 2.6.1.
     [reviewer notes¬] 
2.11
What is the total duration of the subject's participation in this research study
across all visits, including follow-up surveillance? 
* 24 months
    [reviewer notes¬] 
2.12
Does this research study involve any type of planned deception?  
If Yes, you are required to request an alteration of the informed consent process (question
4.7)
* No
    [reviewer notes¬] 
2.13
Does this research study involve the use of UPMC/Pitt protected health
information that will be de-identified by an IRB approved "honest broker"
system?
* No
    [reviewer notes¬] 
2.14
Will protected health information from a UPMC/Pitt HIPAA covered entity be
accessed for research purposes or will research data be placed in the UPMC/Pitt
medical record? 
* No
2.14.1
Will protected health information from a non-UPMC/Pitt HIPAA covered entity be
obtained for research purposes or will research data be placed in the non-
UPMC/Pitt medical record?   
* No

Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.15
Does this research study involve the long-term storage (banking) of biological
specimens? 
* No
    [reviewer notes¬] 
2.16
Will research participants be asked to provide information about their family
members or acquaintances?
* Yes
2.16.1
Describe what information about the third party will be obtained from the
participant:
Only whether there is a family history of type 2 diabetes or other cardiovascular disease in
a first degree relative
2.16.2
If the information about the third party is of a private nature, can the identity of
the third party be readily ascertained or associated with this information?
* 
No
Describe the private information that will be collected and recorded about the third party:
Only whether there is a family history of type 2 diabetes or other cardiovascular disease in
a first degree relative
     [reviewer notes¬] 
2.17
What are the main outcome variables that will be evaluated in this study?
Measurement Description 
Demographic Questionnaire: will be used to collect data on sex, age, race, ethnicity,
education, income and family contact information. 
Weight and Height: will be taken twice using a standardized protocol. Weight will be
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 will be measured at screening events and
the baseline visit only in street clothes, without shoes, using a portable stadiometer (Shorr
productions) and rounded to the nearest 0.1 cm. 
BMI: will be calculated as average weight divided by average height squared (kg/m2). 
Waist Circumference: will be measured as an index of truncal fat using a standardized
protocol. A Gulick tape will be 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 are taken three times and averaged. 
Fasting Glucose and Lipids (total, HDL and LDL cholesterol, and triglycerides): will be
collected via finger stick after at least an 8 hour fast (last food/drink consumption will be
documented prior to collection of sample). We will use the Cholestech LDX® System, with
results available immediately, and adhere to all quality control measures published by the
Cholestech Company.  
Blood Pressure: will be measured using an automatic inflatable digital blood pressure
monitor (OMRON HEM90HXC®) with appropriate cuff size according to a standardized
protocol.  
Nutrition/Nutrition Related Behavior: We will administer 2 questions from the CDC NHANES

Section: Section 2 - Research Design and Methods
Food Frequency Quesitonnaire and 14 items from the Mediterranean Diet Assessment Tool. 
Physical Activity Behavior: We will administer, by interview, the Champs Physical Activity
Questionnaire for Older Adults (46). This survey consists of 41 items that have been shown
to be a highly reliable and valid measure of the weekly frequency and duration of various
physical activities typically undertaken by older adults. It has been shown to be sensitive to
changes following activity interventions in persons aged 65-90. We will also ask some
questions by interview about past month activity level. 
Other behavioral, psychosocial functioning and mood questionnaires and surveys are as
follows: 
SF-12v2 Health Survey: Quality Metric’s SF-12v2® is a shorter version of the SF-36v2®
(47). We will use 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.  
Center for Epidemiological Studies-Depression Scale (CES-D): This 20-item instrument is
used to measure clinical depression and has well-established psychometric properties
including reference norms for the elderly (48, 49). 
Participant Satisfaction Survey: We will adapt a standard one-page post-intervention
program satisfaction survey that has been used previously by the Group Lifestyle Balance
Program and utilizes 5-point Likert scale ratings and other open ended questions. There will
be one version for the GLB 12 and another for the newsletter or phone followup phase. 
Physical Function Tests: Evaluation of physical functional ability will be based on a short-
physical performance battery (SPPB adapted from epidemiologic/longitudinal studies on
aging. We will include: 
Grip Strength Test using a Jamar dynamometer (51) from the Cardiovascular Health Study
(Johns Hopkins) 
Balance, Gait Speed and Chair Stand Tests from the National Institute of Aging 
These measures are been demonstrated to be sensitive to functional decline and frailty and
have associated with adverse health outcomes  
Self-Reported Health Care Utilization: We will administer, by interview, 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 spent in the hospital. It has
been utilized as an outcome measure for several disease self-management programs and
specifically diabetes.  
Social Problem Solving Inventory-Revised: Participants will answer a 25-item survey about
some ways they may think, feel or act when faced with important problems in everday life
situations. The psychometric properties of this instrument are well established in all age
groups. 
2.18
Describe the statistical approaches that will be used to analyze the study data.
* Addressed below:
All analyses will be conducted in consultation with Dr. Arena, the study biostatistician.
Descriptive analyses and graphic displays will be used to identify outliers, missing data and
patterns of attrition that will guide decisions about the use of transformations and
appropriate tests. Demographic variables and baseline measures will be compared between
the GLB+10TC and GLB+NC 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 will be a mixed models
approach in which treatment group, time, and time by group interaction are treated as fixed
effects, and subject and percent weight loss during the first phase of intervention (<3.5%
and >3.5%) are treated as a random effects to account for individual subject variability.
Hypothesis tests will be two-sided and significance will be set at the 0.05 level. Analytical
tools will include SAS (SAS Institute, Inc., Cary NC), Stata (StatCorp LP, College Station, TX)
and StatXact (Cytel, Inc. Cambridge, MA). 
Mixed models are applicable to longitudinal datasets that contain missing observations, with

Section: Section 2 - Research Design and Methods
the assumption that the data are considered to be missing at random (MAR) or ignorable
missing. Although we will be proactive in maximizing subject retention, we anticipate 75%
adherence over the 12-month intervention period. Those who drop out or are lost to follow-
up will be compared to those who have completed intervention sessions and 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). Finally, regression modeling will be
conducted to adjust for covariates, including demographic variables such as age, race, sex,
number of sessions completed, as well as any other variables that have been found to differ
across treatment conditions at baseline. 
Research Questions 
Hypothesis 1 (feasibility): On average, we will enroll ≥107 participants per year for each of
three years to GLB-12; they will complete > 65% of sessions, return ≥ 50% of self-
monitoring records and report above average program satisfaction at the 4-month
assessment. 
Analysis Plan: The overall approach will be to report descriptive statistics, including the total
number of participants enrolled, the distribution of the number of GLB-12 sessions
completed, the percentage of participants completing 8 (65%) or more sessions (the
definition for acceptable attendance), the percentage of participants who return six (50%) or
more of the self monitoring records (the definition for acceptable behavioral adherence) and
the distribution of program satisfaction ratings. Summary descriptive statistics will include
mean, median, standard deviation and confidence intervals for continuous variables and
proportions, ranges and percentiles for categorical variables. 
Hypothesis 2 (effectiveness): On average, participants will achieve ≥ 5% weight loss (the
definition of acceptable weight outcome in prevention programs) and ≥ 150 minutes of self
reported moderately vigorous physical activity minutes per week (the recommended level in
prevention programs), and show corresponding waist, glucose, blood pressure and lipid
improvements (adjusted for medication use).  
Analysis Plan: For the weight measure, we will examine both absolute weight change (kg)
and percent weight change pre to post-intervention (0-4 months). Student t-test and Chi-
Square statistics will be used to assess the absolute and percent weight change outcomes,
respectively. We will also use descriptive statistics to identify the proportion of total
participants achieving ≥ 5% weight loss and the proportion achieving ≥ 150 minutes
Similarly, Student t-tests will also be used to assess pre to post intervention changes in
waist, glucose, lipid, and blood pressure measures. Because we know that medications will
effect these outcomes we will conduct separate sub-group analyses for lipid endpoints to
control for statin use, and for blood pressure endpoints to control for blood pressure
medication use. 
Power and Sample Size Considerations: The primary endpoint of this investigation is defined
as the proportion of participants, in each intervention arm, who maintain the designated
target weight loss of ≥ 5% at 12 months from baseline. Additional power calculations were
derived for the changes in absolute weight loss from 0-12 months and in fasting glucose
levels from 0-12 months. For our primary endpoint of ≥ 5% weight loss at 12 months, with
N = 160 in each arm and assuming no more than 25% attrition, we have 80% power to
detect differences of 19% between the two intervention conditions in the proportion of
subjects achieving this weight loss target. There is 90% power to detect differences of 21%
between the two groups. This translates to roughly half or more of the participants in the
telephonic continued contact group maintaining ≥ 5% weight loss compared to only about
one-third of those in the newsletter control condition. These estimates are based on a
Fisher’s Exact test conducted at alpha = 0.05 two sided with N = 120 in each arm. In
addition, we also calculated power estimates for various differences in absolute weight loss
(lbs) between GLB + 10TC and GLB + NC based on previous GLB outcomes presented in
Table 2 (23). Assuming a two sample t-test conducted at alpha = 0.05 two-sided with a
standard deviation of 10.5 we find that there is 80% power to detect group differences of
3.8 lbs or 90% power to detect group differences of 4.4 lbs between the two arms at 12
months. Finally, for the secondary endpoint analysis of differences between GLB + 10TC and
GLB + NC in fasting plasma glucose changes from 0-12 months and assuming a two sample
t-test conducted at alpha = 0.05 two-sided with a standard deviation of 11.9 based on data
presented in Table 2 (23), we project that there will be 80% power to detect a difference of
≥ 4.3 mg/dl decrease or 90% power to detect a difference of ≥ 5.0 mg/dl decrease between
the two intervention arms. 
Hypothesis 3: GLB+10TC will be associated with more favorable weight, waist, glucose, lipid,
blood pressure gait speed, grip strength, balance and HRQL (based on the physical
component summary and the mental component summary scores from the SF-12v2®)
compared to the GLB + NC group at 12- and 24-month follow up assessments.  

Section: Section 2 - Research Design and Methods
Analysis Plan: We will compare GLB + 10TC and GLB + NC on changes in absolute and
percent weight loss and each of the other outcome measures with a repeated measures
mixed model. To test the treatment effect we will evaluate the coefficients associated with
group and the group by time interaction. Planned contrasts will be constructed from the
mixed model to evaluate differential changes in percent weight loss between the two
conditions from baseline to post-treatment at 12 and 24 months. This procedure will be
utilized for each of the other secondary measures. 
An exploratory aim will be to evaluate direct program costs and self reported health care
utilization. 
Analysis Plan: The overall approach will be to report descriptive statistics, including the
following: overall and component specific program costs, including allocation of time
expenditures by screening staff and GLB interventionists, and the direct cost of all materials
provided. For health care utilization we will summarize the self-reported number of times 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
spent in the hospital in the previous six months. Comparisons will be made between the two
groups (GLB + 10TC and GLB + NC). Summary descriptive statistics will include mean,
median, standard deviation and confidence intervals for continuous variables and
proportions, ranges and percentiles for categorical variables. 
     [reviewer notes¬] 
2.19
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g.,
Navajo Nation) where the cultural background of the subject population differs
substantially from that of Pittsburgh and its surrounding communities? 
* No
Note that copies of training records, licenses, certificates should be maintained in the
study regulatory binder and are subject to audit by the Research Conduct and Compliance
Office (RCCO).
In addition, individuals planning to conduct human subject research outside the United
States must complete an optional module on the CITI training website: International
Studies.  Click here to access the instruction sheet for accessing optional CITI modules. 
     [reviewer notes¬] 
2.21
Will this research study be conducted within a nursing home located in
Pennsylvania?
* No

Section: Section 3 - Human Subjects
     [reviewer notes¬] 
Section 3 - Human Subjects
3.1
What is the age range of the subject population? 
64-82 
3.2
What is their gender? 
* Both males and females
 Provide a justification if single gender selected: 
3.3
Will any racial or ethnic subgroups be explicitly excluded from participation? 
* No
If Yes, identify subgroups and provide a justification: 
3.4
For studies conducted in the U.S., do you expect that all subjects will be able to
comprehend English?
* Yes
    [reviewer notes¬] 
3.5
Participation of Children: Will children less than 18 years of age be studied? 
* No
If No, provide a justification for excluding children: 
This is a study of Medicare eligible retirees
     [reviewer notes¬] 
3.6
Does this research study involve prisoners, or is it anticipated that the research
study may involve prisoners? 
* No
    [reviewer notes¬] 
3.7
Will pregnant women be knowingly and purposely included in this research study?
* No
    [reviewer notes¬] 
3.8
Does this research study involve neonates of uncertain viability or nonviable
neonates?
* No

Section: Section 3 - Human Subjects
     [reviewer notes¬] 
3.9
Fetal Tissues: Does this research involve the use of fetal tissues or organs? 
* No
    [reviewer notes¬] 
--->
3.10
What is the total number of subjects to be studied at this site, including subjects
to be screened for eligibility? 
Note: The number below is calculated by summing the data entered in question 3.11. Any
additions or changes to the values entered in 3.11 will be reflected in 3.10. 
* 1500
3.11
Identify each of the disease or condition specific subgroups (include healthy
volunteers, if applicable) that will be studied.  
Click on the "Add" button and specify for each subgroup:
1) how many subjects will undergo research related procedures at this site; and
2) if applicable, how many subjects will be required to undergo screening
procedures (e.g., blood work, EKG, x-rays, etc.) to establish eligibility.  Do Not
include subjects who will undergo preliminary telephone screening. 
* 
Subgroup
Number to undergo research
procedures
Number to undergo screening
procedures
View Enrolled in GLB 12
session
320
1500
3.12
Provide a statistical justification for the total number of subjects to be enrolled
into this research study at the multicenter sites or this site. 
* If applicable, refer to the statistical section in the protocol or grant. Specify the page
numbers in the textbox. 
Power and Sample Size Considerations: The primary endpoint of this investigation is defined
as the proportion of participants, in each intervention arm, who maintain the designated
target weight loss of ≥ 5% at 12 months from baseline. Additional power calculations were
derived for the changes in absolute weight loss from 0-12 months and in fasting glucose
levels from 0-12 months. For our primary endpoint of ≥ 5% weight loss at 12 months, with
N = 160 in each arm and assuming no more than 25% attrition, we have 80% power to
detect differences of 19% between the two intervention conditions in the proportion of
subjects achieving this weight loss target. There is 90% power to detect differences of 21%
between the two groups. This translates to roughly half or more of the participants in the
telephonic continued contact group maintaining ≥ 5% weight loss compared to only about
one-third of those in the newsletter control condition. These estimates are based on a
Fisher’s Exact test conducted at alpha = 0.05 two sided with N = 120 in each arm.
     [reviewer notes¬] 
3.13
Inclusion Criteria: List the specific criteria for inclusion of potential subjects. 
Study Inclusion Criteria. 
Non-diabetic, Medicare eligible men and women, ages 65-80 (by 1/1/13), with a BMI ≥ 27
and at least one of the following additional risk factors will be included. Eligible participants

Section: Section 3 - Human Subjects
must reside in the Western PA or Tri-State region at least half the year and be available to
attend the 12 in-person sessions at a location closest to their residence. In addition, eligible
participants must meet the following criteria: 
EITHER a score of 15 or greater on the ADA risk test, 
OR one of the following:  
1) Large waist circumference (> 40 inches men, >35 inches women);
2) hypertension or taking hypertension mediciation;
3) physician confirmed low HDL level (<40 mg/dL men, < 50 mg/dL women);
4) physician confirmed elevated triglyceride level ≥ 150 mg/dL;
5) physician confirmed fasting glucose ≥ 100 mg/dL and < 126 mg/DL
The eligibility criterion of BMI ≥ 27 has been selected (as opposed to BMI ≥ 25, a standard
overweight cut point) in order to insure that the selected participants are indeed at higher
risk for diabetes (1) and to insure that elderly women at a BMI of 25 will not be at
increased risk for bone loss and/or muscle loss with weight reduction. 
Finally, study participants must have access to a telephone (including appropriate assistive
devices if they have hearing impairments), and be able to read at the 6th grade level. 
Eligible individuals are those who meet the following criteria: 
1. Overweight or obese (BMI of ≥27 kg/m2)
2. Do not currently have a diagnosis of diabetes
3. Are between the ages of 65-80 as of January 1, 2013
4. Documented evidence of at least one additional health risk factor for diabetes including
EITHER 
a) a score of 15 on the ADA risk screening test, OR
b) one of the following: history of hypertension or currently taking hypertensive
medications; large waist circumference (> 40 inches men, > 35 inches women); physician
confirmed low HDL level (<40 mg/dL men, <50 mg/dL women); physician confirmed high
fasting glucose level (≥ 100 mg/DL and < 126 mg/DL); physician confirmed high
triglyceride level (≥ 150 mg/DL) 
Individuals who meet the above criteria will be invited to complete the informed consent
procedure and will be scheduled for a baseline assessment (it is anticipated that it will take
approximately 1-3 months to complete these procedures prior to the baseline assessment
and the first GLB session).  
3.14
Exclusion Criteria: List the specific criteria for exclusion of potential subjects from
participation. 
Study Exclusion Criteria. 
1) prior diagnosis of diabetes or currently using medicines used to treat diabetes;
2) unable to provide physician (or other health care provider) referral/ clearance for
exercise participation; 
3) a weight loss of 4.5 kgs or more in the past six months (to rule out unintentional weight
loss that may be an indicator of current or incipient physical illness); 
4) current use of weight loss medications;
5) unable to attend at least 75% of the GLB 12-session program
6) unwilling to self-monitor food, activity and weight as prescribed
7) participants who have had bariatric surgery will be excluded if at the time of study
enrollment they are less than 2 years status/post surgery (this is the period in which
individuals are likely to have had the maximum amount of weight loss and some will begin
to experience weight regain). Individuals who are greater than 2 years status/post bariatric
surgery may be considered for inclusion as long as they have not had a weight loss of
greater than 4.5kgs in the past six months. 
Excluded individuals will be referred to other resources as appropriate. 
3.15
Will HIV serostatus be evaluated specifically for the purpose of participation in
this research study? 
* No

Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.1
Select all recruitment methods to be used to identify potential subjects: 
Advertisements
Recruitment Letters and/or Scripts
Research Registry
Pitt + Me
Other Strategies: Described below
Advertisements  
Upload the advertisements for review:
Name
Modified Date
10-4-12 Kozar Letter and Eligibility Checklist-revised.docx
10/4/2012 8:13 PM
10-1-12 Kozar Letter and Eligibility Checklist.docx
10/4/2012 8:00 PM
PowerPoint for In Person Screening Events
11/12/2012 9:37
PM
Letter to participants-outline of next steps-PRS- describe
locations.docx
1/18/2013 11:18
AM
Recruitment Letters and Scripts
Upload recruitment letters/scripts/text: 
Name
Modified Date
GLB Written Screening Consent 5/14/2012 7:52 PM
ADA Risk Screening Test
5/14/2012 7:55 PM
Research Registry
List the IRB approval number and title for each registry source: 
http://www.pepper.pitt.edu/ 
The Pittsburgh Claude D. Pepper Older Americans Independence Center 
(Dr. Steven Albert) The Center for Research on Health and Care, Graduate School of Public
Health, University of Pittsburgh). The IRB approval number for this registry is IRB0503150. 
Dr. Susan Greenspan, a Co-Investigator with the Pitt Retiree Study, introduced us to Dr.
Albert and we made a formal application to use the Registry. We were approved by the
Executive Committee and have received permission to access the database/mailing list.
Letters were generated and sent to registry participants in the same way as was done with
the University of Pittsburgh retiree database (based on age and zipcode).
4.2
Provide a detailed description of your recruitment methods, including identifying
and initiating contact with participants:  
As a community translational research study targeting individuals who had been previously
employed at either the main campus or the four branch campuses of the University of
Pittsburgh, all procedures will be coordinated through the University Human Resources (HR)

Section: Section 4 - Recruitment and Informed Consent Procedures
benefits department utilizing 2 (FTE) project assistants under the supervision of the PI and
the Program Coordinator. All screening and recruitment procedures are being designed to
meet with the approval of Mr. John Kozar, Director of Benefits. Mr. Kozar (and the HR
database) indicate that many of these individuals remain in the Western PA region. 
Annual preparations for screening and recruitment for the GLB-12 session intervention will
commence in September 2012 for years 1, 2, and 3 of the study prior to the benefits
elections deadline in early December. We will target these retirees through mass mailings,
benefits counseling sessions, and/or Medicare benefits screening fairs that are held for this
group. The screening and recruitment activities will take place either by phone (in
association with the mass mailings) or in person (using existing benefits events). 
A letter and/or flyer describing the Group Lifestyle Balance (GLB) program along with the 7-
question American Diabetes Association risk screening test (a form commonly used at
community health screenings to raise awareness, see uploaded attachments) will be
utilized. Once subjects are screened and eligible they will be invited to complete the
informed consent procedures and schedule baseline assessments 
In addition we have added community based screening methods to meet recruitment
targets: 
1. Claude Pepper Registry (as above)
2. Outreach to other community facilities where there may be networks of 65-80 year olds
interested in participation (e.g., church based programs, senior centers, recreational
facilities, municipal and borough facilities associated with programs for older adults).
Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now
captured in 4.1
     [reviewer notes¬] 
4.6
Are you requesting a waiver to document informed consent for any or all
participants, for any or all procedures? (e.g., a verbal or computerized consent
script will be used, but the subjects will not be required to sign a written informed
consent document.  This is not a waiver to obtain consent.
* Yes
4.6.1
Identify the specific research procedures and/or the specific subject populations
for which you are requesting a waiver of the requirement to obtain a signed
consent form.
Addressed below:
If not all, identify the specific procedures and/or subject populations for which you are
requesting a waiver:  
In some, but not all, cases screening will occur completely by phone and the participants will
be determined to be eligible (with the exception of the height and weight confirmation, in
person, to determine BMI status). In those cases where subjects appear to meet all of the
eligibility criteria they may be invited directly to sign informed consent and proceed with
baseline research assessments at the first and only in person contact prior to the start of
intervention.
4.6.2
Indicate which of the following regulatory criteria is applicable to your request for
a waiver of the requirement to obtain a signed consent form.
 45 CFR 46.117(c)(2)
45 CFR 46.117(c)(1) That the only record linking the subject and the research would be
the consent document and the principal risk would be potential harm resulting from a
breach of confidentiality. Each subject will be asked whether the subject wants
documentation linking the subject with the research, and the subject's wishes will govern;
or

Section: Section 4 - Recruitment and Informed Consent Procedures
45 CFR 46.117(c)(2) That the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside
of the research context.
4.6.2.1
Address why the specific research procedures for which you are requesting a
waiver of the requirement to obtain a signed consent form present no more than
minimal risk of harm to the research subjects:
These are procedures that are typically done at health screens and benefits fairs that
present only minimal risk to subjects
4.6.2.2
Justify why the research listed in 4.6.1 involves no procedures for which written
informed consent is normally required outside of the research context:
These are procedures that are typically done at health screens and benefits fairs that
present only minimal risk to subjects
4.6.3
Address the procedures that will be used and the information that will be provided
(i.e., script) in obtaining and documenting the subjects' verbal informed consent
for study participation:
See the Script and Screening Interview attached
Upload Scripts: 
Name
Modified Date
ADA Risk Screen
5/14/2012 8:33 PM
Script for Screening Interview and Verbal Consent 5/14/2012 8:33 PM

Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.7
Are you requesting a waiver to obtain informed consent or an alteration of the
informed consent process for any of the following? 
* No
4.7.1
If Yes, select the reason(s) for your request: 
There are no items to display
General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a
waiver of consent to be approved, the request must meet four criteria. For each request,
you will be asked to provide a justification addressing how each of these criterion is met.
    [reviewer notes¬] 
4.8
Are you requesting an exception to the requirement to obtain informed consent
for research involving the evaluation of an 'emergency' procedure? 
Note: This exception allows research on life-threatening conditions for which available
treatments are unproven or unsatisfactory and where it is not possible to obtain informed
consent. 
* No

Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.9
Upload all consent documents for watermarking: 
Draft Consent Forms for editing: 
Name
Modified Date
Final Revised Consent for Participation in a Research Study-May
22.docx
1/16/2014 9:24
AM
Approved Consent Form(s): 
Name Modified Date
     [reviewer notes¬] 
4.10
Will all potential adult subjects be capable of providing direct consent for study
participation? 
* 
Yes 
     [reviewer notes¬] 
4.11
At what point will you obtain the informed consent of potential research subjects
or their authorized representative? 
Prior to performing any of the research interventions/interactions 
4.11.2
Taking into account the nature of the study and subject population, indicate how
the research team will ensure that subjects have sufficient time to decide whether
to participate in this study.  In addition, describe the steps that will be taken to
minimize the possibility of coercion or undue influence.
We will be marketing obesity management/diabetes prevention programs to retirees during
the Medicare open enrollment benefits selection period. Essential operational procedures are
already in place (marketing materials, mass mailing schedules, “Welcome to Medicare”
benefits fairs and health screening events) and this is a naturally occurring annual cycle.
Thus, what we will be offering (GLB intervention) may be viewed as complimentary to what
these individuals are already seeking (health care) and participation is completely voluntary. 
Using this natural infrastructure as a platform for health dissemination efforts will enhance
sustainability and magnify public health impact. However, we will make it clear to individuals
that there is no obligation to participate in the GLB program and choosing not to do so will in
no way affect their other retirement or medical benefits choices.
     [reviewer notes¬] 
4.12
Describe the process that you will employ to ensure the subjects are fully
informed about this research study.  
* Addressed below:
This description must include the following elements:
who from the research team will be involved in the consent process (both
the discussion and documentation);

Section: Section 4 - Recruitment and Informed Consent Procedures
person who will provide consent or permission; 
information communicated; and
any waiting period between informing the prospective participant about the study
and obtaining consent
In addition, address the following if applicable based on your subject population:
process for child assent and parental permission
continued participation if a child subject turns 18 during participation
process for obtaining proxy consent and assent for decisionally impaired subjects
continued participation if subject regains capacity to consent
All members of the research team have potential to be involved in some aspect of the
consent process including the PI (Elizabeth M. Venditti, PhD) and/or other Co-Investigators
(Marsha Marcus, PhD; Vincent Arena, PhD; Susan Greenspan, MD). In addition research
staff members including the Program Coordinator, Elizabeth Cwenar and other staff (listed
below) may be involved in consenting and documentation. All persons included on the
consent document are listed here: 
Marsha Marcus, PhD (412) 246-6372 marcusmd@upmc.edu 
Vincent Arena, PhD (412) 624-3023 arena@pitt.edu 
Rachel Miller, MS (412) 383-2328 millerr@edc.pitt.edu 
Susan Greenspan, MD (412) 692-2476 greenspn@pitt.edu 
Elizabeth Cwenar, BS, BA (412) 647-1845 cwenare@upmc.edu 
Mary Racek, BSN, MEd (412) 647-1845 racekm@upmc.edu 
Kristin Schroeder, MEd (412) 647-1845 schroederk@upmc.edu 
Bonnie Gillis, RD, MS, LDN (412) 647-1845 gillisbp@upmc.edu 
Non-diabetic, obese retirees aged 65-80, who report at least one additional risk factor for
diabetes will be invited to provide informed consent (approximately 320 persons). During
an approximate one to three month waiting period in which a single wave of the study is
being advertised, individual pre-screening will occur by telephone, at health and benefits
fairs as part of the regular Medicare enrollment events, and/or orientation sessions
arranged by the investigators and research staff. 
The purpose of the pre-screening is to obtain self-reported data from interested subjects
regarding their potential eligibility. The pre-screening check-list and/or phone script
assesses the following: 1) date of birth, 2) sex, 3) ethnic or racial group 4) retirement
status, 5) self-reported weight and height, 6) personal health history and medication use,
7) family health history, and 8) the 7-question diabetes risk test.
We will invite to orientation/informed consent sessions those individuals who self-report a
BMI greater than or equal to 27 and at least one additional risk factor including the
following: 1) hypertension or taking hypertensive medications, 2) a physician referral form
indicating either a large waist circumference (greater than 40 inches men, greater than 35
inches women), low HDL level (less than 40 mg/dL men, less than 50 mg/dL women), high
triglyceride level (greater than or equal to 150 mg/dL) and/or fasting glucose greater than
or equal to 100 mg dL but less than 126 mg/DL. 
Alternatively those individuals with a self-reported BMI greater than or equal to 27 and a
score of 15 on the 7-question diabetes risk test will also be invited to come to an
orientation/consent session. It will be communicated to all individuals who come to the
orientation and consent sessions that a confirmation height and weight (in order to confirm
a BMI of greater than or equal to 27) will be collected. Individuals who do not meet that
criterion will be referred to other programs available through their Medicare plan or
elsewhere in their community 
4.13
Are you requesting an exception to either IRB policy related to the informed
consent process?
For studies involving a drug, device or surgical procedures, a licensed physician who
is a listed investigator is required to obtain the written informed consent unless an
exception to this policy has been approved by the IRB  
For all other studies, a listed investigator is required to obtain consent (Note: In
order to request an exception to this policy, the study must be minimal risk)
* No

Section: Section 4 - Recruitment and Informed Consent Procedures
If Yes, provide a justification and describe the qualifications of the individual who will
obtain consent: 
4.14
Will you inform research subjects about the outcome of this research study
following its completion? 
* Yes
If Yes, describe the process to inform subjects of the results: 
Participants will be mailed a letter from the PI describing the results of the study

Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.1
Describe potential risks (physical, psychological, social, legal, economic or
other) associated with screening procedures, research interventions/interactions,
and follow-up/monitoring procedures performed specifically for this study:  
* 
View
Research Activity:
Assessment Activities 
Common Risks:
Fingerstick blood draw -- temporary discomfort with the finger stick
Surveys and questionnaires -- minor discomfort answering questions
that are personal in nature. 
Infrequent Risks:
Fingerstick blood draw -- possible bruising or redness of the skin,
lightheadedness, and on very rare occasion infection. Physical
function tests -- some lightheadedness or imbalance with gait and
balance tests, muscle strain or soreness with the grip strength test,
or a rare risk of injury or joint discomfort with any the physical
function tests.  
Other Risks:
There is a rare risk that a breach of confidentiality could occur;
however, every effort is made to prevent this from happening.  
View
Research Activity:
Intervention procedures 
Common Risks:
It is common for participants to experience hunger, lightheadedness,
and/or constipation when reducing their calorie intake.  
Infrequent Risks:
The risks associated with exercise occur occasionally (1-10% or 1-10
people in 100) and include fatigue, muscle soreness, and injury such
as sprained ankles or pulled muscles. There may be additional risk of
heart problems for those who have a chronic disease or experience
symptoms with exercise, although this risk is extremely minimal
given the intensity of the recommended exercise, i.e., walking. The
level of activity that we will recommend for you is thought to be
more helpful than harmful, but there is a very small risk of heart
attack or sudden death during exercise. Heart attack has been
estimated to occur less than once out of 500,000 hours of exercise
in people without know heart disease. The risk is greater in people
with heart disease. It is important that you contact your physician or
HCP before increasing the intensity of your physical activity program
or if you develop diabetes, heart disease or other related health
problems during this study. 
Other Risks:
No Value Entered 
5.1.1
Describe the steps that will be taken to prevent or to minimize the severity of the
potential risks: 
Although the overall risk to subjects participating in this protocol is minimal we will
nonetheless protect subjects from all potential risks in the following manner: 
Blood Samples. All study staff will be trained on standard protocols including sterile
procedures. 
Physical Measurements. Privacy screens (or private areas) will be used during the collection
of height, weight and waist data to minimize the possibility that others will be aware of a
subject’s measurements. In addition all study staff will be trained about the need for
sensitivity regarding the stigma of overweight/obesity and how to conduct these
measurements in a professional and respectful manner. 
Questionnaires, Surveys, and Interviews: Staff will be trained to be sensitive to the risk of
participant embarrassment or other psychological discomfort when administering surveys.
They will speak with subjects quietly and work to ensure confidentiality of the information
in a community setting. In addition, subjects may refuse to answer questions that are

Section: Section 5 - Potential Risks and Benefits
distressing or anxiety provoking and will be provided the opportunity to discuss any
question with the Primary Investigator and study staff under her supervision. 
Weight Loss and Physical Activity Lifestyle Intervention: 
Behavioral intervention involves diet, physical activity, and behavior modification
techniques. All participants will be required to receive written medical clearance from their
primary care doctor (or other HCP) to participate. The potential benefits of healthy eating
and activity are believed to far outweigh the risks. This program recommends a healthy
balanced diet, rich in plant based foods, and a regular pattern of meals and snacks
(consistent with USDA recommendations), which reduces the risk of lightheadedness or
constipation that may occur with calorie restriction. In addition, the potential risks during
intervention are minimized by including in the study only those individuals who are of a
sufficiently high BMI level (≥ 27) and in sufficient physical condition (confirmed by having
physician consent) to participate in the intervention. Risks are reduced by proper warm-up
and cool-down periods. All physical assessment staff and lifestyle intervention coaches will
be certified annually in CPR and First Aid training. Any injury or complication will be
immediately reported and all appropriate emergency procedures will be followed. The PI,
the Program Coordinator and Susan Greenspan, MD (a physician co-investigator with areas
of expertise in the areas of lipidology, endocrinology, and geriatrics) will be available to help
staff make decisions regarding the need for emergent medical care. 
In addition, per the Data Safety and Monitoring Plan (DSMP) all adverse events reported
during enrollment in the study will be recorded. Each event will be rated for severity
(1=mild; 2=moderate; 3=severe; 4=life threatening) and degree of association with study
participation (0=definitely unrelated; 1=unlikely, 2=possibly related; 3=probably related;
4=definitely related). The action taken and outcome will also be recorded. Quarterly reports
will include frequency of study withdrawals and complete information on all adverse events.
Information provided in the quarterly reports will include participant identification numbers,
but will not include identifying information such as name. The DSMP quarterly report will be
reviewed by Dr. Melissa Kalarchian the designated DSMP officer. 
Protection against risk and confidentiality. Subjects will be informed that they are under no
obligation to participate in the study and that participation (or non-participation) will in no
way influence the terms of their Medicare benefits. They will be informed that they may
withdraw at any time. To maintain the confidentiality of participants’ responses, all data
gathered, questionnaires, screening information and data forms will be coded with a subject
identification number only. A separate file with participants’ personal information (e.g.,
name and phone numbers) will be maintained. All participant information will be stored in a
locked file cabinet in the research offices of Western Psychiatric Institute and Clinic. Only
the Principal Investigator or a staff member supervised by her will have access to
participant files. Participants will be reminded of the possibility that, in addition to access
given to Dr. Venditti and her research staff, individuals from the agencies funding the
research or other appropriate government agencies may be given access to research
records. At all times, participant information will be handled in a confidential manner
consistent with other research records, and individual names or results will not be
specifically identified in any research publication. 
5.2
What steps will be taken in the event that a clinically significant, unexpected
disease or condition is identified during the conduct of the study? 
* Addressed below:
We will address all emergent medical situations with the study co-investigators or the study
clinical pychologist/behavioral scientist as appropriate. The data and safety monitoring plan
(DSMP) for this trial focuses on close monitoring by the PI (Elizabeth Venditti, PhD) and
Program Coordinator (TBD), in conjunction with an external data safety and monitoring
officer (Melissa Kalarchian, PhD). Safety reports will be generated by the PI in conjunction
with the statistician and adverse events will be reported promptly to the NIH and the
University of Pittsburgh IRB. The Project Coordinator will coordinate this effort and assure
that all co-investigators, the safety officer and NIDDK obtain copies of the reports. In
addition, Dr. Susan Greenspan, MD, has been added as a co-investigator and member of
the research team specifically because of her combined expertise in general internal
medicine, endocrinology, and her substantial expertise in monitoring older adults living in
the community for osteoporosis and risk of falls (serious and non-serious). She will be
consulted by phone as needed with routine data monitoring questions that arise during the
recruitment, assessment or intervention phases of the study and immediately in all

Section: Section 5 - Potential Risks and Benefits
emergency situations, including unexpected disease conditions. Participants will be notified
as will their primary Health Care Provider (HCP) if they give permission to do so.
5.3
All the risk questions (screening, intervention/interaction, follow-up) have been merged into
one question (5.1).
     [reviewer notes¬]  
5.4
Do any of the research procedures pose a physical or clinically significant
psychological risk to women who are or may be pregnant or to a fetus? 
 
* No
 
    [reviewer notes¬]  
5.5
Do any of the research procedures pose a potential risk of causing genetic
mutations that could lead to birth defects? 
 
*  No
 
    [reviewer notes¬]  
5.6
Are there any alternative procedures or courses of treatment which may be of
benefit to the subject if they choose not to participate in this study? 
 
*  Yes - Describe below:
 
If Yes, describe in detail: 
Presently there are not many programs of this kind targeted specifically to Medicare
beneficiaries. However, participants may avail themselves of general weight loss and
physical activity opportunities in the community at large. Most are oriented toward the
general obese population and not diabetes risk reduction per se.
 
 
     [reviewer notes¬]  
5.7
Describe the specific endpoints (e.g., adverse reactions/events, failure to
demonstrate effectiveness, disease progression) or other circumstances
(e.g., subject's failure to follow study procedures) that will result in discontinuing
a subject’s participation? 
 
*  Not applicable - There are no anticipated circumstances that would lead to discontinuing a
subject’s participation in this research study.
 
There are no anticipated circumstances that would lead to stopping this trial 
 

Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬]  
5.8
Will any individuals other than the investigators/research staff involved in the
conduct of this research study and authorized representatives of the University
Research Conduct and Compliance Office (RCCO) be permitted access to research
data/documents (including medical record information) associated with the
conduct of this research study? 
 
*  No
 
  
5.9
Has or will a Federal Certificate of Confidentiality be obtained for this research
study?
*  No
 
5.10
Question has been moved to 5.17
5.11
Question has been moved to 5.16 
 
 
    [reviewer notes¬]  
5.12
Does participation in this research study offer the potential for direct benefit to
the research subjects? 
 
No - Describe the general benefits to society (e.g., increased knowledge; improved safety;
better health; technological advancement) that may result from the conduct of this
research study. 
  
Describe the benefit: 
There will be general benefit to society in determing feasible, sustainable and effective ways
to disseminate evidence based treatments to hi-risk older adults receiving Medicare
coverage. Better health and quality of life may result from the conduct of this study. 
 
5.13
Describe the data and safety monitoring plan associated with this study. If the
research study involves multiple sites, the plan must address both a local and
central review process. 
 
DATA SAFETY AND MONITORING PLAN (DSMP) 
 
Introduction 
 
This study evaluates the dissemination of an evidence-based lifestyle intervention program
for diabetes risk reduction among Medicare eligible adults, aged 65-80, as well as the utility
of a phone compared to newsletter follow-up protocol on observed health outcomes.
Subjects are recruited primarily from the retiree pool of a large public university and
potentially through other primary care venues serving Medicare participants. The data
collected at 0, 4, 12, and 24 months will help evaluate the feasibility and effectiveness of
these procedures as they are implemented in the community. The intervention and
measurement protocols pose minimal risk to participants. Because of this low risk status,
the data and safety monitoring plan (DSMP) for this trial focuses on close monitoring by the
PI (Elizabeth Venditti, PhD) and Program Coordinator (TBD), in conjunction with an external
data safety and monitoring officer (Melissa Kalarchian, PhD). Dr Kalarchian was chosen
because of her experience in behavioral weight management in long term clinical trials with
severely obese individuals. Safety reports will be generated by the PI in conjunction with
the statistician and adverse events will be reported promptly to the NIH and the University
of Pittsburgh IRB. The Project Coordinator will coordinate this effort and assure that all co-
investigators, the safety officer and NIDDK obtain copies of the reports. In addition, Dr.
Susan Greenspan, MD, has been added as a co-investigator and member of the research
team specifically because of her combined expertise in general internal medicine,
endocrinology, and her substantial expertise in monitoring older adults living in the
community for osteoporosis and risk of falls (serious and non-serious). She will be
 
 

Section: Section 5 - Potential Risks and Benefits
consulted by phone as needed with routine data monitoring questions that arise during the
recruitment, assessment or intervention phases of the study and immediately in all
emergency situations. 
 
Safety Review Plan 
 
Weekly or biweekly research team meetings led by the PI, in conjunction with the PC and
research assessment staff will address safety questions and concerns on a case by case
basis. Additional case conferences with the study interventionists will also be convened, at a
minimum of monthly, to address safety questions or concerns that may arise during the
course of the behavior change intervention.  
 
Study data and safety will be reviewed quarterly (and more frequently if needed), as shown
in the table below. Progress reports including 1. Adverse events; 2. Safety; 3. Performance
measures (recruitment, retention and quality of data); and 4. Intervention (compliance and
adherence) will be provided to the Safety Officer following each of the quarterly reviews. An
annual report will be compiled and will include a summary of these areas. In addition, the
annual report will address the areas detailed in the Safety Officer checklist, including
conditions whereby the study might be terminated prematurely. The annual report will be
signed by the Safety Officer and will be forwarded to the IRB and NIDDK and other
applicable recipients who will review progress of this study on an annual basis. 
 
Reported Information 
1. Adverse events will be reported within 24 hours  
2. Safety (rate and severity of adverse events) reports wil be produced quarterly  
3. Performance (recruitment, retention and quality of data) reports will be produced
quarterly 
4. Treatment (compliance and adherence) reports will be produced quarterly 
5. Stopping rules will be evaluated yearly
     [reviewer notes¬]  
Section 5 - Potential Risks and Benefits of Study Participation
5.14
What precautions will be used to ensure subject privacy is respected? (e.g. the
research intervention will be conducted in a private room; the collection of sensitive
information about subjects is limited to the amount necessary to achieve the aims of the
research, so that no unneeded sensitive information is being collected, drapes or other
barriers will be used for subjects who are required to disrobe)
  
Physical Measurements. Privacy screens (or private areas) will be used during the collection
of height, weight and waist data to minimize the possibility that others will be aware of a
subject’s measurements. In addition all study staff will be trained about the need for
sensitivity regarding the stigma of overweight/obesity and how to conduct these
measurements in a professional and respectful manner. 
 
5.15
What precautions will be used to maintain the confidentiality of identifiable
information? (e.g., paper-based records will be kept in a secure location and only be
accessible to personnel involved in the study, computer-based files will only be made
available to personnel involved in the study through the use of access privileges and
passwords, prior to access to any study-related information, personnel will be required to
sign statements agreeing to protect the security and confidentiality of identifiable
information, whenever feasible, identifiers will be removed from study-related information,
precautions are in place to ensure the data is secure by using passwords and encryption,
because the research involves web-based surveys, audio and/or video recordings of
subjects will be transcribed and then destroyed to eliminate audible identification of
subjects)
  
Protection against risk and confidentiality. Subjects will be informed that they are under no
obligation to participate in the study and that participation (or non-participation) will in no
way influence the terms of their Medicare benefits. They will be informed that they may
withdraw at any time even after signing the consent form. To maintain the confidentiality of
participants’ responses, all data gathered, questionnaires, screening information and data
forms will be coded with a subject identification number only. A separate file with
participants’ personal information (e.g., name and phone numbers) will be maintained. All
participant information will be stored in a locked file cabinet in the research offices of
 
 
 
 
 

Section: Section 5 - Potential Risks and Benefits
Western Psychiatric Institute and Clinic. Only the Principal Investigator or a staff member
supervised by her will have access to participant files. Participants will be reminded of the
possibility that, in addition to access given to Dr. Venditti and her research staff, individuals
from the agencies funding the research or other appropriate government agencies may be
given access to research records. At all times, participant information will be handled in a
confidential manner consistent with other research records, and individual names or results
will not be specifically identified in any research publication. 
5.16
If the subject withdraws from the study, describe what, if anything, will happen to
the subject’s research data or biological specimens.
If a subject wthdraws from the study we will continue to use the research data that has
already been collected.  
5.17
Following the required data retention period, describe the procedures utilized to
protect subject confidentiality. (e.g., destruction of research records; removal of
identifiers; destruction of linkage code information; secured long-term retention)
Investigators may continue to use and disclose identifiable information (which may include
identifiable medical information) related to a subjects participation in this research study for
a minimum of five years after final reporting or publication of the project. After this point,
all subject research records will be completely de-identified (no-link will exist between the
partiicpant's name and the assigned research code). Coded data will continue to exist and
research reports may continue to be written but all original research records will be
destroyed.

Section: Section 6 - Costs and Payments
     [reviewer notes¬] 
6.1
Will research subjects or their insurance providers be charged for any of the
procedures (e.g., screening procedures, research procedures, follow-up
procedures) performed for the purpose of this research study? 
*   
No 
    [reviewer notes¬] 
6.2
Will subjects be compensated in any way for their participation in this research
study? 
* Yes
6.2.1
Describe the amount of payment or other remuneration offered for
complete participation in this research study. 
Participants will receive payment for research assessments to help defray costs associated
with study participation and to enhance compliance with the assessment schedule ($25 for
study months 0 and 4, $50 for month 12, and $75 for month 24). Total costs are not to
exceed $175 per individual.
6.2.2
Describe the amount and term of payment or other remuneration that will be
provided for partial completion of this research study. 
as above

Section: Supporting Documentation
     [reviewer notes¬] 
Supporting Documentation Section
References and Other Attachments
Additional documents: 
Name
Modified
Date
Version
American Diabetes Association Risk
Screen
5/12/2012
1:17 PM
0.01
DOCUMENTATION OF APPROVAL-
Crossroads Presbyterian Church
Monroeville.pdf
1/18/2013
5:34 PM
0.01
DSMP and quarterly report template
5/16/2012
1:53 AM
0.01
GLB Leaders Guide & All Participant
Handouts
5/12/2012
1:28 PM
0.01
GLB Misc Program Handouts
5/12/2012
1:28 PM
0.01
Physician Clearance
5/17/2012
4:45 PM
0.01
Please use the Add button to the left to
upload additional documents if needed.
     [reviewer notes¬]  
ClinicalTrials.gov is a registry and results database of publicly and privately supported
clinical studies of human participants conducted around the world.
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov.
Applicable Clinical Trials (ACTs) are studies that meet the following criteria:
The study is an interventional study AND 
The study intervention is a drug, biologic, medical device, radiation or genetic AND
The Study is not Phase 0 or 1 AND
The study has at least one site in the United States or is conducted under an investigational
new drug application or investigational device exemption
NIH Policy
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
As defined by the NIH, a clinical trial is:
A research study in which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to evaluate the effects of
those interventions on health related biomedical or behavioral outcomes. 
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801)
requirements in that it requires registration and results reporting of:
clinical trials of behavioral, surgical and other types of health and medical interventions
phase 1 studies of drugs and biological products
small feasibility studies of device products  
Failure to submit all required registration and results information requested on ClinicalTrials.gov can
jeopardize University grant funding, the future funding of the grantee and subject the University of
Pittsburgh to future monetary penalties.

Section: Supporting Documentation
In addition, to promote transparency of the clinical trials process, the International Committee of
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration
for publication of the trial results.
* Based on the above information, will this study be registered in ClinicalTrials.gov?
Yes 
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor 
Why are you registering your study? (Check all that apply) 
It is strongly encouraged by the NIH
It is required for publication by the International Committee of Medical Journal Editors (
Registration is required in a publically available, searchable database system prior to informed
consent being obtained from the first study participant)
If you are not yet registered and need to establish an account for the PI or other research staff that
may need to access the record, please send an email to the  University of Pittsburgh PRS
administrator at ctgov@pitt.edu with the following information for each individual:
Full name
Telephone number
Pitt or UPMC email address
If you have any questions or concerns, please email us at ctgov@pitt.edu. 
To find out additional information about how to register your study go to:
https://www.clinicaltrials.gov/ct2/manage-recs/how-register