REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Phase: NA
Conditions: Type 2 Diabetes Mellitus, Obesity
Sponsor: Massachusetts General Hospital

 
1
 
Principal Investigators: Linda M Delahanty, MS, RD and Deborah J. Wexler MD MSc 
Department /Division: Department of Medicine/ MGH Diabetes Center   
Protocol Title: Reach Ahead for Lifestyle and Health-Diabetes (REAL HEALTH-Diabetes) 
Protocol Version date:      April 3rd, 2020   
 
I. BACKGROUND AND SIGNIFICANCE 
 
a. Historical background 
The Center for Disease Control and Prevention (CDC) estimates that there are currently 
29 million people with diabetes and 86 million people with pre-diabetes in the U.S. One in 10 
Americans has diabetes now, and, if current trends continue, 1 in 3 Americans will have diabetes 
by 2050. This chronic disease significantly impacts both quality of life and rapidly rising 
national healthcare costs. The estimated cost of diabetes in the U.S. in 2012 was $245 billion 
with $176 billion in direct medical costs and $69 billion in indirect medical costs (disability, 
work loss, premature mortality). Medical expenses for people with diabetes are 2.3 times higher 
than for people without diabetes (1). 
 
b. Previous clinical studies leading up to and supporting the proposed research 
           Studies such as the Diabetes Prevention Program (DPP), Look AHEAD, and the SHIELD 
study illustrate a gap in the quality of diabetes care and its effectiveness in improving long term 
medical outcomes in participants with pre-diabetes and type 2 diabetes (T2DM) (2-5). The DPP 
has demonstrated that a lifestyle intervention aimed at 7% weight loss and 150 minutes of 
weekly activity reduced the risk of developing diabetes by 58% over 2.8 years, compared to 
placebo (2). The Look AHEAD study has compared a program of diabetes support and education 
to a DPP-adapted lifestyle intervention aimed at 7-10% weight loss and 175 minutes of weekly 
activity in people with type 2 diabetes and demonstrated significantly greater weight loss (8.6% 
vs. 0.7%) and fitness after 1 year, resulting in improvements in glycemia, blood pressure, and 
lipids with simultaneous reductions in medications and costs to treat these conditions (3). Yet 
SHIELD showed that while participants with type 2 diabetes comprehend the severity of their 
disease, they lack the skills and decision-making support to make a significant lifestyle change 
(5). These studies highlight a number of behavioral and lifestyle interventions proven to have 
positive outcomes on patient quality of life, health measures, and healthcare costs (6,7). Many 
translation projects of the DPP have been implemented in people with prediabetes (8). However, 
to our knowledge, the Look AHEAD study, which has completed an 11-year efficacious lifestyle 
intervention program for participants with type 2 diabetes, has not yet been translated to the 
clinical practice setting. 
We performed a pilot translation for this project called the IDOLc (Improving Diabetes 
Outcomes through Lifestyle change) study. We randomly assigned 57 MGH primary care 
participants with T2DM and BMI>25kg/m2 who were taking at least one non-metformin, non-
GLP1 diabetes medication to dietitian referral for medical nutrition therapy (RD-MNT) or a 19-
week group lifestyle intervention adapted from the published Look AHEAD curriculum. 
Participants were 61 years old, 59% male, 32% non-white, and weighed 97 kg with mean HbA1c 
8.2%. At 6 months, 46% of group lifestyle vs. 21% of RD-MNT lost >5% body weight 
(P=0.039), with mean weight loss 6.6 (SD 7.0) kg with group lifestyle and 2.1 (3.5) kg in RD-
MNT (P=0.004). Eighty-two percent vs. 38% stopped or reduced diabetes medications 

 
2
(P<0.001), and HbA1c improved by 0.70 (1.13) vs. 0.39 (1.51) in group lifestyle vs. RD-MNT 
(P=0.38), respectively. There was no difference in blood pressure or lipid levels between 
interventions; however, 14% in group lifestyle stopped a blood pressure medication vs. none in 
RD-MNT (P=0.046). Weight loss remained significantly greater in group lifestyle compared to 
RD-MNT at one year. Group lifestyle program cost was $578 per patient. Including changes in 
personnel and medication costs, the group lifestyle program cost $146 per patient more than RD-
MNT. 
 
c. Rationale behind the proposed research, and potential benefits to participants and/or 
society 
Although it is tempting to directly translate successful research methods into clinical care 
without a demonstration that the methodology developed and implemented in a clinical trial is 
effective in a clinical setting, attempts to directly translate such programs can be both ineffective 
and expensive. The challenge of demonstration translational studies is to ensure that the 
interventions are practical and effective, and in turn easily applied to clinical practice. If the 
Look AHEAD lifestyle program proves to be effective in the proposed translation study, 
subsequent steps will include determining how to expand the program to other clinical settings 
more broadly. The goal of this study is to translate the lifestyle program proven in the two 
national clinical studies and the IDOLc pilot study to result in weight loss of 5-10%, increased 
activity to 175 minutes/week, decreased hemoglobin A1c (HbA1c), blood pressure, lipid levels, 
and reduced medications used to treat these conditions into usual care at MGH Community 
Health Centers and practices in communities affected by diabetes and obesity, and to determine 
the reach, cost-effectiveness, and sustainability of the program. Two intervention modalities, in 
person group or telephone conference call group, will be tested against referral to dietitians for 
individual medical nutrition therapy (MNT), the current standard of care.  
This project is funded by the National Institutes of Diabetes and Digestive Diseases 
(NIDDK; grant R18 DK102737, under PAR 12-172, Translational Research to Improve Obesity 
and Diabetes Outcomes). In addition, it aligns with Partners and MGH’s Diabetes Care Redesign 
initiative, which supported the pilot work under a Clinical Innovation Award to Linda Delahanty, 
and with MGH’s Strategic Plan goal to address obesity in diabetes in the communities MGH 
serves.  
While this project is being funded and conducted as research, it is a true translational 
effort meant to bridge the gap between what we know to be effective in clinical trials and what is 
possible in clinical settings. As such, it is a hybrid, with research staff at the MGH Diabetes 
Center acting as a “coordinating center” for central research activities such as screening and 
health center provider co-investigators trained and funded to carry out the work in usual care 
settings. Consequently, there are several novel aspects of this project. 
Group conference call arm. Delivering this intervention via group conference call could 
potentially increase reach by having one central team manage participants across a health system, 
but it has not yet been attempted. Because this is a novel component, we propose to conduct 
structured interviews of eligible participants before launch to obtain feedback on the telephone 
modality and shape the potential use of 3-4 in-person sessions at the beginning of the telephone 
intervention to increase engagement. The group teleconference intervention will be conducted 
using “reserved conference calls” in which participants use their own phones to call into the 
session at a prearranged time using a toll-free number. Participants may apply for reimbursement 
for excess use of cell phone minutes. There is evidence to support the group telephone delivery 

 
3
arm. In the SHINE study, the success of the group telephone delivery of the DPP lifestyle 
intervention program in achieving comparable weight losses to individual phone-delivered 
intervention at 1 year, and continued, sustained weight losses at 2 year follow up compared to 
weight regain in individual phone-delivered intervention in the SHINE study represents exciting 
innovation, effectiveness, and potential for reach but has not been tested using the Look AHEAD 
intervention (9). In addition, a large proportion of patient population at the community health 
centers lack internet access to enable implementation of other novel technologies, but 91% of 
Americans have telephones (10). The telephone intervention is evidence-based, lower cost, and 
more convenient for participants than in-person groups as they do not have to travel, increasing 
reach (11-14).  
Role of the community health center primary care clinician leaders and staff. The 
community health center clinicians will provide logistical and medical oversight to the project, 
anchoring it at each community health center. Dr. Larocca and Dr. Wheeler cross-cover their 
colleagues as members of a practice group; Ms. Chase ANP APRN runs the diabetes programs at 
Chelsea health center, collaborating in the care of patients of all of the physicians and nurse 
practitioners at her practice (inclusion of a nurse practitioner medical leader in the REAL 
HEALTH-Diabetes project enhances generalizability and reach). They will promote the project 
to their colleagues and support recruitment efforts by co-signing recruitment letters (which will 
be created by Diabetes Center Research personnel). More importantly, they will be the 
supervising medical care providers for participants in the program. They will be trained by Dr. 
Wexler (Co-PI). Community health center staff will be funded by the REAL HEALTH-Diabetes 
grant for this work.  
A final potential benefit to health center participants is the ability to offer the lifestyle 
program at no cost to its patients and to train staff in cutting edge lifestyle change strategies.  
 
II. SPECIFIC AIMS 
a. Objectives and hypotheses to be tested in the research project 
 
The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 
2 diabetes and obesity into usual care at community health centers, comparing an in-person 
group program (IP), a telephone conference call (TCC) group program, and referral to medial 
nutrition therapy (MNT), the current standard of care.  
 
Aim 1: To evaluate the effectiveness of the REAL HEALTH-Diabetes lifestyle change program 
comparing in-person (IP) group and telephone conference call (TCC) group intervention to 
individual dietitian referral for MNT. 
H1a. Primary outcome. Weight loss: We hypothesize that the IP and TCC lifestyle groups 
will demonstrate greater weight loss than MNT at 6 months, and that the lifestyle group 
participants will have more sustained weight loss at 12, 24 and 36 months. The sample 
size of 210 provides 80% power to detect a 3.5% difference between any two groups 
adjusting for three group comparisons, 10% drop-out rate, and intraclass correlation 
(ICC=0.02). 
H1b. Secondary outcomes. Medical outcomes: We hypothesize that compared to 
individual MNT, participants in the IP and TCC group interventions will maintain or 
improve HbA1c, blood pressure, and lipids from baseline with reduced medication use 

 
4
(dose and cost) to treat these conditions, both at the end of the intensive intervention and 
at follow-up. 
H1c. Behavioral and psychosocial outcomes: We hypothesize that compared to MNT, the 
lifestyle groups will have greater improvements from baseline in health behaviors and the 
patient-reported outcomes of self-efficacy and health-related quality of life. 
 
Aim 2: To evaluate the reach, adoption, implementation fidelity, and maintenance of the two 
adapted Look AHEAD lifestyle change programs (IP and TCC) at the three community health 
centers, comparing factors across centers using the RE-AIM Model Dimension items checklist.  
We will use a mixed methods approach, first using structured interviews with participants who 
would be eligible to participate to inform the design of the telephonic intervention, then using 
provider surveys and participant structured interviews in years 2-4 to assess engagement and 
adoption by providers and compare responders and non-responders. Participant structured 
interviews will be conducted when the participant has completed the active intervention at year 
2. Structured interviews will be administered by non-blinded study staff, and will follow the 
same procedures as described for the initial structured interviews that indicate the study design 
[see V. Study Procedures].We will also collect quantitative indicators of implementation.  
 
Aim 3: To estimate the incremental cost per percentage point decrease in body weight of the 
implementation strategies assessed in this study compared to usual care. The focus of our 
analysis will be identifying short-term costs and health effects that are relevant to accountable 
care organizations and insurers with the goal of informing the design of payment contracts that 
ensure the adoption of effective and efficient diabetes care, with a particular focus on the 
tradeoffs between costs and effectiveness of telephone compared to in-person format.  
 
III. SUBJECT SELECTION 
a) Inclusion/exclusion criteria  
Eligibility criteria for participation include: 
• Diagnosis of type 2 diabetes 
• Age 18 years or older  
• Overweight or obese (BMI >25 kg/m2) unless of Asian descent then BMI 
criterion is lowered to BMI > 23 kg/m2   
• HbA1c level 6.5<11.5%  
• Systolic blood pressure (SBP) <160 mmHg, diastolic blood pressure (DBP) 
<100 mmHg  
• Willing to lose 5-7% of body weight 
• Willing to increase activity to at least 175 minutes/week  
• Willing to commit to random assignment to either attend and participate in the 
lifestyle change program in person or on the telephone or be referred to Nutrition 
Services for medical nutrition therapy 
• Stable health, with no severe comorbidities that might interfere with their ability 
to participate in a group intervention that includes increasing activity or 
decreasing calories, such as severe psychiatric illness or significant heart disease 
• Ability to understand and communicate effectively in English or Spanish 
• Willing to self-monitor blood glucose 
• Willing to keep a food, exercise, and blood glucose diary  

 
5
• Have a primary care physician at MGH Chelsea, Charlestown, Revere Health 
Centers, or any Partners affiliated practices or be willing to attend sessions, in-
person or by phone, and have medications adjusted by a provider based at one of 
those health centers or the MGH Diabetes Center with communication to the 
referring primary care provider 
 
Exclusion criteria include: 
• Weight greater than 350 pounds 
• Pregnant or planning pregnancy in the next year 
• Currently seeing a dietitian (regular scheduled follow up appointments) or 
participating in a weight loss program and unwilling to stop 
• Weight change of more than 3% body weight in the previous 1 month.  
• Currently enrolled in another diabetes study 
• Lack of availability of telephone 
• Another member of the household is a study participant or a study staff member 
• Overt hypo- or hyperthyroidism, defined as abnormal free T4, who have had 
thyroid medication adjustments in the last three months   
• Long term use (in the 6 months prior to study entry) of medications likely to 
cause weight gain or inhibit weight loss (e.g. corticosteroids, with the exception 
of maximum dose of prednisone 10 mg or equivalent)  
• Previous or planned gastric bypass 
• History of cancer, other than non-melanoma skin cancer, that required therapy in 
the 5 years prior to randomization. 
 
Participants must have (1) a medical need and willingness to lose at least 5% of body 
weight and (2) medical clearance to participate safely in the exercise component of the program 
which has a goal of increasing moderate intensity activity to at least 175 minutes per week.  Each 
participant will be asked to keep a 1-week food, exercise and blood glucose record prior to 
meeting with the dietitian for a screening appointment. In order to participate in this study, 
participants must complete at least 5 of the 7 days of the food, exercise and blood glucose diary. 
Participants will have an intake interview with a dietitian to evaluate readiness to participate in a 
lifestyle intervention program. This interview will not determine eligibility but rather foster the 
ability of each patient to determine his/her own readiness to commit to the program and to help 
him/her decide whether to enroll or defer enrollment until another time when other competing 
priorities and identified barriers to successful participation are reduced. 
 
b) Source of participants and recruitment methods 
Participants will be primarily recruited from health center primary care practices. 
Participants also will be recruited from MGH primary care practices, MGH Diabetes Center, 
Newton-Wellesley Hospital and North Shore Medical Center. Others may participate as long as 
they have a primary care provider or treating provider who can approve their participation. 
Participants can be identified by their primary care physician, endocrinologist, nurse, or nurse 
practitioner. Patient registries will also be used to generate lists of potential participants for 
providers to review and identify eligible participants. Patient registries will also be used to 
generate lists of patients who have agreed to be directly contacted for research in a clinical care 
setting. 

 
6
From this potential pool, we will recruit using the following steps: 
1) Conduct an electronic chart review using the TopCare or RPDR diabetes list to verify 
eligibility criteria and PCP linkage. The current population of each health center is described in 
Table 1. 
 
 
 
 
 
 
 
 
2) Obtain permission for initial contact from each potentially eligible patient’s primary care or 
treating physician (PCP) [see “1. PCP Patient Recruitment Email”]. After permission received, 
study staff will check to see if participant is in the process of being contacted or in the process of 
enrolling in another study (GRADE) that is recruiting concurrently. If participant has already 
been contacted and is interested in GRADE, we will not contact.  
 
3) Send an introductory letter [see Introductory Patient Letters] to PCP-approved participants and 
to patients who have agreed to be directly contacted for research describing the study and 
procedures to opt out of further contact. The introductory letter will be sent along with a 
brochure. In the brochure, potential subjects will be able to learn more about the study. The 
brochure will also include a study phone number and a study email address that participants can 
call or email to either decline further contact or to request that a study coordinator contact them. 
 
4) If no answer is received after 7 days have passed, the potential research subject will be 
contacted by study staff to determine his/her willingness to participate. 
 
5) If the subject is willing to participate, he/she will then undergo initial screening [see “3. 
Screening Phone Call Script”]. During this phone call, the study will be explained in further 
detail, subject questions will be answered, and an initial screening questionnaire to assess 
eligibility will be completed. Participants who remain eligible will be scheduled for an initial 
research visit and/or an introductory orientation session based on preference and mailed a 1-
week food, exercise and blood glucose record, an appointment reminder letter, and an informed 
consent form [see “4. RV1 Appointment Reminder” and “5. Informed Consent Form”] 
(described below “SUBJECT ENROLLMENT”). We will also send them a link to a video about 
the study if they have access to email. (See Figure 1 Recruitment flow). 
 
6) Potential participants who see posters advertising the introductory orientation sessions at the 
health centers may also attend the informational session. They may participate in an in-person 
eligibility screen after the orientation or schedule a phone screening appointment at a later time 
to determine eligibility.   
 
7) At the introductory orientation session, which will be held at their health center, participants 
will meet with the dietitian interventionist. The dietitian interventionist will describe the study 
and go through the informed consent document, provide instructions on completing the 1-week 
Table 1. Characteristics of community health center populations 
 
 
Racial/ethnic distribution 
of population 
Number 
with DM 
Prevalence 
of DM 
Target n to 
recruit 
 
W 
H 
AA 
 
 
 
Charlestown 
79% 
9% 
5% 
1085 
10% 
~45 
Chelsea 
28% 
56% 
9% 
2691 
19% 
~85 
Revere 
64% 
16% 
5% 
2120 
15% 
~85 

 
7
food, activity, and blood glucose diary and answer questions from the group. In individual 
sessions following the group session, the dietitian will answer individual questions in private.  
 
8) If the subject declines to participate or does not wish to answer the questions at any point 
during the phone or in-person screening, he/she will be thanked for his/her time and the call or 
session will be ended. 
 
 
Figure 1. Recruitment flow 
 
In addition to the primary recruitment method described above, we will welcome referrals from 
MGH Primary Care groups. We will leave pamphlets in the waiting rooms of the MGH Primary 
Care groups not based at the community health centers as long as participants are willing to 
attend sessions at the community health centers. We will leave pamphlets in the waiting rooms of 
the MGH Health Centers to inform patients about the study and put flyers up at approved places 
at MGH.  We will also utilize the Broadcast MGH e-mail system to seek study volunteers if 
necessary [see “6. Email Broadcast”]. If a study volunteer contacted the Broadcast MGH e-mail 
system or other posting, we will contact their PCP to make sure it is safe for him or her to 
participate. 
 
IV. SUBJECT ENROLLMENT 
• Mail 
consent 
form
• Mail 
diary
Phone 
screen
•Complete for food, 
exercise, and 
blood sugar diary
In-person 
Screen
•Complete for food, 
exercise, and 
blood sugar diary
Phone 
screen
Orientation session
Conducted by RD and MA
* Describe study
* Review consent
* Answer group questions
*Review instructions for 
food, exercise, and blood 
sugar diary completion
Research Visit 
1
Final review of 
food, exercise, 
and blood 
sugar diary to 
determine 
eligibility 
If eligible and 
consent 
obtained, then 
perform study 
procedures for 
research visit 1 
and 
randomize.
Conducted by 
RD and MA
Poster / 
other non 
prescreen
Orientation 
session
Conducted by RD 
and MA
* Describe study
* Review consent
* Answer group 
questions
*Review 
instructions for 
food, exercise, 
and blood sugar 
diary completion
Intervent
Mail consent 
form and diary 

 
8
Before the intervention programs can begin, study staff will conduct a 6-week pilot study of the 
telephone intervention. Study staff will ask participants who participated in the Improving 
Diabetes Outcomes through Lifestyle Change (IDOLc) study and were randomized to the usual 
care arm and who consented to be recontacted, if they would like to participate.  
 
For recruitment for structured interviews to be used to inform the design of the telephone 
intervention, we will send opt-out letters signed by physician or nurse practitioner co-
investigators to 20 participants at each health center who meet eligibility criteria (drawn from the 
TopCare diabetes roster) letting them know they will receive a call to seek their opinion about a 
diabetes study via telephone interview [See “7. Structure Phone Interview Opt-out Letter”]. 
Those who do not opt out will receive a phone call. At the beginning of the phone call, verbal 
permission for the phone interview will be obtained [See “8. Structured Phone Interview].” We 
will obtain baseline demographic and clinical information on respondents from the electronic 
medical record. 
 
 
 
a. Methods of enrollment for the clinical trial 
     Participants who call to express interest in the study, or who are contacted in follow up to the 
introductory letter to determine interest in participation, will first have a phone or in-person 
screening interview to explain the study protocol, answer questions, determine eligibility and 
willingness to continue the screening process. Those who qualify according to the phone screen 
will be mailed the consent form to review and emailed a brief video about the study [See 9. video 
link]. They will also receive a 1-week food, exercise, and blood glucose diary to complete. Study 
volunteers will be asked to write down what they eat and the portion size, the amount of exercise 
they do, and their blood glucose testing results each day for 1 week and bring this diary to the 
baseline visit, Research Visit 1 (RV1). Ability to keep this log predicts potential participants’ 
readiness for lifestyle change and serves as an eligibility criterion for randomization.  
In order to participate in this study, participants must complete at least 5 of the 7 days of the 
food, exercise and blood glucose diary. If a participant has not completed at least 5 of 7 days of 
the diary, then he or she will be offered a second chance to complete this behavioral task and will 
be rescheduled to complete Research Visit 1 (see below). 
 
Potential volunteers may also attend the introductory sessions to learn about the study. In that 
case, they will subsequently meet with study staff or undergo phone or in-person screen and will 
take home the consent form to review. They will receive a brief video about the study if they 
have access to email. They will also receive a 1-week food, exercise, and blood glucose diary to 
complete for review at Research Visit 1. See Figure 1 for recruitment flow. 
 
b. Procedure for obtaining informed consent 
If a subject meets eligibility criteria for the study and expresses a desire to participate, a 
dietitian or trained member of the research staff will review the consent form and obtain written, 
informed consent from the subject. This process will occur at the beginning of the initial research 
visit before any study procedures are performed. At the time of informed consent, participants 
will receive an explanation of the randomization process so that they are aware that they may or 
may not be assigned to receive the in person or telephone group lifestyle intervention program or 

 
9
referral to Nutrition Services. We will make it clear that the study participants can choose to 
leave the study at any point without providing a reason. We will emphasize that participants 
declining to enroll and those leaving the study midway will not be jeopardizing their usual 
clinical care in any way. Before giving consent, every volunteer will be asked if he or she would 
like to discuss any further questions with the study investigators via telephone. 
 
c. Treatment assignment and randomization 
         The proposed study is a controlled clinical trial comparing three arms: in-person group 
lifestyle change program, telephone conference call lifestyle change program, or referral to 
individual medical nutrition therapy (MNT) for weight loss. The study schema is shown in 
Figure 2.  
 
 
Participants will be randomly assigned to one of these three arms at the end of Research Visit 1 
following informed consent, and data will be collected and compared at baseline and Research 
Visits at 6, 12, 24, and 36 months. For the group-based interventions, dietitians will deliver the 
adapted Look AHEAD lifestyle intervention. The goals of the diabetes lifestyle intervention 
program are weight loss of 5-10% of initial body weight and increased activity levels to 175 
minutes/week of moderate intensity physical activity over 6 months. The adapted Look AHEAD 
session materials used for the pilot program are culturally sensitive and have a Flesch Reading 
Ease score of 74.0 and a Flesch-Kincaid grade level of 5.3. We will have Spanish versions 
(previously used in Look AHEAD) of all session materials available for those who prefer to read 
in Spanish. Materials do not focus on foods specific to individual cultures but rather build skills 
that participants apply to their food preferences. Accomplishment of these goals is expected to 
lead to improvements in weight, HbA1c, blood pressure, and lipid levels and reductions in 
medications used to treat these conditions. 
The REAL HEALTH-Diabetes program is adapted from the published Look AHEAD 
program and will include 19 group sessions offered over a six-month period. The first 14 
sessions will be delivered weekly and the next 5 sessions biweekly. In the subsequent 18 months, 

 
10
group sessions will be delivered monthly from 6-24 months. In addition, participants will be 
offered up to 5 individual MNT sessions over the 2 year intervention period. At these individual 
visits, dietitians will address diabetes-related issues and discuss tailored goals and behaviors, 
based on the Look AHEAD model. Dietitians will provide ongoing feedback to participants’ own 
PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss 
strategies with their patients. Each group will contain up to 10 participants with type 2 diabetes 
and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral 
topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight 
loss success. The program fosters the development of knowledge and lifestyle skills to change 
diet and exercise habits through use of goal-setting, problem-solving, stimulus control and other 
behavioral techniques that have resulted in weight loss, weight maintenance and improved 
glycemic control (7).  
In addition to the teaching component, participants who are taking insulin or medications 
that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and 
submit self-monitoring records for review each week, either by delivering them at the in-person 
sessions or by mailing, faxing, or emailing them to the study team. Patients on oral 
hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do 
targeted monitoring to determine the effects of exercise and meals on blood glucose. The study 
provider at each health center will review BG records and make any needed adjustments to 
insulin or medication doses according to a provided algorithm adapted from Look AHEAD and 
defined in the Manual of Operations on a weekly basis to maintain glycemic control and prevent 
hypoglycemia as participants lose weight during the initial 14 weeks and then biweekly and 
monthly to coincide with the session schedule. This approach was effective and safe in Look 
AHEAD and in our pilot IDOLc study. 
This program is distinct from currently available diabetes group courses based in many of 
the primary care practices because it focuses on developing skills for weight loss and increased 
activity as a means to improve glycemic control. The ultimate goal is to translate this program 
for delivery within the current diabetes self-management education (DSME) group course 
framework and, ultimately, within the context of an accountable care organization, either in 
person or by phone to increase reach. 
A trained member of the study staff will provide MNT referral participants with an 
educational handout [see “11. Educational handout”] emphasizing that modest weight loss (5 – 
10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity 
(equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes and 
schedule them for an appointment with a dietitian from Nutrition Services for follow up. As per 
usual care procedures, Nutrition Services will bill each participant’s health insurer for dietitian 
services received and participants assigned to usual care will be responsible for the payment of 
any deductibles and co-payments required by their insurer for this routine care.  
 
If participants have any questions about costs, we will arrange for them to speak with the study 
doctors and study staff and if necessary someone in Patient Financial Services about these costs.  
 
V. STUDY PROCEDURES 
 
For the structured interview, trained study staff will interview the respondent over the 
telephone to obtain feedback on the design of the telephone intervention after obtaining verbal 

 
11
consent, including consent for audiotaping of the interview. The interview will last 15-20 
minutes. Questions will be both open and closed ended. Interviews will be audiotaped and 
responses will be coded using NVivo software. We will interview at least 10 and up to 20 
subjects from each health center for a total of up to 60 interviews in English. Of this, we will 
seek half men and half women, half 65 or younger and half older than 65, and at least 10 Spanish 
speaking participants, with the remaining 20 distributed across racial and ethnic groups. Once we 
reach saturation on response items, we will close the interview portion of the project and 
establish the definitive protocol for the telephone conference call arm. Each respondent will 
receive $25 for participation (See “8. Structured Interview Script”). Prior to starting both group 
lifestyle programs in Spanish, we will conduct another 10 structured interviews in Spanish. 
 
For the 6-week pilot study: 
After study staff have contacted and discussed the pilot program with the potential 
participants, those who agree to participate will be mailed a consent form to sign and send back. 
Participants will review the consent form over the telephone with study staff when signing. A 
copy of the signed consent will be mailed to the participant. Participants will be informed of how 
to call in for the telephone conferences as well as the schedule for the 6-week program. The 
participants will have the same materials and lessons that are described above. Participants will 
also be asked to maintain a 7-day food, exercise, and blood glucose diary during the 6 weeks 
with study MD review of blood sugars. Medication adjustments will be made, if necessary, with 
changes being relayed to the participant and their physician (see above). 
 
For the randomized controlled trial: 
1. Initial Research Visit (RV1). Research Visit 1 will last about 2 hours. Participants will need to 
fast from midnight until the morning of the visit and wait until after their blood samples are 
drawn to take any diabetes medications [see “4. RV1 Appointment Reminder”].  The participants 
will be met by a member of the study team at their health center. At this meeting, informed 
consent will be obtained by a trained member of the research staff. Participants will have the 
option of speaking with a study MD, RN, or NP if they still have questions after reviewing the 
consent form with other study members. After enrolling in the study, participants will be asked 
to provide their contact information [see “12. Contact Information Sheet”] so they can be 
reached by the study staff throughout the study should they need to reschedule or remind 
participants about an appointment. Next, participants will be asked to provide a blood sample of 
6 cc taken by trained staff. Subject’s blood pressure will be taken resting and will be measured in 
duplicate using an automated device. Height and weight will be measured and then entered into 
the electronic medical record to derive BMI values. Once blood samples, blood pressure, and 
height and weight are recorded, participants can take their diabetes medication(s) and will be 
provided a nutrition bar. Participants will be asked to complete an intake interview with a 
dietitian (that includes review of the 1-week food, exercise and blood glucose diary) to assess 
readiness for participation in a lifestyle intervention program [see “13. Readiness Assessment 
Questionnaires]. They will also be asked to complete a packet of self-administered study 
questionnaires to evaluate weight loss history, health behaviors, self-efficacy, measures of self-
determination, depression, literacy and numeracy, food insecurity, health-related quality-of-life 
and patient satisfaction with quality of care and to obtain demographic information [see “14. 
Baseline and Follow-up Questionnaires]. 

 
12
Participants will then be randomly assigned to either dietitian referral for medical 
nutrition therapy (MNT) or the in-person or telephone group lifestyle intervention program and 
be assigned study ID numbers. After randomization, participants will be given a scale to self-
monitor their weights. Those who are randomly assigned to the MNT arm will receive an 
educational handout to emphasize that modest weight loss (5 – 10%) via caloric restriction and 
gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 
30 minutes daily) is safe and effective in managing diabetes. They will then be referred to 
Nutrition Services for follow up and be given an appointment card with the time, date and 
location of their first Nutrition Service appointment. 
Participants assigned to one of the group lifestyle intervention arms will receive 
information about the dates, times and location so that they can plan their attendance at the 
program [see “15.  Look AHEAD’s group lifestyle intervention materials]. Upon completion of 
the visit, participants will have their parking validated, if applicable, or transportation costs 
reimbursed.  
Participants assigned to the telephone conference call arm receive a binder of materials. 
The binder will contain  
1. Directions for accessing the telephone conference call; 
2. Handout on recognition and management of hypoglycemia (see safety monitoring); 
3. Handout on monitoring blood pressure with weight loss (see safety monitoring);  
4. The program materials for sessions 1-19.  
The structured interviews will inform the design of the group conference call format. 
 
Survey instruments: Patients will complete survey instruments on their own on paper or via 
RedCap web interface at the clinic or from a remote location. The instruments will evaluate 
health behaviors, self-efficacy, measures of self-determination, depression, literacy and 
numeracy, food insecurity, health-related quality-of-life and patient satisfaction with quality of 
care [see “14. Baseline and Follow-up Questionnaires]. Instruments that have validated Spanish 
versions will be administered in Spanish. Study staff will be available to assist with translation of 
untranslated instruments and with completion for participants of low literacy or with visual 
impairment that prevents self-completion. 
 
Blood Samples: Blood samples will be obtained to measure HbA1c and fasting lipids, tests that 
are required in usual care of people with type 2 diabetes. They will be obtained by health center 
phlebotomists at the health center clinical laboratory. Participants and providers will be notified 
that these will be obtained and billed to participants’ insurance at each research visit (0, 6, 12, 
24, and 36 months), since this schedule is less than the recommended frequency for obtaining 
these results in usual care. Drawing them through the usual channels allows automatic entry into 
internal tracking systems and reduces workload on practices that may otherwise need to track 
patients down to meet internal performance framework reporting metrics. Data may be 
abstracted from clinical visits if that participant is unable to complete fasting labs at a research 
visit. Any missing data (second blood pressure, second weight, lipid panel) abstracted from 
clinical data will not be considered a deviation. Participants who are unable to complete their 
outcome visit in-person due to COVID-19 will have the option to email a picture of their weight, 
showing their feet on the scale. Participants will use send secure email unless it is documented 
that they opted out of send secure email at RV1. Instructions on how to measure weight will be 
sent to participants. For participants who have opted out of email communication, data will be 

 
13
abstracted from a clinical visit as described above. The self-reported weights will be analyzed 
separately with sensitivity analyses. This alternative process for collecting weight data will not 
be considered a deviation.  
 
Blood pressure and weight will be measured and entered by study staff into coded fields in the 
electronic medical record. This, too, reflects the integration of the program into usual care, and 
facilitates tracking of these metrics for internal performance framework reporting. 
 
All clinical data will additionally be entered into study databases using RedCap. Survey 
instrument responses will be entered into RedCap. 
 
2. Research Visits (RV2, 3, 4 and 5).   
Research Visits 2-5 will last about 2 hours. Participants will be scheduled for a research visit 6, 
12, 24, and 36 months after the initiation of the intervention with a + 2 month visit window. Any 
clinical data or questionnaires that may be collected outside of the window will count for the 
closest visit window, with the date of data collection documented.  The visit may coincide with a 
usual care appointment. They will receive an appointment reminder letter [see “16. RV2 
Appointment Reminder Intervention and Usual Care”]. Participants will need to fast from 
midnight until the morning of the visit and wait until after their blood samples are drawn to take 
any diabetes medications. The participants will be met by a member of the study team at their 
health center. Participants will be asked to provide a blood sample of 6 cc taken by trained 
phlebotomist in the health center clinical laboratory. Subject’s blood pressure will be taken 
resting and will be measured in duplicate using an automated device. Height and weight will be 
measured and then entered into the electronic medical record to derive BMI values.  Once blood 
samples, blood pressure and height and weight are taken and processed as outlined above, 
participants may take their diabetes medication(s) and will be provided a nutrition bar. Then they 
will be asked to complete self-administered study questionnaires on paper or via RedCap as 
outlined above. Any changes in medication doses for glycemic control, blood pressure and lipid 
management will be reviewed and confirmed by cross checking in electronic medical record. 
 
Research visits will be conducted by a health center medical assistant, RN, or LPN who has 
received CITI certification in Human Subjects research and has been trained and will be funded 
by the REAL HEALTH-Diabetes study for this purpose. Central study personnel will support 
health center staff in training and assessment. Health center staff will also be supervised by the 
health center-based clinician co-investigators. 
 
Participant compensation. Study participants will receive payment of $25 for completing follow 
up assessments at 6 months and 1 year, $50 at 2 years, and $100 at 3 years to promote retention 
for outcome assessment. 
 
Study outcomes/ data to be collected  
 
AIM 1 Outcomes and Assessment Protocol  
Measures at baseline and follow up assessments 
1. Weight/BMI measured in light street clothes (without shoes) using a single calibrated scale at 
each health center. Height measured using a stadiometer at baseline only.  

 
14
2. Resting blood pressure measured using a calibrated sphygmomanometer with appropriate cuff 
sizes based on arm circumference. Average of 2 seated readings at 1 min intervals following a 5 
min period of rest.  
3. Laboratory: Hemoglobin A1c (HbA1c) and fasting lipids will be drawn on site and run in the 
MGH clinical laboratories. HbA1c will be measured by the MGH clinical laboratory.  
4. Medications and doses prescribed for diabetes, blood pressure and lipid management will be 
captured by chart review and phone interview at each outcome assessment as well as at 18 
months. 
5. Health-related quality of life: EQ-5D, a 5-item instrument that is sensitive to health-related 
quality of life in diabetes, including changes in BMI (15). It measures 5 dimensions: mobility, 
self-care, usual activities, pain/discomfort, and anxiety/depression at 3 levels, “no health 
problems,” “moderate health problems,” and “extreme health problems.” In addition, there is a 
20 cm visual analog scale for self-assessment of current overall health (16).  
6. Diabetes-specific quality of life: Diabetes specific quality-of-life will be measured using the 
Problem Areas In Diabetes (PAID) scale, a 20-item self-report measure of diabetes-related 
emotional distress that has shown high internal reliability, sensitivity to change and clinical 
utility (17). The PAID has been rescaled since its first introduction for greater ease of 
interpretation and is scored from 0 to 100, with higher scores indicating greater emotional 
distress (18).   
7. Depression: Measured using the Patient Health Questionnaire 8 (leaving out the question on 
suicidality as is common in research protocols (19). MGH primary care practices are currently 
using the PHQ2 and 9 for depression screening. Participants found to be severely depressed will 
be connected to mental health services. 
8. Health behavior: Dietary behavior will be assessed using the Fat-Related Diet Questionnaire 
(20,21) and the Restraint subscale of Dutch Eating Behavior Questionnaire which rates 
frequency of using ten different restraint behaviors (22). Two questions from the Dietary 
Screener Questionnaire (DSQ) used in the NHANES 2009-2010 series, will be used to assess 
intake of sweetened beverages (23). Activity behavior will be assessed by the Paffenbarger 
Physical Activity Survey and self-reported minutes of physical activity (24). 
9. Self-determination theory measures: 
a. Autonomy: Treatment Self-Regulation Questionnaire (TSRQ). An 18-item tool that measures 
reasons for engaging in a particular behavior (e.g., diet) to assess the degree to which the 
individual holds autonomous reasons for this behavior, i.e., a sense of choice vs. a need to 
comply will be administered at baseline, 6, 24, and 36 month visits (25). It has been shown to 
predict better attendance, greater weight loss, greater maintenance of weight loss and better 
exercise regimen, as well as greater adherence and health behavior change for other behaviors 
(e.g., smoking, medication) (26-29). 
Health Care Climate Questionnaire (HCCQ). A 15-item measure that assesses the degree to 
which respondents find their clinical and weight loss teams to be supportive of their autonomy 
vs. controlling will be administered at 6 month and 24 month visits. For example, do providers 
appear to take the patient’s perspective, minimize control, and foster flexibility and choice, 
promoting feelings of respondent competence and motivation to change behavior (25). 
b. Competence/self-efficacy will be measured using the Diet Self-Efficacy scale, a 16-item scale 
scored from 1 to 5 that measures confidence in one’s ability to adopt healthy dietary behaviors 
and the Exercise Self-Efficacy scale, a 5-item scale scored from 1 to 7 that measures confidence 

 
15
in one’s ability to persist with exercise in situations that involve potential barriers, e.g., negative 
affect and time constraints (30,31). 
c. Relatedness. The construct of relatedness from self-determination theory will be measured 
using the Social Support for Healthy Behaviors scale, a 22-item scale that assesses perceived 
social support from family and friends that is specific to healthy eating and exercise behaviors, 
with good test-retest and internal consistency reliabilities and construct validity (32).  
10. Health literacy and numeracy will be measured with the NVS (newest vital sign), a 6-item 
food-label based assessment validated in English and Spanish, at baseline only (33).  
11. Food insecurity will be measured at baseline, 12 months, 24 months and 36 months with the 
U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research 
Service, USDA, available in English and Spanish (34). 
11. Medication adherence will be measured at baseline, 6 months, 12 months, 24 months, and 
36 months using the 8-item Morisky Medication Adherence Scale (35).  
12. Satisfaction with care will be measured using survey instruments developed for the IDOLc 
pilot which were adapted for pertinence from the Diabetes Quality of Life Measure (DQOL) (36) 
and satisfaction surveys used in previous lifestyle intervention research (37). In addition, 
participants will be asked questions at the end of the 6-month intervention period and at 2 years 
at the end of the intervention period to rate their level of satisfaction with the program and their 
interactions during the visits with the dietitian. 
13. Other Diabetes Care and Costs will be assessed at 6 months, 12 months, 18 months, and 24 
months to determine the cost-effectiveness of all arms of the study.  
Patient-reported outcomes will be completed by participants in a quiet room at the time of 
outcome assessments either on paper or via RedCap web interface. Every effort will be made to 
ensure completion at the time of the research visit, but if this is not possible participants may 
complete assessments later. Outcomes assessors will be trained to review and administer these 
instruments and to help participants when necessary. Outcomes assessors will be blinded to study 
arm. Participants will not be eligible for compensation until all elements of a research visit are 
complete. 
 
These questionnaires typically take about 40-50 minutes to complete. 
 
Table 2. Schedule of questionnaire administration 
 
Questionnaires (S/I)* 
RV1     
(0 Mos) 
RV2     
(6 Mos) 
RV3      
(12 Mos) 
 
RV4      
(24 Mos) 
RV5       
(36 Mos) 
18 
Mos 
Literacy Questionnaire (I) 
X 
  
  
  
  
  
Demographic information (S) 
X 
  
  
  
  
  
Medication and Health Service Utilization (I) 
X 
X 
X 
X 
X 
X 
Contact Information (S)  
X 
X 
X 
  
X 
X 
Health History (S) 
X 
  
  
  
X 
X 
Weight History (S) 
X 
  
  
  
  
  
Treatment Self-Regulation Questionnaire (S) 
X 
X 
  
  
X 
X 
Exercise Self-efficacy Scale (S) 
X 
X 
X 
  
X 
X 
Diet Self-efficacy Scale (S) 
X 
X 
X 
  
X 
X 

 
16
Paffenbarger (S) 
X 
X 
X 
  
X 
X 
Fat-Related Diet Behavior (S) 
X 
X 
X 
  
X 
X 
Program Satisfaction (S) 
  
X 
  
  
X 
  
Satisfaction Surveys (S) 
X 
X 
X 
  
X 
X 
Morisky Medication Adherence (S) 
X 
X 
X 
  
X 
X 
EQ-5D (S) 
X 
X 
X 
  
X 
X 
Problem Areas in Diabetes (PAID) Scale (S) 
X 
X 
X 
  
X 
X 
Restraint Subscale of the Dutch Eating 
Behavior Questionnaire (S) 
X 
X 
X 
  
X 
X 
PHQ-8 (S) 
X 
X 
X 
  
X 
X 
Social Support for Healthy Behaviors (S) 
X 
X 
X 
  
X 
X 
Food Insecurity (S) 
X 
  
X 
  
X 
X 
Health Care Climate Questionnaire (S) 
  
X 
  
  
X 
X 
Dietitian Intake Questionnaire (I) 
X 
  
  
  
  
  
 RV4 Structured Exit Interview (I) 
  
  
  
  
X 
  
 Other Diabetes Related  Care and Costs 
Questionnaire (S) 
  
X 
X 
X  
X 
  
PCP Questionnaire (S) 
  
  
X 
  
X 
  
*(S) Self-administered, (I) Interviewer-administered 
X = Questionnaire being administered at visit 
 
 
 
 
Aim 2: Implementation analysis 
 
We have designed and will evaluate the project according to the RE-AIM model. The RE-AIM 
framework includes participant (Reach, Effectiveness, Maintenance) and organization level 
(Adoption, Implementation, Maintenance) elements to capture the full effect of not only a 
program’s efficacy but also its broader impact and sustainability. 
 
Variables to be collected to gauge overall efficacy of REAL HEALTH-Diabetes are listed after 
the corresponding RE-AIM element of interest. This section is modeled after a framework 
proposed in “RE-AIM for Program Planning” by Belza B. et al. (http://www.prc-
han.org/docs/RE-AIM_issue_brief.pdf) (38). 
 
Reach 
• What percent of your target population (those who are intended to benefit from your 
program) will participate in the program?  
o Many patients with diabetes are not ready or able to participate in this program. 
We estimate a maximal eligibility rate of 20% of the population at a given time. 
This will be the denominator by which we calculate reach.  
• Does your program reach those most in need? Are participants representative of the 
targeted population?    
o Measure: Participation rate at each center and within R/E groups 

 
17
Effectiveness—see Aim 1. 
• Weight loss 
• Medication reduction 
• Behavior change  
• HRQoL and diabetes–specific quality-of-life 
• Cost—see Aim 3 
• Participation (attendance) 
 
Adoption—Goal: to ensure that the program will be adopted by those settings that have 
connections to people in the target population. We will achieve this using the central support and 
study design aiming for the following: 1. Easy-to-understand program communications and 
materials. 2. Compatibility with organizational values—offering lifestyle change programs for 
diabetes and obesity is a priority at MGH and its community health centers. 3. Low disruption to 
organization—the program has been designed to minimally impact general workflow while 
fitting into the patient-centered medical home model. 4. Minimal start-up time, given the 
complexity of the intervention. Training components will be delivered in segments to the 
appropriate audience. 5. Observable results so everyone can see the benefits. We will report on 
program metrics (though not efficacy outcomes) in real time.  
 
Measures of adoption will be: 
• Proportion of PCPs who refer patients 
• 
Structured interview of providers, in years 2-3 of the project. Provider program 
evaluation questions have been adapted from the SHINE study and from the Provider 
Questionnaire used in the IDEATel telemedicine study (39). [See “17. Provider 
questionnaire”]. 
• Willingness of health centers and MGH to continue program 
 
Implementation—Goal: to ensure that the program is delivered with fidelity 
      Measures 
• Are different components delivered as intended?  
o Measure: Audiotape sessions 
• Can different levels of staff implement the program successfully?   
o Measure: Data fidelity/protocol fidelity 
• What parts of the program are flexible or adaptable, without decreasing program 
efficacy?  
• Cost of implementation—see cost analysis section 
 
 Maintenance occurs on the individual and organizational level.  
• Individual: Do participants stay engaged and sustain positive behavior changes over time? 
Does the program produce lasting effects (1-2 years or longer) at the individual level? 
o Measure: 3-year outcome measurement, with focus group or structured interview 
comparing sustainers vs. non sustainers, to be developed in years 4-5 of the project 
and submitted for IRB approval at that time.  
• Organization: How is the program incorporated so it is delivered over the long term? Can 
organizations sustain the program over time—even after initial funding and enthusiasm?  
o Strategies for consideration in years 4-5 of the project 

 
18
▪ Ensure that existing staff have the skills to continue the program; incorporate 
these skills into job descriptions of designated MAs and providers.  
▪ Ensure that supervisors and others know how to monitor quality and fidelity 
and can successfully guide the program.  
▪ Ensure that organizational leadership, including board members, know about 
the program and endorse its value to the organization.  
▪ Ensure that partners are engaged and understand the importance of their 
various contributions.  
▪ Reduce level of resources required. Provide incentives and policy supports.  
▪ Continue contact and technical assistance to participating organizations or 
settings.  
▪ Regularly meet with organizational staff, leaders, and participants to learn 
what they like and what works. Make changes as feasible, attending to 
fidelity.  
▪ Monitor which organizations continue the program and which do not. Explore 
what differentiates these two groups and see if you can do something that 
would help with sustainability. 
o Measure—continuation of program at each site in out years. 
 
AIM 3: To estimate the incremental cost per percentage point decrease in body weight of the 
group treatment models assessed in this study compared to dietitian-delivered MNT. Our 
approach will incorporate the costs and benefits of each intervention, including training and 
implementation costs, staff and participant time, and the savings from reduced medication use. 
We will also examine differences in numbers of visits and hospitalization rates for all models as 
exploratory analyses. We will measure health utility to facilitate subsequent cost-effectiveness 
analysis comparing the care models.  
Evaluation of implementation costs. The focus of our analysis will be identifying short-
term costs and health effects that are relevant to ACOs and insurers with the goal of informing 
the design of payment contracts that align financial incentives ensuring the adoption of effective 
and efficient diabetes care. At the same time, we will collect a broad range of cost data, including 
costs that fall exclusively to participants, to build a foundation for future studies of long-term 
cost-effectiveness taking a societal perspective.  
Primary data will be collected for the three study arms. Each study arm has several cost 
components. These include the cost of personnel time, defined by the differential use of time 
physicians, nurse practitioners, dietitians, and medical assistants will spend on the project, as 
well as the cost of services provided, including medication utilization, health care utilization not 
included in clinician time/reimbursement, program materials, and office space. We will also 
track patient time use, as well as telephone minute, transportation, and parking costs to 
understand the relative financial burden each strategy places on participants.  
Cost of personnel time. Provider time use will be monitored using sessions delivered and self-
report augmented by limited direct observation. Total time devoted to training, outreach, session 
delivery, and patient contact will be estimated by multiplying the total number of times a task 
was performed by the average time devoted to the task. Dietitian referral time will be counted by 
review of completed visit notes which document time. We will assess the total cost of time, 
including time spent on record review and between-visit contact, if any, based on the value of 
each person’s time in hourly wages (salary plus benefits). Direct observation will determine how 

 
19
much time is spent on coordination tasks. Patient time use will be measured using survey 
assessments and valued using labor statistics data adjusted by age and residence. 
Cost of services provided. Cost of services will be estimated using existing data sources, 
including inpatient and outpatient billing and reimbursement data, patient self-reports 
(prescriptions filled), and study data on sessions attended. We will compare the total costs in 
each arm over the study period.  
 
Personnel time, program materials, office space, patient telephone minutes, and parking costs 
will be derived from study records.  
 
Patient travel costs and telephone minute costs will be collected at RV2, 3, and 4 [see “18. 
Patient Travel and Phone Use”]. 
 
Dose, type, fill rate, and co-pays for medications and use of health care services will be collected 
by telephone every 6 months until year 3 (RV5) using pre-populated forms mailed to the 
participant 1 week before the scheduled call to facilitate accurate medication collection. 
Participants will be given a calendar to track health service utilization with a particular focus on 
emergency room visits and hospital admissions outside the Partners system, as these cannot be 
tracked administratively [See “19. Medication and Health Service Utilization”]. Participants will 
receive postcard reminders at 3 months to remind them to keep their health service utilization 
calendar record.  
 
 
 
VI. BIOSTATISTICAL ANALYSIS 
a. Specific data variables (e.g. data collection sheets) 
 
A list of the variables collected via medical chart review, survey instruments (from 
screening interview, research visits, RE-AIM components, and cost estimates) are listed in the 
protocol appendix [see “20. Data variables list”] 
 
b. Study outcomes 
All outcomes will be assessed at baseline (prior to randomization) and at 6, 12, 24 and 36 
month follow up after completion of the lifestyle intervention program. Primary study endpoint 
will be change in weight from 0 to 6 months after enrollment in the intervention, with secondary 
outcomes being weight change at other timepoints, glycemia (HbA1c), blood pressure, and lipids 
and medication prescriptions (number, dose and cost) for these conditions as well as health 
behavior, self-efficacy, measures of self-determination, depression, food insecurity, health 
related quality-of-life, patient satisfaction, and cost. 
 
c. Statistical methods 
For all continuous outcomes (% weight loss, HbA1c, blood pressure, fasting lipid levels, self-
efficacy, health related quality-of-life score, and satisfaction with care), we will compare 
changes from baseline among groups using a mixed effects model that includes group, follow-up 
period (6 months, 1 year, 2 years, 3 years), group and period interaction, baseline weight, and 
community health center. The follow-up period will be modeled as a categorical variable; 

 
20
average changes at each time point by treatment group as well as the overall change (with all 
follow-up visits included in the model) will be presented. Since outcomes from participants 
within the same counseling group might be correlated, all analyses will take into account the 
clustering effect in the mixed effect models. With three treatment groups, multiple comparisons 
adjustment will be applied to reduce the inflation of type I error rate. Randomization codes will 
be generated for each health center and group assignment will occur in a 1:1:1 ratio within each 
site stratified by sex. 
 
d. Power analysis 
Aim 1: 
Sample size/power calculation. 
H1a. IDOLc preliminary data showed 6.7% mean weight loss at 6 months in the lifestyle 
intervention group, which was 4.1% greater than the MNT group. The standard deviation of 
percent weight loss in the pilot cohort was 5.5. Our aim is to detect a clinically meaningful 3.5% 
difference between any of the two study groups (where weight maintenance is defined as weight 
change <3%71). We use the conservative Bonferroni method to adjust for 3-arm multiple 
comparisons, which reduces the two-sided significance level to 0.0167 (0.05/3). Assuming a SD 
of 5.5%, the study will need an effective sample size of 54 per arm to detect a 3.5% difference 
with 80% power. We assume a conservative intraclass correlation coefficient of 0.02 within each 
counseling group, which translates into an inflation factor of 1.2, and 10% drop-out rate based on 
our prior results and the fact that participants receive primary care at study sites. The final 
sample size will be 210, 70 per arm. 
 
 
Further analyses: 
H1b. We hypothesize that participants in the group interventions will maintain or improve 
HbA1c, blood pressure, and LDL with reduced medication use (dose and cost) to treat these 
conditions, both at the end of the intensive intervention and at follow-up, compared to the MNT 
arm. Medication reduction is an outcome that is meaningful to participants and reduces costs to 
payors (40,41). Based on our preliminary data, in which 61% of the lifestyle group had improved 
HbA1c on less medication compared to 31% in the MNT group, we have 81% power to detect a 
difference of 33% with an effective sample size of 54 per group, adjusting for the 3-arm 
comparison. We will perform further analyses employing number of medications, insulin use, 
insulin doses, and Diabetes Medication System Questionnaire, PAM-D or similar weights to 
model differences in medication intensity among groups (42,43). 
H1c. Using the standard deviation estimates from our previous data (44,45), the study will have 
80% power to detect a mean difference of 0.35 (on a scale of 1 to 5) in the change of low-fat diet 
self-efficacy measure between the two lifestyle change arms or between either lifestyle change 
and the MNT arm, assuming a standard deviation of 0.55. For the change in exercise self-
efficacy measure, the study will have 80% power to detect a mean difference of 0.88 (on a scale 
of 1 to 7), respectively, assuming a standard deviation of 1.4. 
 
Aim 2:  
This aim is largely qualitative. For quantitative outcomes we will compare if appropriate but the 
study is not powered to perform statistical analysis on RE-AIM measures. 
 

 
21
Aim 3:  
We will estimate the cost of each treatment model, and compare the incremental cost-
effectiveness as ((total cost[treatment modeli]-total cost[treatment modelj])/(average % weight 
loss[treatment modeli]-average % weight loss[treatment modelj])). A formal cost-utility analysis 
(cost per QALY saved) is beyond the scope of this project, but we will collect data that may be 
used for a future effort if the intervention is effective.  
 
The study was not designed to be powered for detecting differences in cost outcomes, but we 
will use standard modeling methods (e.g. Monte Carlo analyses) to account for uncertainty in 
cost outcomes when calculating incremental cost-effectiveness. 
 
 
VII. RISKS AND DISCOMFORTS 
The risks to the participants will be minor, and be limited to 1) blood drawing, 2) discomfort 
answering questions 3) risks of intervention 4) risks of exercise 5) loss of confidentiality. We 
will address these sequentially. 
 
Blood drawing will be minimal. Five blood draws (total 6 cc) will be taken, one at baseline and 
one each at 6, 12, 24, and 36 months. Results of these blood draws will also be used for usual 
care. Participants may experience a small amount of pain. Occasionally a bruise may be 
produced. There is also a small risk of infection, lightheadedness, and/or fainting. Fasting 
overnight will be required, however a snack will be offered after the blood draw. 
 
Discomfort answering questions. Some participants may feel uncomfortable answering 
questions about their diabetes, health, nutrition and daily activity. Participants will be told that 
that they may skip over the questions in the questionnaires that they do not want to answer.  
 
Risks of the intervention: Changing diet and exercise and losing weight may cause 
hypoglycemia or hypotension. Participants in the group lifestyle intervention will be asked to 
submit weekly food, activity and blood glucose records which will be reviewed by the study 
provider who will make any needed adjustments in diabetes medications to prevent 
hypoglycemia. With every 10 lbs of weight loss, it will be recommended to patients to have their 
blood pressure monitored according to the protocol outlined below. Participants receiving usual 
care will continue to be managed by their primary care physician.  
 
Risks of exercise: There is a risk in all exercise of pulling or straining a muscle.  Participants 
will be advised to slow down or stop if they experience any pain and advised to inform their 
dietitian if they have muscle pain from the exercise at the next appointment. Some participants 
may feel tired or become short of breath from the exercise.  Participants will be advised to stop 
exercising if they experience any pain or pressure in the chest or have moderate shortness of 
breath and to call 911 if they feel there is any risk of having a heart attack.  
 
Subject confidentiality will be protected. In order to protect the privacy of the participants, 
they will be assigned a coded, anonymous numerical identifier at enrollment. Study specific data 
(mostly from the survey instruments) will be linked to this anonymous coded identifier only, and 
will not be part of the medical record. Routine diabetes labs and weight, along with medication 

 
22
changes, will be entered into the electronic medical record by the study MA and provider at each 
site to promote safety and integration of the intervention with usual care. 
 
For study-specific data, the key will be stored in the Diabetes Research Center in a locked 
cabinet and in her password-protected hard drive. Only study personnel who have undergone 
appropriate human research training and signed standard confidentiality agreements will have 
access to these data. All subject-related documents will be stored in locked file cabinets within 
locked offices. However, it cannot be guaranteed that a breach will not occur. 
 
VIII. POTENTIAL BENEFITS 
a. Potential benefits to participating individuals 
Participants will receive usual nutrition and lifestyle care at MGH Nutrition Services or a free 
group in-person or telephone conference call group based nutrition and lifestyle intervention 
program. Based on our pilot data it is likely that participants in all arms will lose weight and 
experience improvements in blood glucose control, blood pressure, and lipid levels and 
reductions in some medications to treat these conditions.  
 
b. Potential benefits to society 
On a societal level, this proposal will be a next step in translating an evidence-based lifestyle 
intervention into high-value clinical care of type 2 diabetes participants in the community health 
center setting. Results and materials from this project will be freely available on a study website.  
 
 
IX. MONITORING AND QUALITY ASSURANCE 
a. Independent monitoring of source data 
A Data Safety Monitoring Plan will be implemented. The PI will review the safety and progress 
of this study on a monthly basis. In addition, the PI will include results of the review in the 
annual progress reports submitted to the IRB. The annual report will include a list of adverse 
events. It will address: 1) whether adverse event rates are consistent with pre-study assumptions; 
2) reason for dropouts from the study; 3) whether all participants met entry criteria; 4) whether 
continuation of the study is justified on the basis that additional data are needed to accomplish 
the stated aims of the study; and 5) conditions whereby the study might be terminated 
prematurely.  
b. Safety monitoring 
The study will employ a Data Safety Monitoring Board of three independent clinical 
investigators (a primary care physician, an endocrinologist, and a psychologist) not affiliated in 
any way with the REAL HEALH-Diabetes study. The DSMB will be charged with overseeing 
rates of recruitment, eligibility criteria, protocol adherence, and the tracking of patient safety. 
The DSMB will establish its own independent meeting schedule and will determine what, if any, 
safety stopping rules will be necessary. At a minimum, the DSMB will meet with the PI (s) and 
co-investigators bi-annually the first year and then annually to evaluate the progress of the study 
and any safety concerns.     
 
The major safety issues in this low-risk study will be the potential for participants to experience 
hypoglycemia and/or hypotension as weight loss occurs in those taking sulfonyureas and/or 
insulin and blood pressure medication. Based on our pilot trial (in which no severe hypoglycemia 

 
23
was reported) and 11+ years experience in the Look AHEAD study during which cases of self-
reported/self-treated hypoglycemia were rare, and no episodes of severe hypoglycemia were 
reported in the lifestyle intervention group at our center, we do not anticipate any substantive 
hypoglycemia issues in the proposed study. Severe hypoglycemia is defined as any episode of 
loss of consciousness/ seizure or documented hypoglycemia (glucose < 70 mg/dl or 3.9 mmol/l) 
that prevents self treatment, or requires hospitalization or treatment by emergency personnel. 
Minor hypoglycemia is defined as self-reported transient symptoms such as lightheadedness, 
tremor, shaking, sweating, tingling, blurry vision, trouble concentrating etc., in combination with 
a documented low blood sugar value that are self-treated by ingestion of carbohydrates and 
resolved on their own or within 15 minutes of such self-treatment.  
 
As a precaution, we will require the participants to self-monitor blood glucose and report any 
incidences of hypoglycemia. In such cases, the study providers will review the records and 
incidences of hypoglycemia and decrease/adjust medications as needed. In addition, the study 
provider will review glucose logs of all participants taking medications that cause hypoglycemia 
(insulin and sulfonylurea) weekly during the first 14 weeks of the study and then bi-weekly in 
weeks 15-26 so that they may pro-actively reduce those medications as participants lose weight 
and blood sugars hit 80-100 mg/dl, the low end of the ADA target range of 80-130 mg/dl. The 
hypoglycemic management guidelines are attached and based on the Look AHEAD trial 
algorithm.  [See “10. Look AHEAD algorithm for medication adjustment based on blood glucose 
results”] 
 
Since the need for blood pressure medications decreased in both Look AHEAD and our pilot 
study in the active lifestyle intervention group, we will monitor blood pressure at baseline and at 
data collection visits as well as evaluate any symptomatic orthostasis reported by participants 
during the course of the study. For patients on blood pressure medication, it is recommended that 
for every 10 lbs of weight loss, participants obtain a seated blood pressure measurement either at 
a pharmacy and/or a visit to the health center. If a seated blood pressure is less than 100/70, or 
participant complains of lightheadedness with blood pressure less than 110/70, either at a 
research outcome visit or by self-report, one blood pressure medication will be held under the 
supervision of the study provider with notification of the referring provider and instructions to 
follow up with the referring provider for blood pressure measurement.  
 
All participants will be given a handout on recognition of management of hypoglycemia and the 
protocol for blood pressure monitoring in their study materials [See “21. Handouts”]. 
 
Study staff will report all adverse events to the PI who will document and log them. The Log will 
include the PI’s evaluation of each event based on severity, whether it is related/unrelated to the 
study intervention, and if the event is anticipated/unanticipated. Based on that determination, the 
PI will follow the reporting requirements to the IRB within the required time frame. The Adverse 
Events Log will be provided to the DSMB on a quarterly basis.   
 
Study staff will have each completed an IRB-required course in ethics and confidentiality in 
clinical research.  Data will be gathered in a subject file that will be identified by number only, 
kept in a locked cabinet, and be made available only to authorized, trained study staff. 
 

 
24
c. Adverse event reporting guidelines 
Each subject is evaluated for any adverse events. Any event that is reported to either the PIs, co-
investigators, or the study staff by the subject or medical staff caring for the subject and which 
meets the criteria will be documented as such. Any event that is reported will then generate an 
adverse event report, which will be submitted to the IRB. The report will include a description of 
the event, when and how it was reported, as well as any official chart records or documentation 
to corroborate the event or the reporting of the event. Any severe and/or unanticipated adverse 
event will be immediately reported to the IRB.  All other adverse events will be reported in a 
timely fashion to the IRB preferably within 2 weeks of the date of the event. All adverse events 
will be summarized annually and submitted to the IRB. 
 
d. Data integrity 
The research team will ensure that the documentation of all consent forms, questionnaires and 
diaries are adequate and accurate. Electronic data capture will be stored on RedCAP, the Partners 
Research Computing HIPAA and research-compliant electronic data capture system. The 
research team will also ensure that all paperwork is securely stored in locked drawers.  
Documents that include participants’ PHI will be kept separately from documents that include 
the participants’ study code. 
 
The research team will maintain confidentiality of data. All study demographic and survey data 
will be entered by study staff to RedCap. Each participant will be given a coded ID. A master 
key of the coded IDs and participant MRNs will be kept in a secure and password protected file 
by the PI as well as within RedCap.  Only study staff that requires access to the password 
protected file or RedCap will be given access to it.  
 
Separation of subject names and identifiable health information from the data will be done 
through the use of unique identifiers. All information transferred via the Internet will be done 
using at least 128-bit SSL encryption. All email sent out of the Partners firewall will be sent 
through Send Secure if any medication or diagnoses are included. Virus and password-protected 
facilities will be provided for the research team. All mobile devices will be encrypted to the 
standard defined by the Partners Laptop and Portable device encryption policies. 
 
X. REFERENCES 
1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates 
and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: 
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 
2011.  
 
2. The Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 
diabetes with lifestyle intervention or metformin. N Engl J Med. 2002; 346(6):393- 403. 
 
3. Espeland MA, Glick HA, Bertoni A, et al; Look AHEAD Research Group. Impact of an 
intensive lifestyle intervention on use and cost of medical services among overweight and obese 
adults with type 2 diabetes: The action for health in diabetes. Diabetes Care. 2014;37(9):2548-56. 
 

 
25
4. The Look AHEAD Research Group. Long term effects of lifestyle intervention on weight and 
cardiovascular risk factors in individuals with type 2 diabetes: four year results of the Look 
AHEAD trial. Arch Intern Med. 2010; 170(17):1566-1575. 
5. Green AJ, Bazata DD, Fox KM, Grandy S for the SHIELD Study Group. Health-related 
behaviours of people with diabetes and those with cardiometabolic risk factors: results from 
SHIELD. Int J Clin Pract 2007; 61(11): 1791-1797. 
6. The DPP Research Group. The Diabetes Prevention Program: A description of the lifestyle 
intervention. Diabetes Care 2002; 25: 2165- 2171. 
 
7. Wadden TA, Smith West D, Delahanty LM, Jakicic JM, Rejeski J, Berkowitz RI, Williamson 
DA, Kelley DE, Kumanyika SK, Hill JO, Tomchee CM and the Look AHEAD Research Group.  
The Look AHEAD study: A description of the lifestyle intervention and the evidence supporting 
it. Obesity 2006; 14 (5): 737-752. 
 
8. Whittemore R. A systematic review of the translational research on the Diabetes Prevention 
Program. TBM 2011; 1: 480-491.  
 
9. Weinstock RS, Trief PM, Cibula D, Morin PC, Delahanty LM. Weight Loss Success in 
Metabolic Syndrome by Telephone Interventions: Results from the SHINE Study. J Gen Intern 
Med 2013 
 
10. Duggan M. Cell phone activities 2013. Washington, D. C.: Pew Research Center September 
16, 2013. 
 
11. Befort CA, Donnelly JE, Sullivan DK, Ellerbeck EF, Perri MG. Group versus individual 
phone-based obesity treatment for rural women. Eat Behav 2010;11:11-7. 
 
12. van Wier MF, Ariens GA, Dekkers JC, Hendriksen IJ, Smid T, van Mechelen W. Phone and 
e-mail counselling are effective for weight management in an overweight working population: A 
randomized controlled trial. BMC Public Health 2009;9:6. 
 
13. Donnelly JE, Smith BK, Dunn L, et al. Comparison of a phone vs. clinic approach to achieve 
10% weight loss. Int J Obes 2007;31:1270-6. 
 
14. Digenio AG, Mancuso JP, Gerber RA, Dvorak RV. Comparison of methods for delivering a 
lifestyle modification program for obese patients: a randomized trial. Ann Intern Med 
2009;150:255-62. 
 
15. Janssen MF, Lubetkin EI, Sekhobo JP, Pickard AS. The use of the EQ-5D preference-based 
health status measure in adults with type 2 diabetes mellitus. Diabetic Medicine 2011; 28(4):395-
413. 
 
16. U.S. Valuation of the EuroQol EQ-5D™ Health States. January 2012. Agency for Healthcare 
Research and Quality, Rockville, MD.http://www.ahrq.gov/rice/EQ5Dproj.htm 

 
26
 
17. Polonsky, W.H., Anderson, B.J., Lohrer, P.A., Welch, G., Jacobson, A.M., Aponte, J.E. & 
Schwartz, C.E. Assessment of diabetes-related distress. Diabetes Care, 1995; 18, 754-760. 
 
18. Welch, G.W., Jacobson, A.M. & Polonsky, W.H. The Problem Areas in Diabetes Scale. An 
evaluation of its clinical utility. Diabetes Care 1997; 20, 760-766. 
 
19. Kroenke K, Spitzer RL. The PHQ-9: a new depression diagnostic and severity measure. 
Psychiatric Annals 2002;32:509-521 
 
20. Kristal AR, Shattuck AL, Henry J. Patterns of dietary behavior associated with selecting diets 
low in fat: Reliability and validity of a behavioral approach to dietary assessment. J Am Diet 
Assoc. 1990; 90(214-220).  
 
21. Glasgow RE, Perry JD, Toobert DJ, Hollis JF. Brief assessments of dietary behavior in field 
settings. Addict Behav. 1996; 21: 239-47. 
 
22. Ref Van Strien T, Frijters JER, Defares PB. The Dutch Eating Behavior Questionnaire 
(DEBQ) for assessment of restrained, emotional, and external eating behavior. International 
Journal of Eating Disorders 1986;5:295-315. 
 
23. Applied Research Cancer Control and Population Sciences. Available at: , 2014. 
 
24. Paffenbarger RS, Wing AL, Hyde RT. Physical activity as an index of heart attack risk in 
college alumni. Am J Epidemiol. 1978; 108: 161-175. 
 
25. Williams GC, Grow VM, Freedman ZR, Ryan RM, Deci EL. Motivational predictors of 
weight loss and weight-loss maintenance. J Pers Soc Psychol 1996;70:115-26. 
 
26. Silva MN, Vieira PN, Coutinho SR, et al. Using self-determination theory to promote physical 
activity and weight control: a randomized controlled trial in women. J Behav Med 2010;33:110-
22. 
 
27. Williams GC, Rodin GC, Ryan RM, Grolnick WS, Deci EL. Autonomous regulation and 
long-term medication adherence in adult outpatients. Health Psychol 1998;17:269-76. 
 
28. Williams GC, Cox EM, Kouides R, Deci EL. Presenting the facts about smoking to 
adolescents: effects of an autonomy-supportive style. Arch Pediatr Adolesc Med 1999;153:959-
64. 
 
29. Williams GC, Gagne M, Ryan RM, Deci EL. Facilitating autonomous motivation for smoking 
cessation. Health Psychol 2002;21:40-50. 
 
30. Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-
efficacy. Nurs Res 1992;41:347-51. 
 

 
27
31. Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior 
change. Res Q Exerc Sport 1992;63:60-6. 
 
32. Sallis JF, Grossman RM, Pinski RB, Patterson TL, Nader PR. The development of scales to 
measure social support for diet and exercise behaviors. Prev Med 1987;16:825-36. 
 
33. Accessed on September 9, 2014 at www.pfizerhealthliteracy.com. 
 
34. Blumberg, SJ, T Bialostosky K, Hamilton WL, Briefel, RR. The effectiveness of a short form 
of the household food security scale,” American Journal of Public Health 1999; 89: 1231-34. 
 
35. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported 
measure of medication adherence. Med Care. 1986;24:67-74. 
 
36. The DCCT Research Group. Influence of intensive diabetes treatment on quality-of-life 
outcomes in the Diabetes Control and Complications Trial (DCCT). Diabetes Care 1996; 19:195-
203. 
 
37. Toobert DJ, Strycker LA, Glasgow RE, Barrera Jr M, Angell K. Effects of the Mediterranean 
Lifestyle Program on multiple risk  behaviors and psychosocial outcomes among women at risk 
for heart disease. Ann Behav Med. 2005;29:128-137 
 
38. Belza, B., Toobert, D. and Glasgow, R. RE-AIM for Program Planning: Overview and 
Applications. 1st ed. Accessed on September 9, 2014 at: http://www.prc-han.org/docs/RE-
AIM_issue_brief.pdf 
 
39. Tudiver F, Wolff TL, Morin PC, et al. Primary care providers' perceptions of home diabetes 
telelmedicine care in the IDEATel project. J Rural Health. 
 
40.Delahanty LM, Grant RW, Wittenberg E, et al. Association of diabetes-related emotional 
distress with diabetes treatment in primary care patients with Type 2 diabetes. Diabet Med 
2007;24:48-54. 
 
41.Grant RW, Pabon-Nau L, Ross KM, Youatt EJ, Pandiscio JC, Park ER. Diabetes oral 
medication initiation and intensification: patient views compared with current treatment 
guidelines. Diabetes Educ 2011;37:78-84. 
 
42. Peyrot M, Harshaw Q, Shillington AC, Xu Y, Rubin RR. Validation of a tool to assess 
medication treatment satisfaction in patients with Type 2 diabetes: the Diabetes Medication 
System Rating Questionnaire (DMSRQ). Diabet Med 2012;29:1060-6. 
 
43. Monahan PO, Lane KA, Hayes RP, McHorney CA, Marrero DG. Reliability and validity of 
an instrument for assessing patients' perceptions about medications for diabetes: the PAM-D. 
Qual Life Res 2009;18:941-52. 
 

 
28
44.Delahanty LM, Peyrot M, Shrader PJ, Williamson DA, Meigs JB, Nathan DM. Pretreatment, 
psychological, and behavioral predictors of weight outcomes among lifestyle intervention 
participants in the Diabetes Prevention Program (DPP). Diabetes Care 2013;36:34-40. 
 
45.Delahanty LM, Meigs JB, Hayden D, Williamson DA, Nathan DM. Psychological and 
behavioral correlates of baseline BMI in the diabetes prevention program (DPP). Diabetes Care 
2002;25:1992-8. 
 
 
XI. STUDY SCHEMATIC 
 
 
 
 
 
 
 
 
 
XII. APPENDICES 
1. PCP Recruitment E-mail 
2. Introductory Patient Letter 
3. Screening Phone Call Script 
4. RV1 Appointment Reminder 
5. Informed Consent Form 
6. Email Broadcast 
7. Structured Phone Interview Opt-out Letter 
8. Structured Phone Interview 
9. http://youtu.be/BMBHV5i_yMc  
10. Educational Handout  
11. Contact Information sheet 
12. Readiness Assessment Questionnaires 
13. Baseline and Follow-up Questionnaires 
14. Look AHEAD’s 19 session group lifestyle intervention materials 
15. RV2 Appointment Reminder-Intervention and Usual Care 
16. Provider Questionnaire 
17. Other Diabetes Care and Costs 
18. Medication and Health Service Utilization 
19. Data Variables List 
20. Handouts 
Table 3. Study Timeline 
 
Year 1 
Year 2 
Year 3 
Year 4 
Year 5 
Completion / revision of protocol 
X 
 
 
 
 
 
 
 
 
 
Finalize IRB approval  
X 
 
 
 
 
 
 
 
 
 
Train project staff 
X 
 
 
 
 
 
 
 
 
 
Participant recruitment  
X 
X 
X 
X 
X 
 
 
 
 
 
Conduct of the intervention 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Analysis of results  
 
 
 
 
 
 
 
X 
X 
 
Cost analysis 
 
 
 
 
 
 
 
X 
X 
X 
Publication and dissemination  
 
 
 
 
 
 
 
 
X 
X 

 
29
18. Data Variables List (to be collected/confirmed from electronic medical record) 
 
1. Age (date of birth) 
2. Height 
3. Weight 
4. Hba1c 6.5< 11% 
5. Blood pressure <160/100 
6. Diabetes medications and doses 
7. Blood pressure medications and doses 
8. Lipid medications and doses 
9. Any severe comorbidities  
10. Any weight change of more than 3%in past 3 months 
11. Type 2 diabetes 
12.  Billing charges 
 
RV1 Content Domains (and corresponding survey items)  
1. Demographic information (race/ethnicity, income, educational attainment) 
a. Health history 
b. Medication and Health Service Utilization 
2. Readiness for lifestyle change questionnaires 
3. Health behavior 
a. Dietary behavior 
1. Fat-related Diet Questionnaire  
          
2. Restraint Subscale of the Dutch Eating Behavior Questionnaire 
 
 
3. Dietary Screener Questionnaire (2 questions) 
b. Activity behavior 
1. Paffenbarger 
4. Depression 
a. PHQ-8 
5. Quality-of-life 
a. Diabetes–specific quality of life 
1. Problem Areas in Diabetes (PAID) Scale 
b. Health-related quality of life 
1. EQ-5D 
6. Self-determination theory measures: 
a. Autonomy 
 
1. Treatment Self-Regulation Questionnaire 
b. Competence/Self-efficacy 
1. Diet Self-efficacy Scale 
2. Exercise Self-efficacy Scale 
 
c. Relatedness 
 
 
1. Social Support for Healthy Behaviors scale 
7. Health literacy 
8. Food insecurity 
9. Satisfaction Surveys 
10. Participant Travel and Phone Use 

 
30
11. Medication adherence 
 
a. Morisky Medication Adherence 
 
 
RV2 Content Domains (and corresponding survey items)  
1. Medication and Health Service Utilization 
2. Health behavior 
a. Dietary behavior 
1. Fat-related Diet Questionnaire  
          
2. Restraint Subscale of the Dutch Eating Behavior Questionnaire 
 
 
3. Dietary Screener Questionnaire 
b. Activity behavior 
1. Paffenbarger 
3. Depression 
a. PHQ-8 
4. Quality-of-life 
a. Diabetes–specific quality of life 
1. Problem Areas in Diabetes (PAID) Scale 
b. Health-related quality of life 
1. EQ-5D 
5. Self determination theory measures: 
a. Autonomy 
 
1. Treatment Self-Regulation Questionnaire 
 
2. Health Care Climate Questionnaire 
b. Competence/Self-efficacy 
1. Diet Self-efficacy Scale 
2. Exercise Self-efficacy Scale 
 
c. Relatedness 
 
 
1. Social Support for Healthy Behaviors scale 
6. Satisfaction Surveys 
7.  Other Diabetes Care and Costs8. Medication adherence 
 
a. Morisky Medication Adherence 
 
RV3 Content Domains (and corresponding survey items) 
1. Medication and Health Service Utilization 
2. Health behavior 
a. Dietary behavior 
1. Fat-related Diet Questionnaire  
          
2. Restraint Subscale of the Dutch Eating Behavior Questionnaire 
 
 
3. Dietary Screener Questionnaire 
b. Activity behavior 
1. Paffenbarger 
3. Depression 
a. PHQ-8 
4. Quality-of-life 
a. Diabetes–specific quality of life 

 
31
1. Problem Areas in Diabetes (PAID) Scale 
b. Health-related quality of life 
1. EQ-5D 
5. Self determination theory measures: 
a. Competence/Self-efficacy 
1. Diet Self-efficacy Scale 
2. Exercise Self-efficacy Scale 
 
b. Relatedness 
 
 
1. Social Support for Healthy Behaviors scale 
6. Food insecurity 
7. Satisfaction Surveys 
8. Other Diabetes Care and Costs 
9. Medication adherence 
 
a. Morisky Medication Adherence 
 
18 Month Content Doman (Telephone Call) 
1. Medication and Health Service Utilization 
2. Other Diabetes Care and Costs 
 
RV4 Content Domains (and corresponding survey items) 
1. Health history 
2. Medication and Health Service Utilization 
3. Health behavior 
a. Dietary behavior 
1. Fat-related Diet Questionnaire  
          
2. Restraint Subscale of the Dutch Eating Behavior Questionnaire 
 
 
3. Dietary Screener Questionnaire 
b. Activity behavior 
1. Paffenbarger 
4. Depression 
a. PHQ-8 
5. Quality-of-life 
a. Diabetes–specific quality of life 
1. Problem Areas in Diabetes (PAID) Scale 
b. Health-related quality of life 
1. EQ-5D 
6. Self determination theory measures: 
a. Autonomy 
 
1. Treatment Self-Regulation Questionnaire 
 
2. Health Care Climate Questionnaire 
b. Competence/Self-efficacy 
1. Diet Self-efficacy Scale 
2. Exercise Self-efficacy Scale 
 
c. Relatedness 
 
 
1. Social Support for Healthy Behaviors scale 
7. Food insecurity 

 
32
8.  Satisfaction Surveys 
9. Other Diabetes Care and Costs 
10. Medication adherence 
 
a. Morisky Medication Adherence 
 
RV5 Content Domains (and corresponding survey items) 
1. Health history 
2. Medication and Health Service Utilization 
3. Health behavior 
a. Dietary behavior 
1. Fat-related Diet Questionnaire  
          
2. Restraint Subscale of the Dutch Eating Behavior Questionnaire 
 
 
3. Dietary Screener Questionnaire 
b. Activity behavior 
1. Paffenbarger 
4. Depression 
a. PHQ-8 
5. Quality-of-life 
a. Diabetes–specific quality of life 
1. Problem Areas in Diabetes (PAID) Scale 
b. Health-related quality of life 
1. EQ-5D 
6. Self determination theory measures: 
a. Autonomy 
 
1. Treatment Self-Regulation Questionnaire 
 
2. Health Care Climate Questionnaire 
b. Competence/Self-efficacy 
1. Diet Self-efficacy Scale 
2. Exercise Self-efficacy Scale 
 
c. Relatedness 
 
 
1. Social Support for Healthy Behaviors scale 
7. Food insecurity 
8.  Satisfaction Surveys 
9. Participant Travel and Phone Use 
10. Medication adherence 
 
a. Morisky Medication Adherence