Community Servings: Food as Medicine for Diabetes
Phase: NA
Conditions: Diabetes
Sponsor: Massachusetts General Hospital

 
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Principal Investigators: Seth A. Berkowitz MD MPH; Deborah Wexler MD MSc  
Department /Division: Department of Medicine/ Division of General Internal Medicine and 
MGH Diabetes Center   
Protocol Title: Community Servings: Food as Medicine-Diabetes  
Protocol Version date: 19 April 2015 
 
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 2014 was $265 billion 
with $176 billion in direct medical costs and $89 billion is 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 
          Food insecurity, defined as limited access to nutritious food due to cost2, has been 
associated with increased prevalence of diabetes3, 4, and worse diabetes control.5, 6 Food 
insecurity may worsen diabetes by decreasing consumption of fresh fruits and vegetables and 
increasing consumption of inexpensive, calorie-dense food, and which in turn leads to greater 
Hemoglobin A1c, an indicator of hyperglycemia, over time7. 
 
 
c. Rationale behind the proposed research, and potential benefits to participants and/or 
society 
Approximately 20% of diabetes patients report food insecurity, a number that increases to 
over 25% among those with the worst metabolic control.5 The prevalence of food insecurity is 
also 20% in the MGH Population we surveyed (data not yet published). Hyperglycemia is 
particularly responsive to dietary changes,8 yet few interventions have attempted to address food 
insecurity in diabetes care. Prior studies have examined the impact of the Supplemental Nutrition 
Assistance Program (SNAP, formerly the Food Stamp Program), but have not found important 
improvements in diabetes outcomes for participants9. This may be because neighborhood access 
to produce and other high quality food is low for many SNAP participants, or because making 
healthy food choices is difficult in resource-constrained environments. Additionally, recent 
sociological work has shown that expecting low-income women to cook healthy meals for their 
families induces a significant burden10, and the burden of these expectations may drive less 
healthy food choices. Additionally, while significant time is needed for healthy food 
preparation11, low-income patients often face limited leisure time, and multiple competing 
demands for both time and financial resources. Alternatively, direct provision of healthy foods 
was incidentally noted to improve diabetes outcomes in a prior randomized controlled trial12, but 
this study was not conducted with the goal of addressing food insecurity. 
In this study, we propose to test whether home delivery of freshly prepared meals 
specifically tailored to the needs of diabetes patients improves their dietary quality. We 

 
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hypothesize that the delivery of the meals will help them eat more healthily and improve the food 
security of participants. Secondary outcomes in this pilot study will be weight and metabolic 
control, along with psychological aspects of diabetes care. 
This project aligns with MGH’s Strategic Plan goal to address diabetes in the 
communities MGH serves. Further, this project will serve as an important test of the concept of 
‘Food as Medicine’, the idea that we can improve management of chronic, diet-sensitive diseases 
by approaching the food people eat with the same rigor we apply to pharmaceutical studies. 
 
II. SPECIFIC AIMS 
a. Objectives and hypotheses to be tested in the research project 
 
The goal of this pilot project is to demonstrate that enrolling MGH diabetes patients in the 
Community Servings nutritionally tailored meal delivery service is feasible and leads to dietary 
improvements that would be expected to offer clinical benefits in larger scale studies over longer 
timeframes. To maximize the knowledge gained from participation in this study, we will 
measure several self-reported, laboratory, and clinical outcomes, but the primary purpose of this 
study is to provide pilot data for a larger proposal. 
 
Aim 1: To evaluate the effectiveness of receiving Community Servings meals on dietary quality 
for food insecure diabetes patients with severe hyperglycemia (HbA1c > 8.0%) 
H1. Primary outcome. Healthy Eating Index 2010 (HEI) score: We hypothesize that the 
CS group will demonstrate greater improvements in dietary quality, as assessed by HEI 
score, at 12 weeks, compared with usual care. The sample size of 50 provides 80% power 
to detect a 5 point difference between the CS and usual care groups, assuming an 11 point 
standard deviation and accounting for a 10% drop-out rate. 
H1b. Secondary exploratory outcomes. Medical outcomes: We hypothesize that 
compared with usual care, CS group participants will improve HbA1c, blood pressure, 
weight, and lipids from baseline at the end of the intervention. 
H1c. Behavioral and psychosocial outcomes: Because meal provision will reduce stress 
related to procuring healthy meals, and free up household resources that would otherwise 
be spent on food, we hypothesize that compared with usual care, the CS groups will have 
greater improvements from baseline in patient-reported outcomes of diabetes distress and 
material need security. 
 
Aim 2: To evaluate the feasibility of providing meals and patient experience with the CS 
program, particularly focusing on factors that determine acceptability, continuation, and 
scalability  
We will use a mixed methods approach using participant structured interviews and 
surveys to assess engagement and satisfaction with the program, and participant 
interviews or focus groups to compare responders and non-responders. We will also 
collect quantitative indicators of feasibility and implementation such as percent of meals 
delivered and consumed, enrollment and persistence with the program, and logistical 
issues in order to plan for a future full-scale intervention. 
 
 

 
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Aim 3: To estimate the incremental cost per point increase of HEI of the CS group compared 
with 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. 
 
III. SUBJECT SELECTION 
a) Inclusion/exclusion criteria  
Eligibility criteria for participation include: 
 Diagnosis of type 2 diabetes 
 Age 18 years or older    
 HbA1c level >8.0%  
 Report food insecurity as indicated by the 2-item USDA Food Security Survey 
Module13 
 Willing to commit to random assignment to either receive CS meals immediately 
or as a waitlist control 
 Stable health, with no severe medical comorbidities that might interfere with 
their ability to participate in the intervention, such as severe psychiatric illness or 
imminent hospitalization 
 Be willing to keep a food diary  
 Be willing to attend and complete a baseline, 12 week, and 24 week assessment 
at MGH 
 Be able to understand and communicate effectively in English  
 Have a primary care physician within the MGH practice based research network 
 Live in an area where Community Servings can deliver meals 
 Ability to store and prepare Community Servings meals 
 
Exclusion criteria include: 
 Must not be pregnant or planning pregnancy in the next year 
 Currently enrolled in another diabetes study 
 Receiving episodic treatments that may increase blood glucose levels (e.g. 
prednisone) 
 Have a food allergy or intolerance that would preclude consumption of meals 
 
 
b) Source of participants and recruitment methods 
Participants will be recruited from MGH primary care practices. Participants can be identified by 
their primary care physician, nurse or nurse practitioner, dietician, or another clinician they have 
a relationship with. Patient registries will also be used to generate lists of potential participants 
for providers to review and identify eligible participants. We also have a small number of 
patients who have participated in a prior study on food insecurity and diabetes, and given 
permission to be re-contacted (Protocol number 2013P000552 PI: Deborah Wexler). These 
patients will start the recruitment process at Step 3, below. 
From this potential pool, we will recruit using the following steps: 
1) Conduct a manual electronic chart review using the primary care operations improvement 
diabetes registry to verify eligibility criteria and PCP linkage.  

 
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2) Obtain permission for initial contact from each potentially eligible patient’s primary care 
physician (PCP) [see “PCP Patient Recruitment E-mail”]. 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 or REAL HEALTH) that is recruiting concurrently. If participant has 
already been contacted and is interested in GRADE or REAL HEALTH, we will not contact. 
 
3) Send an introductory letter [see “Introductory Patient Letter”] to PCP-approved participants 
describing the study and procedures to opt out. This letter will include a phone number that 
participants can call to either decline further contact or to request that a study coordinator contact 
them. 
4) If no answer is received after 2 weeks 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 
“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 mailed an appointment reminder letter, food diary, and an informed consent 
form [see “Appointment Reminder” and “Informed Consent Form”] (described below 
“SUBJECT ENROLLMENT”).  
7) If the subject declines to participate, or does not wish to answer the questions at any point 
during the phone screening, he/she will be thanked for his/her time and the call will be ended. 
 
 
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 practices. We will also use the Broadcast MGH email system to seek study volunteers if 
necessary [see “Email Broadcast”]. If a study volunteer contacts 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 
 
a. Methods of enrollment for the clinical trial 
     Participants who call to express interest in the study, or 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. They will also receive a 1 week food diary to 
complete. Study volunteers will be asked to write down what they eat and the portion size, and 
bring this diary to the baseline visit, Research Visit 1 (RV1). Ability to keep this log predicts 
potential participants’ readiness for dietary change and serves as an eligibility criterion for 
randomization.  
In order to participate in this study, participants must complete at least 4 of the 7 days of 
the food diary. If a participant has not completed at least 4 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). 

 
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b. Procedure for obtaining informed consent 
If a subject meets eligibility criteria for the study and expresses a desire to participate, a 
member of the research team will personally 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 CS meals immediately. 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 they 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 two arms: immediate receipt of 
CS meals for 12 weeks, and a wait list control group that receives usual care for the first 12 
weeks. The study schema is shown in Figure 1. Participants will be randomly assigned to one of 
these arms at the end of Research Visit 1 following informed consent, and data will be collected 
and compared at baseline and Research Visits at 12 and 24 weeks, along with a telephone check-
in after 2 weeks. Those receiving CS meals will receive 10 nutritionally tailored (created with 
guidance from a registered dietitian on staff at Community Servings to be in accord with dietary 
recommendations for diabetes patients) meals that are delivered frozen once weekly. Adherence 
to these meals is expected to lead to improvements in HEI 2010 score, HbA1c, blood pressure, 
and lipid levels and possibly weight. 
Both groups will receive a balanced meal planning handout from choosemyplate.gov[see 
“Educational Handout”]. 
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 
 
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 “Visit Instructions for Participants”]. The 
participants will be met by a member of the study team at MGH.  At this meeting, informed 
consent will be obtained by study personnel. After enrolling in the study, participants will be 
asked to provide their contact information 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 mL taken by trained staff. Blood 
pressure will be taken resting and will be measured in duplicate using an automated device.  
Height and weight will be measured to derive BMI values. Once blood samples, blood pressure 
and height and weight are taken, participants can take their diabetes medication(s) and will be 
provided a snack. Participants will then be asked to complete a packet of self-administered study 
questionnaires to evaluate diet, health behaviors, depression, literacy and numeracy, food 

 
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insecurity, health-related quality-of-life, and obtain demographic information via RedCap web 
interface at the diabetes research center[see “Baseline Questionnaires and “Dietary 
Assessment”]. Study staff will be available to assist with completion for participants of low 
literacy or with visual impairment that prevents self-completion. 
Participants will then be randomly assigned to either immediate CS meals or usual care 
followed by CS meals after 12 weeks, and be assigned study ID numbers. Participants in both 
arms will receive a balanced meal planning handout from choosemyplate.gov[see “Educational 
Handout”].  
Participants assigned to the CS meals will receive information about the receipt of the 
meals (scheduling, storage and preparation requirement). They will also provide contact 
information to be shared with Community Servings to facilitate delivery[see “Intake For Meal 
Delivery”].  Upon completion of the visit, participants will receive a parking voucher or a check 
in the mail for $10 to cover transportation, if applicable. They will also receive a set of diaries to 
fill out while receiving meals to document consumption of the meals, and to provide feedback 
regarding satisfaction with the program and suggestions for improvement. This can be filled out 
on paper. 
Patients will discuss their case with a representative of community servings, who will go 
over procedures for receiving meals. The patient will be given a copy of Community Servings’ 
Client Guidelines, and sign the Community Servings Client agreement. They will also be given a 
copy of this to keep [see “Community Servings Agreement and Guidelines”]. 
 
 
All clinical data and survey instrument responses will be entered into study databases using 
RedCap, either directly by participants or by study staff. Study staff and/or the principal 
investigator will quality check the data after entry. 
 
While receiving meals, the participants will fill out diaries tracking food consumption and 
feedback [see “Meal Receipt Diary”] 
 
2. Research Visit (RV2 and 3).   
Research Visit 2-3 will last about 2 hours. Participants will be scheduled for a research visits 12 
and 24 weeks after the initiation of the intervention with a + 2 week visit window. They will 
receive an appointment reminder[see “Appointment Reminder”]. 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 “Visit Instructions for Participants”]. The participants will be 
met by a member of the study team. Participants will be asked to provide a blood sample of 6 mL 
taken by trained staff. 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 snack. Then they will be asked to complete self-
administered study questionnaires on paper or via RedCap as outlined above [see “Dietary 
Assessment” and “RV 2-3 Questionnaire”]. 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. Participants assigned to usual care initially will, at RV2, receive 

 
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information about Community Servings meals and delivery, and provide contact information as 
the other group did in RV1 
 
Research visits will be conducted by study staff who have received CITI certification in Human 
Subjects research and has been trained and will be funded by the study for this purpose.  
 
Participant compensation. Study participants assigned to the immediate CS meals group will 
receive payment of $25 for completing follow up assessment at 24 weeks to promote retention 
for outcome assessment, as they will stop receiving meals at 12 weeks. Study participants 
assigned to the delayed CS meals group will receive payment of $25 for completing follow up 
assessment at 12 weeks to promote attendance, as they will have not yet received meals, and to 
ensure equal compensation for the groups.  
 
Study outcomes/ data to be collected  
 
AIM 1 Outcomes and Assessment Protocol  
Measures at baseline and follow up assessments 
1. Demographics and clinical history (completed at baseline only): Participants will report 
their race/ethnicity, educational attainment, household income, household size, 
prescription drug coverage, health literacy14, country of birth, and age at which they were 
diagnosed with diabetes. 
2. Dietary Assessment: The patients diet will be assessed from data provided using the 
Dietary Screener Questionnaire, which asks food frequency questions with a 1-month 
look back window. Supplementary dietary information will come from the initial 1 week 
food diary, and a total of seven 24-hour food recall assessments: 3 in-person assessment 
from each research visit, and 4 telephone assessments: one covering a weekday period 
and one covering a weekend period both on and off CS meals. This information will be 
collected using the ASA24 module. 
3. Weight/BMI measured in light street clothes (without shoes) using a single calibrated 
scale at the diabetes research center. Height measured using a stadiometer.  
4. Resting blood pressure measured using a calibrated sphygmomanometer with 
appropriate cuff sizes based on arm circumference. Average of 2 readings, first manual 
and second automated at 1 min intervals following a 5 min period of rest.  
5. Laboratory: Hemoglobin A1c (HbA1c) and fasting lipids will be drawn on site and run 
as research assays at MGH laboratories.  
6. Medications and doses prescribed for diabetes, blood pressure and lipid management will 
be captured by chart review at each outcome assessment. 
7. Food Insecurity: The USDA’s Food Security Survey module, well-validated, and widely 
used on national epidemiologic surveillance surveys such as NHANES and NHIS. We 
will use the 10 adult referenced items, modified to have a 1 month look back period.2, 15 
8. Diabetes Distress: Diabetes distress scale (DDS), a validated 17-item questionnaire that 
measures diabetes distress across 4 domains: Emotional burden, regimen distress, 
physician related distress, and interpersonal distress.16 
9. Depression: Measured using the Patient Health Questionnaire 8 (leaving out the question 
on suicidality as is common in research protocols17). MGH primary care practices are 

 
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currently using the PHQ2 and 9 for depression screening. Participants found to be 
severely depressed will be connected to mental health services. 
10. Medication adherence will be measured at baseline, 12 and 24 weeks using the 5-item 
Medication Adherence Rating Scale (MARS).18-20   
11. Cost-related medication underuse: measured using the 4 cost-related medication 
underuse items from MEPS/NHIS.21 
12. Food/Medication trade-offs: 4 questions about trade-offs between affording food, 
medications, and meeting other basic needs 
13. Simon Task and Consideration of Future Consequences: cognitive tests meant to 
measure the burden of food scarcity and possible improvement.22, 23 
 
Patient-reported outcomes will be completed by participants in a quiet room at the time of 
outcome assessments. Outcomes assessors will be trained to review and administer these 
instruments and to help participants when necessary. 
 
These questionnaires typically take about 40-50 minutes to complete. 
 
Aim 2: Feasibility/Implementation and Patient experience analysis 
 
In this pilot study, we will assess and evaluate the feasibility and implementation of the program, 
and patients’ experience with the CS program, with a particular emphasis on scaling the 
intervention from a pilot study to one that can test changes in clinical outcomes. In order to do 
this, we will need to optimize both the patient experience and the implementation of the 
intervention. To obtain these key data, we will utilize a mixed methods approach that combines 
quantitative data regarding implementation, quantitative data regarding patient satisfaction, and 
qualitative data on the patient experience with the program. 
 
We will track meal delivery and timeliness, along with any logistical issues that arise such as 
participants being unable to accept delivery. All intervention participants will receive a diary to 
track meal consumption and as an opportunity to provide feedback about the program. The 
qualitative portion of the study will consist of focus groups with a semi-structured interview 
follow-up. We anticipate conducting up to 4 focus groups with 4-8 participants, with up to 20 
semi-structured interviews. Topics of discussion for the focus groups and interviews will be 
guided based on our experiences implementing the intervention, but are anticipated to include 
discussions of patient satisfaction and suggestions for improvement regarding the food (type, 
quantity, cultural background), service/meal delivery, coordination between Community 
Servings and MGH/health care providers, and ways to support diabetes management in addition 
to food provision, and include feedback on currently available resources with regard to language 
needs and cultural relevance. 
 
 
AIM 3: To estimate the incremental cost per patient receiving CS meals, compared with those 
receiving usual care. Our approach will incorporate the costs and benefits of the intervention, 
including training and implementation costs, staff and participant time, and any savings from 
reduced medication use. We will also examine differences in numbers of visits and 

 
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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 study arms. The main cost components include the 
cost of services provided, including cost of meals and delivery, medication utilization, health 
care utilization, and program materials, as well as the cost of personnel time to deliver the meals. 
To minimize respondent burden, we will collect most information on health care utilization and 
medications from the electronic medical record. However, we will ask patients about care 
received outside the MGH system that we would not otherwise have access to. 
 
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, and cost estimates) are listed in the protocol appendix [see 
‘Data variables list’]. 
 
b. Study outcomes 
All outcomes will be assessed at baseline (prior to randomization) and at 12 and 24 
weeks. Primary study endpoints will be change in HEI 2010, with secondary outcomes being 
food quality, weight change, glycemia (HbA1c), blood pressure, and lipids and medication 
prescriptions (number, dose and cost) for these conditions as well as health behavior, depression, 
food insecurity, diabetes distress and 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 (12 weeks or 24 weeks), group and period interaction, and baseline HEI 2010 score. The 
follow-up period will be modeled as a categorical variable; 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.  
 
d. Power analysis 
Aim 1: 
Sample size/power calculation. 
H1a. A difference of 5 points on HEI 2010 score is considered clinically meaningful. The 
standard deviation of HEI 2010 scores in national cohorts is 11.24 Our aim is to detect a clinically 
meaningful difference of 5 points between the groups. Assuming a SD of 11, the study will need 
an effective sample size of 38 (19 per arm) to detect a 10-point difference with 80% power. We 
assume a conservative 25% dropout rate. The final sample size will be 50, 25 per arm. 

 
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Further analyses: 
H1b and H1c. We hypothesize that participants the CS meals will maintain or improve food 
quality, HbA1c, blood pressure, and LDL, along with improvement in psychological factors such 
as diabetes distress, and material needs issues such as food insecurity. In this pilot study, we do 
not anticipate sufficient power to detect clinically meaningfully differences in these outcomes. 
Instead, we hope to generate data that will be used to inform the design of future interventions.  
 
Aim 2:  
We will analyze feasibility and implementation data using descriptive statistics. For quantitative 
patient experience outcomes we will compare groups if appropriate, but the study is not powered 
to perform statistical analyses for this aim. We will analyze qualitative results using thematic 
coding.  
 
Aim 3:  
We will estimate the cost of each treatment model. A formal cost-effectiveness or 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.  
 
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) loss of confidentiality. We will address these 
sequentially. 
 
Blood drawing will be minimal. Three blood draws (total 6 mL) will be taken, one at baseline 
and one each at 12 and 24 weeks. Results of these blood draws may 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: The risk of this intervention, which simply provides food, is minimal. 
Community Servings will work with participants to avoid foods they might be allergic too, but it 
is possible they may be allergic to a food they do not know about.  
 
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.  
 
For study-specific data, the key will be stored in the MGH General Internal Medicine Office in a 
locked cabinet and in the principal investigator’s 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 

 
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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 free, nutritionally tailored meals. Because food insecurity is an inclusion 
criterion, provision of these meals will increase access to healthy foods among food insecure 
diabetes patients. Based on prior nutritional work, it is possible that participants receiving the 
meals 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 step towards testing the idea of ‘food as medicine’ in 
the high-value clinical care of type 2 diabetes participants. Results will be shared through 
presentation at scientific meetings and manuscripts, and will inform future interventions of this 
type. 
 
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 
For this pilot, the study will employ a Data Safety Monitor who is an independent clinical 
investigator not affiliated with the study. The safety monitor will be charged with overseeing 
rates of recruitment, eligibility criteria, protocol adherence, and the tracking of patient safety. 
The data safety monitor will determine what, if any, safety stopping rules will be necessary. At a 
minimum, the monitor will meet with the PI (s) and co-investigators at 6, 12, and 24 weeks, and 
at study conclusion (should the study run long due to slower than anticipated recruitment) to 
evaluate the progress of the study and any safety concerns.   
   
Study staff will document and log all adverse events for review by the PI. 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 DSM on a monthly basis.   
 
Study staff will have each completed an IRB-required course in ethics and confidentiality in 
clinical research.  Data will be largely electronic, stored on password protected Partners 
computers behind the partners firewall. Any data recorded on paper will be gathered in a subject 

 
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file that will be identified by number only, kept in a locked cabinet, and be made available only 
to authorized, trained study staff. 
 
c. Adverse event reporting guidelines 
Each subject is evaluated for any adverse events. Any event that is reported to either the PIs 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 at the appropriate time. 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, related, 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 per reporting guidelines depending on the severity 
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. 
In: U.S. Department of Health and Human Services, ed. Atlanta, GA2011. 
2. 
Bickel G, Nord M, Price C, Hamilton W, Cook J. Guide to Measuring Household Food 
Security, Revised 2000. In: U.S. Department of Agriculture Food and Nutrition Service, 
ed. Alexandria VA2000. 
3. 
Seligman HK, Bindman AB, Vittinghoff E, Kanaya AM, Kushel MB. Food insecurity is 
associated with diabetes mellitus: results from the National Health Examination and 

 
13
Nutrition Examination Survey (NHANES) 1999-2002. J Gen Intern Med. Jul 
2007;22(7):1018-1023. 
4. 
Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease 
among low-income NHANES participants. J Nutr. Feb 2010;140(2):304-310. 
5. 
Berkowitz SA, Baggett TP, Wexler DJ, Huskey KW, Wee CC. Food insecurity and 
metabolic control among U.S. adults with diabetes. Diabetes Care. Oct 
2013;36(10):3093-3099. 
6. 
Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and 
glycemic control among low-income patients with type 2 diabetes. Diabetes Care. Feb 
2012;35(2):233-238. 
7. 
Berkowitz SA, Gao X, Tucker KL. Food-insecure dietary patterns are associated with 
poor longitudinal glycemic control in diabetes: results from the Boston puerto rican 
health study. Diabetes Care. Sep 2014;37(9):2587-2592. 
8. 
Coppell KJ, Kataoka M, Williams SM, Chisholm AW, Vorgers SM, Mann JI. Nutritional 
intervention in patients with type 2 diabetes who are hyperglycaemic despite optimised 
drug treatment--Lifestyle Over and Above Drugs in Diabetes (LOADD) study: 
randomised controlled trial. BMJ. 2010;341:c3337. 
9. 
Nicholas LH. Can Food Stamps help to reduce Medicare spending on diabetes? Econ 
Hum Biol. Jan 2011;9(1):1-13. 
10. 
Bowen S, Elliott S, Brenton J. The Joy of Cooking? Contexts. August 1, 2014 
2014;13(3):20-25. 
11. 
Monsivais P, Aggarwal A, Drewnowski A. Time spent on home food preparation and 
indicators of healthy eating. Am J Prev Med. Dec 2014;47(6):796-802. 
12. 
Salas-Salvado J, Bullo M, Babio N, et al. Reduction in the incidence of type 2 diabetes 
with the Mediterranean diet: results of the PREDIMED-Reus nutrition intervention 
randomized trial. Diabetes Care. Jan 2011;34(1):14-19. 
13. 
Hager ER, Quigg AM, Black MM, et al. Development and validity of a 2-item screen to 
identify families at risk for food insecurity. Pediatrics. Jul 2010;126(1):e26-32. 
14. 
Chew LD, Griffin JM, Partin MR, et al. Validation of screening questions for limited 
health literacy in a large VA outpatient population. J Gen Intern Med. May 
2008;23(5):561-566. 
15. 
Coleman-Jensen A, Nord M, Andrews M, Carlson S. Statistical Supplement to 
Household Food Security in the United States in 2011. In: U.S. Department of 
Agriculture Economic Research Service, ed2012. 
16. 
Polonsky WH, Fisher L, Earles J, et al. Assessing psychosocial distress in diabetes: 
development of the diabetes distress scale. Diabetes Care. Mar 2005;28(3):626-631. 
17. 
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity 
measure. J Gen Intern Med. Sep 2001;16(9):606-613. 
18. 
Farmer A, Kinmonth AL, Sutton S. Measuring beliefs about taking hypoglycaemic 
medication among people with Type 2 diabetes. Diabet Med. Mar 2006;23(3):265-270. 
19. 
McAdam-Marx C, Bellows BK, Unni S, et al. Impact of adherence and weight loss on 
glycemic control in patients with type 2 diabetes: cohort analyses of integrated medical 
record, pharmacy claims, and patient-reported data. J Manag Care Pharm. Jul 
2014;20(7):691-700. 

 
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20. 
Sutton S, Kinmonth AL, Hardeman W, et al. Does electronic monitoring influence 
adherence to medication? Randomized controlled trial of measurement reactivity. Ann 
Behav Med. Dec 2014;48(3):293-299. 
21. 
Berkowitz SA, Seligman HK, Choudhry NK. Treat or Eat: Food Insecurity, Cost-related 
Medication Underuse, and Unmet Needs. Am J Med. Apr 2014;127(4):303-310 e303. 
22. 
Whitaker KL, Good A, Miles A, Robb K, Wardle J, von Wagner C. Socioeconomic 
inequalities in colorectal cancer screening uptake: does time perspective play a role? 
Health Psychol. Nov 2011;30(6):702-709. 
23. 
Strathman A., Gleicher F., Boninger D. S., Edwards C. S. The consideration of future 
consequences: Weighing immediate and distant outcomes of behavior. Journal of 
Personality and Social Psychology. 1994;66:742-752. 
24. 
Guenther PM, Kirkpatrick SI, Reedy J, et al. The Healthy Eating Index-2010 is a valid 
and reliable measure of diet quality according to the 2010 Dietary Guidelines for 
Americans. J Nutr. Mar 2014;144(3):399-407. 
 
 

 
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XI. STUDY SCHEMATIC 
 
 
XII. APPENDICES 
1. PCP Recruitment E-mail 
2. Introductory Patient Letter 
3. Screening Phone Call Script 
4. Appointment Reminder 
5. Informed Consent Form 
6. Email Broadcast 
7. Educational Handout 
8. Visit Instructions for Participants 
9. Intake for Meal Delivery 
10. Baseline (RV1) Questionnaires 
11. Dietary Assessments 
12. Meal Receipt Diary 
13. Follow up (RV2-3) Questionnaires 
14. RV2-3 Appointment Reminder 
15. Data Variables List 
16. Community Servings Agreement and Guidelines 

 
16
Data Variables List (to be collected/confirmed from electronic medical record) 
 
1. Age and date of birth 
2. Race/ethnicity 
3. Gender 
4. Education 
5. Insurance 
6. Height 
7. Weight 
8. Hba1c  
9. Blood pressure  
10. Lipids  
11. Medications and doses 
12. Co-morbidities 
13. Visits  
14. Billing charges 
15. Questionnaire items 
16. Dietary Assessment Items