Meals for Moms: A Postpartum Medically-Tailored Meal Program to Promote Weight Loss and Blood Glucose Control Among Women With Hyperglycemia in Pregnancy
Phase: NA
Conditions: Diabetes, Gestational, Gestational Weight Gain, Postpartum Weight Retention
Sponsor: Wake Forest University Health Sciences

 
1 
Protocol Version 5 (05/13/2022) 
 
 
 
Meals for Moms 
 
 
IRB00072715 
 
NCT04866823 
 
IRB Approval Date:  05/23/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
2 
Protocol Version 5 (05/13/2022) 
Meals For Moms Pilot Study 
 
 
 
 
 
Principal Investigator:  
Morgana Mongraw-Chaffin, PhD 
 
Co-investigator(s):  
Kristina Henderson Lewis, MD MPH SM  
Joseph Skelton, MD, MS 
Deepak Palakshappa, MD MSHP  
Joseph Aloi, MD  
David Stamilio, MD MS  
Seth Berkowitz, MD MPH  
 
Sponsor or funding source:  
NCDRC and NIDDK 
 
 
 

 
3 
Protocol Version 5 (05/13/2022) 
I. 
Background, Rationale and Context 
 
Pregnancy and the peripartum period can function as a “stress test” for future development of 
cardiometabolic disease,1 with and gestational diabetes (GDM) and excessive gestational weight gain (GWG) 
portending worse outcomes later in a mother’s life.2,3 The prevalence of both conditions continues to increase 
with the obesity epidemic,4,5 highlighting the urgent need for successful interventions to reverse maternal 
weight gain and promote normoglycemia. The early postpartum period provides a critical opportunity to address 
dietary behaviors that underlie both weight and dysglycemia. Postpartum medically-tailored meal (MTM) 
delivery is a novel intervention approach that may allow for improved glycemic control and weight loss in a 
traditionally hard-to-engage patient population. There is currently no available data on the cost, feasibility, or 
effectiveness of providing MTM to postpartum women. 
 
A. GDM Plus Excess GWG Increases Risk of Adverse Maternal & Child Health Outcomes 
Incidence of GDM has substantially increased over the past two decades,4,5 and there is a need for interventions 
to reduce its long-term health impacts for mother and baby. Excess retained weight after pregnancy, impacting 
up to 80% of women, has important health consequences including development of Type 2 Diabetes Mellitus.6 
GDM and gestational weight retention confer higher risk of complications in subsequent pregnancies and 
cardiovascular disease in the future.6,7  
 
B. The Postpartum Period: A Opportunity to Improve Maternal Metabolic Health 
Most cardiometabolic perturbations from pregnancy will either resolve or persist within 12 weeks after 
delivery.8 Further, the first 6 months after a baby is born are generally the period of most rapid weight loss for 
new mothers.6 Weight plateau and even regain typically occur by 12 months postpartum, with consequences for 
short and long-term glycemic control.9 Despite the opportunity to improve women’s cardiometabolic health 
trajectories during the early postpartum period, many aspects of traditional weight loss and glycemic control 
interventions, such as intensive in-person visits and meal planning/preparation are quite difficult to implement 
and sustain while caring for a newborn infant. Attendance rates at postpartum clinical visits are low,10 only 50% 
for Medicaid patients,11 exemplifying the fact that new mothers have limited bandwidth for self-care activities. 
Postpartum dysglycemia & weight retention pose both an opportunity and a challenge for primary and 
secondary prevention of obstetric and cardiometabolic outcomes in women.  
 
C. MTM programs are promising for treating Type 2 Diabetes, but there has been little uptake in practice 
MTMs are designed with nutritional content (caloric density, macronutrient breakdown, and other features) 
tailored to a specific chronic disease state,12 and typically operationalized by community-partners experienced 
in food preparation and delivery at the request of health systems or payers. Intervention studies using MTM to 
treat diet-related disease have shown great promise, especially for Type 2 Diabetes Mellitus where initial 
studies have found that MTM have been effective in improving diet quality and glycemic control.13,14 Despite 
growing evidence that MTM programs can improve health and decrease medical care costs,15 few of them have 
been translated from research into routine clinical practice, likely due to the high cost.16 Where MTM programs 
are available, they are often restricted to short periods of time despite the chronic nature of the diseases they are 
intended to treat. Such high costs are not viewed as sustainable for long-term chronic disease management by 
health systems or payers. To our knowledge, MTM programs have not been used for primary prevention. Use of 
MTM for a time-limited but critical period, such as the first 3 months postpartum, may have greater 
translational potential among health systems & payers. 
 
 
II. 
Objectives 
 

 
4 
Protocol Version 5 (05/13/2022) 
The purpose of this proposal is to test the feasibility of providing medically tailored meals for postpartum 
women who had gestational diabetes and gestational weight gain that exceeds the IOM guidelines. The first 
objective is to understand the feasibility (n/% of meals successfully ordered & delivered, program cost per 
participant, and completion rate of CGM data collection) and acceptability (using participant surveys and 
interviews with key stakeholders) of the intervention and outcome measures. The second objective is to explore 
the preliminary effectiveness of the program, via 3-month changes in CGM markers of dysglycemia (primary) 
as well as: maternal diet quality, maternal weight and infant weight change, initiation and maintenance of 
breastfeeding, household food insecurity, and validated measures of financial and overall stress (exploratory). 
 
III. 
Methods and Measures 
 
A. Design 
The Meals for Moms study is a pilot study 
to test the feasibility and acceptance of 
using continuous glucose monitors to 
measure changes in glucose associated 
with providing medically tailored meals to 
postpartum women who had gestational 
diabetes.  A schematic of study enrollment, 
intervention design, and follow-up is 
included in Figure 1.  
 
B. Setting 
The Meals for Moms pilot study is a 
collaborative partnership between 
researchers and clinicians from Wake 
Forest Baptist Medical Center and 
Providence Community Kitchen, a 
subsidiary of the Second Harvest 
Foodbank of Northwest North Carolina.  
 
C. Subjects selection criteria 
The principles guiding the selection of the 
following inclusion and exclusion criteria 
are to ensure the enrollment of participants 
who meet 2 major criteria: 1) high risk for 
future adverse health outcomes due to the 
diagnosis of GDM and excessive GWG; 
and 2) no medical contraindications to 
participate in a medically tailored meal 
program.  Participants will include 30 
women in the third trimester of a singleton 
pregnancy or who have recently given 
birth (within the previous 14 days) who 
receive obstetric care at a Wake Forest Baptist Health clinic and reside in Forsyth County, NC. 
 
Inclusion Criteria 
• Demographics: Women 18 years of age and older who reside in Forsyth County, NC 
 
Screening in EHR of patients seen at WFBH 
OB/GYN to identify women with GDM and 
excessive GWG in third trimester of 
pregnancy 
Telephone contact to assess interest, 
conduct screening, schedule Virtual Visit 1 
Virtual Visit 1: Informed Consent, data 
collection, enrollment 
Participants will receive CGM, daily diaries, 
digital scale via mail 
Virtual Visit 2: instructions for 
CGM placement, weight 
measurement 
MTM Treatment Group: 
• Weekly home delivery of 
10 MTM meals (5 lunch, 5 
dinner) for 12 weeks 
• Weekly educational 
videos 
• Monthly (n=3) check-ins 
with study staff 
Control Group: 
• Written nutrition materials, 
info on WIC referrals, 
community resources, food 
banks 
• Weekly educational videos 
• Monthly (n=3) check-ins 
with study staff 
 
Delivery 
CGM, diary completion  
Virtual Visit 3: instructions for 
CGM removal and return 
Virtual Visit 4: CGM 
placement, data collection  
CGM, diary completion  
Virtual Visit 2: instructions for 
CGM placement, weight 
measurement 
CGM, diary completion  
Virtual Visit 3: instructions for 
CGM removal and return 
Virtual Visit 4: CGM 
placement, data collection  
CGM, diary completion  
Weeks 10-12 
(14 days) 
Approx. 4 days 
before 
Est. Delivery Date 
Within 2 weeks of 
Delivery 
Weeks 1-2  
(14 days) 
Figure 1. Schematic of Study Participation 

 
5 
Protocol Version 5 (05/13/2022) 
• Pregnancy: Currently 24 or more weeks into a singleton pregnancy or who have given birth within the 
past 14 days 
• Clinical evidence of GDM defined as either: 
o 3-hour oral glucose tolerance test (OGTT) results obtained in the second trimester of pregnancy 
that show at least 2 abnormal values in any of the following combinations:  
▪ Fasting glucose > 95 mg/dL and 1h > 180 mg/dL 
▪ Fasting glucose > 95 mg/dL and 2h > GE 155 mg/dL 
▪ Fasting glucose  > 95 mg/dL and 3h > 140 mg/dL 
▪ 1h > 180 mg/dL and 2h > 155 mg/dL 
▪ 1h > 180 mg/dL and 3h > 140 mg/dL 
▪ 2h > 155 mg/dL and 3h > 140 mg/dL 
o A diagnosis of “gestational diabetes" included on the Problem List in Wake One during current 
pregnancy, regardless of OGTT values 
• Pre-gravid overweight or obesity or excessive GWG: Overweight or obese (BMI >25.0 kg/m2) prior to 
current pregnancy OR most recent weight exceeds predicted weight gain for current weeks gestational 
age based on starting BMI defined as: 
o Pre-pregnancy BMI of 30 kg/m2 or more and weight at most recent clinical visit 20+ pounds over 
pre-pregnancy weight 
o Pre-pregnancy BMI of 25-29.9 kg/m2 and weight at most recent clinical visit 25+ pounds over 
pre-pregnancy weight 
• English Proficiency: Able to read/understand English at or above a level sufficient to comprehend 
recruitment, informed consent, and intervention materials. 
• Access to a smart phone/tablet/computer capable of connecting to video calls or teleconferencing 
software. 
• Access to freezer space to store 10 frozen meals delivered to the home each week.  
• Willingness to Accept Treatment Assignment:  Prospective participants must be willing to accept 
assignment to either the medically tailored meal intervention or the comparison intervention condition. 
 
Exclusion Criteria 
• Clinical history of diabetes (type 1 or 2) pre-pregnancy  
• Non-singleton pregnancy 
• Other chronic diseases or medical conditions that would increase risk or make participation otherwise 
unsafe, including special dietary needs. A clinician investigator will review the medical record for all 
potential participants to determine if any such conditions exist.  
• Known food allergies or sensitivities.  Potential participants who report special dietary requirements 
including vegetarians, vegans, those who follow kosher or other specialized diets will be excluded due 
to the small nature of this pilot study.  
• History of allergic skin reaction to adhesive tape  
• Unable or unwilling to wear a CGM device  
• Is scheduled for an MRI during the study weeks, making use of the CGM device unsafe 
• Other:  Conditions/criteria likely to interfere with participation and acceptance of treatment group 
assignment, including the following: inability/unwillingness to give informed consent, major psychiatric 
or cognitive problems (schizophrenia, dementia, self-reported substance or alcohol abuse), participation 
in another research study that would interfere with Meals for Moms 
 
D. Sample Size 
We anticipate recruiting a sample of 30 women (12 African-American, 10 Hispanic, 8 Non-Hispanic White). 
This is a pilot study and is not powered to test the effect of the MTM intervention on any outcome. The 

 
6 
Protocol Version 5 (05/13/2022) 
estimates obtained in this study will be used to design a fully powered randomized controlled trial assessing the 
effect of a post-partum MTM intervention on blood glucose. Estimates of retention and adherence will be used 
to modify the sample size to account for dropouts and poor adherence. Estimates of the participation and accrual 
rates will be used to judge the feasibility of the subsequent trial given the required sample size relative to patient 
availability and our ability to recruit them into our trial.  
 
 
E.  Screening and Enrollment 
We will generate weekly datasets using the Clarity reporting relational database in WakeOne to identify 
potentially eligible women within the electronic health record (EHR).  The EHR data pulls will identify women, 
age 18 years or older, in their third trimester of pregnancy seen for obstetric care in a WFBH clinic in the past 
week who had a diagnosis of GDM with excessive GWG, and for whom English is the documented primary 
language. Datasets of up to 50 women who meet these criteria will be output weekly to a secure folder on the 
PHS network which only IRB-approved study staff may access. Datasets will also include patient name, age, 
MRN, expected delivery date, pre-gravid height and weight (to calculate BMI), current weight, diagnosis of 
GDM, and OGTT results. Research staff will then access individual EHR data to identify contact information 
and will place a telephone call to potential participants to discuss the study and to assess additional eligibility 
criteria. As we anticipate that some women who meet eligibility criteria may not appear in these datasets until 
very close to their expected delivery date and may not be reached for recruitment pre-partum, we will also 
attempt to contact women who appear in the dataset who have recently given birth (within the past 14 days).  
Additionally, a physician investigator will review diagnostic codes associated with recent encounters for all 
potential participants to identify any potential diagnoses or health conditions that may make participation unsafe 
or increase risk, including diagnosis of Type 1 or Type 2 diabetes pre-pregnancy, cardiovascular disease, 
essential hypertension, and dyslipidemia.  
 
Potential participants who 1) satisfy the inclusion/exclusion criteria previously described, and 2) indicate that 
they are willing to provide written informed consent will be invited to complete a virtual baseline visit and be 
enrolled in the study. Informed consent will be obtained at the beginning of this visit (see Section I.b. Informed 
Consent for details). Given current patient volumes, we anticipate recruiting 1-2 women per week over a period 
of 3-4 months. As the study timeline is brief, 20 
participants will be recruited into a MTM treatment 
group to ensure the feasibility of the intervention 
approach is tested.  If sufficient time remains, an 
additional 10 participants will be recruited into a usual 
care comparison condition.  
 
After  enrollment, participants will be routinely 
monitored via the EHR to determine when they are 
admitted for delivery and to check for any potential 
problems during the delivery. To standardize anticipated 
contacts across all participants, the Estimated Date of 
Delivery (EDD) will be used to schedule meal 
deliveries, mailings, and email contacts for both 
treatment groups. Our plan is to initiate participant data 
collection post-partum within 2 weeks of delivery. 
Study staff will contact the participant approximately 
one week after the EDD to check on delivery status. We 
will also collect contact information during the 
enrollment process for an alternative contact person in 
Table 1. Outline of Weekly Video Emails 
Week 
Video 
1 
The 4th Trimester (St. Louis Children’s Hospital video)  
2 
HELP -Mindfulness 
3 
HELP - ABCs of emotions 
4 
Phone visit with study team (no email)  
5 
HELP - Tipping the calorie balance 
6 
HELP -  Healthy Eating 
7 
HELP -  More About Healthy Eating 
8 
Phone visit with study team (no email)  
9 
HELP - Physical Activity 101 
10 
HELP - Problem solving 
11 
HELP - Creating an environment for success 
12 
Phone visit with study team (no email) 

 
7 
Protocol Version 5 (05/13/2022) 
the case of negative outcomes during or after delivery. Study staff will make at least five (5) attempts by phone, 
email, or text message to reach enrolled participants or their alternate contacts in the 2 weeks following the 
EDD. Continuous glucose monitors, readers, daily diaries, digital scales, and informational materials about the 
study and healthy diet resources will be delivered to participants by mail after the participant has been reached 
and continued participation is 
confirmed. Those participants who do 
not respond to study contact after 
delivery  
or who decline further participation will 
not receive study-related materials or 
meal delivery and will be considered as 
drop-outs. For those participants who 
are recruited and enrolled after giving 
birth, data collection will begin from 
the date of recruitment and informed 
consent.   
 
 
F. Interventions and Interactions 
Although frequent in-person sessions 
for nutrition education and lifestyle 
change counseling are typically part of 
glycemic control and weight loss 
interventions, our unique patient 
population does not allow for a 
traditional “intensive lifestyle 
intervention” (recovery from delivery, 
infant child at home, frequent newborn 
doctor visits). Accordingly, we focus on 
meal delivery as the main intervention 
component, coupled with the provision 
of nutrition and lifestyle information to 
increase the knowledge base and build 
a foundation for further improvements 
in lifestyle behaviors after the 3-month 
post-partum period in both treatment 
groups.  Participants in both treatment 
groups will receive an educational 
email each week (unless there is a 
scheduled phone visit with the study 
team) with resources for women post-
partum. These emails will include short 
informational videos, developed as part 
of a community-based translation of the 
Diabetes Prevention Program (HELP 
PD, IRB00000613), that contain core 
content on the physiological, emotional, 
cognitive, and behavioral basics of 
losing weight as well as adopting and 
Table 2. Outline of Monthly Phone Contacts 
Month 
Topic and Progress Check 
Research Study 
Health-related 
Goal Setting 
Month 
One 
General Check In- Self Care: 
• Meal delivery 
(MTM group only) 
• SMART goal 
setting 
• Sharing the importance of 
self-care and ideas for 
self-care activities 
• Meal prep  (MTM 
group only) 
• Help participant 
set a modest goal 
for self-care 
• How are you prioritizing 
self-care?  
• Weekly videos from 
study team 
• “Goods and Bads” 
exercise for self-care  
• Problems with 
digital scale / tips on 
weighing  
• Encourage to attend 6 
week postpartum visit 
• Other feedback 
o Help with concerns 
about healing body 
o Ideas for contraception 
o Help with 
breastfeeding or 
feeding concerns 
o General health help 
and advice 
Month 
Two 
General Check In- Dietary 
Awareness: 
• Meal delivery 
(MTM group only) 
• SMART goal 
setting 
• Brief primer on label 
reading (food label 
exercise) 
• Meal prep  (MTM 
group only) 
• Help participant 
set a modest goal 
for dietary habit 
change 
• Practice with food labels 
• Weekly videos from 
study team 
• Eat breakfast 
• Encourage to teach other 
family members (esp. 
those that do shopping) 
• Self-weighing on 
digital scale 
• Try to notice 
when I am 
hungry 
• Other feedback 
• Have a healthy 
snack option in 
the house 
• Practice label 
reading 
Month 
Three 
General Check In- Physical 
Activity: 
• Meal delivery 
(MTM group only) 
• SMART goal 
setting 
• Brief primer on walking 
for exercise 
• Meal prep  (MTM 
group only) 
• Help participant 
set a modest goal 
for exercise habit 
change 
• Discuss what they have 
liked and not liked about 
exercise in the past? 
• Weekly videos from 
study team 
• What are their current 
barriers to exercising? 
• Self-weighing on 
digital scale 
• Other feedback 

 
8 
Protocol Version 5 (05/13/2022) 
maintaining an active lifestyle. We will also include videos developed specifically for post-partum women on 
self, care, diet, and physical activity as appropriate. In order to address potential issues with access to 
availability of food and to increase the representation of diverse populations across the socioeconomic 
spectrum, all participants will be provided information on WIC access, local food banks, and other resources for 
healthy eating to address potential food insecurity. An outline of the weekly video emails is included in Table 1.  
 
All participants will be scheduled for monthly individual visits with a member of the study team to discuss 
progress to date, potential barriers, and set goals for the upcoming month. During the first month, these visits 
will focus on self-care; in month 2, the focus will be dietary awareness; in month 3, participants will discuss 
physical activity with a member of the study team. A complete outline of the monthly phone calls is included in 
Table 2. 
 
 
a. Medically-Tailored Meal (MTM) Intervention 
A standardized series of MTMs appropriate for women with GDM will be developed in partnership with 
Providence Community Kitchen chefs. Participants will receive 10 meals each week (5 lunch, 5 dinner) over the 
course of 12 weeks for a total of 120 meals. Meals will be designed to create a slight caloric deficit in order to 
promote gradual weight loss, but with sufficient energy intake and macronutrient balance to allow 
breastfeeding. These meals will be roughly 40% carbohydrate, 30% protein, and 30% fat in composition and 
will be consistent with recommendations from the American Diabetes Association for women who have been 
diagnosed with GDM. We will plan up to 20 unique lunch and dinner recipes for the series. Providence will 
prepare each meal to be between 450-600 kcal and to contain 6 ounces of protein, 4 ounces of vegetable and I 
cup of whole grain (at a minimum).  An example menu of 10 meals (1 week) is included in Appendix A and an 
example of the nutritional information that will be provided with each meal is included in Appendix B. In 
addition to receiving the MTMs, participants will be advised to supplement their own breakfast +/- snacks to 
reach a total daily calorie goal determined by starting BMI category. Note that we will provide participants with 
lists of healthy, low-cost ADA compliant snacks and breakfast ideas that would meet the caloric requirements, 
so that they do no need to track calories on their own. We do not expect the women to keep track of calories, 
but rather are providing them with a meal structure that should help them remain within the designated calorie 
range for their BMI category. Using the snack lists plus consuming provided lunches and dinners, the daily 
dietary structure we will advise will include 5 eating episodes, structured as follows: 
 
BMI 30-39.9 – 1600 kcal daily (so long as breastmilk production not reduced) 
• Breakfast 200-300 kcal  
• Lunch (provided most days; on own 2d per week) 450-600 kcal 
• Mid-Afternoon snack (on own) – 100-200 kcal 
• Dinner (provided most days; on own 2d per week) 450-600 kcal 
BMI 40-49.9  - 1800 kcal daily 
• Breakfast 200-300 kcal  
• Mid-morning snack: 200 kcal 
• Lunch (provided most days) 450-600 kcal 
• Mid-Afternoon snack (on own) – 200 kcal 
• Dinner (provided most days) 450-600 kcal 
BMI 50+  - 2000 kcal daily 
• Breakfast 200-300 kcal  
• Mid-morning snack: 200 kcal 
• Lunch (provided most days) 450-600 kcal 
• Mid-Afternoon snack (on own) – 200 kcal 
 

 
9 
Protocol Version 5 (05/13/2022) 
• 
Dinner (provided 
most days) 450-
600 kcal 
• 
After-dinner 
snack: 200 kcal 
 
As described previously, 
study staff will run 
weekly EHR reports to 
identify when a 
participant is admitted to 
the hospital for delivery. 
About one week post-
EDD, a member of the 
study team will contact 
the participant via text 
or phone call to ensure 
that she has delivered 
and is still planning to 
participate. We will 
coordinate with the 
participant and/or other 
household member to 
initiate home delivery of 
MTMs within 2 weeks 
(14 days) of delivery. 
Once per week, for a period of 3 months, 10 MTM (5 lunches and 5 dinners) portioned to feed one adult and 
frozen for ease of storage will be delivered directly to the participant’s home by Providence Kitchen staff. MTM 
deliveries will include reheating instructions and recipe cards with nutritional information.  During the monthly 
phone visits with a member of the study team, participants in the MTM treatment group will also be given the 
opportunity to provide feedback on the weekly meal delivery, food preparation, and troubleshoot any potential 
issues with this component of the intervention.  
 
b. Usual Care Comparison Group 
As in the MTM group, participants will be contacted by a member of the study team via text or phone call to 
ensure that she has delivered and is still planning to participate before the email/phone visit schedule is initiated.  
 The current standard of care for Wake Forest patients who had GDM during pregnancy includes no additional 
follow-up or intervention in the postpartum period. The monthly phone visits and weekly emails described 
above will therefore be significantly more intervention than they would normally receive. In addition, 
participants in the comparison group will receive written materials on self-care, nutrition, and exercise after 
pregnancy and community resources for healthy living. They will also receive specific information about 
following a diet consistent with recommendations from the American Diabetes Association for women who 
have been diagnosed with GDM, including forming their meals with roughly 40% carbohydrate, 30% protein, 
and 30% fat in composition and what their calorie goal should be for the day based on their BMI category.  
Participants in the comparison group will also receive the ADA placemat and electronic scale, as mentioned 
above.  
 
Participants will receive $50 and $75 grocery store gift cards upon return of the CGM devices at the end of the 
first and second CGM data collection, respectively ($125 total). Additionally, participants in the comparison 
Table 3.  Measures to be Collected 
  
Visit 
Primary Measures or Constructs  
Screening 
Baseline 
Intervention 
Follow-Up 
Study evaluation of acceptability 
  
  
  
x 
Process measures 
 
 
 
x 
CGM 
  
x 
  
x 
Secondary Measures of Constructs 
 
 
 
 
Maternal and infant anthropometrics 
  
x 
x  
x  
Rapid Eating Assessment for Participants (REAP-S) 
  
x 
  
x 
Food Insecurity 
  
x 
  
x 
Awareness of GDM, management 
  
x 
  
  
Diet-related comorbidities 
x 
  
  
  
Infant feeding plans and practice 
  
x 
  
x 
Financial stress 
  
x 
  
  
Overall stress 
  
x 
  
  
Confusion Hubub and Order Scale (CHAOS) 
  
x 
  
  
Plans for weight-loss 
  
x 
  
  
Health literacy 
  
x 
x 
  
Social support 
  
x 
  
x 
Data collection for recruitment and retention 
 
 
 
 
Pregnancy, delivery history 
  
x 
  
  
OGTT 
x 
  
  
  
Demographics 
  
x 
  
  
 
 
 
 
 

 
10 
Protocol Version 5 (05/13/2022) 
group will also receive 2 weeks (20 meals) of medically tailored meals from Providence Community Kitchen at 
the conclusion of their participation in the study. These meals will be delivered to the participant’s home in a 
single delivery or will be available for pick-up.  
 
G. Measures 
Measures in this study have been selected to reflect the feasibility, acceptability, and preliminary effectiveness 
objectives of this pilot study and include participant self-reported constructs, existing medical history and 
pregnancy history information from the EHR, and data collected directly via CGM. A table outlining the time 
points at which each measure is collected and the mode of collection is included in Table 3.  
 
Demographics: We are collecting self-reported data on gender, race, ethnicity, highest level of education, 
marital status, and the number of adults and children living in the home. 
 
Continuous Glucose Monitoring: Participants will wear a blinded FreeStyle Libre Pro CGM at baseline (first 2 
weeks after delivery) and at follow up (after 3 months). CGM devices will be mailed to participants and a 
member of the study team will video call participants to provide instructions and real time guidance on 
attachment and activation of the CGM. In order to facilitate collecting baseline post-partum CGM data and 
weight, this call will occur as close to the actual date of delivery as is possible. The participants will wear the 
CGM for 14 days at the beginning (initial month) and end (3 months) of the study. They will also keep a daily 
diary of the timing of meals, sleeping, and exercise (Appendix C). Study staff will call participants on day 14 to 
remind them to remove the sensor and provide instructions and guidance if needed for removal.  At the 
conclusion of the 3 months, an abbreviated remote virtual visit to aid in placement and activation of the second 
continuous glucose monitor will be conducted.  Participants will return the continuous glucose monitors, 
readers, and daily diaries to the study coordinator by mail using prepaid mailers. A 1-page report with a 
summary of the 14-day glucose data (graph of glucose values with information on the normal range) will be 
provided back to participants together with a cover letter for them to share with their health care provider if they 
choose. 
 
Table 4 shows the guideline-based CGM measures that we will analyze,17 using time in range 70-180 mg/dL, 
expecting that deviations in time in range will be lower both in duration and in amplitude for those with GDM 
than is typically seen in those with Type 2 Diabetes Mellitus. We will also investigate changes in glucose 
management indicator, an estimated measure of HbA1c from the CGM.18 We will also combine timestamped 
CGM data with diary responses about sleep and meal timing to describe: maximum postprandial glucose peak, 
steepness of glucose trajectories including increase and decrease, and nighttime hypoglycemic dipping during 
sleep and response to exercise.  
 
During CGM wear time, participants will complete daily diaries documenting the timing of sleeping, waking, 
eating, and exercise. Only the time of the activity start will be recorded with no additional details. Start time of 
the CGM device will be recorded for the purpose of combining these data sources. These diaries were 
unanimously considered easy 
to complete by participants in a 
previous study.19 The diaries 
will allow us to investigate 
additional diurnal glucose 
metrics that might be related 
more strongly to MTMs 
including postprandial glucose 
spikes, nocturnal dipping 
Table 4. Standardized CGM Metrics for Clinical Care 
Measure 
Explanation 
Mean Glucose 
  
Glucose Management Indicator (GMI) 
Roughly equivalent to HbA1c 
Glycemic Variability (% coefficent of variation) 
Target < 36% 
Time in range (%) 
70 mg/dL < time < 180 mg/dL 
Time above range (%) 
180 mg/dL , time 
Time below range (%) 
Time < 70 mg/dL 

 
11 
Protocol Version 5 (05/13/2022) 
during sleep, and response to exercise. 
 
Anthropometrics: Maternal height, infant weight, and infant length will be collected from the EHR at baseline. 
Maternal weight will be collected within 2 weeks of delivery, at 2 months, and at 3 months using a digital scale 
mailed to the participant and facilitated by a member of the study team during the study telephone/virtual visit. 
In addition to collecting a maternal weight, participants will be provided instructions to weight their infant at the 
initial post-partum visit. We anticipate that some participants may not want to know their post-partum weight or 
could experience a negative emotional response to seeing that weight; therefore, participants will be provided 
with digital scales (BodyTrace) that will transmit weight data via cellular connection. These scales will transmit 
the data electronically to a digital platform (Carium) that will then provide aggregate data on all study 
participants to the study team.  The display feature of the scale will be covered to prevent either the maternal 
weight or infant weight being displayed to the participant.  
 
Medical History: Information on history of chronic diseases and other serious health conditions will be 
collected from the EHR in order to implement the eligibility criteria. Additionally, we will ask participants 
about their diagnosis of GDM during the current pregnancy, the strategies they may have employed to manage 
GDM, and their past pregnancy history.  
 
Home environment: Participating women will complete the Confusion, Hubbub, and Order Scale (CHAOS). 
The CHAOS measure includes 15 items and is designed to capture environmental confusion in the home.20 In 
addition, participants will be asked to answer a series of questions about financial stress and food insecurity.21 
 
Dietary Habits and Quality: We will evaluate diet quality and dietary habits using a short, validated 
questionnaire, the Rapid Eating and Activity Assessment for Participants Short Version (REAP-S).22 The 
REAP-S was originally developed as a tool for primary care to providers rapidly assess and discuss nutrition 
and physical activity patterns with patients and consists of 16 questions and designed to focus making it more 
practical for use with low-literacy populations in clinical settings. The REAP-S can be used to quickly assess 
the relative intake of fat, cholesterol, fiber, sugar, and selected food groups. 
 
Overall Stress: We will use the Stress Overload Scale-Short (SOS-S), a self-report measure that has 
demonstrated accuracy in identifying people who will develop stress-related pathology in the wake of stressful 
experiences.23 The SOS-S is also frequently used as a viable diagnostic tool for stress and stress-related 
disorders across diverse populations in the clinical setting.23  
 
Plans for Weight-Loss: We will collect a series of questions on satisfaction with weight-status, plans to lose 
weight post-partum, motivation level for weight-loss, and self-efficacy for weight-loss at baseline for all 
participants.  
  
Health Literacy: We plan to use a series of single-item questions to assess confidence in filling out medical 
forms, frequency with which participants need help to read health information, and to rate their own reading 
ability. These questions have been validated for identifying patients with inadequate and marginal literacy in 
healthcare settings with limited time for administration.24 
 
We will also administer the Newest Vital Sign (NVS) to participating women as part of the monthly phone visit 
in month 2. The NVS is based on a nutrition label from an ice cream container and is designed to gauge ability 
to understand food labeling and nutrition literacy.25 Women will be provided the label via mail or email prior to 
the visit then asked 6 questions about it.   
 

 
12 
Protocol Version 5 (05/13/2022) 
Social Support: We plan to collect the Lubben Social Network Scale (LSNS-6) to assess social support in study 
participants at both baseline and 3-months post-partum.26 Originally developed as a measure of social isolation 
in seniors, this measure has been previously validated in post-partum populations.26  
 
Process measures: In order to assess the feasibility of the MTM intervention, we will collect information from 
Providence Kitchen on the number of meals successfully delivered, the cost of meal preparation and meal 
delivery, any problems encountered with meal delivery, and nutritional information on the meals (kCal per 
meal, macronutrient composition and sodium content). In both treatment groups, we will assess the 
acceptability of other intervention components including the number of videos watched and the number of 
monthly phone visits completed. To assess the feasibility of CGM in this population, we will quantify the 
number of days the CGM was worn by each participant and collect data on any technical problems with the 
CGM devices or Adverse Events reported. 
 
Study Evaluation: Follow-up data collection will also include a brief exit evaluation to determine general 
satisfaction/dissatisfaction with the MTM intervention, written/video education materials, CGM monitoring, 
and overall study experience. 
 
H. Analytical Plan 
Since this pilot study is primarily about feasibility, analysis will be limited. We will describe baseline 
characteristics including demographics and cardiometabolic risk factors by CGM metrics. We will use mixed 
models with a random subject effect to estimate change in glucose metric variables across follow up with 
adjustment for demographics and other relevant confounders of dysglycemia. We will assess differences in 
CGM metric changes between participants receiving the MTM intervention and controls with independent 
sample t-tests. We will conduct similar analysis for change in weight. 
 
 
I. Data Management 
Case report forms and interviewer-administered questionnaires will be collected on paper and will be reviewed 
for completeness and accuracy in real time by the study staff during the visit. These forms will then be data 
entered by the study team member. Participant self-administered questionnaires will be emailed directly to the 
participant for completion prior to each data collection visit. We will use the Research Electronic Data Capture 
(REDCap) system for secure, web-based data entry and management. Use of the REDCap system allows real-
time monitoring and reporting of study accrual, data collection, and retention rates. If needed, data can be 
securely downloaded directly by study team members for use in analyses. All data will reside securely within 
REDCap, and will not be linked to any other servers or analytic programs. 
 
Electronic data are managed centrally, with a feedback mechanism through e-mail and web-based reporting. 
After reviewing forms for gross errors and missing data, study staff enters data from case report forms and 
interviewer-administered questionnaires through a web browser. No electronic data are housed locally, but 
automated data reports are available for the staff to request on-line. Validation checks are applied during the 
data entry process. These checks include intra- and inter-form checks for consistency of responses, range 
checking, and checks for required fields and skip patterns.  
 
Participants will be enrolled and assigned IDs through the REDCap interface. Once inclusion and exclusion 
criteria are verified and the informed consent is completed, study staff will enroll participants and receive IDs 
immediately. Data collection and participant status will be tracked with a web-based interface.  
 

 
13 
Protocol Version 5 (05/13/2022) 
The REDCap data management system will also provide confidentiality and data security. A very high level of 
data encryption during transmission (128 bit) coupled with the use of IDs, rather than subject names, provides 
adequate data security. The use of text containing identifying information is avoided.  
 
J. Human Subjects Protection 
Potential risks to participants due to the proposed research are minimal. The medically tailored meals will be 
designed in consultation with a dietitian from the Endocrinology Department to follow American Diabetes 
Association guidelines and be appropriate for the initiation and maintenance of breastfeeding. Continuous 
glucose monitoring systems are considered minimally invasive, involving a sensor probe placed in the 
subcutaneous tissue to measure glucose levels in the interstitial fluid, with risks primarily including infection at 
device insertion site and skin irritation from tape used to secure the device. 
 
Setup and removal of the continuous glucose monitors will happen with real time virtual support and guidance 
from a highly trained study coordinator. Dr. Joseph Aloi is a practicing endocrinologist with extensive 
experience managing continuous glucose monitor devices. He will supervise the continuous glucose data 
collection and assess each resulting report for safety concerns. If necessary, he will contact participants directly 
with results that indicate the need for medical follow up; However, there are no alerts as the data are not 
available in real-time and the data collected are not clinically actionable at the time of the data download.  
 
The investigators for the proposed research will receive only de-identified data and will have no contact with 
participants unless necessitated by participant need. This study poses minimal risk of loss of confidentiality for 
participants, but we will use data safety best practices to ensure that participant data remain secure and 
confidential. 
 
a. Subject Recruitment Methods 
Participants will be screened for eligibility through the Obstetric Department at Wake Forest Baptist Health by 
obtaining a list of eligible patients from the EHR. The study coordinator will call potential participants to 
confirm eligibility and determine interest in volunteering for the study. All communication between the study 
coordinator and potential participants will be kept strictly confidential. Any information obtained during 
recruitment and screening from individuals who decline to participate will be destroyed at the end of the study.  
 
b. Informed Consent 
Informed consent will be obtained remotely for all participants. We will use a Zoom (or other web-based 
platform) meeting to perform web-based informed consent. At the outset of the consent meeting, we will email 
prospective participants a link to a pdf version of the informed consent document. We will ask them to share 
their screen and open the consent form, which we will review with them, reviewing all required elements of 
consent, the content of the study, assessing for understanding and answering any questions they have. If the 
participant requests additional time to review the consent form, we will schedule a follow-up meeting as needed 
for signing. In order for weight to be measured remotely, we are planning to provide participants with a digital 
scale that will be used to transmit weight measurements directly to Carium, Inc., an internet-based platform 
used in the clinical setting to deliver telehealth or remote patient monitoring. In order to link the digital scale to 
a specific participant, members of the study team will register the scale and sync it to the Carium website before 
shipping to the participant. Only the study identification number will be registered to link the scale; no 
identifying information for participants will be provided to Carium  The consent form includes information on 
the digital scale and Carium website. We have also included an option for participants to receive study 
communication via SMS text message in the consent form.  
 
Once that process is complete, we will ask the participant to sign the consent document using the “pencil” 
function in their iPhone or computer’s pdf viewer, save the signed copy and email it back to our research staff. 

 
14 
Protocol Version 5 (05/13/2022) 
At that point, the staff member will also sign and date the consent form, and save the form with both signatures 
in the study folder on the secure network drive to which only IRB-approved study staff have access. A copy of 
the signed consent will also be emailed or printed and mailed (participant preference) to the participant for their 
records. 
 
c. Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study outcomes, minimizing to 
the fullest extent possible the collection of any information that could directly identify subjects, and maintaining 
all study information in a secure manner.  To help ensure subject privacy and confidentiality, only a unique 
study identifier will appear on the data collection forms. Any collected patient identifying information 
corresponding to the unique study identifier will be maintained on a linkage file, store separately from the data. 
The linkage file will be kept secure, with access limited to designated study personnel.  Following data 
collection subject identifying information will be destroyed one year after study completion consistent with data 
validation and study design, producing an anonymous analytical data set. Data access will be limited to study 
staff.  Data and records will be kept locked and secured, with any computer data password protected. No 
reference to any individual participant will appear in reports, presentations, or publications that may arise from 
the study. In order to complete data collection and intervention activities, participant names and contact 
information will be provided to Providence Kitchen for meal delivery in the MTM arm. The consent form 
includes language notifying the participants of this process and assuring them that no health information will be 
provided to Providence Kitchen. 
 
K. Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of study 
participants.  The principal investigator will be assisted by other members of the study staff. In addition, the 
Institutional Data and Safety Monitoring Board (I-DSMB) available through the Wake Forest Clinical and 
Translational Science Institute will provide independent oversight for this study. Adverse events and safety 
alerts that are reported during any participant contact or study activity will be logged and submitted to the 
DSMB and IRB. 
 
 
L. Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will be 
promptly reported by the principal investigator or designated member of the research team to the DSMB, IRB, 
and sponsor or government agency where appropriate. 
 
 
 
 

 
15 
Protocol Version 5 (05/13/2022) 
 
References 
 
1. 
Williams D. Pregnancy: a stress test for life. Current opinion in obstetrics & gynecology. 
2003;15(6):465-471. 
2. 
Gilmore LA, Klempel-Donchenko M, Redman LM. Pregnancy as a window to future health: Excessive 
gestational weight gain and obesity. Seminars in perinatology. 2015;39(4):296-303. 
3. 
Sullivan SD, Umans JG, Ratner R. Gestational diabetes: implications for cardiovascular health. Current 
diabetes reports. 2012;12(1):43-52. 
4. 
CDC. QuickStats: Gestational Weight Gain Among Women with Full-Term, Singleton Births, 
Compared with Recommendations - 48 States and the District of Columbia, 2015. . MMWR Morb 
Mortal Wkly Rep 2016;65:1121. 
5. 
Dickens LT, Thomas CC. Updates in Gestational Diabetes Prevalence, Treatment, and Health Policy. 
Current diabetes reports. 2019;19(6):33. 
6. 
Institute of Medicine. Weight Gain During Pregnancy: Reexamining the Guidelines. Washington (DC): 
National Academy of Sciences; 2009. 
7. 
Gunderson EP, Sun B, Catov JM, et al. Gestational Diabetes History and Glucose Tolerance After 
Pregnancy Associated With Coronary Artery Calcium in Women During Midlife: The CARDIA Study. 
Circulation. 2021;143(10):974-987. 
8. 
13. Management of Diabetes in Pregnancy. Diabetes care. 2017;40(Suppl 1):S114-s119. 
9. 
Gunderson EP. Childbearing and obesity in women: weight before, during, and after pregnancy. 
Obstetrics and gynecology clinics of North America. 2009;36(2):317-332, ix. 
10. 
McKinney J, Keyser L, Clinton S, Pagliano C. ACOG Committee Opinion No. 736: Optimizing 
Postpartum Care. Obstetrics and gynecology. 2018;132(3):784-785. 
11. 
Masho SW, Cha S, Karjane N, et al. Correlates of Postpartum Visits Among Medicaid Recipients: An 
Analysis Using Claims Data from a Managed Care Organization. Journal of women's health (2002). 
2018;27(6):836-843. 
12. 
Berkowitz SA, Terranova J, Randall L, Cranston K, Waters DB, Hsu J. Association Between Receipt of 
a Medically Tailored Meal Program and Health Care Use. JAMA internal medicine. 2019;179(6):786-
793. 
13. 
Palar K, Napoles T, Hufstedler LL, et al. Comprehensive and Medically Appropriate Food Support Is 
Associated with Improved HIV and Diabetes Health. Journal of urban health : bulletin of the New York 
Academy of Medicine. 2017;94(1):87-99. 
14. 
Berkowitz SA, Delahanty LM, Terranova J, et al. Medically Tailored Meal Delivery for Diabetes 
Patients with Food Insecurity: a Randomized Cross-over Trial. Journal of general internal medicine. 
2019;34(3):396-404. 
15. 
Berkowitz SA, Terranova J, Hill C, et al. Meal Delivery Programs Reduce The Use Of Costly Health 
Care In Dually Eligible Medicare And Medicaid Beneficiaries. Health affairs (Project Hope). 
2018;37(4):535-542. 
16. 
Swinburne M, Garfield K, Wasserman AR. Reducing Hospital Readmissions: Addressing the Impact of 
Food Security and Nutrition. The Journal of law, medicine & ethics : a journal of the American Society 
of Law, Medicine & Ethics. 2017;45(1_suppl):86-89. 
17. 
Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data 
Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes care. 
2019;42(8):1593-1603. 
18. 
Bergenstal RM, Beck RW, Close KL, et al. Glucose Management Indicator (GMI): A New Term for 
Estimating A1C From Continuous Glucose Monitoring. Diabetes care. 2018;41(11):2275-2280. 

 
16 
Protocol Version 5 (05/13/2022) 
19. 
Mongraw-Chaffin M, Beavers DP, McClain DA. Hypoglycemic symptoms in the absence of diabetes: 
Pilot evidence of clinical hypoglycemia in young women. Journal of clinical & translational 
endocrinology. 2019;18:100202. 
20. 
Matheny AP J, Wachs TD, Ludwig JL, Phillips K Bringing order out of chaos: psychometric 
characteristics of the confusion, hubbub, and order scale Journal of Applied Developmental Psychology. 
1995;16(3):429–444. 
21. 
Blumberg SJ, 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(8):1231-1234. 
22. 
Johnston CS, Bliss C, Knurick JR, Scholtz C. Rapid Eating Assessment for Participants [shortened 
version] scores are associated with Healthy Eating Index-2010 scores and other indices of diet quality in 
healthy adult omnivores and vegetarians. Nutrition journal. 2018;17(1):89. 
23. 
Amirkhan JH. A Brief Stress Diagnostic Tool: The Short Stress Overload Scale. Assessment. 
2018;25(8):1001-1013. 
24. 
Powers BJ, Trinh JV, Bosworth HB. Can this patient read and understand written health information? 
Jama. 2010;304(1):76-84. 
25. 
Weiss BD, Mays MZ, Martz W, et al. Quick assessment of literacy in primary care: the newest vital 
sign. Annals of family medicine. 2005;3(6):514-522. 
26. 
Mandai M, Kaso M, Takahashi Y, Nakayama T. Loneliness among mothers raising children under the 
age of 3 years and predictors with special reference to the use of SNS: a community-based cross-
sectional study. BMC Women's Health. 2018;18(1):131. 
 
 
 

 
17 
Protocol Version 5 (05/13/2022) 
Appendix A. Example Weekly MTM Menu (10 meals) 
 
 
 
 
 
Grilled Chicken w/Sundried Tomato Pesto
Beef Pot Roast
Brocolli w/lemon
Mashed Potatoes
WG Pasta w/Roasted Red Peppers & Garlic 
Glazed Carrots
Salisbury Steak w/Mushrooms & Onion
Cheese & Turkey Pepperoni Pizza
Roasted Potatoes 
Squash Medley
Southern Green Beans
White Bean Chicken Chilli
Roast Turkey
Brown Rice
Stuffing, Gravy
Corn Niblets
Butternut Squash
Alaskan Salmon w/lemon butter
Chicken Parm
Asparagus Spears
WG Pasta Marinara
Quinoa Pilaf
Roasted Brussel Sprouts
Pork Loin w/Apples
Pit Ham
Braised Red Cabbage
Yams
Noodles (WG)
Green Breans
All items include 6 ounces of protein, 4 ounces of vegetable and I cup of whole grain at a minimum.  

 
18 
Protocol Version 5 (05/13/2022) 
Appendix B. Example Nutrition Information 
 
 
 
 

 
19 
Protocol Version 5 (05/13/2022) 
Appendix C. Continuous Glucose Monitoring Diary 
 
 
Study Diary 
 
Participant ID: 
 
________________________ 
 
Which glucose monitor?  1st?________  OR 2nd?___________ 
 
Date of glucose monitor placement:_______________________ 
 
Time of glucose monitor placement:_______________________ 
 
Date of glucose monitor removal:_________________________ 
 
Time of glucose monitor removal:_________________________ 
 
 
 
 
 
 
 
 
 
 

 
20 
Protocol Version 5 (05/13/2022) 
Day 1 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
Ex: 8:00am 
Breakfast        
3:00pm      
Snack         
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 2 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 

 
21 
Protocol Version 5 (05/13/2022) 
 
Day 3 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 4 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 

 
22 
Protocol Version 5 (05/13/2022) 
What time did I go to sleep today?   
 
____________ 
 
Day 5 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 6 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 

 
23 
Protocol Version 5 (05/13/2022) 
 
What time did I go to sleep today?   
 
____________ 
 
Day 7 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 8 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 

 
24 
Protocol Version 5 (05/13/2022) 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 9  
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 10 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 

 
25 
Protocol Version 5 (05/13/2022) 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 11 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 12 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 

 
26 
Protocol Version 5 (05/13/2022) 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 13 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________ 
 
Day 14 
What time did I wake up today?   
 
____________ 
 
What time did I eat today?  (include all meals and snacks) 
 
Time  
Meal  
 
Time  
Meal  
 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
_________ 
___________  
_________ 
____________ 
 
What time did I exercise today? 
 
I did not exercise today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 

 
27 
Protocol Version 5 (05/13/2022) 
What time did I nap today?  
                           I did not nap today. 
Time  
Activity 
 
 
 
 
 
_________ 
_____________________________________________ 
 
_________ 
_____________________________________________ 
 
 
What time did I go to sleep today?   
 
____________