Feasibility of a Meal Delivery Intervention for Postpartum Weight Management
Phase: NA
Conditions: Postpartum Weight Retention, Obesity
Sponsor: University of Alabama at Birmingham

Feasibility of a meal delivery intervention for postpartum 
weight management 
 
 
Study Protocol & Statistical Analysis Plan 
 
NCT05579990 
 
 
Date of Last Protocol Approval: 4/10/2025 
 
 
Camille Worthington, Assistant Professor, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 

  
Feasibility of a meal delivery intervention for 
postpartum weight management 
 
Principal Investigator: Camille Schneider Worthington 
Sponsor: NIMHD 
National Clinical Trial (NCT) Identified Number:  NCT05579990 
 
Version Number:  v1.0 
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
1.2 
Schedule of Activities (SoA) ............................................................................................................... 2 
2 
INTRODUCTION ............................................................................................................................................ 3 
2.1 
Study Rationale .................................................................................................................................... 3 
2.2 
Background........................................................................................................................................... 3 
2.3 
Risk/Benefit Assessment .................................................................................................................... 5 
2.3.1 
Known Potential Risks ..................................................................................................... 5 
2.3.2 
Known Potential Benefits ................................................................................................ 6 
3 
STUDY DESIGN ............................................................................................................................................. 6 
3.1 
Overall Design ...................................................................................................................................... 7 
3.2 
End of Study Definition ....................................................................................................................... 7 
4 
STUDY POPULATION .................................................................................................................................. 7 
4.1 
Inclusion Criteria .................................................................................................................................. 7 
4.2 
Exclusion Criteria ................................................................................................................................. 8 
4.3 
Screen Failures .................................................................................................................................... 8 
4.4 
Strategies for Recruitment and Retention ........................................................................................ 8 
5 
STUDY INTERVENTION .............................................................................................................................. 9 
5.1 
Study Intervention(s) Administration ................................................................................................. 9 
5.1.1 
Study Intervention Description ....................................................................................... 9 
5.1.2 
Dosing and Administration ............................................................................................ 10 
5.2 
Measures to Minimize Bias: Randomization ..................................... Error! Bookmark not defined. 
5.3 
Study Intervention Compliance ........................................................................................................ 10 
5.4 
Concomitant Therapy ........................................................................... Error! Bookmark not defined. 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL .................................................................................................................... 10 
6.1 
Discontinuation of Study Intervention ............................................................................................. 10 
6.2 
Subject Discontinuation/Withdrawal from the Study ..................................................................... 10 
6.3 
Lost to Follow-Up ............................................................................................................................... 11 
7 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 11 
7.1 
STUDY Assessments ........................................................................................................................ 11 
7.2 
Adverse Events and Serious Adverse Events ............................................................................... 14 
7.2.1 
Definition of Adverse Events (AE) ............................................................................... 14 
7.2.2 
Definition of Serious Adverse Events (SAE) .............................................................. 14 
7.2.3 
Classification of an Adverse Event .............................................................................. 14 
7.2.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 15 
7.2.5 
Adverse and serious adverse Event Reporting ......................................................... 15 
7.3 
Unanticipated Problems .................................................................................................................... 16 
7.3.1 
Definition of Unanticipated Problems (UP) ................................................................. 16 
7.3.2 
Unanticipated Problem Reporting ................................................................................ 16 
8 
STATISTICAL CONSIDERATIONS .......................................................................................................... 16 
8.1 
Statistical Hypotheses ....................................................................................................................... 17 
8.2 
Sample Size Determination .............................................................................................................. 17 

  
8.3 
Statistical Analyses............................................................................................................................ 17 
8.3.1 
General Approach .......................................................................................................... 17 
8.3.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 17 
8.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 17 
8.3.4 
Safety Analyses .............................................................................................................. 18 
8.3.5 
Baseline Descriptive Statistics ..................................................................................... 18 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 18 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 18 
9.1.1 
Informed Consent Process ........................................................................................... 18 
9.1.2 
Study Discontinuation and Closure ............................................................................. 19 
9.1.3 
Confidentiality and Privacy ........................................................................................... 19 
9.1.4 
Quality Assurance and Quality Control ....................................................................... 19 
9.1.5 
Data Handling and Record Keeping ............................................................................ 20 
9.1.6 
Protocol Deviations ........................................................................................................ 20 
9.1.7 
Conflict of Interest Policy .............................................................................................. 21 
9.2 
Abbreviations ...................................................................................................................................... 22 
10 
REFERENCES ............................................................................................................................................. 23 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR). The Principal 
Investigator will assure that no deviation from, or changes to, the protocol will take place without prior 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial subjects. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both the 
protocol and the consent form must be obtained before any subject is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to the study. 
All changes to the consent form will be IRB approved; a determination will be made regarding whether a 
new consent needs to be obtained from subjects who provided consent, using a previously approved 
consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Feasibility of a meal delivery intervention for postpartum weight 
management 
Study Description: 
This is a single-group pilot study to assess the feasibility and acceptability 
of a meal delivery intervention among low-income postpartum women 
with obesity. 
Objectives: 
 
The objectives of the study are to assess the feasibility and acceptability of 
a meal delivery intervention among low-income postpartum mothers with 
obesity. 
Endpoints: 
The primary endpoint is participant adherence to the 8-week study 
intervention. 
Study Population: 
Participants will be 11 mothers who are 5-45 weeks postpartum, have 
obesity, and qualify for Medicaid or the Special Supplemental Nutrition 
Program for Women, Infants, and Children (i.e., have a household income 
at or below 185 percent of the federal poverty line). 
Phase: 
N/A 
Description of Study 
Intervention: 
An 8-week meal delivery intervention consisting of 10 home-delivered 
meals per week provided by a local meal delivery company supplemented 
by remote weekly behavioral support with study staff to help low-income 
postpartum women with obesity lose weight. 
Study Duration: 
8-weeks 
Subject Duration: 
8-weeks 
 
 
 
 

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1.2 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Enrollment/ 
Baseline 
Weekly during Meal 
Delivery Intervention 
8-weeks 
(Follow-Up) 
Demographics 
X 
 
 
Pregnancy & Medical History 
X 
 
 
Intervention Adherence Survey 
 
X 
 
Diet Satisfaction (Diet Satisfaction 
Questionnaire; DSAT-28)1 
X 
 
X 
Anthropometrics (weight, height) 
X 
 
X 
Food Security (18-item US 
Household Food Security Survey 
Module) 
X 
 
X 
Perceived Stress (10-item 
Perceived Stress Scale; PSS-10)2,3 
X 
 
X 
Healthy Eating Self-Efficacy (from 
Lipsky LM et al. 2016)4 
X 
 
X 
Weight Control Self-Efficacy (from 
Lipsky LM et al. 2016)4 
X 
 
X 
 
 
 
 

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INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Many women fail to return to their pre-pregnancy weight postpartum (i.e., postpartum weight 
retention, PPWR).5-10 PPWR and interpregnancy weight gain are important predictors of long-term 
obesity risk.11-13 Despite gaining similar amounts of weight during pregnancy, Black women are more 
likely to retain and accrue considerable amounts of weight postpartum compared to White women.13-16 
PPWR and interpregnancy weight gain negatively impact maternal cardiometabolic health and increase 
risk for adverse outcomes in subsequent pregnancies which are more common among Black women and 
those of lower socioeconomic status.17-24 Black and lower income women are also disproportionately 
burdened by obesity,25 which further increases the risk for PPWR, interpregnancy weight gain, and 
adverse health outcomes.26-28 Behavioral interventions to prevent PPWR have had limited success, 
particularly among women with obesity.29-32 Most PPWR interventions involve high participant burden 
and fail to sufficiently address both the psychological (e.g., low self-efficacy) and material (e.g., food 
insecurity) barriers and needs of low-income, minority women.31-36 One promising and novel alternative 
approach capable of overcoming many of these barriers is the provision of healthy, home-delivered 
meals. In non-pregnant populations, meal delivery has been used to help manage various conditions 
including obesity with cost-effective and encouraging results.37-43 Importantly, meal delivery for 
postpartum weight management may be sustainable given the cost-savings demonstrated in other 
populations and the recent expansion by public and private insurers to cover home-delivered 
meals.41,42,44-46 Despite demonstrated success for managing other medical conditions, meal delivery for 
managing postpartum weight has not been studied.37-43,47 Thus, the purpose of the proposed pilot study 
is to assess the feasibility and acceptability of a meal delivery intervention for postpartum weight loss 
among predominantly Black and low-income postpartum women with obesity using a single-group 
design. Findings from this pilot study will inform future refinements to the intervention which we plan to 
test and further refine in a future pilot study. 
 
2.2 
BACKGROUND  
 
An estimated 60-75% of women fail to return to their pre-pregnancy weight (i.e., postpartum weight 
retention, PPWR) and up to 60% of women actually gain weight postpartum. 5-10 PPWR and 
interpregnancy weight gain are important predictors of long-term obesity risk.11-13 Women of lower 
socioeconomic status and from racial/ethnic minority groups are disproportionately affected13 and 
represent “priority populations” (i.e., those deserving priority in public health and clinical efforts).48 
Despite gaining similar amounts of weight during pregnancy,13 Black women are estimated to retain an 
average of 6.4 pounds more and are twice as likely to retain more than 20 pounds at 1-year postpartum 
compared to their White counterparts.14,15 Additionally, there is evidence of racial/ethnic differences in 
weight trajectories postpartum. On average, Black and White women lose similar amounts of weight 
across the first 6 weeks to 3 months postpartum, after which Black women exhibit gains in weight and 
body mass index (BMI) from 3 to 12 months postpartum while White women continue to lose weight 
across the first year postpartum.49,50 Women with lower levels of education and those of lower income 
have also been shown to be an increased risk of PPWR.5,7 This is extremely concerning, as excess weight 
retention or weight gain following pregnancy may be particularly harmful, given evidence of preferential 
central fat deposition postpartum.51-53 Visceral adipose tissue, which is associated with several 
cardiometabolic risk factors,54,55 is estimated to increase by 30-45% in the first year postpartum.51-53 

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PPWR and interpregnancy weight gain can exacerbate these unfavorable changes in body composition 
and cardiometabolic health, which can have important short- and long-term health implications.51,52,56,57 
PPWR and interpregnancy weight gain not only alter a woman’s future chronic disease trajectory, 
increasing the risk for new or worsening obesity,11,12,58 but also increase risk for adverse outcomes in 
subsequent pregnancies including hypertensive disorders of pregnancy,17 preterm delivery,18,19 and 
caesarean birth20,59 which are more common among women from priority populations.21-24 Black and 
lower income women are also disproportionately burdened by obesity,25 which further increases the risk 
for PPWR, interpregnancy weight gain, and adverse maternal-child health outcomes.26-28 Thus, there is 
great interest in effective interventions to improve postpartum weight management due to the 
important health implications for women and children, particularly among priority populations. 
 
Unfortunately, even the most intensive behavioral interventions, which typically focus on caloric 
restriction, improving diet, and/or increasing physical activity, have had limited success for PPWR, 
particularly among women with obesity.29-32,60 Based on meta-analyses, <2.5-kg weight reductions are 
observed with postpartum lifestyle intervention compared to standard care.29,30,32 Lifestyle interventions 
for PPWR also show high levels of attrition and poor intervention adherence.29-32,60 The postpartum 
period is important not only for maternal weight management and long-term obesity risk, but also for 
preparing women for healthy subsequent pregnancies as part of preconception planning. Entering 
subsequent pregnancies with excess adiposity increases the risk for PPWR,10,27 creating a cycle in which 
women accrue additional weight with each pregnancy, leading to new or worsening obesity.27 Exposure 
to maternal overweight/obesity in utero, in turn, increases the child’s subsequent risk for developing 
obesity,61,62 type 2 diabetes,63-65 and cardiovascular disease.66 Thus, postpartum weight management 
interventions are needed to promote healthy weight and prevent new or worsening obesity among 
mothers, as well as to prevent complications in subsequent pregnancies and reduce offspring long-term 
risk for obesity and chronic diseases.26,61,66 
 
Most postpartum weight management interventions are intensive, comprehensive, and involve high 
participant burden by requiring significant effort and psychological and physical resources (e.g., self-
regulation, time, financial means, access to healthy foods).32,33 Such interventions may not adequately 
address social determinants of health (SDH; e.g., income, education, race/ethnicity, access to care, 
residential environment) that contribute to disparities in PPWR and obesity in priority populations.67 
Most PPWR interventions also fail to address psychological (e.g., stress, low self-efficacy) and material 
(e.g., food insecurity, transportation) barriers of low-income and minority women.31-36 Achieving 
meaningful behavior change may be especially challenging postpartum, as women face additional 
stressors and barriers including lack of time for cooking/shopping, limited access to healthy food, and 
lack of basic cooking skills.31,34-36,68-70 Women with a higher BMI may have more perceived barriers and 
lower self-efficacy to healthy behavior change postpartum.70 A simplified approach targeting a few key 
behaviors may be particularly well-suited for under-resourced populations.71 Also, postpartum weight 
management strategies are needed that more effectively address insufficient and/or diminished effort 
and resources, which is particularly relevant for priority populations. 
 
Meal delivery overcomes many barriers common to postpartum weight management interventions that 
disproportionately burden priority populations. The provision of prepared meals to women’s homes 
offers access to healthy food, thereby providing a physical and financial resource to support healthy 
eating regardless of income, geographic location, or access to transportation. Meal delivery reduces 
time and effort involved for meal planning, shopping, and preparation and requires less cognitive and 
behavioral self-regulation. In addition, pre-portioned meals modify the home food environment, which 
can support healthy habit formation and improve weight outcomes.72,73 

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Previous studies in non-postpartum populations demonstrate that meal delivery is an effective tool for 
managing weight, type 2 diabetes, and cardiovascular disease.37-43 However, use of meal delivery to 
manage PPWR and promote the attainment of a health weight postpartum has not been studied. Meal 
delivery also has additional health benefits that may be particularly impactful postpartum. In non-
postpartum priority populations, the provision of home-delivered meals has been shown to improve 
food insecurity and self-efficacy, reduce stress, and participants report high levels of treatment 
satisfaction.40,74-78 These factors may have important implications for promoting healthy weight loss 
postpartum. For instance, food insecurity has been associated with PPWR, and this association may be 
stronger among women with obesity.79 There is also evidence that lower self-efficacy for healthy 
behaviors and weight control may be an important predictor of PPWR,4 and women with obesity are 
more likely to report lower self-belief in their ability to manage their weight postpartum.70 Similarly, 
perceived stress has been shown to predict weight retention following childbirth.80 Thus, by potentially 
improving these constructs, meal delivery may confer additional benefits for postpartum weight 
management. 
 
The purpose of the proposed pilot study is to assess the feasibility and acceptability of a meal delivery 
intervention among predominantly Black and low-income postpartum women with obesity using a 
single-group design. If meal delivery is effective for managing weight postpartum, it may be sustainable 
given the cost-savings demonstrated in other populations (e.g., individuals with type 2 diabetes, 
cardiovascular disease).37-41 In 2020, Medicare Advantage expanded to allow coverage of home-
delivered meals.44 More insurers are piloting meal delivery programs to address SDH for chronic disease 
management,45,46,81-84 with hundreds of contracts between medically-tailored meal providers and health 
insurance plans nationwide.85 A growing number of meal delivery programs are participating in 
healthcare innovation projects and receiving reimbursement for Medicaid, Medicare, and dually-eligible 
populations in at least 17 states.46,81 Thus, there is the long-term possibility for meal delivery for 
maternal weight management postpartum to be offered as a covered health care service, thereby 
providing an accessible community resource and shift in health care policies. 
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
This study involves providing a healthy meal delivery intervention to promote weight loss among low-
income mothers who are 5-45 weeks postpartum. Those with conditions that may put them at increased 
risk or unique nutritional needs that would make the meal delivery intervention inadvisable will be 
excluded. Although unlikely, participants may experience normal and temporary physiologic reactions or 
weight fluctuations associated with healthy dietary changes, such as flatulence (frequency: rare; 
severity: mild). There is a risk of experiencing an allergic reaction to meals, which is judged to be low as 
participants self-select meals from provided menus with ingredients. Additionally, participants will be 
asked to report any food allergies or intolerances at baseline and the PI (who is a registered dietitian) 
will work with the study’s meal delivery partner to accommodate participant food allergies and 
intolerances, as needed. Participants will also be provided with meal plans designed by the PI (who is a 
Registered and Licensed Dietitian) in accordance with current micronutrient and macronutrient 
recommendations for postpartum women. Participants will be instructed to self-weigh at least once per 
week during the study intervention using a study-provided scale and will be asked to report their weekly 
weight measurements using a Qualtrics survey sent via email each week of the study intervention. 

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Concerning weight fluctuations (e.g., weight gain) will be reported to and reviewed by the PI. 
Concerning weight fluctuations will be investigated and adjustments will be made to meal plans or study 
procedures, if necessary. Participants will also be closely monitored for any negative effects relating to 
the meal delivery intervention. Should it be determined that continued participation is contraindicated 
for a participant, they will be withdrawn from the study. Given that this is a non-invasive meal delivery 
intervention for postpartum weight management, we do not anticipate that withdrawals will be 
common. There is a risk of foodborne illness with meal delivery which is judged to be low as we are 
partnering with an experienced meal delivery company that operates in compliance with local, state, 
and federal food safety regulations. All meals will be delivered in insulated packaging with frozen gel 
packs to keep food cold in transit and meal delivery times will be scheduled with participants. In 
compliance with the Alabama Department of Public Health, home-delivered meals can be safely stored 
in the refrigerator for 7 days. Thus, fully prepared, refrigerated meals will be delivered once per week to 
participants’ homes. All meals will also come with re-heating instructions. In the unlikely event a 
participant experiences distress from completing any of the self-report surveys, she will be allowed to 
skip items or discontinue the assessment. There is a low risk of emotional or psychological discomfort 
from participants answering personal questions about their health, eating, and activity behaviors. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Participants will receive 10 healthy meals per week during the 8-week study at no cost to them. 
Participants in the study may feel less stress by saving time on planning, shopping, and preparing meals, 
improving food insecurity, and may feel good about themselves by eating a healthier diet postpartum. 
Having a healthier diet and less stress postpartum could have mental and physical health benefits 
postpartum. 
 
Meal delivery may reduce postpartum weight retention and improve cardiometabolic health 
management, diet quality, food security, stress, and reduce barriers to healthy eating postpartum. This 
is important give that approximately 60-75% of women fail to return to their pre-pregnancy weight (i.e., 
postpartum weight retention) and many women gain weight postpartum. Postpartum weight retention 
and interpregnancy weight gain are important predictors of long-term obesity risk. Postpartum weight 
retention and interpregnancy weight gain negatively impact maternal cardiometabolic health and 
increase risk for adverse outcomes in subsequent pregnancies which are more common among Black 
women and those of lower socioeconomic status. Black and lower income women are also 
disproportionately burdened by obesity, which further increases the risk for postpartum weight 
retention, interpregnancy weight gain, and adverse health outcomes. To-date, traditional diet and 
weight management programs for postpartum women have been largely unsuccessful. Thus, promotion 
of healthy diet and postpartum weight loss may improve these outcomes. Participation in this study may 
enhance our understanding of meal delivery as a strategy for improving maternal health among 
underserved populations. Given the health risks associated with postpartum weight retention and 
interpregnancy weight gain, and the challenges of successful weight management postpartum, such 
information is clinically relevant and has potential for public health impact. Ultimately, results could 
inform public policy to leverage programs and/or modify insurance coverage to promote sustainability, 
which would have a meaningful public health impact on both short and long-term maternal health. 
 
 
3 
STUDY DESIGN  
 

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3.1 
OVERALL DESIGN 
  
This is a single-group intervention trial in which mothers who are 5-45 weeks postpartum and enroll in 
the trial will receive 10 meals per week for a total of 8-weeks. 
 
Potentially eligible participants will be primarily recruited through the UAB Center for Women’s 
Reproductive Health (CWRH). CWRH nursing staff will prescreen medical records of participants who 
delivered at UAB. Potentially eligible women will be approached in the postpartum recovery unit 
following delivery or at their 6-week postpartum appointment by a CWRH research nurse and told about 
the study. Interested women who meet initial eligibility criteria will be contacted by study staff at 5-45 
weeks postpartum to complete a secondary pre-screening via telephone to confirm eligibility. 
Supplemental recruitment will occur via flyers/ads distributed at UAB obstetrics/gynecological offices, 
UAB pediatrics clinics, UAB lactation centers, UAB Nurse Family Partnership, local day care centers and 
churches, local breastfeeding and/or parent support groups, and Birmingham neighborhood 
associations. Interested women will respond via phone call or email to the public advertisements and be 
screened by phone. 
 
Interested and eligible women will be scheduled to attend an Enrollment/Baseline Assessment visit 
during which informed consent will be completed. Those who consent to enroll in the study will then 
complete baseline study measurements including surveys and anthropometrics. 
 
Within 1-2 weeks of completing the baseline assessment, participants will receive their first study meal 
delivery order. All participants will receive the study meal delivery intervention for a total of 8-weeks. 
During the study intervention, participants will be emailed a weekly Qualtrics survey to complete to 
report intervention adherence. 
 
During the final week of the study meal delivery intervention, participants will complete Follow-up 
(week 8) assessment visit measurements, including surveys and anthropometrics. 
 
3.2 
END OF STUDY DEFINITION 
 
While Primary Completion will be defined as the date of the week 8 follow-up assessment data 
collection of the last participant, the End of Study will be the date of completion of the participant 
medical record data abstraction, as these data will provide necessary data to characterize postpartum 
weight retention and necessary covariates for the conduct of our statistical analyses (e.g., accounting for 
gestational weight gain). 
 
 
4 
STUDY POPULATION 
 
4.1 
INCLUSION CRITERIA 
 
To be eligible women must meet the following inclusion criteria: 
• 
Medicaid eligible and/or have a household income at or below 185 percent of the federal 
poverty line 
• 
18 years of age or older 

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• 
Initiated prenatal care at a University of Alabama at Birmingham prenatal clinic 
• 
Experienced a healthy singleton pregnancy 
• 
5-45 weeks postpartum at enrollment 
• 
Body mass index of 30 kg/m2 or greater at enrollment 
• 
Residing within the meal company's delivery radius 
• 
Willing to consent 
 
4.2 
EXCLUSION CRITERIA 
 
• 
Self-reported major health condition (such as renal disease, cancer, or Type 1 or Type 2 
diabetes) 
• 
Current treatment for severe psychiatric disorder (such as schizophrenia) 
• 
Past or current diagnosis of anorexia or bulimia 
• 
Current use of medication expected to significantly impact body weight 
• 
Current substance abuse 
• 
Participation in another dietary and/or weight management intervention postpartum 
• 
Unable to understand and communicate in English 
• 
Unwilling or unable to consume study meals 
 
4.3 
SCREEN FAILURES 
 
Interested women who do not meet study inclusion criteria will be informed of this decision by study 
staff and reassured that this will not change the quality of the services and care that they receive 
through the University of Alabama at Birmingham. 
 
4.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Recruitment will primarily occur through UAB Center for Women’s Reproductive Health (CWRH) 
inpatient research staff. For this, CWRH inpatient clinical research staff will perform chart reviews of 
women on the postpartum recovery unit (following delivery) or who are attending their 6-week 
postpartum checkup (6th floor of the Women and Infants Center). Participants who meet initial 
eligibility criteria based on the chart review will be approached by a CWRH inpatient research staff 
member to briefly tell the potential participant about the study, give them a study flyer, and assess 
initial interest. Because enrollment will not occur until participants are 5-45 weeks post-delivery, 
participants who are interested when approached by CWRH inpatient research staff will be asked to give 
their permission to be contacted when they are 5-45 weeks postpartum to remind them about the 
study/confirm they are still interested in participating. Participant contact information will be collected 
for participants who opt-in to being contacted when they are within the 5–45-week postpartum 
enrollment window by study staff. When potential participants recruited through the CWRH inpatient 
research staff are 5-45 weeks post-delivery, they will complete a secondary pre-screening by telephone 
to confirm eligibility. Supplemental recruitment will occur via flyers/ads distributed at UAB 
obstetrics/gynecological offices, UAB pediatrics clinics, UAB lactation centers, UAB Nurse Family 
Partnership, local day care centers and churches, local breastfeeding and/or parent support groups, and 
Birmingham neighborhood associations. Interested women will respond via phone call or email to the 
public advertisements and be screened by phone. 
 

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While participants will receive 10 free meals/week for the duration of the 8-weeks study, we will employ 
strategies (implemented with participants in both intervention arms) that we have found effective for 
retention, including: (1) providing gift cards of $40 for completion of baseline and follow-up data 
collection visits, with incentives paid after each assessment; (2) ensuring frequent contacts with 
participants through weekly check-ins to not only obtain meal orders but also maintain engagement and 
foster open communication; and (3) providing reminder phone calls before scheduled study visits. 
 
 
5 
STUDY INTERVENTION 
 
5.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
5.1.1 STUDY INTERVENTION DESCRIPTION 
 
After completing baseline data collection, all participants will receive 10 fully prepared lunch/dinner-
style meals per week for a total of 8 weeks. Prior studies indicate that providing 10 meals or meal 
replacements per week is effective for weight management.43,86 We are partnering with a local 
company, Nourish Foods, to prepare and deliver study meals. Participants will select the 10 meals that 
they want each week from a weekly rotating menu that includes nutrition and ingredient information to 
accommodate participants with food aversions or allergies. Participants place meal orders weekly with 
study staff who will submit orders to the meal delivery partner. During these weekly contacts, trained 
staff also provide brief behavioral support, including evidence-based strategies of problem-solving, 
action-planning, and principles of motivational interviewing to help participants identify and navigate 
adherence barriers.87-91 Staff will document the duration and topics discussed. Each week of the 
intervention, participants will be automatically sent an electronic survey to report the number of study-
provided meals consumed by participants (versus others in the household versus thrown out), as we 
understand meals may be shared in food insecure households. The study coordinator will be available 
when collecting weekly meal orders to help participants navigate these challenges in multi-member 
households. If a participant does not place their weekly order, study staff will select meals based on 
participant preferences and allergies collected at baseline. Meals will be delivered once per week to 
participants’ homes, which is in compliance with the Alabama Department of Public Health guidelines. 
 
To supplement provided meals, participants will be given a study scale and instructed to weigh 
themselves at least once per week and report their weekly weight measurement on an automated 
weekly electronic survey. The study coordinator will monitor participant weights and report any 
concerning weight fluctuations to the PI who is a Registered Dietitian and can make adjustments to 
participant meal plans as needed to support healthy weight loss postpartum. This weight measurement 
will also allow study staff to track participant weight gain across the intervention as the goal is to 
support participants in losing 0.5 to 1 kg (or 1 to 2.2 pounds) of weight per week. To support adherence 
to the 0.5 to 1 kg (i.e., 1 to 2.2 pound) per week weight loss, participants will be given a Weight Tracking 
Sheet handout to help them track their weekly weight loss. Staff will also keep a Weight Tracking Sheet 
for each participant. To support the healthy integration of study meals within participants’ diets to 
promote 0.5 to 1 kg/week (i.e., 1 to 2.2 pounds/week) weight loss, participants will be given a variety of 
written meal plans corresponding to their individual calorie goal, as well as relevant tools (i.e., 
measuring cups, portion size guides) to support use of meal plans, portion control, and appropriate 
integration of prepared meals into participant’s diets. Calories goals will be calculated using the USDA 
Dietary Reference Intake Calculator for Medical Professionals92 with gender, age, height, weight, activity 

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level, and lactation status as inputs, and reduced by 750 calories/day to promote weight loss of 0.5 to 1 
kg per week.93,94 Meal plans will comply with current micronutrient and macronutrient 
recommendations for postpartum women.95 Participants will also be given a Fast-Food Handout to help 
them select healthier meals when eating out. 
5.1.2 DOSING AND ADMINISTRATION 
 
Participants in the study receive 10 lunch/dinner-style meals per week delivered to their homes free of 
charge for a total of 8-weeks. Participants will select the 10 meals that they want each week from a 
weekly rotating menu that includes nutrition and ingredient information to accommodate participants 
with food aversions or allergies. Participants place meal orders weekly with study staff who will submit 
orders to the meal delivery partner. If a participant does not place their weekly order, study staff will 
select meals based on participant preferences and allergies collected at baseline to ensure they receive 
meals each week. Each week of the intervention, participants will be automatically sent an electronic 
survey to report the number of study-provided meals consumed by participants (versus others in the 
household versus thrown out). 
 
5.2 
STUDY INTERVENTION COMPLIANCE 
 
Participants place meal orders weekly with study staff who will submit orders to the meal delivery 
partner. If a participant does not place their weekly order, study staff will select meals based on 
participant preferences and allergies collected at baseline to ensure they receive meals each week. Each 
week of the intervention, participants will be automatically sent an electronic survey to report the 
number of study-provided meals consumed by participants (versus others in the household versus 
thrown out). Study staff completing weekly check-in calls with participants will document the duration 
and topics discussed. 
 
 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
6.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
Participants will continue to receive the study intervention for the 8-weeks study. The study 
intervention may be discontinued for a participant if a clinical adverse event (AE) or other medical 
condition or situation occurs such that continued participation in the study intervention would not be in 
the best interest of the subject. 
 
6.2 
SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a subject from the study for the following reasons: 
 
• 
Significant study intervention non-compliance  

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• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
subject 
Subjects who sign the informed consent form, receive the study intervention, and subsequently 
withdraw, or are withdrawn or discontinued from the study, will not be replaced. 
6.3 
LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he or she fails to complete 3 scheduled check-in visits in 
a row or fails to complete the follow-up visit and is unable to be contacted by the study site staff.  
 
The following actions must be taken if a subject fails to be available for a required study visit: 
• 
The site will attempt to contact the subject and reschedule the missed visit and counsel the 
subject on the importance of maintaining the assigned visit schedule and ascertain if the subject 
wishes to and/or should continue in the study. 
• 
Before a subject is deemed lost to follow-up, the investigator or designee will make every effort 
to regain contact with the subject (where possible, 3 telephone calls and, if necessary, a certified 
letter to the subject’s last known mailing address or local equivalent methods). These contact 
attempts should be documented in the subject’s medical record or study file.  
• 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 
 
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 
STUDY ASSESSMENTS  
 
All study participants will complete 2 in-person study assessments: 1) Enrollment/Baseline Visit and 2) 
Week 8 Follow-up Visit. During the 8-week meal delivery intervention, participants will also be sent a 
weekly electronic survey to report adherence with consuming the study meals (the number of study-
provided meals consumed by participants [versus others in the household versus thrown out]) and to 
self-report their last weight measurement. 
 
Enrollment/Baseline Visit: This visit will take place when participants are 5 to 45 weeks post-delivery. 
Participants will come to the study laboratory and the visit will take approximately 2-2.5 hours. Staff will 
review the consent form in detail with the potential participant and answer all of their questions. After 
providing informed consent to participate in the study, the Baseline Visit will continue with the 
completion of the following: 
  
Weight and height measurements: Participant weight and height will be measured. 
  
Questionnaires: At the Baseline Visit (i.e., Study Visit 1), participants will complete the following 
questionnaires: 
• 
FORM 01: Food Allergies & Aversions 
• 
FORM 02: Demographics 
• 
Income Supplemental Questions Form 

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• 
FORM 03: Pregnancy & Infant History 
• 
FORM 04: Pittsburgh Sleep Quality Index (PSQI) 
• 
FORM 05: Perceived Stress Scale (PSS-10) 
• 
FORM 06: Diet Satisfaction (DSAT-28) 
• 
FORM 07: Self-Efficacy 
• 
FORM 08: Barriers to Healthy Eating 
• 
FORM 09: Infant Feeding 
• 
FORM 10: Edinburgh Postnatal Depression Scale (EPDS) 
• 
FORM 11: Multidimensional Scale of Perceived Social Support (MSPSS) 
• 
FORM 12: Nutrition Security Survey 
• 
Household Food Security Survey 
• 
International Physical Activity Questionnaire 
 
24-hour diet recalls: Participant 24-hour dietary recalls will be collected using the Automated Self-
administered 24-hour Dietary Assessment Tool (ASA24). For this, participants will be asked to report 
everything they had to eat and drink during the previous day (from midnight-to-midnight) including 
any dietary supplements. The diet recall will take approximately 30-45 minutes. Participants will be 
given measuring cups and spoons to assist them with estimating portion sizes when completing the 
diet recall. Participants will also be given the ASA24 Information handout to assist them with 
completing 2 additional dietary recalls after Study Visit 1. For this, in the 1-2 weeks following Study 
Visit 1 (e.g., before beginning the meal delivery intervention) participants will be contacted to 
complete two additional 24-hour dietary recalls. These recalls may be completed by participants 
using a unique login for the ASA24 system or, if participants struggle to complete recalls or do not 
have internet or computer/tablet/cellphone access to complete the recalls themselves, a study staff 
member may complete the 24-hour recall with the participant over the phone using ASA24. The 
ASA24 Dietary Assessment Tool is a free, web-based tool developed by the National Cancer Institute 
of the National Institutes of Health for the collection of 24-hour dietary recalls for research. The 
ASA24 system does NOT collect any identifying data for study participants. Rather, researchers 
specify a unique numeric identifier for each respondent. Researchers must use a separate system or 
database outside of the ASA24 system to store participant numeric identifiers. 
 
Intervention Data Collection: All N=11 women who enroll in the study will receive the study meal 
delivery intervention. At the baseline visit, women who consent to participate in the study will meet 
with a trained study staff member who will explain the procedures for placing weekly meal orders and 
show them how to complete weekly online Qualtrics Surveys which will be sent to participants via email. 
Participants will be given a study scale and instructed to weigh themselves at least once per week and 
report their weekly weight measurement on the weekly Qualtrics survey. As part of the weekly emailed 
Qualtrics survey, participants will also be asked to report intervention adherence (e.g., number of study 
meals they ate versus others versus that they threw away), adverse events (e.g., flatulence, new or 
worsening gastroesophageal reflux), and satisfaction with the study meals. Staff will complete weekly 
calls with participants to obtain their meal orders and to complete a brief check-in to see on how they 
are doing and utilize motivational interviewing techniques to help women who are struggling to comply 
with the intervention to problem-solve and develop weekly goals. Staff will document the duration and 
topics discussed during weekly telephone contacts. 
 

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Week 8 Follow-up Visit: This visit will take place during the final week for the study meal delivery 
intervention. Participants will come to the study laboratory and the visit will take approximately 2-2.5 
hours. Participants will be asked to complete the following: 
 
Weight measurements: Participant weight will be measured with participants in light clothing and 
no shoes. 
 
Questionnaires: At the Follow-up Visit, participants will complete the following questionnaires: 
• 
FORM 04: Pittsburgh Sleep Quality Index (PSQI) 
• 
FORM 05: Perceived Stress Scale (PSS-10) 
• 
FORM 06: Diet Satisfaction (DSAT-28) 
• 
FORM 07: Self-Efficacy 
• 
FORM 08: Barriers to Healthy Eating 
• 
FORM 09: Infant Feeding 
• 
FORM 10: Edinburgh Postnatal Depression Scale (EPDS) 
• 
FORM 11: Multidimensional Scale of Perceived Social Support (MSPSS) 
• 
FORM 12: Nutrition Security Survey 
• 
FORM 13: Health & Demographics Update 
• 
FORM 14: Program Satisfaction 
• 
Household Food Security Survey 
• 
International Physical Activity Questionnaire 
  
Semi-structured, one-on-one interview: Participants will complete a semi-structured, one-on-one 
interview with a member of the research team. These one-on-one interviews (lasting up to 60 
minutes) will be conducted using an interview guide. Interviews will be audio-recorded, transcribed 
verbatim, and the file will be erased after the transcripts have been verified for completeness. The 
transcription will not have any identifiable data included as participants will use anonymous names 
or nicknames during the interview sessions. The recording will be stopped at the end of the 
interview. 
 
24-hour diet recalls (Follow-Up): Participants will be contacted on 3 separate days and asked to 
complete three 24-hour dietary recalls over the last 2 weeks of the study intervention (e.g., when 
participants are still receiving the meal delivery intervention) using the same procedures as 
described for the Baseline Visit. Briefly, the 24-hour recalls will either be completed directly by 
participants using the ASA24 system or will be completed over the phone with study staff (and study 
staff will enter participant recall information into ASA24). Participants will be asked to report 
everything they had to eat and drink during the previous day (from midnight-to-midnight) including 
any dietary supplements. Each diet recall will take approximately 30-45 minutes. Participants will be 
sent a copy of the How to Add a Nourish Meal Instructions handout that will instruct them on how 
to add one of the study-provided meals to a dietary recall in ASA24. 
 
Participant Medical Records: A designated study staff member with appropriate approvals will obtain 
access to participant medical records for the retrieval of: date at gestational age (weeks at first dating 
ultrasound, date (which will be used to calculate gestational age (weeks)) and weight measured at the 
first prenatal visit; maternal weight and date (which will be used to calculate gestational age (weeks)) at 
their last prenatal care visit; maternal weight (if available) and gestational age at delivery; maternal 
diagnosis with gestational diabetes or hypertensive disorders of pregnancy and mode of delivery. 

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7.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
   
7.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
7.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) is considered “serious” if, in the view of either the investigator or sponsor, it 
results in any of the following outcomes: 
 
• 
Death 
• 
A life-threatening adverse event (of note, the term “life-threatening” refers to an event in which 
the subject was at risk of death at the time of the event, rather than to an event which 
hypothetically might have caused death if it were more severe) 
• 
inpatient hospitalization or prolongation of existing hospitalization 
• 
a persistent or significant incapacity or substantial disruption of the ability to conduct normal 
life functions 
• 
or a congenital anomaly/birth defect. 
 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment 
in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
 
7.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
7.2.3.1 SEVERITY OF EVENT 
For adverse events (AEs), the following guidelines will be used to describe severity:  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the subject’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a subject’s usual daily activity and may require systemic drug therapy 
or other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of 
note, the term “severe” does not necessarily equate to “serious.” 
 
7.2.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the subject based on temporal relationship and his/her clinical judgment. The 
degree of certainty about causality will be graded using the categories below. In a clinical trial, the study 
product must always be suspect.  
 

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• 
Related – The AE is known to occur with the study intervention, there is a reasonable possibility 
that the study intervention caused the AE, or there is a temporal relationship between the study 
intervention and event. Reasonable possibility means that there is evidence to suggest a causal 
relationship between the study intervention and the AE. 
• 
Not Related – There is not a reasonable possibility that the administration of the study 
intervention caused the event, there is no temporal relationship between the study intervention 
and event onset, or an alternate etiology has been established. 
 
7.2.3.3 EXPECTEDNESS  
The Principal Investigator will be responsible for determining whether an adverse event (AE) is expected 
or unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is 
not consistent with the risk information previously described for the study intervention. 
7.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits or via weekly electronic surveys sent to participants during the study 
intervention which asks participants to report potential AEs. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the subject is screened will be considered as 
baseline and not reported as an AE. However, if the study subject’s condition deteriorates at any time 
during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The Study Coordinator will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study visit, the Study Coordinator will inquire about the occurrence of 
AE/SAEs since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
 
7.2.5 ADVERSE AND SERIOUS ADVERSE EVENT REPORTING  
All serious adverse events must be reported to the IRB according to regulatory requirements. The 
Principal Investigator will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol or package insert and must 
include an assessment of whether there is a reasonable possibility that the study intervention caused 
the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported 
in accordance with the protocol unless there is evidence suggesting a causal relationship between the 

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study intervention and the event (e.g., death from anaphylaxis). In that case, the investigator must 
immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the Principal 
Investigator deems the event to be chronic or the subject is stable. Other supporting documentation of 
the event may be requested and should be provided as soon as possible. 
 
7.3 
UNANTICIPATED PROBLEMS 
 
7.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
• 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
7.3.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing Institutional Review Board 
(IRB). The UP report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are serious adverse events (SAEs) will be reported to the IRB within 10 working days of 
the investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB within 10 working days of the investigator becoming 
aware of the problem.  
 
 
8 
STATISTICAL CONSIDERATIONS  
 

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8.1 
STATISTICAL HYPOTHESES 
 
• 
Primary Efficacy Endpoint(s): The primary aim of this study is to assess the feasibility of the 
study meal delivery intervention. Hypothesis 1: We will successfully achieve >80% intervention 
adherence, defined as consuming at least 80% of received study meals, during the 8-week 
intervention. 
 
• 
Secondary Efficacy Endpoint(s): The secondary aim is to characterize the acceptability of the 
study meal delivery intervention. Hypothesis 2a: We will collect data to characterize study 
participation rate and achieve <20% attrition. Hypothesis 2b: Participant reported diet 
satisfaction will show improvements from baseline to follow-up. 
 
8.2 
SAMPLE SIZE DETERMINATION 
 
The goal of this pilot study was to collect preliminary data regarding the feasibility and acceptability of a 
meal delivery intervention among postpartum women. As this is a feasibility pilot with the primary goal 
of capturing process data, a formal power calculation was not conducted. Indeed, effect estimates 
based on small pilot studies are too imprecise and should not be used to inform future trials.96 Instead, 
we followed recommendations from the National Center for Complementary and Integrative Health 
(NCCIH) that sample sizes for feasibility studies should be based on “practical considerations including 
participant flow, budgetary constraints, and the number of participants needed to reasonably evaluate 
feasibility goals.” With these considerations in mind, the present study aimed to recruit a minimum of 
10 participants and up to 20 participants based on the available budget. This was a single-group trial 
with the primary goal being to obtain process data and preliminary data to inform intervention 
refinements before pursuing funding for subsequent pilot testing. 
 
8.3 
STATISTICAL ANALYSES 
 
8.3.1 GENERAL APPROACH 
 
At each time of measurement, descriptive statistics will be used to summarize demographic 
characteristics and process measures, including rates of study participant, retention, and intervention 
adherence. Average values of outcome measures (e.g., diet satisfaction) will be calculated for baseline 
and follow-up. No formal statistical analyses will be conducted as this was a single group feasibility study 
that was not designed to be powered to detect statistical significance.  
 
8.3.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
For the primary endpoint of participant intervention adherence, the proportion of weekly study meals 
that participants reported a)they consumed, b) other household members consumed, and c) that were 
thrown away/uneaten will be calculated based on completed weekly electronic surveys. 
 
8.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
For secondary endpoints, study participation rate (percentage of eligible subjects who agreed to 
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who complete follow-up) will be calculated and reported. Visual representation of the flow of 
participants through the study will be reported through a CONSORT diagram. Change in participant 
satisfaction with the diet will be reported as the mean total diet satisfaction score, as well as the mean 
scores on subscales for Cost Factor and Planning & Preparation Factor, at baseline and follow-up will be 
reported.1 
 
8.3.4 SAFETY ANALYSES 
 
Rates and severity of adverse events will be summarized using descriptive statistics. 
 
8.3.5 BASELINE DESCRIPTIVE STATISTICS 
 
At baseline, descriptive statistics will be used to summarize demographic characteristics and outcome 
measures by study arm and for the entire sample. 
 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO SUBJECTS 
 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
subject and written documentation of informed consent is required prior to conducting study screening 
procedures. A separate screening consent form will not be used. 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the subject will be asked to read and review the document. The 
investigator will explain the research study to the subject and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the subject’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research subjects.  Subjects will have 
the opportunity to carefully review the written consent form and ask questions prior to signing. The 
subjects should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The subject will sign the informed consent document prior to any 
procedures being done specifically for the study. Subjects must be informed that participation is 
voluntary and that they may withdraw from the study at any time, without prejudice. A copy of the 
informed consent document will be given to the subjects for their records. The informed consent 
process will be conducted and documented in the source document (including the date), and the form 
signed, before the subject undergoes any study-specific procedures. The rights and welfare of the 
subjects will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 

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9.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to regulatory authorities.  If the study is prematurely 
terminated or suspended, the Principal Investigator (PI) will promptly inform study subjects and the 
Institutional Review Board (IRB), will provide the reason(s) for the termination or suspension.  Study 
subjects will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the IRB. 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
 
Subject confidentiality and privacy is strictly held in trust by the participating investigators and their 
staff. Therefore, the study protocol, documentation, data, and all other information generated will be 
held in strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Principal Investigator.  
 
All research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB) may inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to 
such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB and/or Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
stored at the UAB Department of Medicine, Division of General Internal Medicine and Population 
Science research office. This will not include the subject’s contact or identifying information. Rather, 
individual subjects and their research data will be identified by a unique study identification number. 
The study data entry and study management systems used by research staff will be secured and 
password protected.  
 
9.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 

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The site will perform internal quality management of study conduct, data collection, documentation and 
completion.  Quality control (QC) procedures will be completed by the Data Manager during data entry 
into the appropriate CRF. Any missing data or data anomalies will be communicated to the Study 
Coordinator for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated are collected, documented (recorded), and reported in compliance 
with the protocol, International Conference on Harmonisation Good Clinical Practice (ICH GCP), and 
applicable regulatory requirements.  
 
The site will provide direct access to all trial related sites, source data/documents, and reports for the 
purpose of monitoring and inspection by local and regulatory authorities. 
 
9.1.5 DATA HANDLING AND RECORD KEEPING  
 
9.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the 
Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, completeness, 
legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hard copies of source document worksheets will be used for recording data for each subject enrolled in 
the study.  
 
9.1.5.2 STUDY RECORDS RETENTION  
 
Study documents should be retained for a minimum of 3 years after the completion of the study. These 
documents should be retained for a longer period, however, if required by local regulations.  
 
9.1.6 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the Principal Investigator to use continuous vigilance to identify and report 
deviations within 10 working days of identification of the protocol deviation.  Protocol deviations must 

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be sent to the reviewing Institutional Review Board (IRB) per their policies. The Principal Investigator is 
responsible for knowing and adhering to the reviewing IRB requirements.  
 
9.1.7 CONFLICT OF INTEREST POLICY 
 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical.  Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.   
 
 
 

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9.2 
ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

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10 REFERENCES  
1. 
James BL, Loken E, Roe LS, et al. Validation of the Diet Satisfaction Questionnaire: a new measure of 
satisfaction with diets for weight management. Obes Sci Pract. Dec 2018;4(6):506-514. doi:10.1002/osp4.299 
2. 
Cohen S. Perceived stress in a probability sample of the United States. 1988; 
3. 
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. Dec 
1983;24(4):385-96.  
4. 
Lipsky LM, Strawderman MS, Olson CM. Weight-related self-efficacy in relation to maternal body weight 
from early pregnancy to 2 years post-partum. Matern Child Nutr. Jul 2016;12(3):569-78. doi:10.1111/mcn.12149 
5. 
Endres LK, Straub H, McKinney C, et al. Postpartum weight retention risk factors and relationship to 
obesity at 1 year. Obstet Gynecol. Jan 2015;125(1):144-52. doi:10.1097/aog.0000000000000565 
6. 
Archuleta J, Chao SM. Maternal Characteristics that Impact Postpartum Weight Retention: Results from 
the 2016 Los Angeles Mommy and Baby (LAMB) Follow-Up Study. Matern Child Health J. Jan 2021;25(1):151-161. 
doi:10.1007/s10995-020-03082-3 
7. 
Siega-Riz AM, Herring AH, Carrier K, Evenson KR, Dole N, Deierlein A. Sociodemographic, perinatal, 
behavioral, and psychosocial predictors of weight retention at 3 and 12 months postpartum. Obesity (Silver 
Spring). Oct 2010;18(10):1996-2003. doi:10.1038/oby.2009.458 
8. 
Onyango AW, Nommsen-Rivers L, Siyam A, et al. Post-partum weight change patterns in the WHO 
Multicentre Growth Reference Study. Matern Child Nutr. Jul 2011;7(3):228-40. doi:10.1111/j.1740-
8709.2010.00295.x 
9. 
Lederman SA, Alfasi G, Deckelbaum RJ. Pregnancy-associated obesity in black women in New York City. 
Matern Child Health J. Mar 2002;6(1):37-42.  
10. 
Schneider CR, Biggio JR, Chandler-Laney PC. Association of early pregnancy body mass index with post-
partum weight change among African-American women. Clin Obes. Jun 2018;8(3):170-175. doi:10.1111/cob.12241 
11. 
Rooney BL, Schauberger CW. Excess pregnancy weight gain and long-term obesity: one decade later. 
Obstet Gynecol. Aug 2002;100(2):245-52.  
12. 
Linné Y, Dye L, Barkeling B, Rössner S. Weight development over time in parous women--the SPAWN 
study--15 years follow-up. Int J Obes Relat Metab Disord. Dec 2003;27(12):1516-22. doi:10.1038/sj.ijo.0802441 
13. 
Weight Gain During Pregnancy: Reexamining the Guidelines (National Academies Press) 868 (2009). 
14. 
Parker JD, Abrams B. Differences in postpartum weight retention between black and white mothers. 
Obstet Gynecol. May 1993;81(5 ( Pt 1)):768-74.  
15. 
Boardley DJ, Sargent RG, Coker AL, Hussey JR, Sharpe PA. The relationship between diet, activity, and 
other factors, and postpartum weight change by race. Obstet Gynecol. Nov 1995;86(5):834-8. doi:10.1016/0029-
7844(95)00283-w 
16. 
Headen IE, Davis EM, Mujahid MS, Abrams B. Racial-Ethnic Differences in Pregnancy-Related Weight. 
Advances in Nutrition. 2012;3(1):83-94. doi:10.3945/an.111.000984 
17. 
Teulings N, Masconi KL, Ozanne SE, Aiken CE, Wood AM. Effect of interpregnancy weight change on 
perinatal outcomes: systematic review and meta-analysis. BMC Pregnancy Childbirth. Oct 28 2019;19(1):386. 
doi:10.1186/s12884-019-2566-2 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
24 
18. 
Ju AC, Heyman MB, Garber AK, Wojcicki JM. Maternal Obesity and Risk of Preterm Birth and Low 
Birthweight in Hawaii PRAMS, 2000-2011. Matern Child Health J. Jun 2018;22(6):893-902. doi:10.1007/s10995-
018-2464-7 
19. 
Cnattingius S, Villamor E, Johansson S, et al. Maternal obesity and risk of preterm delivery. Jama. Jun 12 
2013;309(22):2362-70. doi:10.1001/jama.2013.6295 
20. 
Dude AM, Lane-Cordova AD, Grobman WA. Interdelivery weight gain and risk of cesarean delivery 
following a prior vaginal delivery. Am J Obstet Gynecol. Sep 2017;217(3):373.e1-373.e6. 
doi:10.1016/j.ajog.2017.05.024 
21. 
Minhas AS, Ogunwole SM, Vaught AJ, et al. Racial Disparities in Cardiovascular Complications With 
Pregnancy-Induced Hypertension in the United States. Hypertension. Aug 2021;78(2):480-488. 
doi:10.1161/hypertensionaha.121.17104 
22. 
Hanson C, Samson K, Anderson-Berry AL, Slotkowski RA, Su D. Racial disparities in caesarean delivery 
among nulliparous women that delivered at term: cross-sectional decomposition analysis of Nebraska birth 
records from 2005-2014. BMC Pregnancy Childbirth. Apr 15 2022;22(1):329. doi:10.1186/s12884-022-04666-3 
23. 
Lee H, Okunev I, Tranby E, Monopoli M. Different levels of associations between medical co-morbidities 
and preterm birth outcomes among racial/ethnic women enrolled in Medicaid 2014-2015: retrospective analysis. 
BMC Pregnancy Childbirth. Jan 13 2020;20(1):33. doi:10.1186/s12884-020-2722-8 
24. 
Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2019. Natl Vital Stat Rep. Apr 
2021;70(2):1-51.  
25. 
Driscoll AK, Gregory EC. Increases in Prepregnancy Obesity: United States, 2016-2019. NCHS Data Brief. 
2020;(392):1-8.  
26. 
Santos S, Voerman E, Amiano P, et al. Impact of maternal body mass index and gestational weight gain on 
pregnancy complications: an individual participant data meta-analysis of European, North American and Australian 
cohorts. BJOG : an international journal of obstetrics and gynaecology. 2019;126(8):984-995. doi:10.1111/1471-
0528.15661 
27. 
Gunderson EP. Childbearing and obesity in women: weight before, during, and after pregnancy. Obstet 
Gynecol Clin North Am. Jun 2009;36(2):317-32, ix. doi:10.1016/j.ogc.2009.04.001 
28. 
Lipsky LM, Strawderman MS, Olson CM. Maternal weight change between 1 and 2 years postpartum: the 
importance of 1 year weight retention. Obesity (Silver Spring). Jul 2012;20(7):1496-502. doi:10.1038/oby.2012.41 
29. 
Michel S, Raab R, Drabsch T, Günther J, Stecher L, Hauner H. Do lifestyle interventions during pregnancy 
have the potential to reduce long-term postpartum weight retention? A systematic review and meta-analysis. Obes 
Rev. Apr 2019;20(4):527-542. doi:10.1111/obr.12809 
30. 
Lim S, Hill B, Teede HJ, Moran LJ, O'Reilly S. An evaluation of the impact of lifestyle interventions on body 
weight in postpartum women: A systematic review and meta-analysis. Obesity Reviews. 2020;21(4):e12990. 
doi:https://doi.org/10.1111/obr.12990 
31. 
McKinley MC, Allen-Walker V, McGirr C, Rooney C, Woodside JV. Weight loss after pregnancy: challenges 
and opportunities. Nutr Res Rev. Dec 2018;31(2):225-238. doi:10.1017/s0954422418000070 
32. 
Dodd JM, Deussen AR, O'Brien CM, et al. Targeting the postpartum period to promote weight loss: a 
systematic review and meta-analysis. Nutr Rev. Aug 1 2018;76(8):639-654. doi:10.1093/nutrit/nuy024 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
25 
33. 
Christiansen PK, Skjøth MM, Rothmann MJ, Vinter CA, Lamont RF, Draborg E. Lifestyle interventions to 
maternal weight loss after birth: a systematic review. Systematic Reviews. 2019/12/16 2019;8(1):327. 
doi:10.1186/s13643-019-1186-2 
34. 
Murray-Davis B, Grenier L, Atkinson SA, et al. Experiences regarding nutrition and exercise among women 
during early postpartum: a qualitative grounded theory study. BMC Pregnancy and Childbirth. 2019/10/21 
2019;19(1):368. doi:10.1186/s12884-019-2508-z 
35. 
Graham M, Uesugi K, Olson C. Barriers to weight-related health behaviours: a qualitative comparison of 
the socioecological conditions between pregnant and post-partum low-income women. Matern Child Nutr. Apr 
2016;12(2):349-61. doi:10.1111/mcn.12135 
36. 
Carter-Edwards L, Østbye T, Bastian LA, Yarnall KS, Krause KM, Simmons TJ. Barriers to adopting a healthy 
lifestyle: insight from postpartum women. BMC Res Notes. Aug 17 2009;2:161. doi:10.1186/1756-0500-2-161 
37. 
Haynes RB, Kris-Etherton P, McCarron DA, et al. Nutritionally complete prepared meal plan to reduce 
cardiovascular risk factors: a randomized clinical trial. J Am Diet Assoc. Sep 1999;99(9):1077-83. 
doi:10.1016/s0002-8223(99)00257-6 
38. 
Metz JA, Stern JS, Kris-Etherton P, et al. A randomized trial of improved weight loss with a prepared meal 
plan in overweight and obese patients: impact on cardiovascular risk reduction. Arch Intern Med. Jul 24 
2000;160(14):2150-8. doi:10.1001/archinte.160.14.2150 
39. 
Imai S, Kozai H, Matsuda M, et al. Intervention with delivery of diabetic meals improves glycemic control 
in patients with type 2 diabetes mellitus. J Clin Biochem Nutr. Jan 2008;42:59-63. doi:10.3164/jcbn.2008010 
40. 
Berkowitz SA, Delahanty LM, Terranova J, et al. Medically Tailored Meal Delivery for Diabetes Patients 
with Food Insecurity: a Randomized Cross-over Trial. J Gen Intern Med. Mar 2019;34(3):396-404. 
doi:10.1007/s11606-018-4716-z 
41. 
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 Aff (Millwood). Apr 2018;37(4):535-542. 
doi:10.1377/hlthaff.2017.0999 
42. 
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 Intern Med. Jun 1 2019;179(6):786-793. 
doi:10.1001/jamainternmed.2019.0198 
43. 
Jeffery RW, Wing RR, Thorson C, et al. Strengthening behavioral interventions for weight loss: a 
randomized trial of food provision and monetary incentives. J Consult Clin Psychol. Dec 1993;61(6):1038-45. 
doi:10.1037//0022-006x.61.6.1038 
44. 
Willink A, DuGoff EH. Integrating Medical and Nonmedical Services - The Promise and Pitfalls of the 
CHRONIC Care Act. N Engl J Med. Jun 7 2018;378(23):2153-2155. doi:10.1056/NEJMp1803292 
45. 
Medi-Cal Medically Tailored Meals Pilot Program. California Food is Medicine Coalition. 2020. 
https://calfimc.org/medical-pilot 
46. 
7th Annual Food is Medicine Symposium. https://www.youtube.com/watch?v=p1cWxCO2Jfc&t=543s.  
47. 
Mellor DD, Whitham C, Goodwin S, Morris M, Reid M, Atkin SL. Weight loss in a UK commercial all meal 
provision study: a randomised controlled trial. J Hum Nutr Diet. Aug 2014;27(4):377-83. doi:10.1111/jhn.12171 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
26 
48. 
National Academies of Sciences E, Medicine, Health, et al. Setting the Stage: Key Definitions and Contexts. 
In: Callahan EA, ed. A Health Equity Approach to Obesity Efforts: Proceedings of a Workshop. National Academies 
Press (US) 
Copyright 2019 by the National Academy of Sciences. All rights reserved.; 2019. 
49. 
Walker L, Freeland-Graves JH, Milani T, et al. Weight and behavioral and psychosocial factors among 
ethnically diverse, low-income women after childbirth: II. Trends and correlates. Women Health. 2004;40(2):19-34. 
doi:10.1300/J013v40n02_02 
50. 
Walker LO, Freeland-Graves JH, Milani T, et al. Weight and behavioral and psychosocial factors among 
ethnically diverse, low-income women after childbirth: I. Methods and context. Women Health. 2004;40(2):1-17. 
doi:10.1300/J013v40n02_01 
51. 
Janumala I, Toro-Ramos T, Widen E, et al. Increased Visceral Adipose Tissue Without Weight Retention at 
59 Weeks Postpartum. Obesity (Silver Spring). Mar 2020;28(3):552-562. doi:10.1002/oby.22736 
52. 
Cho GJ, Yoon HJ, Kim EJ, Oh MJ, Seo HS, Kim HJ. Postpartum changes in body composition. Obesity (Silver 
Spring). Dec 2011;19(12):2425-8. doi:10.1038/oby.2011.163 
53. 
Gunderson EP, Sternfeld B, Wellons MF, et al. Childbearing may increase visceral adipose tissue 
independent of overall increase in body fat. Obesity (Silver Spring). May 2008;16(5):1078-84. 
doi:10.1038/oby.2008.40 
54. 
Elffers TW, de Mutsert R, Lamb HJ, et al. Body fat distribution, in particular visceral fat, is associated with 
cardiometabolic risk factors in obese women. PLoS One. 2017;12(9):e0185403. doi:10.1371/journal.pone.0185403 
55. 
Liu J, Fox CS, Hickson D, Bidulescu A, Carr JJ, Taylor HA. Fatty Liver, Abdominal Visceral Fat, and 
Cardiometabolic Risk Factors. Arteriosclerosis, Thrombosis, and Vascular Biology. 2011;31(11):2715-2722. 
doi:doi:10.1161/ATVBAHA.111.234062 
56. 
Liu J, Song G, Meng T, Zhao G, Guo S. Weight retention at six weeks postpartum and the risk of gestational 
diabetes mellitus in a second pregnancy. BMC Pregnancy Childbirth. Aug 1 2019;19(1):272. doi:10.1186/s12884-
019-2423-3 
57. 
Kew S, Ye C, Hanley AJ, et al. Cardiometabolic implications of postpartum weight changes in the first year 
after delivery. Diabetes Care. Jul 2014;37(7):1998-2006. doi:10.2337/dc14-0087 
58. 
Rooney BL, Schauberger CW, Mathiason MA. Impact of perinatal weight change on long-term obesity and 
obesity-related illnesses. Obstet Gynecol. Dec 2005;106(6):1349-56. doi:10.1097/01.AOG.0000185480.09068.4a 
59. 
Paramsothy P, Lin YS, Kernic MA, Foster-Schubert KE. Interpregnancy weight gain and cesarean delivery 
risk in women with a history of gestational diabetes. Obstet Gynecol. Apr 2009;113(4):817-823. 
doi:10.1097/AOG.0b013e31819b33ac 
60. 
Lim S, Liang X, Hill B, Teede H, Moran LJ, O'Reilly S. A systematic review and meta-analysis of intervention 
characteristics in postpartum weight management using the TIDieR framework: A summary of evidence to inform 
implementation. Obes Rev. Jul 2019;20(7):1045-1056. doi:10.1111/obr.12846 
61. 
Voerman E, Santos S, Patro Golab B, et al. Maternal body mass index, gestational weight gain, and the risk 
of overweight and obesity across childhood: An individual participant data meta-analysis. PLoS medicine. 
2019;16(2):e1002744-e1002744. doi:10.1371/journal.pmed.1002744 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
27 
62. 
Page KA, Luo S, Wang X, et al. Children Exposed to Maternal Obesity or Gestational Diabetes Mellitus 
During Early Fetal Development Have Hypothalamic Alterations That Predict Future Weight Gain. Diabetes Care. 
2019;42(8):1473-1480. doi:10.2337/dc18-2581 
63. 
Maftei O, Whitrow MJ, Davies MJ, Giles LC, Owens JA, Moore VM. Maternal body size prior to pregnancy, 
gestational diabetes and weight gain: associations with insulin resistance in children at 9-10 years. Diabet Med. Feb 
2015;32(2):174-80. doi:10.1111/dme.12637 
64. 
Eitmann S, Németh D, Hegyi P, et al. Maternal overnutrition impairs offspring's insulin sensitivity: A 
systematic review and meta-analysis. Matern Child Nutr. Oct 2020;16(4):e13031. doi:10.1111/mcn.13031 
65. 
Dabelea D, Crume T. Maternal environment and the transgenerational cycle of obesity and diabetes. 
Diabetes. Jul 2011;60(7):1849-55. doi:10.2337/db11-0400 
66. 
Razaz N, Villamor E, Muraca GM, Bonamy AE, Cnattingius S. Maternal obesity and risk of cardiovascular 
diseases in offspring: a population-based cohort and sibling-controlled study. Lancet Diabetes Endocrinol. Jul 
2020;8(7):572-581. doi:10.1016/s2213-8587(20)30151-0 
67. 
Havranek EP, Mujahid MS, Barr DA, et al. Social Determinants of Risk and Outcomes for Cardiovascular 
Disease. Circulation. 2015;132(9):873-898. doi:doi:10.1161/CIR.0000000000000228 
68. 
Coates R, Ayers S, de Visser R. Women's experiences of postnatal distress: a qualitative study. BMC 
Pregnancy Childbirth. Oct 14 2014;14:359. doi:10.1186/1471-2393-14-359 
69. 
Faria-Schützer DB, Surita FG, Rodrigues L, Turato ER. Eating Behaviors in Postpartum: A Qualitative Study 
of Women with Obesity. Nutrients. Jul 10 2018;10(7)doi:10.3390/nu10070885 
70. 
Moore AP, Flynn AC, Adegboye ARA, Goff LM, Rivas CA. Factors Influencing Pregnancy and Postpartum 
Weight Management in Women of African and Caribbean Ancestry Living in High Income Countries: Systematic 
Review and Evidence Synthesis Using a Behavioral Change Theoretical Model. Front Public Health. 2021;9:637800. 
doi:10.3389/fpubh.2021.637800 
71. 
Gardner B, Lally P, Wardle J. Making health habitual: the psychology of 'habit-formation' and general 
practice. Br J Gen Pract. Dec 2012;62(605):664-6. doi:10.3399/bjgp12X659466 
72. 
Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment 
intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. Jan 1 2018;107(1):12-19. 
doi:10.1093/ajcn/nqx005 
73. 
Gorin AA, Raynor HA, Niemeier HM, Wing RR. Home grocery delivery improves the household food 
environments of behavioral weight loss participants: results of an 8-week pilot study. Int J Behav Nutr Phys Act. 
Nov 14 2007;4:58. doi:10.1186/1479-5868-4-58 
74. 
Lee JS, Johnson MA, Brown A. Older Americans Act Nutrition Program improves participants' food security 
in Georgia. J Nutr Gerontol Geriatr. 2011;30(2):122-39. doi:10.1080/21551197.2011.566526 
75. 
Edwards DL, Frongillo EA, Jr., Rauschenbach B, Roe DA. Home-delivered meals benefit the diabetic elderly. 
J Am Diet Assoc. May 1993;93(5):585-7. doi:10.1016/0002-8223(93)91824-a 
76. 
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. doi:10.1007/s11524-016-0129-7 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
28 
77. 
Wright L, Sanchez A, Jakubec P, Ross J. Food Fighters: A Food Recovery-Meal Delivery Program Benefits 
Meal Recipients, Volunteers and Agencies. Journal of Hunger & Environmental Nutrition. 2021:1-13. 
doi:10.1080/19320248.2021.1883496 
78. 
Buys DR, Campbell AD, Godfryd A, et al. Meals Enhancing Nutrition After Discharge: Findings from a Pilot 
Randomized Controlled Trial. J Acad Nutr Diet. Apr 2017;117(4):599-608. doi:10.1016/j.jand.2016.11.005 
79. 
Laraia B, Vinikoor-Imler LC, Siega-Riz AM. Food insecurity during pregnancy leads to stress, disordered 
eating, and greater postpartum weight among overweight women. Obesity. 2015;23(6):1303-1311. 
doi:https://doi.org/10.1002/oby.21075 
80. 
Whitaker K, Young-Hyman D, Vernon M, Wilcox S. Maternal stress predicts postpartum weight retention. 
Matern Child Health J. Nov 2014;18(9):2209-17. doi:10.1007/s10995-014-1470-7 
81. 
Food is Medicine Coalition Policy Opportunities. Food is Medicine Coalition. 
https://static1.squarespace.com/static/580a7cb9e3df2806e84bb687/t/5eb5bb10b3d9275aafe35bd3/1588968208
856/Fall+2019+FIMC+PolicyOpportunities+%282%29.pdf 
82. 
Downer S, Garfield K, Sukys K, et al. Massachusetts Food is Medicine State Plan. 2019.  
83. 
Skopec L, Ramos C, Aarons J. Are Medicare Advantage Plans Using New Supplemental Benefit Flexibility to 
Address Enrollees’ Health-Related Social Needs? 2019. 
https://www.urban.org/sites/default/files/publication/101067/sdh_medicare_advantage_1.pdf 
84. 
Food as Medicine Model: A Framework for Improving Member Health Outcomes and Lowering Health 
Costs. Health Partners Plans. 2020. https://www.healthpartnersplans.com/media/100225194/food-as-medicine-
model.pdf 
85. 
Greenwald R. Food is Medicine. Harvard Law School Center for Health Law and Policy Innovation. 2020. 
https://www.chlpi.org/wp-content/uploads/2013/12/Greenwald-Hunger-Caucus-Food-is-Medicine-Presentation-1-
16-17.pdf 
86. 
Phelan S, Wing RR, Brannen A, et al. Randomized controlled clinical trial of behavioral lifestyle 
intervention with partial meal replacement to reduce excessive gestational weight gain. Am J Clin Nutr. Feb 1 
2018;107(2):183-194. doi:10.1093/ajcn/nqx043 
87. 
Dutton GR, Perri MG. Delivery, evaluation, and future directions for cognitive-behavioral treatments of 
obesity. In: Wadden TA, Stunkard AJ, eds. The Oxford Handbook of Cognitive and Behavioral Therapies Oxford 
University Press; 2016:419-437. 
88. 
Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatr Clin North Am. Dec 
2011;34(4):841-59. doi:10.1016/j.psc.2011.08.006 
89. 
Miller WR, Rollnick S. Motivational interviewing: Helping people change, 3rd edition. Motivational 
interviewing: Helping people change, 3rd edition. Guilford Press; 2013:xii, 482-xii, 482. 
90. 
West DS, DiLillo V, Bursac Z, Gore SA, Greene PG. Motivational interviewing improves weight loss in 
women with type 2 diabetes. Diabetes Care. May 2007;30(5):1081-7. doi:10.2337/dc06-1966 
91. 
DiLillo V, Siegfried NJ, Smith West D. Incorporating motivational interviewing into behavioral obesity 
treatment. Cognitive and Behavioral Practice. 2003/03/01/ 2003;10(2):120-130. 
doi:https://doi.org/10.1016/S1077-7229(03)80020-2 
92. 
Dietary Reference Intake Calculator for Healthcare Professionals. U.S. Department of Agriculture. 
Accessed February 9, 2021. https://www.nal.usda.gov/fnic/dri-calculator/ 

Postpartum Meal Study 
Version 1.0 
 
10 APR 2025 
 
 
29 
93. 
Phelan S, Brannen A, Erickson K, et al. 'Fit Moms/Mamás Activas' internet-based weight control program 
with group support to reduce postpartum weight retention in low-income women: study protocol for a 
randomized controlled trial. Trials. Feb 25 2015;16:59. doi:10.1186/s13063-015-0573-9 
94. 
The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. Dec 
2002;25(12):2165-71. doi:10.2337/diacare.25.12.2165 
95. 
Dietary Guidelines for Americans, 2020-2025 (U.S. Department of Agriculture and U.S. Department of 
Health and Human Services) (2020). 
96. 
Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Caution regarding the use of pilot studies to 
guide power calculations for study proposals. Arch Gen Psychiatry. May 2006;63(5):484-9. 
doi:10.1001/archpsyc.63.5.484 
 

Page 1 of 9
FOR206 Version Date: 03/12/24
CONSENT FORM TO BE PART OF A RESEARCH STUDY
Title of Research:
Feasibility of a meal delivery intervention for postpartum weight 
management
UAB IRB Protocol #:
IRB-300010155
Principal Investigator:
Camille Worthington, PhD, RDN, LDN
Sponsor:
UAB Obesity Health Disparities Research Center
General Information
You are being asked to take part in a research study. This research study is 
voluntary, meaning you do not have to take part in it. The procedures, risks, and 
benefits are fully described further in the consent form.
Purpose
The purpose of the study is to test if a meal delivery program helps postpartum 
women like you have healthier diets and lose weight after having a baby.
Duration & Visits
You will be in this study for up to 11 weeks.
Overview of Procedures
This study will include 2 assessment study visits: one at the start of the study 
when you are 5-45 weeks post-delivery and another about 8 weeks later. Within 
two weeks of each visit, a study member will call you three times to ask you about 
everything you had to eat/drink the day before to learn about your diet. At both 
visits, you will also be asked to fill out questionnaires about your health, stress, 
activity level, and sleep. Within 1-2 weeks of completing the first study 
assessment visit, you will begin getting 10 study-provided meals per week 
delivered to your home for you to eat for a total of 8 weeks. While you are 
receiving the study meals, you will be asked to complete a weekly online survey 
and a brief phone call with a study member about how you are doing with the 
meal program. At the second study visit, you will also complete a one-on-one 
interview with a study member to give us feedback on how you liked the meal 
program.
Risks
The most common risks may include normal reactions associated with healthy 
dietary changes, such as gastrointestinal discomfort, though this would be 
temporary. 
Benefits
You may or may not benefit from being in this study.
Alternatives
If you do not want to take part in the study, the alternative is to not participate.
Purpose of the Research Study
We are asking you to take part in a research study. The purpose of this research study is to test whether 
providing women, like you, who recently had a baby with 10 meals per week can help them have a healthier 
diet and lose weight. We are partnering with a local meal delivery company, Nourish Kitchen, to provide the 
study meals. You will get to select which meals you want from Nourish Kitchen’s weekly rotating menu of meal 
options. This is a pilot study, which is an initial small scale study to understand if the meal delivery program as 
we have designed it is well-liked and works for postpartum women. Therefore, we will also ask you to give us 
your feedback on how you like the meal delivery program and what changes you would like to see us make if 
we do more meal delivery programs like this in the future. You may want to talk about the study with your 
family, friends, or medical provider. If you do not understand parts of this form, please ask questions. This 
UAB IRB
Approved
13-Apr-2024

Page 2 of 9
FOR206 Version Date: 03/12/24
study will enroll 20 women who are 5 to 45 weeks post-delivery and received their prenatal care at a 
University of Alabama at Birmingham (UAB) clinic.
Study Participation & Procedures
If you agree to join the study, you will be asked to complete 2 study visits: 1) at the beginning of the study 
when you are 5-45 weeks post-delivery and 2) the second about 8 weeks later. Starting 1-2 weeks after you 
complete the first study visit, you will begin receiving 10 study-provided meals per week delivered to your 
home. These meals will be provided to you free of charge and you will get to choose your study meals from 
Nourish Kitchen’s rotating weekly menu. You will receive study meals for a total of 8 weeks. While you are 
receiving study meals, we will send you a brief electronic survey to complete once per week and call you each 
week to check-in on how you are doing and to get your meal delivery order for the next week.  We describe all 
of these components of the study in detail, below.
Study Visit 1: When you are 5-45 weeks postpartum, you will come to the UAB Medical Towers Building for the 
first study assessment visit. This visit will take about 2 to 2 ½ hours. We will go over the consent form. If you 
agree to be in the study, we will measure your weight and height to be sure you are eligible. You will complete 
a series of surveys asking you about your health, work and education, usual sleep habits and stress, food 
insecurity, diet, and physical activity. You will also be asked to complete 3 diet recalls to tell us about what you 
had to eat the day before: 1 recall will be done at Study Visit 1 and the other 2 diet recalls can be done on the 
computer at home or by telephone with a research staff member in the 1-2 weeks after Study Visit 1. We 
estimate the total time you will spend completing the 2 diet recalls at home will be about 1 to 1 ½ hours.
Study Meal Delivery Program: All 20 women who enroll in the study will receive the study meal delivery 
program. So, if you agree to be in the study, you will begin receiving the study meal delivery program after you 
complete Study Visit 1 (including the telephone diet recalls). You will begin receiving 10 study meals per week 
delivered to your home beginning when you are 5-47 weeks post-delivery and continuing for a total of 8 
weeks. Each week, a study staff member will call you to check-in to see how you are doing with eating your 
meals, help you problem-solve any challenges you are having, and take your meal order for the next week. All 
study meals will be provided and delivered by Nourish Kitchen, a local meal delivery company. Therefore, your 
contact information (name, phone number, email address, address where you want your meals delivered) will 
be shared with Nourish Kitchen and their staff so that they can schedule and deliver your study meals to your 
home each week. Nourish Kitchen publishes their menus, which change weekly, with ingredients on their 
website which you can use to help you decide which meals you want each week. Study staff will then place 
your meal order for you with Nourish Kitchen. Study meals will be delivered to you once per week by Nourish 
Kitchen. All study meals come with nutritional information and the ingredient list, as well as re-heating 
instructions. Meal expiration dates are clearly indicated on the label of each meal. You will also be given a 
variety of example meal plans to help show you what types of foods you should be eating outside of the study-
provided meals and a weight tracking sheet to help you gradually lose weight postpartum.
Each week of the study meal delivery program, you will be sent an electronic survey to complete to confirm 
you received your 10 meals for the week, to report how many of last week’s meals you ate and how much you 
enjoyed them, and to report any issues you think the meals are causing you (for instance, if you feel gassy after 
eating a study meal). At Study Visit 1, you will be given a weighing scale and asked to weigh yourself once per 
week during the study and to report your weekly weight as part of the weekly electronic survey. This is to help 
make sure that you are losing a healthy amount of weight postpartum while receiving the study meal delivery 
program.

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Study Visit 2: During the last week of the study meal delivery program, you will be scheduled to come to the 
UAB Medical Towers Building to complete the second (and final) study visit. This study visit will take about 2 to 
2 ½ hours. We will measure your weight and you will be asked to complete a series of surveys (similar to Study 
Visit 1) and to participate in a one-on-one interview with a member of the research team. In the 1-2 weeks 
before your scheduled Study Visit 2, you will be asked to complete 3 diet recalls to tell us about what you had 
to eat the day before. We estimate the time you will spend completing the 3 telephone diet recalls will be 
about 1 ½ to 2 ¼ hours.
The study surveys and other measures you will be asked to complete at study visits and during the study meal 
delivery program are described in detail below.

Weight measurement (Visits 1 & 2; 2 minutes): We will measure your weight.

Height measurement (Visit 1 only, 4 minutes): We will measure your height.

Food Allergies & Aversions Survey (Study Visit 1 only; 3 minutes): Asks questions about any food 
allergies or food intolerances (e.g., lactose intolerance) that you have, as well as any strong food 
aversions or foods you strongly dislike. This will help us know what foods you need to avoid when 
ordering your study meals.

Demographics Survey (Study Visit 1 only; 10 minutes): Asks questions about your employment, 
education, relationship status, income level, race, and nutrition programs you may participate in.

Pregnancy & Infant History Survey (Study Visit 1 only; 5 minutes): Asks questions about your pregnancy 
history.

Pittsburgh Sleep Quality Index [PSQI] Survey (Study Visit 1 and Study Visit 2; 3-5 minutes): Asks 
questions about your usual sleep habits during the past month.

Perceived Stress Scale [PSS-10] Survey (Study Visit 1 and Study Visit 2; 1-2 minutes): Asks about 
different thoughts and feelings you may have experienced during the last month.

Diet Satisfaction [DSat-28] Survey (Study Visit 1 and Study Visit 2; 2-3 minutes): Asks questions about 
your satisfaction with different aspects of your diet such as how healthy it is, cost, and convenience.

Self-Efficacy Survey (Study Visit 1 and Study Visit 2; 5 minutes): Asks about your feelings and thoughts 
about different statements related to eating healthy and losing weight after having a baby.

Barriers to Healthy Eating Survey (Study Visit 1 and Study Visit 2; 1-2 minutes): Asks you about certain 
barriers you may face related to eating healthy.

Infant Feeding Survey (Study Visit 1 and Study Visit 2; 4 minutes): Asks about the types of foods you are 
feeding your infant (e.g., breast milk, formula, solid foods).

Edinburg Postnatal Depression Scale (Study Visit 1 and Study Visit 2; 2 minutes): Asks questions about 
how you have been feeling over the past 7 days.

Multidimensional Scale of Perceived Social Support (Study Visit 1 and Study Visit 2; 3 minutes): Asks 
about the support you get from others around you.

Nutrition Security Survey (Study Visit 1 and Study Visit 2; 3 minutes): Asks about your household’s 
ability to decide what you eat over the past 30 days.

Household Food Security Survey (Study Visit 1 and Study Visit 2; 1-5 minutes): Asks about the food 
eaten in your household in the last 30 days and whether you were able to afford the food you need.

International Physical Activity Survey (Study Visit 1 and Study Visit 2; 25-30 minutes): Asks you about 
how much time you have usually spent doing different types of physical activities.

24-hour Diet Recalls (Study Visit 1 and by computer or telephone; 30-45 minutes per recall): The 24-
hour diet recall interview gets a detailed summary of all foods, drinks, and dietary supplements you 
had during a complete 24-hour period (from midnight-to-midnight) for the day before the interview. 
Information is collected on the time of each eating occasion, the type of meal (breakfast, lunch, 
supper, snack), and the location of the meal (home, school, other), as well as what and how much was 
consumed. You will be asked to complete 6 total diet recalls for the study: one at Study Visit 1 + two by 

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computer or telephone in the 1-2 weeks after Study Visit 1 + three by computer or telephone in the 1-
2 weeks before Study Visit 2.

Telephone Recall Availability Form (Study Visit 1 and Study Visit 2; 3-5 minutes): Asks you to indicate 
days of the weeks/times you are most likely to be available to receive a call to complete a 24-hour 
telephone diet recall. 

Weekly Electronic Survey (weekly during meal delivery program; 5 minutes): Each week of the meal 
delivery program, you will be emailed or texted a link to a study survey to indicate that you received 
your 10 study meals; to report the number study meals that you ate last week; to report any 
symptoms you have had after eating meals (like if you got an upset stomach after eating a study meal); 
to rank how satisfied you were with last week’s meals; to report your weekly weight; and if your phone 
number or address where you want your study meals delivered has changed.

Health and Demographics Update Survey (Study Visit 2 only; 5 minutes): Asks about changes to your 
employment and nutrition programs you may participate in.

Program Satisfaction Survey (Study Visit 2 only; 5-7 minutes): Asks about how satisfied you were with 
the study meal delivery program staff and the study meals themselves.

One-on-one Interview (Study Visit 2 only; 30-60 minutes): During your interview you will be asked a 
series of questions related to health concerns you have since having a baby, your expectations about 
the study meal delivery program, experience in the study meal delivery program, including program 
structure, delivery, and other resources, program engagement, ideas for future improvements, and 
additional information you want to provide that you think would be helpful for us to know. Your 
interview will take about 30-60 minutes to complete and will be audio-recorded using a digital 
recorder. Then, a written record of the audio recording will be typed. The written reports from the 
recording will give researchers helpful information to understand your and other participants’ 
experiences in the study meal delivery program and how to improve future meal delivery programs 
like this one. 
Medical Record Data: As part of this study, we will retrieve medical records from your most recent pregnancy. 
The information study investigators will receive from your medical records include the date and your 
gestational age at your first dating ultrasound during your most recent pregnancy; the date and your 
gestational age and weight from your first and last prenatal care visit for your most recent pregnancy; your 
gestational age when you gave birth; your weight at delivery; and information about your pregnancy/birth 
outcomes (including whether you were diagnosed with any medical condition during your pregnancy such as 
gestational diabetes or preeclampsia and whether you baby was delivered by Cesarean section or vaginally).
If you are currently or have used any illicit (street) drug(s) during your most recent pregnancy, we ask that you 
not participate in this study.
Additional Information:
Your de-identified private information (private information with all identifiers removed) may be used for 
future research studies or distributed to another researcher for future research studies without additional 
informed consent. This is only when there are no identifiers associated with the data.
Risks and Discomforts
The risks to you for participating in this study are judged to be low.

While unlikely, you may experience normal, temporary reactions associated with making new healthy 
diet changes, such as gastrointestinal discomfort or flatulence.

There is a risk of experiencing an allergic reaction to meals, but this is judged to be very low since you 
will be selecting your meals each week from menus with ingredients provided by Nourish Kitchen.

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
There is a risk of foodborne illness with meal delivery, which is judged to be low as we are using an 
experienced company (Nourish Kitchen) that operates in compliance with local, state, and federal food 
safety regulations. All meals will be kept cold in transit and delivery times will be scheduled with you to 
ensure meals do not sit out too long. Meals also come with reheating instructions and are marked 
clearly with their expiration date.

Some questions on the study surveys ask about personal information, such as income and information 
about your health.  There is a small risk that you will feel uncomfortable or not want to answer these 
questions.  If this happens, you can choose to skip any questions at any time.

We will have to share your name, phone number, email address, and the address where you want your 
study meals delivered with a private meal delivery company we are contracting to provide study 
meals, Nourish Kitchen. By participating in this study, your name and contact information will be 
shared with Nourish Kitchen staff and delivery drivers to allow them to schedule and deliver your study 
meals. As such, there is a risk of loss of confidentiality associated with the information we provide to 
Nourish Kitchen. Only necessary information to provide you with the study meal delivery will be 
shared with Nourish Kitchen (this information is limited to your name, phone number, email address, 
and the address where you want your meal delivered). 

There is a risk of potential loss of privacy and confidentiality. This risk is small. We will take precautions 
to minimize this risk and assure confidentiality of data managed and stored at UAB. All self-reported 
questionnaire responses will only be identified by ID number. All interviews will be audio-recorded and 
transcribed but your name will not be used in transcripts. You do have the options to choose an 
anonymous name or nickname at the beginning of the interview. All data collected during this study 
will be securely stored as paper records in locked storage cabinets as well as electronic records. All 
electronic records will be stored on a secure, password-protected server. Only staff involved in the 
project will have access to records related to this research study.
Information for Women of Childbearing Potential, Nursing Mothers, and/or Men Capable of Fathering a 
Child
To be eligible to participate in this study, you must have had a baby within the last 5-45 weeks. The study is 
specifically designed for and targeting postpartum women. The provision of 10 healthy meals per week does 
not cause any extra risk to mothers who may be nursing.
Benefits
You may benefit from participating in this study, as all participants in the study will receive 10 healthy meals 
per week. These meals may make it easier for you to eat a healthier diet and lose weight after having a baby. 
Providing you with 10 meals per week free of charge may help you feel less stress by saving you time on 
planning, grocery shopping, and preparing meals; giving you access to healthier foods; and improving your 
food security (not having to worry about having enough food). Together, a healthier diet and less stress could 
have some benefits to your mental and physical health postpartum.
Because not much is known about how meal delivery postpartum can benefit mom’s health, your participation 
in this study may provide valuable information to the medical community to help us better understand if meal 
delivery-based programs could be used to improve mom’s weight and health after having a baby.
Alternatives
Your alternative is to not participate in this study.

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Confidentiality and Authorization to Use and Disclose Information for Research Purposes
Federal regulations give you certain rights related to your health information. These include the right to know 
who will be able to get the information and why they may be able to get it. The study doctor must get your 
authorization (permission) to use or give out any health information that might identify you.
What protected health information may be used and/or given to others?
All medical information, including but not limited to information and/or records of any diagnosis or treatment 
of disease or condition, which may include sexually transmitted diseases (e.g., HIV, etc.) or communicable 
diseases, drug/alcohol dependency, etc.; all personal identifiers, including but not limited to your name, social 
security number, medical record number, date of birth, dates of service, etc.; any past, present, and future 
history, examinations, laboratory results, imaging studies and reports and treatments of any kind, including but 
not limited to drug/alcohol treatment, psychiatric/psychological treatment; financial/billing information, 
including but not limited to copies of your medical bills; any other information related to or collected for use in 
the research study, regardless of whether the information was collected for research or non-research (e.g., 
treatment) purposes; records about any study drug you received or about study devices used; and consent 
forms from past studies that might be in your medical record.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of the 
results. You can search this website at any time.
Who may use and give out this information?
Information about your health may be used and given to others by the study doctor and staff. They might see 
the research information during and after the study.
Who might get this information?
All individuals/entities listed in the informed consent document(s), including but not limited to, the physicians, 
nurses and staff and others performing services related to the research (whether at UAB or elsewhere). Your 
information may also be given to the sponsor of this research. “Sponsor” includes any persons or companies 
that are working for or with the sponsor, or are owned by the sponsor, or are providing support to the sponsor 
(e.g., contract research organization).
Information about you and your health which might identify you may be given to:

the Office for Human Research Protections (OHRP)

the U.S. Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) agencies

Governmental agencies in other countries

Governmental agencies to whom certain diseases (reportable diseases) must be reported

the University of Alabama at Birmingham - the physicians, nurses and staff working on the research study 
(whether at UAB or elsewhere); other operating units of UAB, UAB Hospital, UAB Highlands Hospital, 
University of Alabama Health Services Foundation, Children’s of Alabama, Eye Foundation Hospital, and 
the Jefferson County Department of Health, as necessary for their operations; the UAB IRB and its staff

the billing offices of UAB and UAB Health Systems affiliates and/or Children’s of Alabama and its billing 
agents
Why will this information be used and/or given to others?
Information about you and your health that might identify you may be given to others to carry out the 
research study. The sponsor will analyze and evaluate the results of the study. In addition, people from the 

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sponsor and its consultants will be visiting the research site. They will follow how the study is done, and they 
will be reviewing your information for this purpose.
This research will be covered by a Certificate of Confidentiality from the National Institutes of Health. The 
researchers with this Certificate may not disclose or use information, documents, or biospecimens that may 
identify you in any federal, state, or local civil, criminal, administrative, legislative, or other action, suit, or 
proceeding, or be used as evidence, for example, if there is a court subpoena, unless you have consented for 
this use. Information, documents, or biospecimens protected by this Certificate cannot be disclosed to anyone 
else who is not connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse or communicable diseases but not for federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings, see below); if you have consented to the disclosure, 
including for your medical treatment; or if it is used for other scientific research, as allowed by federal 
regulations protecting research subjects.
The Certificate cannot be used to refuse a request for information from personnel of the United States federal 
or state government agency sponsoring the project that is needed for auditing or program evaluation by the 
UAB Forge AHEAD Center which is funding this project or for information that must be disclosed in order to 
meet the requirements of the federal Food and Drug Administration (FDA). You should understand that a 
Certificate of Confidentiality does not prevent you from voluntarily releasing information about yourself or 
your involvement in this research. If you want your research information released to an insurer, medical care 
provider, or any other person not connected with the research, you must provide consent to allow the 
researchers to release it.
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, state, or local 
law of child abuse and neglect, or harm to self or others.
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to 
in this informed consent document.
Information obtained during the course of the study which, in the opinion of the investigator(s), suggests that 
you may be at significant risk of harm to yourself or others will be reportable to a third party in the interest of 
protecting the rights and welfare of those at potential risk.
What if I decide not to give permission to use and give out my health information?
By signing this consent form, you are giving permission to use and give out the health information listed above 
for the purposes described above. If you refuse to give permission, you will not be able to be in this research.
May I review or copy the information obtained from me or created about me?
You have the right to review and copy your health information. However, if you decide to be in this study and 
sign this permission form, you will not be allowed to look at or copy your information until after the research is 
completed.
May I withdraw or revoke (cancel) my permission?
Yes, but this permission will not stop automatically. The use of your personal health information will continue 
until you cancel your permission.
You may withdraw or take away your permission to use and disclose your health information at any time. You 
do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to 
continue being in this study.

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When you withdraw your permission, no new health information which might identify you will be gathered 
after that date. Information that has already been gathered may still be used and given to others. This would 
be done if it were necessary for the research to be reliable.
Is my health information protected after it has been given to others?
If you give permission to give your identifiable health information to a person or business, the information may 
no longer be protected. There is a risk that your information will be released to others. Including others 
outside of UAB, without your permission.
Voluntary Participation and Withdrawal
Whether or not you take part in this study is your choice. There will be no penalty if you decide not to be in it. 
If you decide not to be in the study, you will not lose any benefits you are otherwise owed.
You are free to withdraw from this study at any time. Your choice to leave the study will not affect your 
relationship with this institution. Contact the study investigator, Camille Worthington (205-975-7274), if you 
want to withdraw from the study.
You may be removed from the study without your consent if the sponsor ends the study, if the study doctor 
decides it is not in the best interest of your health, or if you are not following the study rules.
If you are a UAB student or employee, taking part in this research is not a part of your UAB class work or 
duties. You can refuse to enroll, or withdraw after enrolling at any time before the study is over, with no effect 
on your class standing, grades, or job at UAB. You will not be offered or receive any special consideration if you 
take part in this research.
Cost of Participation
There will be no cost to you for taking part in this study. All study meals and study-related assessments will be 
provided to you at no cost during the 11 week study period.
The costs of your standard medical care will be billed to you and/or your insurance company in the usual 
manner.
Payment for Participation
You will be paid $25 for each study visit, plus an additional $30 for completing all six 24-hour dietary recalls (if 
you complete less than 6 of the 24-hour recalls, you will be compensated $5 per recall you completed). If you 
withdraw from the study, you will be paid $25 for each study visit and $5 for each 24-hour dietary recall you 
completed. Payments will be made within 7 days of completing each study visit (one payment within 7 days of 
completing Study Visit 1 procedures and within 7 days of completing Study Visit 2 procedures) if you complete 
the entire study. The total payment you may receive is $80. If you do not finish the entire study, you will be 
paid at the time you decide to stop taking part in the study. Ask the study staff about the method of payment 
that will be used for this study (e.g., check, cash, gift card, direct deposit).

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Payment for Research-Related Injuries
UAB has not provided for any payment if you are harmed as a result of taking part in this study. If such harm 
occurs, treatment will be provided. However, this treatment will not be provided free of charge.
UAB and the UAB Obesity Health Disparities Research Center have not provided for any payment if you are 
harmed as a result of taking part in this study. If such harm occurs, treatment will be provided. However, this 
treatment will not be provided free of charge.
New Findings
You will be told by the study investigator or the study staff if new information becomes available that might 
affect your choice to stay in the study.
Questions
If you have any questions, concerns, or complaints about the research or a research-related injury including 
available treatments, please contact the study investigator. You may contact Dr. Camille Worthington at (205) 
975-7274.
If you have questions about your rights as a research participant, or concerns or complaints about the 
research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. 
Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
Legal Rights
You are not waiving any of your legal rights by signing this consent form.
Signatures
Your signature below indicates that you have read (or been read) the information provided above and agree to 
participate in this study. You will receive a copy of this signed consent form.
Signature of Participant
Date
Signature of Person Obtaining Consent
Date
Reviewed by:
Signature of Principal Investigator Reviewing Consent Document
Date