Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) Childhood Obesity
Phase: NA
Conditions: Pediatric Obesity, Nutrition Disorders, Overnutrition, Child, Obesity
Sponsor: Boston Children's Hospital

 
 
 
 
Intervening in Food Insecurity to Reduce and Mitigate (InFoRM) 
Childhood Obesity 
 
National Clinical Trial (NCT) Identified Number: NCT05586269 
Principal Investigator: Allison Wu, MD, MPH 
Sponsor: Boston Children’s Hospital 
2023-01-23 
 
Description: Study protocol and analysis plan 
 
 

 
 
STUDY PROTOCOL 
BACKGROUND 
“Food is medicine” focuses on the integration of food and nutrition interventions, also referred to as 
nutrition security, in the healthcare system. Medically tailored meal (MTM) programs have been shown to 
reduce food insecurity, improve dietary quality, and decrease healthcare utilization for adults with chronic 
illnesses.41,2 This evidence has paved the way for Medicaid in some states, including MA, CA, NY, and MI, to 
reimburse MTMs and similar nutrition support for eligible adults. Meal kits with step-by-step home preparation 
instructions, which further provide nutrition education alongside healthy food, are an innovative adaptation to 
MTMs. EatWell, a Boston-based company, provides healthy, culturally tailored meal kits with fresh ingredients 
and easy-to-follow recipes to food-insecure populations. Despite the evidence in adults, there is a major 
knowledge gap and a lack of evidence to support nutrition security interventions such as meal kits to treat 
obesity and nutritional disorders in children and families. But the potential is substantial since childhood is an 
important period where health behaviors such as diet can set the stage for cardiometabolic health over the 
lifespan.3,4 
SPECIFIC AIM 
Pilot a 6-week meal kit delivery program using a randomized, cross-over trial design in 30 families with 
children (6-11 years old) with food insecurity and obesity.  
 
DESIGN  
Study Design & Population: Drawing from children who receive primary care at Boston Children’s at Martha 
Eliot Health Center (Martha Eliot), we will recruit dyads (child + primary caregiver/parent). Martha Eliot serves 
families who are predominantly publicly insured (~75%) and self-identify as Hispanic or Latinx (~70%). Prior to 
the pandemic, ~12% of families at Martha Eliot reported food insecurity. Children with BMI ³95th percentile and 
a positive screen for food insecurity screened routinely on the 2-item Hunger Vital Sign™5 will be eligible. We 
will use a randomized, cross-over trial study design. We have chosen this design due to concern about the 
ethics of withholding a potentially beneficial intervention to a vulnerable population of families with unmet social 
needs. We have also chosen this design because it provides a randomized control trial method. 
Inclusion Criteria: Dyads (also referred to as “participants”) including children who are 1) 6 to 11 years old 2) 
with a BMI ³95th percentile 3) screened positive on the 2-item Hunger Vital Sign™ 4) in a household of £5 
people, 5) living with an English and/or Spanish-speaking caregiver and 6) living within the EatWell delivery 
map boundaries in the greater Boston area. 
Exclusion Criteria: Participants (either child or parent) with a history of 1) food allergies or intolerance to dairy, 
gluten, soy, or any potential component of the meal kit; 2) malabsorptive intestinal disease (e.g., Crohn’s 
disease, celiac disease); 4) type 1 or 2 diabetes; 5) solid tumor or bone marrow transplant; or 6) enteral tube 
dependence. 
Intervention: EatWell meal kits will be delivered once weekly to households for 6 weeks. Healthy meal kits are 
developed by a trained chef and registered dietician. Each household will receive one meal kit per week.  
Randomization: Participants will be randomized to one of two intervention sequences: 
A) Meal kit intervention without delay followed by newsletter + pantry referral (standard of care) 
B) Newsletter + pantry referral followed by meal kit intervention after a delay of 8 weeks 
The printed newsletter lists additional local food assistance resources.  
Sampling/Power: A pilot study is defined as “a small-scale test of the methods and procedures to be used on a 
larger scale.”6 We will assess the feasibility of an intervention to be refined for a larger-scale RCT. We will also 
assess the short-term impact of the pilot intervention. The planned sample of 30 dyads (a total of 30 children + 
30 caregivers) is based on practical considerations, including participant flow, budgetary constraints, and the 
number needed to reasonably evaluate the feasibility of the intervention.  
Study Visits: We have outlined the three study visits (Table 1), which will initially collect baseline demographic, 
medical and dietary history, provide questionnaires, and measure weight and height. Follow-up visits will be 

 
conducted between Periods 1 and 2 (6 weeks), and then after Period 2 (14 weeks). Follow-up visits will include 
dietary assessments and questionnaires and measure the children’s weight and height.   
Table 1. Outline of study visits and measures collected 
Study Visit 
Measures 
V1, in-person: Participants will meet 
with the study physician and 
research assistant to review 
eligibility criteria and obtain 
informed consent (including assent 
from eligible participants).  
• 
Baseline demographics: age, sex, insurance type, and race and ethnicity. 
• 
Medical history: to assess for underlying gastrointestinal, endocrinologic, cardiometabolic, allergic 
conditions, and current and past medication history.  
• 
Dietary assessment   
• 
Questionnaires  
• 
Anthropometrics: weight, height, and calculated BMI for each child 
V2, in-person:  Participants will 
meet with the research assistant. 
• 
Dietary assessment 
• 
Questionnaires  
• 
Anthropometrics 
V3, in-person: 
Participants will meet with the study 
physician and research assistant.  
• 
Dietary assessment 
• 
Questionnaires  
• 
Anthropometrics 
 
Study Outcomes: The primary, intention-to-treat analysis will examine the feasibility of the meal kit delivery 
intervention. We will assess primary outcomes of feasibility of recruitment, randomization, retention, 
adherence, protocol, and assessments.7 Primary outcomes will be assessed throughout the study. We will 
assess secondary outcomes of the intervention’s short-term impact, which will include questionnaires on food 
insecurity and anthropometrics. Secondary outcomes will be assessed at Visits 1-3. We will additionally include 
the assessments we plan to include in a future RCT, including diet quality, mealtime behaviors, and perceived 
stress.  
Analysis Plan: Consistent with the goal of pilot studies, our analysis will be mainly descriptive.8 However, we 
will collect secondary outcomes including severity of household food insecurity and child BMI. We will collect 
and describe dietary quality and mealtime behaviors, among other assessments, and EHR data. We will 
present secondary outcomes as means (with standard deviations) or proportions.  
 
 

 
 
ADVERSE EVENT CRITERIA AND REPORTING PROCEDURES 
This proposal seeks to pilot and evaluate implementation of a nutrition security intervention using weekly meal 
kit delivery in food-insecure families with children 6 to 11 years old with obesity. This intervention will be tested 
at Boston Children’s at Martha Eliot Health Center. This proposed study will leverage the existing partnership 
with EatWell meal kits. EatWell meal kits are prepared at Commonwealth Kitchen in Boston, MA, which 
adheres to a rigorous food safety program and complies with National Restaurant Association ServeSafe 
requirements and FDA requirements, and other applicable regulations, in addition to being regularly inspected 
by the City of Boston. The meal kits occasionally contain gluten and diary, but do not contain tree nuts or 
peanuts, although they are manufactured in a shared use facility and the product may contain trace amounts of 
Milk, Eggs, Fish, Shellfish, Tree Nuts, Peanuts, Wheat, and Soy. Any patients with food allergies or intolerance 
to potential components of EatWell meal kits will be excluded from participation to avoid any risk of allergic 
reaction to any of the meals. Therefore, this study poses minimal risk to participants. 
 
We will obtain approval from the Boston Children’s Institutional Review Board (IRB) for each of the aims, and 
we will participate in their standard annual continuing review process. We will also require that all staff and 
investigators working on this project complete human subjects research training. We will establish a data 
safety and monitoring board (DSMB) that will meet every 4 months. We will include experienced clinical trial 
researchers who are independent experts outside of our research team, in addition to Dr. Wu, Dr. Duggan and 
Dr. Liu. The Principal Investigator, Dr. Wu, will be responsible for monitoring the safety of this study. Dr. Wu 
will promptly report adverse events and other study-related information to the IRB. Clinical staff at the health 
center will be directed to report any suspected events related to this research to Dr. Wu. Protocol deviations 
will be reported to the IRB, along with an annual status report as per IRB guidelines. Adverse events are not 
anticipated for this study given the low-risk nature of the proposal. 
 
DATA MANAGEMENT METHODS 
All study data will be stored on password-protected computers and identified with study IDs. Analytic data files 
will contain no identifying information. No study report will allow identification of individual participants. 
Individual patient data collected as part of the intervention surveys or interviews will be kept confidential. 
Access to identifiable information will be strictly limited to study personnel who require such information to 
complete the work (e.g., study physician and research coordinator). Whenever possible, printed materials that 
contain identifying information (e.g. thank you letters) will contain no information revealing diagnoses, 
treatment, or other clinical information. All study staff will have CITI certifications and will be trained in IRB 
protocols.  
 
STATISTICAL POWER AND SAMPLE CONSIDERATIONS 
STATISTICAL DESIGN 
 
 
 
 
 
 
 
 
 
 
 
 
We will use a randomized, cross-over trial study design. We also chose this design because it provided a 
randomized control trial method. Participants will be individually randomized to one of two intervention 
sequences: 
A) Meal kit intervention without delay followed by newsletter + pantry referral (standard of care) 
B) Newsletter + pantry referral followed by meal kit intervention after a delay of 8 weeks 
Each group will receive 6 weeks of meal kit delivery and will be observed in the study for a total of 14 weeks. 
 
POWER 
 
 
 
 
 
 
 
 
 
 
 
The goal of our pilot study is to assess the feasibility, short-term impact, and implementation of a pilot nutrition 
security intervention using a meal kit delivery program. Results will be used to refine the intervention for a 
larger scale trial. The sample of 30 families is based on practical considerations, including participant flow, 
budgetary constraints, and the number needed to reasonably evaluate feasibility goals. 
 
 
 
 

 
 
 
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Medically Tailored Meal Delivery for Diabetes Patients with Food Insecurity: a Randomized Cross-over 
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