An interventional study of Nutrition Secure Indianapolis Food Box Intervention and Nutrition Secure Indianapolis Nutrition Education in Nutrition Intervention, Healthy Eating and Diet, Healthy, sponsored by Purdue University. Enrolling by invitation at 2 sites in United States. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Purdue University · Not applicable, Interventional, and Prevention
Dietary quality is the lowest in the lifespan during childhood through adolescents, a period of rapid growth and development. Protein food recommendations and requirements for protein as a nutrient, along with other nutrients, are unmet by the largest percentage of any age group during adolescence with additional risks for those living in low-resource households. High quality animal source proteins and other healthful foods including fruits, vegetables, dairy and whole grains are less accessible to households with fewer economic resources. Food box interventions have been successful in improving dietary quality in other community interventions, especially when these interventions provide culturally relevant foods with nutrition education support that is tailored to the population. This study will evaluate the effect of a weekly, 12-month food box intervention program, referred to as the Nutrition Secure Indianapolis (NSI) Program, on child dietary quality and household food security in low-income, ethnically diverse populations using a longitudinal, controlled design. Low-income households (n=500) in Indianapolis participating in the NSI Program will be invited to join a research program evaluation study. Study assessments will include repeated 24-hour dietary recalls to determine usual intake, the U.S. Household Food Security Survey Module, a short-form mental health assessment, and a voluntary health screening, from before and after the 12-month intervention period. The aim of this study is to improve dietary quality per the Healthy Eating Index and other dietary outcomes among children and adolescents living in low-resource and ethnically diverse households through a longitudinal healthful food box intervention containing animal source proteins and other dietary components, compared with a control.
In 2023, food insecurity, defined as reduced quality, variety, or desirability of diet with or without reduced food intake, affected 17.9 percent of households with children in the United States. Food insecurity may impact the growth and development of school-aged children and adolescents, increasing the risk of behavioral and emotional problems, reduced academic performance, and mental health issues such as anxiety and depression. In addition to mental and emotional health, childhood food insecurity is associated with poor physical health outcomes, such as increased risk of cardiovascular disease, obesity, diabetes, and anemia. Adults in food insecure households may also experience adverse health outcomes such as an increased risk of chronic disease and poor mental health outcomes related to stress and depression, yet children may be especially vulnerable to adverse outcomes due their need for nutrient rich diets at critical stages of growth.
Dietary quality is a modifiable risk factor linking food insecurity to many of the poor health outcomes mentioned. Compared with those living in food secure situations, those experiencing food insecurity may have lower dietary quality and be less likely to fulfill nutrient requirements, which is associated with poor health outcomes. Food insecurity is consistently associated with lower dietary quality among adults. Adult food insecurity is linked with decreased consumption of fruits, vegetables, and dairy products, as well as reduced intakes of vitamin A, vitamin B6, calcium, magnesium, and zinc. However, adults in food insecure households often prioritize nutritious foods for children by implementing behavioral food coping strategies. Childhood food insecurity is also associated with a higher risk of inadequate intake of vitamin D, magnesium, calcium, and choline compared to their food secure peers. Yet, evidence of a similar association of food insecurity with lower dietary quality in children as in adults remains mixed in the United States.
In food insecure households with children, protein is a critical component of dietary quality for both adults and children. Adolescents aged 14 to 18 years are at greatest risk of inadequate protein intakes, with up to 8 percent of males and 23 percent of females failing to meet the Estimated Average Requirement (EAR) for dietary protein. While protein food means are consumed close to the target amounts, protein foods are frequently consumed in forms with high in saturated fat or sodium, commonly as part of mixed dishes such as sandwiches, casseroles, and processed meats. Total protein foods are a component of dietary quality as measured by the Healthy Eating Index (HEI) which includes meats, poultry, eggs, seafood, nuts, seeds, and soy products. Approximately 49 percent of food insecure households do not meet the recommended intake for total protein foods, suggesting reduced access to higher-quality protein sources which limits overall dietary quality in children and adults.
Given the more recent rising prevalence of food insecurity in the United States since 2022 and its negative relationship to diet quality and health, prior studies have implemented food box interventions to provide supplementary nutritious foods to food insecure families. One monthly food box intervention reported making improvements in adult food security at one year and improvements in child daily intake of fruits, vegetables, and whole grains; however, the intervention did not result in a significant reduction in child food insecurity. Therefore, the Nutrition Secure Indianapolis (NSI) program aims to enhance dietary quality among adults and children in food insecure households through a weekly food box intervention that includes animal-source proteins, such as pork, alongside fresh produce, whole grains, and dairy. This program will highlight the role of high-quality protein sources in supporting dietary quality among diverse populations, including Hispanic households in urban Indianapolis neighborhoods. Individuals participating in this program will be asked to join a Purdue research program evaluation study to understand how the NSI program improves food security and dietary outcomes among adults and children in low-income households. The results could lead to improved dietary intervention strategies for vulnerable populations experiencing food insecurity to reduce the risk of chronic disease and improve long-term health outcomes.
Research objectives:
Researchers from Purdue have been contracted by HATCH, an Indianapolis not-for-profit organization, to assess and collect outcome data to measure the impact of a collaborative initiative called the NSI Program to access proper nutrition and improved outcomes with the long-term goal of creating a model for global change. The intervention arm of the NSI Program will offer weekly food boxes and monthly educational lessons to households with children in Indianapolis the control arm of the project will not offer the food boxes. Purdue will evaluate this program by collecting, managing, and analyzing data from participants of the NSI Program who consent to also being part of a research study. Regardless of participation in the research study, the households eligible for the NSI Program will still be able to participate in the planned NSI intervention or control groups of the study. Households participating in the NSI Program will be invited to join the study and complete a screener, consent and assent forms, as well as study pre- and post-assessments on participant characteristics and dietary intake (2 dietary recalls at baseline and 1-year follow-up) from parent-child pairs in the NSI Program. Pre- and post-program characteristic surveys will be completed in Qualtrics and address questions regarding general health, food security, ideas and practices on food and nutrition knowledge, and mental health. Pre- and post-dietary assessments will be collected in the Automated Self-Administered 24-Hour Dietary Assessment (ASA24) website to measure dietary intake and change in eating behaviors.
After the baseline study assessments are completed, the NSI Program Nutrition Secure Indianapolis will coordinate for parent/legal guardian-child pairs in the Intervention Group to receive a weekly food box containing 8 pounds of protein and 12 pounds of produce, as well as milk and eggs. Food boxes will be distributed for 1 year. Purdue researchers will not be involved in the delivery of the NSI program including the preparation or distribution of the food boxes or any other education offered.
Purdue University is the lead sponsor of 175 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
- Has a way to refrigerate and warm or cook food, in the place where they live
This group will receive the weekly food box over the 1-year "intervention period".
Other: Nutrition Secure Indianapolis Food Box Intervention · Behavioral: Nutrition Secure Indianapolis Nutrition Education
This group will not receive the food box over the 1-year "intervention period".
The 250 intervention group families will receive a weekly food box that contains 8 lb animal protein and 16 lb dairy (1/2 gl milk), 2-3 varieties of fruits/vegetables/wk (10 lbs), and whole grains (1 lb) where total HEI\>80. Food boxes will be distributed for 1 year. As such, the study is expected to take approximately 13-14 months to complete.
Families in the experimental group who are receiving the food box will also be encouraged to attend monthly educational courses, including information on cooking skills, gardening, financial literacy, as well as nutrition education classes.
Change in dietary quality from baseline to 12 months
Determined based on the Healthy Index Score, where 100 indicates complete alignment with the Dietary Guidelines for Americans and 0 is the minimum score, as calculated from two 24-hour dietary recalls.
Time frame: Two 24-hour dietary recalls on two non-consecutive days at baseline and 12 months later
Change in food security from baseline to 12 months
Determined based on the 18-item US Household Food Security Survey Module
Time frame: Food security of the previous 12 months at baseline and 12 months later
Change in pediatric mental health from baseline to 12 months
Determined based on the PROMIS Pediatric Short Form GenPop v3.0 - Anxiety 8a
Time frame: Childhood anxiety of the previous 7 days at baseline and 12 months later
Change in health parameters from baseline to 12 months
Determined based on voluntary bloodwork collected by the Gennesaret clinic
Time frame: Optional blood sample collected at baseline and within two weeks of the completion of the program
Change in lipid levels from baseline to 12 months
Determined based on voluntary bloodwork collected by the Gennesaret clinic
Time frame: Optional blood sample collected at baseline and within two weeks of the completion of the program
Change in hemoglobin A1C from baseline to 12 months
Determined based on voluntary bloodwork collected by the Gennesaret clinic
Time frame: Optional blood sample collected at baseline and within two weeks of the completion of the program
Change in iron levels from baseline to 12 months
Determined based on voluntary bloodwork collected by the Gennesaret clinic
Time frame: Optional blood sample collected at baseline and within two weeks of the completion of the program
Plan to share: No
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