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Nutrition InterventionNCT07620028

Improving Dietary Quality Through Animal Source Protein Accessibility in a Low-Resource Setting

A study testing Nutrition Secure Indianapolis Food Box Intervention and Nutrition Secure Indianapolis Nutrition Education in people with Nutrition Intervention and Healthy Eating, run by Purdue University at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
What is being tested?
Nutrition Secure Indianapolis Food Box Intervention and Nutrition Secure Indianapolis Nutrition Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
2 sitesUnited States
Study dates
14 May 2026to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Lives in Indianapolis Neighborhood
  • 18 years or older
  • Reads and speaks English or Spanish
  • Willingness to answer study assessments at the beginning and again one year later at the end of the study
  • Has a child (or is the legal guardian) aged 5-18 years old who lives with them during the week while the child attends school (not preschool)
  • Willingness to allow one of their children to participate in the study and complete study assessments
  • Willingness to stay in touch with research staff for the entire length of the study (~13-14 months)

Who cannot join

  • Has a way to refrigerate and warm or cook food, in the place where they live

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Mary Rigg Neighborhood Center

    Indianapolis, Indiana, 46221

  • Community Alliance of the Far Eastside

    Indianapolis, Indiana, 46226

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Nutrition Secure Indianapolis Food Box Intervention, Nutrition Secure Indianapolis Nutrition Education
Keywords
Food box intervention, Nutrition education, Food security, Diet quality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition Secure Indianapolis Food Box InterventionOther

    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.

  • Nutrition Secure Indianapolis Nutrition EducationBehavioural

    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.

Study groups in NCT07620028
Study groupRoleWhat they receive
Intervention Group: Mary Rigg Neighborhood CenterExperimentalThis group will receive the weekly food box over the 1-year "intervention period".
Receives: Other: Nutrition Secure Indianapolis Food Box Intervention; Behavioral: Nutrition Secure Indianapolis Nutrition Education
Control: The Community Alliance of the Far EastsideNo interventionThis group will not receive the food box over the 1-year "intervention period".

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Two 24-hour dietary recalls on two non-consecutive days at baseline and 12 months later

  2. Change in food security from baseline to 12 months

    Determined based on the 18-item US Household Food Security Survey Module

    Measured: Food security of the previous 12 months at baseline and 12 months later

  3. Change in pediatric mental health from baseline to 12 months

    Determined based on the PROMIS Pediatric Short Form GenPop v3.0 - Anxiety 8a

    Measured: Childhood anxiety of the previous 7 days at baseline and 12 months later

  4. Change in health parameters from baseline to 12 months

    Determined based on voluntary bloodwork collected by the Gennesaret clinic

    Measured: Optional blood sample collected at baseline and within two weeks of the completion of the program

Secondary outcomes (3)
  1. Change in lipid levels from baseline to 12 months

    Determined based on voluntary bloodwork collected by the Gennesaret clinic

    Measured: Optional blood sample collected at baseline and within two weeks of the completion of the program

  2. Change in hemoglobin A1C from baseline to 12 months

    Determined based on voluntary bloodwork collected by the Gennesaret clinic

    Measured: Optional blood sample collected at baseline and within two weeks of the completion of the program

  3. Change in iron levels from baseline to 12 months

    Determined based on voluntary bloodwork collected by the Gennesaret clinic

    Measured: Optional blood sample collected at baseline and within two weeks of the completion of the program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start14 May 2026
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
2-arm, intervention and control, parallel design
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07620028
Sponsor's protocol ID
HATCH-2025
Status last verified
May 2026
First submitted
20 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cabili C, Briefel R, Forrestal S, Gabor V, Chojnacki G. A Cluster Randomized Controlled Trial of a Home-Delivered Food Box on Children's Diet Quality in the Chickasaw Nation Packed Promise Project. J Acad Nutr Diet. 2021 Jan;121(1S):S59-S69. doi: 10.1016/j.jand.2020.08.012.

    PubMed 33342526
  • Briefel RR, Chojnacki GJ, Gabor V, Forrestal SG, Kleinman R, Cabili C, Gleason PM. A Cluster Randomized Controlled Trial of a Home-Delivered Food Box on Food Security in Chickasaw Nation. J Acad Nutr Diet. 2021 Jan;121(1S):S46-S58. doi: 10.1016/j.jand.2020.07.021.

    PubMed 33342524
  • Berryman CE, Lieberman HR, Fulgoni VL 3rd, Pasiakos SM. Protein intake trends and conformity with the Dietary Reference Intakes in the United States: analysis of the National Health and Nutrition Examination Survey, 2001-2014. Am J Clin Nutr. 2018 Aug 1;108(2):405-413. doi: 10.1093/ajcn/nqy088.

    PubMed 29931213
  • Leung CW, Epel ES, Ritchie LD, Crawford PB, Laraia BA. Food insecurity is inversely associated with diet quality of lower-income adults. J Acad Nutr Diet. 2014 Dec;114(12):1943-53.e2. doi: 10.1016/j.jand.2014.06.353. Epub 2014 Aug 1.

    PubMed 25091796
  • Jun S, Cowan AE, Dodd KW, Tooze JA, Gahche JJ, Eicher-Miller HA, Guenther PM, Dwyer JT, Potischman N, Bhadra A, Forman MR, Bailey RL. Association of food insecurity with dietary intakes and nutritional biomarkers among US children, National Health and Nutrition Examination Survey (NHANES) 2011-2016. Am J Clin Nutr. 2021 Sep 1;114(3):1059-1069. doi: 10.1093/ajcn/nqab113.

    PubMed 33964856
  • Liebe RA, Holmes C, Misyak SA. Differing Within-Household Food Security Statuses Are Associated with Varied Maternal Mental Health Outcomes. Nutrients. 2024 May 18;16(10):1522. doi: 10.3390/nu16101522.

    PubMed 38794760
  • Hanson KL, Connor LM. Food insecurity and dietary quality in US adults and children: a systematic review. Am J Clin Nutr. 2014 Aug;100(2):684-92. doi: 10.3945/ajcn.114.084525. Epub 2014 Jun 18.

    PubMed 24944059
  • Morales ME, Berkowitz SA. The Relationship between Food Insecurity, Dietary Patterns, and Obesity. Curr Nutr Rep. 2016 Mar;5(1):54-60. doi: 10.1007/s13668-016-0153-y. Epub 2016 Jan 25.

    PubMed 29955440
  • Kirkpatrick SI, Dodd KW, Parsons R, Ng C, Garriguet D, Tarasuk V. Household Food Insecurity Is a Stronger Marker of Adequacy of Nutrient Intakes among Canadian Compared to American Youth and Adults. J Nutr. 2015 Jul;145(7):1596-603. doi: 10.3945/jn.114.208579. Epub 2015 May 20.

    PubMed 25995277
  • Seligman HK, Laraia BA, Kushel MB. Food insecurity is associated with chronic disease among low-income NHANES participants. J Nutr. 2010 Feb;140(2):304-10. doi: 10.3945/jn.109.112573. Epub 2009 Dec 23.

    PubMed 20032485
  • Pourmotabbed A, Moradi S, Babaei A, Ghavami A, Mohammadi H, Jalili C, Symonds ME, Miraghajani M. Food insecurity and mental health: a systematic review and meta-analysis. Public Health Nutr. 2020 Jul;23(10):1778-1790. doi: 10.1017/S136898001900435X. Epub 2020 Mar 16.

    PubMed 32174292
  • Eicher-Miller HA, Mason AC, Weaver CM, McCabe GP, Boushey CJ. Food insecurity is associated with iron deficiency anemia in US adolescents. Am J Clin Nutr. 2009 Nov;90(5):1358-71. doi: 10.3945/ajcn.2009.27886. Epub 2009 Sep 23.

    PubMed 19776137
  • Fulay AP, Lee JM, Baylin A, Wolfson JA, Leung CW. Associations between food insecurity and diabetes risk factors in US adolescents in the National Health and Nutrition Examination Survey (NHANES) 2007-2016. Public Health Nutr. 2024 Feb 12;27(1):e68. doi: 10.1017/S1368980024000284.

    PubMed 38343166
  • Kral TVE, Chittams J, Moore RH. Relationship between food insecurity, child weight status, and parent-reported child eating and snacking behaviors. J Spec Pediatr Nurs. 2017 Apr;22(2):10.1111/jspn.12177. doi: 10.1111/jspn.12177. Epub 2017 Mar 21.

    PubMed 28321980
  • Tester JM, Laraia BA, Leung CW, Mietus-Snyder ML. Dyslipidemia and Food Security in Low-Income US Adolescents: National Health and Nutrition Examination Survey, 2003-2010. Prev Chronic Dis. 2016 Feb 11;13:E22. doi: 10.5888/pcd13.150441.

    PubMed 26866948

Questions about this trial

What is this clinical trial studying?

A study testing Nutrition Secure Indianapolis Food Box Intervention and Nutrition Secure Indianapolis Nutrition Education in people with Nutrition Intervention and Healthy Eating, run by Purdue University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in dietary quality from baseline to 12 months (time frame: Two 24-hour dietary recalls on two non-consecutive days at baseline and 12 months later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07620028, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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