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

NCT07620028 | Enrolling By Invitation

• 1 other identifier: HATCH-2025
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Nutrition Intervention; Healthy Eating; Diet, Healthy; Hunger; Food Security

Keywords

Food box intervention; Nutrition education; Food security; Diet quality

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

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

Secondary Outcomes (3)

• Change in lipid levels from baseline to 12 months

  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

  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

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

Study Arms (2)

Intervention Group: Mary Rigg Neighborhood Center

EXPERIMENTAL

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

Control: The Community Alliance of the Far Eastside

NO INTERVENTION

This group will not receive the food box over the 1-year "intervention period".

Interventions

Nutrition Secure Indianapolis Food Box Intervention OTHER

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.

Intervention Group: Mary Rigg Neighborhood Center

Nutrition Secure Indianapolis Nutrition Education BEHAVIORAL

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.

Intervention Group: Mary Rigg Neighborhood Center

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Lives in Indianapolis Neighborhood
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Purdue University: lead

Study Sites (2)

Mary Rigg Neighborhood Center

Indianapolis, Indiana, 46221, United States

Location

Community Alliance of the Far Eastside

Indianapolis, Indiana, 46226, United States

Location

Related Publications (16)

• 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.

  PMID: 33342526 BACKGROUND

• 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.

  PMID: 33342524 BACKGROUND

• 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.

  PMID: 29931213 BACKGROUND

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  PMID: 25091796 BACKGROUND

• 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.

  PMID: 33964856 BACKGROUND

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  PMID: 38794760 BACKGROUND

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  PMID: 24944059 BACKGROUND

• 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.

  PMID: 29955440 BACKGROUND

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  PMID: 25995277 BACKGROUND

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  PMID: 20032485 BACKGROUND

• 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.

  PMID: 32174292 BACKGROUND

• 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.

  PMID: 19776137 BACKGROUND

• 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.

  PMID: 38343166 BACKGROUND

• 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.

  PMID: 28321980 BACKGROUND

• 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.

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• Shankar P, Chung R, Frank DA. Association of Food Insecurity with Children's Behavioral, Emotional, and Academic Outcomes: A Systematic Review. J Dev Behav Pediatr. 2017 Feb/Mar;38(2):135-150. doi: 10.1097/DBP.0000000000000383.

  PMID: 28134627 BACKGROUND

Study Officials

• Heather Eicher-Miller, PhD

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 2-arm, intervention and control, parallel design

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 2, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)