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

NCT07620028 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-06-02

No results posted yet for this study

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

Interventions

OTHER

Nutrition Secure Indianapolis Food Box Intervention

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.

BEHAVIORAL

Nutrition Secure Indianapolis Nutrition Education

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.

Sponsors & Collaborators

  • Purdue University

    lead OTHER

Principal Investigators

  • Heather Eicher-Miller, PhD · Purdue University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620028 on ClinicalTrials.gov