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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Purdue University
Study ID
NCT07620028
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
May 14, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group: Mary Rigg Neighborhood Center
    This group will receive the weekly food box over the 1-year "intervention period".
  • No Intervention: Control: The Community Alliance of the Far Eastside
    This group will not receive the food box over the 1-year "intervention period".

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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Community Alliance of the Far EastsideIndianapolisIndiana46226-
Mary Rigg Neighborhood CenterIndianapolisIndiana46221-

Find similar trials in Indianapolis, IN

By research site
Community Alliance of the Far Eastside· Indianapolis, INMary Rigg Neighborhood Center· Indianapolis, IN

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