NCT07220291

Brief Summary

The goal of this clinical trial is to understand if monthly food support increases food security in food insecure households. The main questions it aims to answer are:

  • Does monthly food support increase household food security?
  • Does monthly food support reduce stress, increase dietary diversity, and improve self-reported wellness in recipients? Researchers will compare households receiving monthly food support to households that do not receive study-related food support. Participants will complete questionnaires regarding food insecurity, stress, wellness, and dietary diversity at baseline and after 3 months.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Nov 2025Sep 2026

First Submitted

Initial submission to the registry

October 21, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

October 21, 2025

Last Update Submit

October 21, 2025

Conditions

Keywords

Alaska Nativeruralfood securityfood sovereigntyfood support

Outcome Measures

Primary Outcomes (1)

  • Food security

    Household Hunger Scale, US Agency for International Development. Participant reported 30-day look back at household food security using 9 frequency-of-occurrence questions (rarely, sometimes, or often). Responses tabulated into household hunger score (little/no, moderate, severe hunger).

    Assessed at baseline and after 3 months of food support or wait list condition

Secondary Outcomes (3)

  • Dietary diversity

    At baseline and after 3 months of food support or wait list

  • Perceived Stress

    At baseline and following 3 months of food support or wait list

  • Yup'ik Wellness

    At baseline and after 3 months of food support or wait list

Study Arms (2)

Food support

EXPERIMENTAL

Monthly food box shipped to rural Alaska Native households that include traditional proteins when available (e.g., caribou, salmon) and are pro-rated in value by household size.

Other: Food support

Wait list control

NO INTERVENTION

Households allocated to the wait list arm will receive food support as described in the intervention arm after 3 months.

Interventions

A monthly box of food shipped to a household that preferentially contains traditional protein such as moose meat or salmon. Additional food items included to compliment the protein for preparing meals, such as rice or canned vegetables. The monthly value of the food box contents will be $100, $200, or $250 depending on household size (\<5 people, 5-10 people, and \>10 people). Food support will be provided for 3 months prior to assessing outcomes. Households will continue to receive food support in both arms (intervention and wait list) after the study ends.

Also known as: Food box
Food support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Live in a Yukon-Kuskokwim Delta community served by the Yukon Kuskokwim Health Corporation
  • Self-reported need for food support.

You may not qualify if:

  • Existing food support through Neqkiuryaraq
  • Under 18 years of age
  • Planning to move outside of YK Delta within 4 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physician

Study Record Dates

First Submitted

October 21, 2025

First Posted

October 23, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Tribal sovereignty and data ownership limits data sharing.