Increasing Affordable Fruits and Vegetables for Families With Food Insecurity

April 3, 2025 updated by: Elizabeth Adams, University of South Carolina

Increasing Use of SNAP Fruit and Vegetable Incentive Programs for Families With Food Insecurity

Investigator will test an intervention to increase use of a fruit and vegetable incentive program in South Carolina for families in the Supplemental Nutrition Assistance Program (SNAP) experiencing food insecurity. Caregivers are randomized to an intervention or an education-only, wait-list control group. The investigators hypothesize the intervention will improve diet-related outcomes, above and beyond the education-only wait-list control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will test an intervention to increase use of a fruit and vegetable incentive program for families in the Supplemental Nutrition Assistance Program (SNAP) using a randomized controlled trial design. Caregivers are randomized to the intervention or an education-only wait-list control group. All caregivers are given brief education about a SNAP fruit and vegetable incentive program. Caregivers in the intervention are also given an initial "free trial" of this program and free home delivery. The primary aim is to examine intervention efficacy on diet-related outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
296

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Recruiting
        • University of South Carolina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Primary caregiver 18+ years of age
  • Has a child 2-10 years of age
  • Speaks English
  • Screens positive for food insecurity
  • Currently enrolled in the Supplemental Nutrition Assistance Program (SNAP)
  • Lives with a feasible radius for home delivery
  • Consistent access to a phone that receives text messages

Exclusion Criteria:

  • Anticipate no longer being enrolled in SNAP during the study duration
  • Recent use of the SNAP fruit and vegetable incentive program
  • Caregiver or child has a medical condition that impacts their ability to eat fruits and vegetables
  • Caregiver or child has a significant food allergy, preference, or intolerance that impacts their ability to eat fruits and vegetables

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diet intervention
Caregivers will receive brief education about a SNAP fruit and vegetable incentive program in South Carolina during their child's pediatrician visit. Following the visit, caregivers will receive a "free trial" of this SNAP program to encourage first-time use. After the free trial, caregivers can continue purchasing the same fruit and vegetable boxes at a steeply discounted price using their SNAP card. Free home delivery during the "free trial" and for all subsequent boxes purchased at a discounted rate will be offered during the full study duration.
Behavioral: Veggie Vouchers
Caregivers will receive brief education about a SNAP fruit and vegetable incentive program in South Carolina during their child's pediatrician visit. Following the visit, caregivers will receive a "free trial" of this SNAP program to encourage first-time use. After the free trial, caregivers can continue purchasing the same fruit and vegetable boxes at a steeply discounted price using their SNAP card. Free home delivery during the "free trial" and for all subsequent boxes purchased at a discounted rate will be offered during the full study duration.
No Intervention: Education-only wait-list control
Caregivers will only receive brief education about a SNAP fruit and vegetable incentive program in South Carolina during their child's pediatrician visit. Once caregivers complete all study measures, they will be moved off the wait list and offered the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Child diet quality
Time Frame: Baseline, 6, 18, and 30 weeks
Caregivers will complete a 3-day food record for their child's dietary intake. Child diet quality will then be assessed using the Healthy Eating Index.
Baseline, 6, 18, and 30 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Caregiver diet quality
Time Frame: Baseline, 6, 18, and 30 weeks
Caregivers will complete a 3-day food record for their dietary intake. Caregiver diet quality will then be assessed using the Healthy Eating Index.
Baseline, 6, 18, and 30 weeks
Child Eating Behaviors
Time Frame: Baseline, 6, 18, and 30 weeks
The Children's Eating Behavior Questionnaire will be used to assess children's food fussiness. The food fussiness sub-scale consists of 5-pt Likert scale items ranging from Never (1) to Always (5). The mean of the response values is calculated. Higher score indicating a greater degree of food fussiness.
Baseline, 6, 18, and 30 weeks
Process metrics
Time Frame: Through study completion, an average of 3 years
Process metrics will examine the reach of families who received brief education during clinic visits at each site, utilization of the free trial, use of home delivery, and families who cycled off SNAP within the study duration (%, #, timing).
Through study completion, an average of 3 years
Intervention utilization
Time Frame: Through study completion, an average of 3 years
Semi-structured phone interviews and surveys will be administered to caregivers to elicit perceptions on intervention components, barriers/facilitators to intervention use, and suggestions for future dissemination.
Through study completion, an average of 3 years
Perspectives of the intervention
Time Frame: Through study completion, an average of 3 years
Focus groups and online surveys will be administered to key informants to assess barriers and facilitators to intervention implementation and sustainability.
Through study completion, an average of 3 years
Food security
Time Frame: Baseline, 6, 18, and 30 weeks
The United States Department of Agriculture Household Food Security Module (18-item) will be administered. Higher scores indicate less food security.
Baseline, 6, 18, and 30 weeks
Availability Pillar of Food Security
Time Frame: Baseline, 6, 18, and 30 weeks
The Perceived Limited Availability scale will be administered (6-items). Items are summed to create a total score for food stores (3-items) and food pantries (3 items). Each total score ranges 0-3. Higher scores are considered less desirable.
Baseline, 6, 18, and 30 weeks
Utilization Pillar of Food Security
Time Frame: Baseline, 6, 18, and 30 weeks
The Utilization Barriers scale (8-items) will be administered. Items are summed to create a score ranging 0-8. Higher scores are considered less desirable.
Baseline, 6, 18, and 30 weeks
Stability Pillar of Food Security
Time Frame: Baseline, 6, 18, and 30 weeks
The Food Insecurity Stability scale (12-items) will be administered. Participants receive 4 scores, each ranging from 0-3 for chronic, seasonal, monthly, and intermittent food insecurity. Higher scores indicate a greater degree of chronic, seasonal, monthly, and intermittent food insecurity.
Baseline, 6, 18, and 30 weeks
Nutrition Security
Time Frame: Baseline, 6, 18, and 30 weeks
Nutrition security will be measured using the Household Nutrition Security scale (4-items). Item scores range 0 ("Always") to 4 ("Never"). The mean of item scores is calculated. Higher scores indicate a greater degree of nutrition security.
Baseline, 6, 18, and 30 weeks
Household Healthfulness Choice
Time Frame: Baseline, 6, 18, and 30 weeks
The Household Healthfulness Choice (3-items) survey will be administered. Items are scored from 4 ("Always") to 0 ("Never"). The mean of the item scores is calculated. Higher scores indicate a greater degree healthfulness choice.
Baseline, 6, 18, and 30 weeks
Dietary Choice
Time Frame: Baseline, 6, 18, and 30 weeks
The Dietary Choice (3-items) survey will be administered. Item scores range from 0 ("Always") to 4 ("Never"). The mean of the item scores is calculated. Higher scores indicate a greater degree of dietary choice.
Baseline, 6, 18, and 30 weeks
SNAP fruit and vegetable incentive program utilization
Time Frame: Through study completion, an average of 3 years
Purchasing data will be used to quantify the number and type of produce boxes purchased as part of the Supplemental Nutrition Assistance Program (SNAP) fruit and vegetable incentive program in South Carolina.
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Virginia Commonwealth University
Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00136502
  • R01DK140677 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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