- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06828445
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
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
Interventional
Enrollment (Estimated)
296
Phase
- 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
- Name: Elizabeth Adams, PhD
- Phone Number: 803-777-0269
- Email: elizabeth-adams@sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29204
- Recruiting
- University of South Carolina
-
Contact:
- Elizabeth Adams, PhD
- Phone Number: 803-777-0269
- Email: elizabeth-adams@sc.edu
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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.
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)
March 6, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
February 10, 2025
First Submitted That Met QC Criteria
February 10, 2025
First Posted (Actual)
February 14, 2025
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID 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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