DietPhase 1NCT06828445
Increasing Affordable Fruits and Vegetables for Families With Food Insecurity
A Phase 1 study testing Veggie Vouchers in people with Diet, run by University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet
- What is being tested?
- Veggie Vouchers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2025to Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29204
Elizabeth Adams, PhD, 803-777-0269, elizabeth-adams@sc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Diet
- Being tested
- Veggie Vouchers
- Keywords
- food insecurity, diet, Supplemental Nutrition Assistance Program, fruit, vegetable, healthy eating, pediatrician
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veggie VouchersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Diet intervention | Experimental | 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. Receives: Behavioral: Veggie Vouchers |
| Education-only wait-list control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Child diet quality
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.
Measured: Baseline, 6, 18, and 30 weeks
Secondary outcomes (13)
Caregiver diet quality
Caregivers will complete a 3-day food record for their dietary intake. Caregiver diet quality will then be assessed using the Healthy Eating Index.
Measured: Baseline, 6, 18, and 30 weeks
Child Eating Behaviors
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.
Measured: Baseline, 6, 18, and 30 weeks
Process metrics
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).
Measured: Through study completion, an average of 3 years
Intervention utilization
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.
Measured: Through study completion, an average of 3 years
Perspectives of the intervention
Focus groups and online surveys will be administered to key informants to assess barriers and facilitators to intervention implementation and sustainability.
Measured: Through study completion, an average of 3 years
Food security
The United States Department of Agriculture Household Food Security Module (18-item) will be administered. Higher scores indicate less food security.
Measured: Baseline, 6, 18, and 30 weeks
Availability Pillar of Food Security
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.
Measured: Baseline, 6, 18, and 30 weeks
Utilization Pillar of Food Security
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.
Measured: Baseline, 6, 18, and 30 weeks
Stability Pillar of Food Security
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.
Measured: Baseline, 6, 18, and 30 weeks
Nutrition Security
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.
Measured: Baseline, 6, 18, and 30 weeks
Household Healthfulness Choice
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.
Measured: Baseline, 6, 18, and 30 weeks
Dietary Choice
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.
Measured: Baseline, 6, 18, and 30 weeks
SNAP fruit and vegetable incentive program utilization
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.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start6 Mar 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DietStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 296 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Elizabeth Adams, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828445
- Sponsor's protocol ID
- Pro00136502
- Other IDs
- R01DK140677
- Status last verified
- Apr 2025
- First submitted
- 10 Feb 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Use of SNAP Fruit and Vegetable Incentive Programs for Families With Food Insecurity
- ClinicalTrials.gov ID
- NCT06828445
- Acronym / sponsor ID
- Pro00136502
- Conditions
- Diet
- Keywords
- food insecurity, diet, Supplemental Nutrition Assistance Program, fruit, vegetable, healthy eating, pediatrician
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 296 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, Cornell University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet intervention | Experimental | Behavioral: Veggie VouchersCaregivers 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. |
| Education-only wait-list control | No intervention | –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. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veggie VouchersCaregivers 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. | Behavioural | Diet intervention |
Primary outcome
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.
13 secondary outcomes
Caregiver diet quality
Time frame: Baseline, 6, 18, and 30 weeks
Child Eating Behaviors
Time frame: Baseline, 6, 18, and 30 weeks
Process metrics
Time frame: Through study completion, an average of 3 years
Intervention utilization
Time frame: Through study completion, an average of 3 years
Perspectives of the intervention
Time frame: Through study completion, an average of 3 years
Food security
Time frame: Baseline, 6, 18, and 30 weeks
Availability Pillar of Food Security
Time frame: Baseline, 6, 18, and 30 weeks
Utilization Pillar of Food Security
Time frame: Baseline, 6, 18, and 30 weeks
Stability Pillar of Food Security
Time frame: Baseline, 6, 18, and 30 weeks
Nutrition Security
Time frame: Baseline, 6, 18, and 30 weeks
Household Healthfulness Choice
Time frame: Baseline, 6, 18, and 30 weeks
Dietary Choice
Time frame: Baseline, 6, 18, and 30 weeks
SNAP fruit and vegetable incentive program utilization
Time frame: Through study completion, an average of 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Veggie Vouchers in people with Diet, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Adams, PhD (803-777-0269, elizabeth-adams@sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child diet quality (time frame: Baseline, 6, 18, and 30 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.