Diet, HealthyNCT04827654
Increasing Adoption of Fruits and Vegetables Into Family Diet
A study testing Weekly produce box and gift card in people with Diet, Healthy, run by University of Texas at Austin at 7 sites in United States.
Trial summary
The investigators are interested in maximizing the consumption of fruits and vegetables (F\&V) in elementary school children by increasing the access to F\&V by providing them in the home environment via direct delivery (F\&V bag \& recipes) and a gift card to purchase preferred choices. Read more about this study
- Who is it for?
- Ages 4 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy
- What is being tested?
- Weekly produce box and gift card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2021to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Families must be participants in the Boys and Girls "Club on the Go" program. They could sign up to become a participant while we are recruiting.
- Caregiver must be able to come to the same "Club on the Go" site every week.
- At least one child in the family must be k-5 student.
- Caregiver must be able to read and write in English or Spanish to answer assessments.
Who cannot join
- Reference child with any medical condition in which they have to follow a specific diet.
- Caregiver cannot read and write in English or Spanish.
- Reference child not living with caregiver for majority of time (75% or greater).
- Families that do not meet the inclusion criteria
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Booker T. Washington
Austin, Texas, 78702
Chalmers Court
Austin, Texas, 78702
Meadowbrook Elementary School
Austin, Texas, 78704
Home Club
Austin, Texas, 78723
Walnut Creek Elementary School
Austin, Texas, 78753
NYOS Kramer
Austin, Texas, 78758
Elgin High School
Elgin, Texas, 78621
About this study
Official title: The Impact of Providing Choices for Fruits and Vegetable Access on Child Diet
The investigators are interested in maximizing the consumption of fruits and vegetables (F\&V) in elementary school children by increasing the access to F\&V by providing them in the home environment via direct delivery (F\&V bag \& recipes) and a gift card to purchase preferred choices. This also decreases barriers to trying F\&V and switching to a more F\&V-focused diet, e.g., access, cost, knowledge of what to do with fruits and vegetables by their families in household diet, and a period of time to try and get used to more F\&V in the diet without worrying about access and cost.
We hypothesize that at the end of 4 weeks, children in families that were given access to a F\&V produce box with associated recipes, a gift card to purchase preferred choices, and a cooking incentive kit, consumed significantly better diets as measured with a diet composite score compared with children in families who did not receive increased F\&V access.
- Conditions
- Diet, Healthy
- Being tested
- Weekly produce box and gift card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly produce box and gift cardDietary supplement
Weekly box of produce (5-10 lbs) and $10.00 gift card to a local grocery store to purchase preferred produce. If progress on self-goals completed, an additional $10.00 card provided, weekly, for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Families in the intervention arm will receive a program of 4 weeks of access to fruit and vegetables through direct access (produce box) and a gift card to the grocery store for purchase of preferred produce. Receives: Dietary Supplement: Weekly produce box and gift card |
| Control Group | No intervention | Families in the control group will not receive any produce boxes or gift cards during the study period. At the end of the study period they will receive gift cards of equivalent amount. |
What is being measured
The primary outcome is the main question the study is designed to answer.
School Physical Activity and Nutrition (SPAN) questionnaire elementary version
dietary recall measure for fruit and vegetables scale of 0-12 with higher scores equating to more vegetable consumption
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start31 Mar 2021
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, outcomes on reference child and reference caregiver; In the intervention arm, fruits and vegetables and vouchers cover more than 1 cup a day increase for families, using an average of 5 people as family size.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Boys and Girls Club of Austin
- Responsible party
- Principal investigator, Maninder Kahlon, University of Texas at Austin
- Investigators
- Maninder Kahlon, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827654
- Sponsor's protocol ID
- 00000566
- Status last verified
- Sep 2021
- First submitted
- 29 Mar 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsho LE, Klerman JA, Wilde PE, Bartlett S. Financial incentives increase fruit and vegetable intake among Supplemental Nutrition Assistance Program participants: a randomized controlled trial of the USDA Healthy Incentives Pilot. Am J Clin Nutr. 2016 Aug;104(2):423-35. doi: 10.3945/ajcn.115.129320. Epub 2016 Jun 22.
PubMed 27334234Sharma SV, Markham C, Chow J, Ranjit N, Pomeroy M, Raber M. Evaluating a school-based fruit and vegetable co-op in low-income children: A quasi-experimental study. Prev Med. 2016 Oct;91:8-17. doi: 10.1016/j.ypmed.2016.07.022. Epub 2016 Jul 25.
PubMed 27471022Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.
PubMed 30024798Kahlon MK, Aksan NS, Aubrey R, Barnes J, Clark N, Cowley-Morillo M, Engelman L, Guerra J, Guevara A, Marshall A, Hoelscher DM. Effect of Brief Produce Exposure and Unconstrained Grocery Gift Cards on Caregiver Influence on Diet of Elementary Age Children: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212973. doi: 10.1001/jamanetworkopen.2022.12973.
PubMed 35622367
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Providing Choices for Fruits and Vegetable Access on Child Diet
- ClinicalTrials.gov ID
- NCT04827654
- Acronym / sponsor ID
- 00000566
- Conditions
- Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Boys and Girls Club of Austin
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 1 Apr 2021 (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.
The investigators are interested in maximizing the consumption of fruits and vegetables (F\&V) in elementary school children by increasing the access to F\&V by providing them in the home environment via direct delivery (F\&V bag \& recipes) and a gift card to purchase preferred choices. This also decreases barriers to trying F\&V and switching to a more F\&V-focused diet, e.g., access, cost, knowledge of what to do with fruits and vegetables by their families in household diet, and a period of time to try and get used to more F\&V in the diet without worrying about access and cost.
We hypothesize that at the end of 4 weeks, children in families that were given access to a F\&V produce box with associated recipes, a gift card to purchase preferred choices, and a cooking incentive kit, consumed significantly better diets as measured with a diet composite score compared with children in families who did not receive increased F\&V access.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, outcomes on reference child and reference caregiver; In the intervention arm, fruits and vegetables and vouchers cover more than 1 cup a day increase for families, using an average of 5 people as family size.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Weekly produce box and gift cardFamilies in the intervention arm will receive a program of 4 weeks of access to fruit and vegetables through direct access (produce box) and a gift card to the grocery store for purchase of preferred produce. |
| Control Group | No intervention | –Families in the control group will not receive any produce boxes or gift cards during the study period. At the end of the study period they will receive gift cards of equivalent amount. |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Families must be participants in the Boys and Girls "Club on the Go" program. They could sign up to become a participant while we are recruiting.
- Caregiver must be able to come to the same "Club on the Go" site every week.
- At least one child in the family must be k-5 student.
- Caregiver must be able to read and write in English or Spanish to answer assessments.
Key exclusion criteria (4 listed)
- Reference child with any medical condition in which they have to follow a specific diet.
- Caregiver cannot read and write in English or Spanish.
- Reference child not living with caregiver for majority of time (75% or greater).
- Families that do not meet the inclusion criteria
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 |
|---|---|---|
| Weekly produce box and gift cardWeekly box of produce (5-10 lbs) and $10.00 gift card to a local grocery store to purchase preferred produce. If progress on self-goals completed, an additional $10.00 card provided, weekly, for 3 weeks. | Dietary supplement | Intervention group |
Primary outcome
School Physical Activity and Nutrition (SPAN) questionnaire elementary version
Time frame: 24 hours
dietary recall measure for fruit and vegetables scale of 0-12 with higher scores equating to more vegetable consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Results publication: PubMed 27334234Olsho LE, Klerman JA, Wilde PE, Bartlett S. Financial incentives increase fruit and vegetable intake among Supplemental Nutrition Assistance Program participants: a randomized controlled trial of the USDA Healthy Incentives Pilot. Am J Clin Nutr. 2016 Aug;104(2):423-35. doi: 10.3945/ajcn.115.129320. Epub 2016 Jun 22.
- Results publication: PubMed 27471022Sharma SV, Markham C, Chow J, Ranjit N, Pomeroy M, Raber M. Evaluating a school-based fruit and vegetable co-op in low-income children: A quasi-experimental study. Prev Med. 2016 Oct;91:8-17. doi: 10.1016/j.ypmed.2016.07.022. Epub 2016 Jul 25.
- Results publication: PubMed 30024798Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.
- Derived from this study: PubMed 35622367Kahlon MK, Aksan NS, Aubrey R, Barnes J, Clark N, Cowley-Morillo M, Engelman L, Guerra J, Guevara A, Marshall A, Hoelscher DM. Effect of Brief Produce Exposure and Unconstrained Grocery Gift Cards on Caregiver Influence on Diet of Elementary Age Children: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2212973. doi: 10.1001/jamanetworkopen.2022.12973.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maninder Kahlon, PhD principal investigator
University of Texas at Austin
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly produce box and gift card in people with Diet, Healthy, run by University of Texas at Austin at 7 sites 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 4 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: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School Physical Activity and Nutrition (SPAN) questionnaire elementary version (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827654, which also lists 4 linked publications.
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 29 Sep 2021.