- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04827654
Increasing Adoption of Fruits and Vegetables Into Family Diet
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78702
- Booker T. Washington
-
Austin, Texas, United States, 78702
- Chalmers Court
-
Austin, Texas, United States, 78704
- Meadowbrook Elementary School
-
Austin, Texas, United States, 78723
- Home Club
-
Austin, Texas, United States, 78753
- Walnut Creek Elementary School
-
Austin, Texas, United States, 78758
- NYOS Kramer
-
Elgin, Texas, United States, 78621
- Elgin High School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
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.
|
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.
|
NO_INTERVENTION: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- Sharma 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.
- Seligman 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.
- Kahlon 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. Erratum In: JAMA Netw Open. 2022 Aug 1;5(8):e2231672.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 00000566
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diet, Healthy
-
University of ReadingActive, not recruitingDiet Modification | Diet, Healthy | Diet HabitUnited Kingdom
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
Washington State UniversityUnited States Department of Agriculture (USDA)Not yet recruitingHealth Behavior | Diet, Healthy | Diet HabitUnited States
-
University of HawaiiPennington Biomedical Research Center; United States Department of Agriculture...RecruitingDiet, HealthyUnited States
-
Harokopio UniversityRecruiting
-
Universitas Katolik Widya Mandala SurabayaNot yet recruitingDiet, HealthyIndonesia
-
Ohio State University Comprehensive Cancer CenterRecruitingHealthy DietUnited States
-
Purdue UniversityMushroom CouncilCompleted
-
University of PalermoCompleted
Clinical Trials on Weekly produce box and gift card
-
Akron General Medical CenterThe Cleveland Clinic; The University of AkronActive, not recruitingHypertension | Obesity | Type 2 Diabetes | Pre-diabetesUnited States
-
Inova Health Care ServicesUniversity of California, Berkeley; Department of Health and Human Services; Abdul... and other collaboratorsCompleted
-
University of MichiganNational Opinion Research CenterActive, not recruitingPregnancyUnited States
-
Duke UniversityPfizer; Agency for Healthcare Research and Quality (AHRQ)CompletedCardiovascular DiseaseUnited States