Clinical trial NCT04827654: Increasing Adoption of Fruits and Vegetables Into Family Diet
Official title: The Impact of Providing Choices for Fruits and Vegetable Access on Child Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Boys and Girls Club of Austin
First posted: 2021-04-01
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Caregiver must be able to come to the same "Club on the Go" site every week.
3. At least one child in the family must be k-5 student.
4. Caregiver must be able to read and write in English or Spanish to answer assessments.

Exclusion Criteria:

1. Reference child with any medical condition in which they have to follow a specific diet.
2. Caregiver cannot read and write in English or Spanish.
3. Reference child not living with caregiver for majority of time (75% or greater).
4. Families that do not meet the inclusion criteria

Primary outcomes:
measure: School Physical Activity and Nutrition (SPAN) questionnaire elementary version
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Booker T. Washington
state: Texas
city: Austin
country: United States
facility: Chalmers Court
state: Texas
city: Austin
country: United States
facility: Meadowbrook Elementary School
state: Texas
city: Austin
country: United States
facility: Home Club
state: Texas
city: Austin
country: United States
facility: Walnut Creek Elementary School
state: Texas
city: Austin
country: United States
facility: NYOS Kramer
state: Texas
city: Elgin
country: United States
facility: Elgin High School
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.