NCT04827654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

March 29, 2021

Last Update Submit

September 27, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours

Study Arms (2)

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.

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.

Interventions

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.

Intervention group

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Booker T. Washington

Austin, Texas, 78702, United States

Location

Chalmers Court

Austin, Texas, 78702, United States

Location

Meadowbrook Elementary School

Austin, Texas, 78704, United States

Location

Home Club

Austin, Texas, 78723, United States

Location

Walnut Creek Elementary School

Austin, Texas, 78753, United States

Location

NYOS Kramer

Austin, Texas, 78758, United States

Location

Elgin High School

Elgin, Texas, 78621, United States

Location

Related Publications (4)

  • 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.

Study Officials

  • Maninder Kahlon, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Individuals collecting data will be blinded to the participant randomization status.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

March 31, 2021

Primary Completion

June 30, 2021

Study Completion

July 31, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations