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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04827654
Other study ID # 00000566
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date July 31, 2021

Study information

Verified date September 2021
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date July 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 11 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Weekly produce box and gift card
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.

Locations

Country Name City State
United States Booker T. Washington Austin Texas
United States Chalmers Court Austin Texas
United States Home Club Austin Texas
United States Meadowbrook Elementary School Austin Texas
United States NYOS Kramer Austin Texas
United States Walnut Creek Elementary School Austin Texas
United States Elgin High School Elgin Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas at Austin Boys and Girls Club of Austin

Country where clinical trial is conducted

United States, 

References & Publications (3)

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 — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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