Increasing Adoption of Fruits and Vegetables Into Family Diet

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Completed
• CT.gov ID: NCT04827654
• Collaborator: Boys and Girls Club of Austin (Other)
• Enrollment: 68
• Locations: 7
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site: 9.7
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diet, Healthy	Dietary Supplement: Weekly produce box and gift card	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Investigator, Outcomes Assessor)
• Masking Description: Individuals collecting data will be blinded to the participant randomization status.
• Primary Purpose: Health Services Research
• Official Title: The Impact of Providing Choices for Fruits and Vegetable Access on Child Diet
• Actual Study Start Date: Mar 31, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

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.	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.
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.

Outcome Measures

Primary Outcome Measures

1. School Physical Activity and Nutrition (SPAN) questionnaire elementary version [24 hours]

   dietary recall measure for fruit and vegetables scale of 0-12 with higher scores equating to more vegetable consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Booker T. Washington	Austin	Texas	United States	78702
2	Chalmers Court	Austin	Texas	United States	78702
3	Meadowbrook Elementary School	Austin	Texas	United States	78704
4	Home Club	Austin	Texas	United States	78723
5	Walnut Creek Elementary School	Austin	Texas	United States	78753
6	NYOS Kramer	Austin	Texas	United States	78758
7	Elgin High School	Elgin	Texas	United States	78621

Sponsors and Collaborators

• University of Texas at Austin
• Boys and Girls Club of Austin

Investigators

• Principal Investigator: Maninder Kahlon, PhD, University of Texas at Austin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maninder Kahlon, Associate Professor, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT04827654
• Other Study ID Numbers: 00000566
• First Posted: Apr 1, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 29, 2021