'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children.

NCT06010784 | Completed

• 1 other identifier: STUDY00004545
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this community-based randomized trial in elementary-aged children and a caregiver (parent/guardian) is to test the effect of providing families with produce and grocery store gift cards (family support) in conjunction with an after-school program for physical activity and healthy eating on improving children's overall diet, in comparison to the child only attending the after-school program without the family support. Participating families will:

• receive weekly produce bags delivered to their home, recipes, and gift cards to a local grocery store (family support)
• the child will attend the after-school program during the school year Researchers will compare the child's diet and eating scores with those in the after-school program alone.

Conditions

Diet, Healthy Growth

Keywords

elementary; after-school program; fruits and vegetable prescription; incentive; produce; school-aged children; family support; CATCH; diet; produce prescription; produce rx; Healthy Eating Index; nutrition incentive; SNAP

Outcome Measures

Primary Outcomes (2)

• Child's fruit and vegetable intake as measured by the Texas School Physical Activity and Nutrition (TX SPAN) 2019-2020 dietary assessment questions

  This study will use the section of the TX SPAN data collection instrument related to food choices via structured interview (English or Spanish). 32 questions reference specific marker foods or food groups asking the number of times each food group was consumed on the previous day (analogous to a 24h recall), with responses 0 times, 1 time, 2 times or 3 or more times. Total FV variety will be measured by summing the items that ask about fruit and vegetable varieties (excluding juice). More on the TX SPAN can be found at \<go.uth.edu/SPAN\>.

  Baseline, mid-point (4 weeks), end-point (19 weeks)

• Child's overall diet quality as assessed by SPAN Healthy Eating Index (SHEI)

  As described in 2015 Ranjit et al. SPAN Healthy Eating Index (SHEI) is a composite measure comprising both healthy and unhealthy items from diet measures available in the TX SPAN. Healthy score is the sum of previous day consumption of baked or grilled (not fried) meats, milk, yogurt, brown rice, brown pasta, a variety of vegetable types, fruits (not fruit juice), and beans. Unhealthy score is the sum of consumption of fried meat, red meat, sugar-sweetened beverages, salty fried snacks, and a variety of dessert items. These are reverse coded, so that the lowest frequency represented the healthiest eating practice. These two sums are combined into the single composite SHEI and rescaled from 0-100, where higher scores mean healthier eating practices.

  Baseline, mid-point (4 weeks), end-point (19 weeks)

Secondary Outcomes (2)

• Guardian's fruits and vegetables intake as measured by the NHANES 2009-2010 Dietary Screening Questionnaire (DSQ)

  Baseline, mid-point (4 weeks), end-point (19 weeks)

• BMI-for-age percentile

  Baseline, end-point (19 weeks)

Other Outcomes (3)

• Guardian's mental health as assessed by the Mental Component Score (MCS-12) of the Short-Form 12 Health Survey version 1 (SF-12v1)

  Baseline, end-point (19 weeks)

• Child's mental health status as measured by the Strengths & Difficulties Questionnaire (SDQ)

  Baseline, mid-point (4 weeks), end-point (19 weeks)

• Child's physical activity engagement as measured by the physical activity questions in the Texas School Physical Activity and Nutrition (TX SPAN) 2nd grade 2019-2020

  Baseline, end-point (19 weeks)

Study Arms (2)

Intervention: After-school program + family support

EXPERIMENTAL

Behavioral: Family support; Behavioral: BGCAA's after-school program with CATCH curriculum

Control: After-school program only

ACTIVE COMPARATOR

Behavioral: BGCAA's after-school program with CATCH curriculum

Interventions

Family support BEHAVIORAL

* Family tip sheets sent via mobile text at the start of the program and then every 3 weeks, to a total of 6 mobile text messages * Weeks 1-4 (4 weeks): i. Welcome package mailed in the first week of the program ii. Weekly: one 10-lbs box of produce iii. Recipes accompanying each box (sample recipe card attached to submission) iv. Bi-Weekly: Grocery store gift cards (2x USD 20, to a total of USD 40) * Weeks 5-19 (total of 10 weeks over the 19-week study timeline): i. An optional online form ("goal sheet") is sent to the parent/caregiver every other week (total 5) with questions about trying new FV items to be submitted in the next 7 days. As an incentive, a USD 10 gift card is sent to those who complete it (a potential total of USD 50). ii. Week 11: an extra USD 20 gift card in the week after a school holiday to re-engage participants due to the school-year break.

Intervention: After-school program + family support

BGCAA's after-school program with CATCH curriculum BEHAVIORAL

1. The whole BGCAA's after-school program runs for 3h, Mon-Fri for the school year across all sites where the organization offers the program. All children enrolled are expected to attend a minimum of 2x/week. 2. In the BGCAA's after-school program, children participate in active recreational time (approx. 60 min, offered 1x/week at a minimum) which is a mixture of free play, structured physical activity games, and/or sports activities (including soccer, football, and basketball). 3. Uniquely to sites participating in the study, BGCAA's staff will deliver selected CATCH (Coordinated Approach to Child Health) curriculum components in blocks of 45-60 min, 2x/week, as part of the after-school program. The curriculum will focus on healthy eating education and physical activity designed for elementary school-aged children. More information on CATCH at https://catch.org/ (accessed 8/11/2023)

Control: After-school program only; Intervention: After-school program + family support

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Index guardian must be at least 18 years old
• Child must be enrolled in grade 1 to 5 (aged approx. 6-11 y-o) for the 2023-2024 school year
• Child must be enrolled in the BGCAA after-school program at the beginning of the 2023-24 fall semester at one of the 11 sites where BGCAA offers after-school program to elementary school-aged children
• Index parent must be able to speak English and/or Spanish

You may not qualify if:

• Already having a sibling enrolled in the study
• Child having serious food allergies or dietary restrictions associated with produce products

Sponsors & Collaborators

• University of Texas at Austin: lead
• Boys & Girls Clubs of the Austin Area: collaborator

Study Sites (1)

Boys & Girls Clubs of Austin

Austin, Texas, 78723, United States

Location

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: Research staff responsible for data collection are blinded to the arm allocation of the participant. At the end-point, however, a set of questions about the participant's experience in the program may unblind staff collecting the data. To minimize influence of unblinding, those set of questions will be ask at the end of the data collection period and ensure structured interview techniques are followed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Community-based trial, two arms randomized on a 1:1 ratio, stratified by SNAP beneficiary status.

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 25, 2023
• Study Start: September 6, 2023
• Primary Completion: April 3, 2024
• Study Completion: August 1, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)