Clinical trial NCT06010784: 'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children.
Official title: FUEL: Food, fUn, frEsh, famiLy Program. Improving Children's Diet Through Afterschool Program and Family Support.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Boys & Girls Clubs of the Austin Area
First posted: 2023-08-25
Enrollment: 119
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community-based trial, two arms randomized on a 1:1 ratio, stratified by SNAP beneficiary status.
Primary purpose: PREVENTION

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.

Detailed description: Children in grades 1 to 5 and enrolled in after-school program offered by the Boys \& Girls Clubs of Austin Area (BGCAA) in selected schools, together with their caregiver (a parent/guardian), will be randomized into one of the two arms:

* Intervention group will receive, for 4 wks, 10 lbs of produce delivered weekly at home and one USD 20 gift card sent bi-weekly (total USD 40). Then, for 15 wks, the caregiver will receive every other week an electronic interactive health goals reminder survey to complete, for which they receive USD10 if completed. The goal sheets are optional activities.
* Control group will receive $120 as grocery store e-gift cards at the end of the study.

Regardless of the allocation arm, the child will attend the BGCAA's afterschool program as part of their family's association with the organization. The program runs daily, and the children are encouraged to attend at least 2x/wk. The "Coordinated Approach to Child Health" (CATCH) program will be delivered as part of the BGCAA program 2x/week.

Primary question: Does a 19-week after-school evidence-based program on nutrition education and physical activity for elementary-aged children improve overall child diet better when resources to encourage healthy eating are also provided to caregivers than when such resources are not provided?

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Child's fruit and vegetable intake as measured by the Texas School Physical Activity and Nutrition (TX SPAN) 2019-2020 dietary assessment questions
timeFrame: Baseline, mid-point (4 weeks), end-point (19 weeks)
measure: Child's overall diet quality as assessed by SPAN Healthy Eating Index (SHEI)
timeFrame: Baseline, mid-point (4 weeks), end-point (19 weeks)
Secondary outcomes:
measure: Guardian's fruits and vegetables intake as measured by the NHANES 2009-2010 Dietary Screening Questionnaire (DSQ)
timeFrame: Baseline, mid-point (4 weeks), end-point (19 weeks)
measure: BMI-for-age percentile
timeFrame: Baseline, end-point (19 weeks)
Other outcomes:
measure: Guardian's mental health as assessed by the Mental Component Score (MCS-12) of the Short-Form 12 Health Survey version 1 (SF-12v1)
timeFrame: Baseline, end-point (19 weeks)
measure: Child's mental health status as measured by the Strengths & Difficulties Questionnaire (SDQ)
timeFrame: Baseline, mid-point (4 weeks), end-point (19 weeks)
measure: 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
timeFrame: Baseline, end-point (19 weeks)
Locations:
city: Austin
country: United States
facility: Boys & Girls Clubs of Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: