- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010784
'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children. (FUEL)
FUEL: Food, fUn, frEsh, famiLy Program. Improving Children's Diet Through Afterschool Program and Family Support.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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?
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Austin, Texas, United States, 78723
- Boys & Girls Clubs of Austin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention: After-school program + family support
|
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.
|
|
Active Comparator: Control: After-school program only
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child's fruit and vegetable intake as measured by the Texas School Physical Activity and Nutrition (TX SPAN) 2019-2020 dietary assessment questions
Time Frame: Baseline, mid-point (4 weeks), end-point (19 weeks)
|
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)
Time Frame: Baseline, mid-point (4 weeks), end-point (19 weeks)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Guardian's fruits and vegetables intake as measured by the NHANES 2009-2010 Dietary Screening Questionnaire (DSQ)
Time Frame: Baseline, mid-point (4 weeks), end-point (19 weeks)
|
The DSQ FV module has 10 items that capture frequency of consumption of fruits and vegetables and their sources (such as vegetables in recipes) in the past 30 days.
It does not require participants to report serving size.
Responses are converted to daily cup equivalent estimates.
|
Baseline, mid-point (4 weeks), end-point (19 weeks)
|
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BMI-for-age percentile
Time Frame: Baseline, end-point (19 weeks)
|
Twice during the program, all children in the after-school program will participate in an interactive activity during a field day where BGCAA staff (blinded to the study arm allocation) measures the children's weight, height and how high they can jump. Because body weight may be a sensitive issue to some children and/or their families, it was proposed to embed it in the daily after-school activities, minimizing the focus on direct and open measurement of weight. First, height will be measured using a stadiometer against the wall before the activity. Then, the child will stand on a mat with an integrated scale that will measure their weight. Finally, the children will write their name on an athletic tape and/or post-it notes and jump to stick it to a wall. |
Baseline, end-point (19 weeks)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Guardian's mental health as assessed by the Mental Component Score (MCS-12) of the Short-Form 12 Health Survey version 1 (SF-12v1)
Time Frame: Baseline, end-point (19 weeks)
|
Self-reported measure assessing the impact of health on an individual's everyday life, often used as a quality of life measure.
Two summary scores are reported: 1) a mental component score (MCS-12) and 2) a physical component score (PCS-12).
The United States population average PCS-12 is 50 points with standard deviation of 10 points.
|
Baseline, end-point (19 weeks)
|
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Child's mental health status as measured by the Strengths & Difficulties Questionnaire (SDQ)
Time Frame: Baseline, mid-point (4 weeks), end-point (19 weeks)
|
SDQ is a brief psychological assessment and behavioral screening tool for 2-17 year-olds (Goodman, 1997), reported by their parents/guardians in the study.
25 items are divided between 5 scales: 1) emotional symptoms (5 items); 2) conduct problems (5 items); 3) hyperactivity/inattention (5 items); 4) peer relationship problems (5 items); 5) prosocial behavior (5 items), with the timeframe of past 6 months.
Scores in the sections 1 to 4 are added to generate a total difficulties score (20 items).
Higher scores indicate greater difficulties (poorer mental health status).
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Baseline, mid-point (4 weeks), end-point (19 weeks)
|
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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
Time Frame: Baseline, end-point (19 weeks)
|
Questions are posed to the guardian.
Two items assess 1) how many days in the past week the child was physically active for at least 60 min.
and 2) played outdoors for at least 30 min.
outside of school hours.
The other 5 items assess attitude and usual engagement in physical activity.
The demographics survey at baseline will ask whether the child has limited physical ability to engage in activities.
|
Baseline, end-point (19 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maninder Kahlon, PhD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00004545
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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