Diet, Healthy GrowthFUELNCT06010784
'Food, Fun, Fresh, Family' Program for Healthy Eating and Growth for Elementary-age Children.
A study testing Family support and BGCAA's after-school program with CATCH curriculum in people with Diet, Healthy Growth, run by University of Texas at Austin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Diet, Healthy Growth
- What is being tested?
- Family support and BGCAA's after-school program with CATCH curriculum
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2023to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Already having a sibling enrolled in the study
- Child having serious food allergies or dietary restrictions associated with produce products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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?
- Conditions
- Diet, Healthy Growth
- Being tested
- Family support, BGCAA's after-school program with CATCH curriculum
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family supportBehavioural
- 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):
- 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):
- 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.
BGCAA's after-school program with CATCH curriculumBehavioural
- 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.
- 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).
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention: After-school program + family support | Experimental | Not described Receives: Behavioral: Family support; Behavioral: BGCAA's after-school program with CATCH curriculum |
| Control: After-school program only | Active comparator | Not described Receives: Behavioral: BGCAA's after-school program with CATCH curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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>.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, mid-point (4 weeks), end-point (19 weeks)
BMI-for-age percentile
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.
Measured: Baseline, end-point (19 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start6 Sep 2023
- Primary completion13 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, Healthy GrowthStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Community-based trial, two arms randomized on a 1:1 ratio, stratified by SNAP beneficiary status.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Boys & Girls Clubs of the Austin Area
- Responsible party
- Principal investigator, Maninder Kahlon, University of Texas at Austin
- Investigators
- Maninder Kahlon, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010784
- Sponsor's protocol ID
- STUDY00004545
- Acronym
- FUEL
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: By request
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUEL: Food, fUn, frEsh, famiLy Program. Improving Children's Diet Through Afterschool Program and Family Support.
- ClinicalTrials.gov ID
- NCT06010784
- Acronym / sponsor ID
- FUEL / STUDY00004545
- Conditions
- Diet, Healthy Growth
- Keywords
- elementary, after-school program, fruits and vegetable prescription, incentive, produce, school-aged children, family support, CATCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Boys & Girls Clubs of the Austin Area
- Study start
- 6 Sep 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Community-based trial, two arms randomized on a 1:1 ratio, stratified by SNAP beneficiary status.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Already having a sibling enrolled in the study
- Child having serious food allergies or dietary restrictions associated with produce products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family support* 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. | Behavioural | Intervention: After-school program + family support |
| BGCAA's after-school program with CATCH curriculum1. 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) | Behavioural | Control: After-school program only, Intervention: After-school program + family support |
Primary outcome
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>.
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.
2 secondary outcomes
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)
BMI-for-age percentile
Time frame: Baseline, end-point (19 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. By request
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An Optimized Programming of Healthy Children (APPROACH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maninder Kahlon, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family support and BGCAA's after-school program with CATCH curriculum in people with Diet, Healthy Growth, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.