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| Name | Class |
|---|---|
| Boys & Girls Clubs of the Austin Area | UNKNOWN |
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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:
Researchers will compare the child's diet and eating scores with those in the after-school program alone.
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:
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: After-school program + family support | Experimental |
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| Control: After-school program only | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family support | Behavioral |
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. |
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, mid-point (4 weeks), end-point (19 weeks) |
| 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) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maninder Kahlon, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boys & Girls Clubs of Austin | Austin | Texas | 78723 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 24, 2023 | Sep 21, 2023 | Prot_SAP_001.pdf |
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Community-based trial, two arms randomized on a 1:1 ratio, stratified by SNAP beneficiary status.
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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.
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| BGCAA's after-school program with CATCH curriculum | Behavioral |
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| 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. | Baseline, end-point (19 weeks) |
| Baseline, end-point (19 weeks) |
| Child's mental health status as measured by the Strengths & Difficulties Questionnaire (SDQ) | 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). | 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 | 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) |