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| Name | Class |
|---|---|
| Brighter Bites | UNKNOWN |
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The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| Arm 2 | Experimental |
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| Arm 3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm 1 | Other | : Local retailer produce vouchers ($25 value) will be distributed to the families biweekly over a 32-week period for a total of 16 vouchers. The vouchers can be redeemed for fresh produce at the grocery store that issued the vouchers. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline, 9 months after baseline | |
| Change in systolic blood pressure | Baseline, 9 months after baseline | |
| Change in diastolic blood pressure | Baseline, 9 months after baseline | |
| Change in hemoglobin A1c | Baseline, 9 months after baseline | |
| Change in Aspartate transaminase (AST) | Baseline, 9 months after baseline | |
| Change in alanine aminotransferase (ALT) | Baseline, 9 months after baseline | |
| Change in Lipid panel | Baseline, 9 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in amount of fruit and vegetable intake | Baseline, 9 months after baseline | |
| Change in amount of junk food consumed | Baseline, 9 months after baseline | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Markham, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| C000608097 | DMAC2L protein, human |
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| Arm 2 | Other | Boxes of fresh fruits and vegetables (F&V), each containing approximately 50 servings of F&V, will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V boxes will be distributed to families every 2 weeks over 32 weeks. |
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| Arm 3 | Other | subjects in this arm will receive the usual standard of care at the clinic for the study period |
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| Brighter Bites app | Other | Participants in Arms 1 and 2 will also receive nutrition education using the Brighter Bites app which includes recipes for a variety of meal types or produce types, all of which are searchable. Recipes include the average cost to prepare, the number of servings, and the calories for the recipe. The Brighter Bites app also includes healthy living "Brighter Choices" suggestions such as tips for how to store different types of foods, gardening tips, and tips to pack a healthy lunchbox. In addition to the Brighter Bites app, trained staff will facilitate virtual nutrition education for patient families. |
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| Change in number of times subject eats out at restaurants |
| Baseline, 9 months after baseline |
| Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch | Baseline, 9 months after baseline |
| Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions | Baseline, 9 months after baseline |
| Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child | Baseline, 9 months after baseline |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |