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| Name | Class |
|---|---|
| Brighter Bites and Humana Foundation | UNKNOWN |
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The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes 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 |
|---|---|---|---|
| Produce prescription program | Experimental |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Produce prescription program | Other | Boxes of fresh fruit 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. Participants 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | baseline , post intervention (32 weeks after baseline) | |
| Change in systolic blood pressure | baseline , post intervention (32 weeks after baseline) | |
| Change in diastolic blood pressure | baseline , post intervention (32 weeks after baseline) | |
| Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work | baseline , post intervention (32 weeks after baseline) | |
| Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work | baseline , post intervention (32 weeks after baseline) | |
| Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work | baseline , post intervention (32 weeks after baseline) | |
| Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) | |
| Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) | |
| Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work |
| Measure | Description | Time Frame |
|---|---|---|
| Change in amount of fruit and vegetable intake | baseline , post intervention (32 weeks after baseline) | |
| Change in amount of junk food consumed | baseline , post intervention (32 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shreela Sharma, 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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| Standard of care | Other | Standard of care includes routine lab work collection and weight and diet counseling for overweight or obese children. Additionally, referrals placed to community resources for those identified with Social Determinants of Health(SDOH) needs. |
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| baseline , post intervention (32 weeks after baseline) |
| Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work | baseline , post intervention (32 weeks after baseline) |
| Change in number of times subject eats out at restaurants | baseline , post intervention (32 weeks after baseline) |
| Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch | baseline , post intervention (32 weeks 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 , post intervention (32 weeks after baseline) |
| Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child | baseline , post intervention (32 weeks after baseline) |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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