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| Name | Class |
|---|---|
| USDA The Gus Schumacher Nutrition Incentive Program (GusNIP) | UNKNOWN |
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The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Produce Prescription Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Produce Prescription Group | Other | Participants will receive 16 produce bags, each containing approximately 50 servings of F&V. The produce bags will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F&V bags will be distributed to families every 2 weeks for 16 distributions (over approximately 32 weeks). Participants will also receive nutrition education, including MyPlate.gov's Start Simple App for adolescents, and a Virtual Culinary Medicine Program for parents; these nutrition education programs are theory-driven, tailored to diverse populations, and proven to support behavior change. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index (BMI) | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in systolic blood pressure | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in diastolic blood pressure | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in hemoglobin A1c as assessed by blood work | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in Aspartate transaminase (AST) assessed by blood work | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in Alanine transaminase (ALT) assessed by blood work |
| Measure | Description | Time Frame |
|---|---|---|
| Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool | This is a 2 item questionnaire and each is categorically scored as often true, sometimes true or never true, higher number indicating higher prevalence of household food insecurity | baseline , post intervention (32 weeks after baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Jye Chuang, DrPH, M.S. | Contact | 713-500-9244 | Ru-Jye.Chuang@uth.tmc.edu | |
| Mallika Mathur | Contact | Mallika.Mathur@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Jye Chuang, DrPH, M.S. | 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 |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control Group | Other | Participants in this group will be selected from de-identified Electronic Health Record (EHR) provided by Legacy Community Health with a 1-to-1 match to the intervention group participant's demographic characteristics and Medicaid eligibility. |
|
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. |
| baseline , post intervention (32 weeks after baseline) |
| Change in lipid panels assessed by blood work | This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations. | baseline , post intervention (32 weeks after baseline) |
| Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service | This is a 6 item questionnaire and raw scores range from 0-6, higher score indicating worse outcome | baseline , post intervention (32 weeks after baseline) |
| Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener | This is a 4 item questionnaire, each is scored from 0-4, higher score indicating better outcome | baseline , post intervention (32 weeks after baseline) |
| 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) |
| 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) |
| Change in impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A) | This is a 9 item questionnaire and each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 27, higher score indicating worse outcome | baseline , post intervention (32 weeks after baseline) |
| Healthcare usage as assessed by the number of well-visits | post intervention (32 weeks after baseline) |
| Healthcare usage as assessed by the number of visits due to illness | post intervention (32 weeks after baseline) |
| Healthcare usage as assessed by the number of no shows to clinic appointments | From 6 months prior to the intervention to two months post-intervention |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |