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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03869 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IC-4480925 | Other Identifier | Roswell Park Cancer Institute |
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behavioral intervention is being prepared
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| Name | Class |
|---|---|
| UB Clinical and Translational Science Institute | UNKNOWN |
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This study is being done to see how produce delivery with or without nutritional education affects what people eat and if it can help improve diet and nutrition in low-income families and their ability to get enough healthy food. Research shows strong evidence regarding the role of diet in new cancer rates and cancer deaths. Although dietary guidelines have been established at the national level to improve diet quality, the average dietary quality remains low in American households, particularly in low-income communities. These disadvantaged communities are also more likely to be food insecure (having limited or uncertain access to nutritious food). FreshFix is a community-based organization that provides nutritious foods from local farmers to communities in Western New York and offers a Half-Price Produce delivery program which is targeted for lower-income and underserved communities. Participating in the FreshFix program with access to nutritional education materials may decrease food insecurity and improve diet quality in low-income families.
PRIMARY OBJECTIVES:
I. To develop a nutrition security intervention to improve the nutrition security of low-income households.
II. To determine the feasibility of the nutrition security intervention.
SECONDARY OBJECTIVE:
I. To refine the intervention by engaging community-based organizations and households enrolled in the nutrition security intervention to ascertain the barriers and facilitators of intervention implementation.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study.
ARM II: Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enhanced food box, educational materials, call) | Experimental | Participants receive enhanced delivery half-price food boxes delivered by a community health worker and assistance on the proper handling and storage of the food over 24 weeks on study. Participants receive nutritional education materials and access to additional educational resources on the FreshFix online ordering platform. Participants also receive a dietary recall phone call at baseline and at 6 months on study. |
|
| Arm II (standard food box) | Active Comparator | Participants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food Assistance Programs | Behavioral | Receive enhanced delivery half-price food boxes delivered by a community health worker |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in nutrition security | Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research. | Baseline to 24 weeks |
| Intervention acceptability | Conducted at 24 week follow up via phone or text based survey | At 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Yeary | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Food Assistance Programs | Behavioral | Receive the standard half-price produce box delivery delivered by FreshFix staff |
|
| Health Promotion and Education | Other | Receive nutritional education materials and resources |
|
| Questionnaire Administration | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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| Telephone-Based Intervention | Behavioral | Receive a dietary recall phone call |
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| ID | Term |
|---|---|
| D063105 | Food Assistance |
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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