Obesity-Related Malignant Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALFood Assistance Programs
Receive enhanced delivery half-price food boxes delivered by a community health worker
OTHERHealth Promotion and Education
Receive nutritional education materials and resources
OTHERQuestionnaire Administration
Ancillary studies
OTHERSurvey Administration
Ancillary studies
BEHAVIORALTelephone-Based Intervention
Receive a dietary recall phone call
Sponsors
Roswell Park Cancer Institute
UB Clinical and Translational Science Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Lives in Western New York (WNY) * Is the person responsible for at least half of the food purchasing and preparation * Categorized as having marginal, low of very low food security * Able to access to internet and e-mail/text messages * Speaks and understands English
Exclusion criteria
* Participants that are unable to speak and understand English * Participants that are unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant(s) is/are an unsuitable candidate to receive the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nutrition security | Baseline to 24 weeks | Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research. |
| Intervention acceptability | At 24 weeks | Conducted at 24 week follow up via phone or text based survey |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKaren Yeary
Roswell Park Cancer Institute
Outcome results
None listed