Obesity-Related Malignant NeoplasmNCT07039630
A Food Security Intervention for the Prevention of Cancer in Low-income Families
A study testing Food Assistance Programs, Health Promotion and Education and Questionnaire Administration in people with Obesity-Related Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Food Assistance Programs, Health Promotion and Education and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: A Sustainable Nutrition Security Intervention for Low-Income Households
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Obesity-Related Malignant Neoplasm
- Being tested
- Food Assistance Programs, Health Promotion and Education, Questionnaire Administration, Survey Administration, Telephone-Based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Assistance ProgramsBehavioural
Receive enhanced delivery half-price food boxes delivered by a community health worker
Food Assistance ProgramsBehavioural
Receive the standard half-price produce box delivery delivered by FreshFix staff
Health Promotion and EducationOther
Receive nutritional education materials and resources
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
Telephone-Based InterventionBehavioural
Receive a dietary recall phone call
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Food Assistance Programs; Other: Health Promotion and Education; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention |
| 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. Receives: Behavioral: Food Assistance Programs; Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nutrition security
Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research.
Measured: Baseline to 24 weeks
Intervention acceptability
Conducted at 24 week follow up via phone or text based survey
Measured: At 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start15 Nov 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Why it stopped: behavioral intervention is being prepared
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- UB Clinical and Translational Science Institute
- Responsible party
- Sponsor
- Investigators
- Karen Yeary, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039630
- Sponsor's protocol ID
- IC-4480925
- Other IDs
- NCI-2025-03869, IC-4480925
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sustainable Nutrition Security Intervention for Low-Income Households
- ClinicalTrials.gov ID
- NCT07039630
- Acronym / sponsor ID
- IC-4480925
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: behavioral intervention is being prepared
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- UB Clinical and Translational Science Institute
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (enhanced food box, educational materials, call) | Experimental | Behavioral: Food Assistance Programs, Other: Health Promotion and Education, Other: Questionnaire Administration, Other: Survey Administration, Behavioral: Telephone-Based InterventionParticipants 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 | Behavioral: Food Assistance Programs, Other: Questionnaire Administration, Other: Survey AdministrationParticipants receive the standard half-price produce box delivery delivered by FreshFix staff over 24 weeks on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Assistance ProgramsReceive enhanced delivery half-price food boxes delivered by a community health worker | Behavioural | Arm I (enhanced food box, educational materials, call) |
| Food Assistance ProgramsReceive the standard half-price produce box delivery delivered by FreshFix staff | Behavioural | Arm II (standard food box) |
| Health Promotion and EducationReceive nutritional education materials and resources | Other | Arm I (enhanced food box, educational materials, call) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (enhanced food box, educational materials, call), Arm II (standard food box) |
| Survey AdministrationAncillary studies | Other | Arm I (enhanced food box, educational materials, call), Arm II (standard food box) |
| Telephone-Based InterventionReceive a dietary recall phone call | Behavioural | Arm I (enhanced food box, educational materials, call) |
Primary outcome
Change in nutrition security
Time frame: Baseline to 24 weeks
Diet quality will be assessed by recall interview administered through the Nutrition Data System for Research.
Intervention acceptability
Time frame: At 24 weeks
Conducted at 24 week follow up via phone or text based survey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Yeary principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Assistance Programs, Health Promotion and Education and Questionnaire Administration in people with Obesity-Related Malignant Neoplasm, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in nutrition security (time frame: Baseline to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.