CSA Program for Healthy Eating Habits

(BASIS Trial)

Overseen By Stella Yi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Unable to complete baseline survey

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

4000 Participants Needed

Trial Summary

What is the purpose of this trial?

BASIS aims to implement a whole-of-community intervention in Brooklyn for improving diet and the social and /built environments for English-, Chinese-, Spanish-, and Bangla-speaking communities. This is achieved through five main pillars: by 1) improving food access (subsidized, culturally tailored fresh produce box program), 2) providing nutrition education, 3) conducting experiential learning (gardening workshops, cooking demonstrations, farm tours, physical activity sessions, arts-based sessions), 4) assisting with economic security (SNAP/WIC enrollment, workforce development, small business owner engagement), and 5) contributing to policy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What evidence supports the effectiveness of the CSA Program for Healthy Eating Habits treatment?

Research shows that programs promoting fruit and vegetable intake can lead to small increases in consumption, which may help reduce chronic disease risk. Additionally, community-based programs that provide financial incentives for fresh produce have been effective in improving diet quality and health outcomes. ^{1 2 3 4 5}

Is the CSA Program for Healthy Eating Habits safe for humans?

The studies reviewed focus on improving access to fruits and vegetables through community-supported agriculture (CSA) and nutrition education, primarily for low-income families. They do not report any safety concerns, suggesting that participating in CSA programs is generally safe for humans. ^{6 7 8 9 10}

How does the CSA model treatment differ from other treatments for healthy eating habits?

The CSA model treatment is unique because it involves a community-supported agriculture approach, where low-income families receive subsidized shares of local produce and participate in nutrition classes, focusing on improving diet quality through direct access to fresh fruits and vegetables. ^{6 9 11 12 13}

Research Team

Stella Yi, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 living in Brooklyn who are interested in improving their diet. Participants must be willing and able to consent, and capable of completing a survey in English, Mandarin, or Cantonese.

Inclusion Criteria

Willing and able to provide consent

Currently living in Brooklyn

Exclusion Criteria

I cannot complete the survey in English, Mandarin, or Cantonese.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive culturally adapted produce boxes and participate in nutrition education and experiential learning activities

20 weeks

Weekly visits for produce box distribution and activities

Follow-up

Participants are monitored for changes in social cohesion, ethnic pride, fruit and vegetable intake, and sense of belonging

4 weeks

Treatment Details

Interventions

• CSA model

Trial Overview The study tests a subsidized community-supported agriculture (CSA) program tailored for Chinese American immigrants. It includes culturally appropriate produce and nutrition education aimed at promoting healthy eating habits.

Participant Groups

Group I: Intervention Group - CSA Model Experimental Treatment 1 Intervention

English-, Chinese-, Spanish-, and Bangladeshi-speaking community members (adults 18+ years) residing in Sunset Park and surrounding neighborhoods will participate in a culturally adapted systems-level program for improving diet. The intervention will be evaluated through baseline and follow-up surveys and skin carotenoid assessments.

Group II: Control Group Active Control 1 Intervention

Mexican-identifying community members (adults 18+ years) residing in Mott Haven, Bronx and Chinese-identifying community members (adults 18+ years) residing in Chinatown, Manhattan and Flushing, Queens will form the comparison community. Recruited participants from the comparison communities will complete evaluation components (surveys and skin carotenoid assessments) but not receive the intervention.

CSA model is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Lynparza for:

• Breast cancer
• Ovarian cancer
• Fallopian tube cancer
• Peritoneal cancer
• Pancreatic cancer
• Prostate cancer

Approved in United States as Lynparza for:

• Ovarian, fallopian tube, and primary peritoneal cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Approved in Canada as Lynparza for:

• Ovarian cancer
• Breast cancer
• Prostate cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

A systematic review of 44 studies found that interventions promoting fruit and vegetable intake can lead to small but significant increases in consumption, particularly in individuals with preexisting health conditions, with increases ranging from 0.1 to 1.4 servings per day.

Face-to-face education and counseling were the most effective methods for increasing intake, while community-based multicomponent interventions also showed positive results, indicating that various approaches can be effective in promoting healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions designed to increase adult fruit and vegetable intake can be effective: a systematic review of the literature. Pomerleau, J., Lock, K., Knai, C., et al.[2023]

Culinary medicine programs, which include teaching kitchens and gardens, have shown promising preliminary outcomes in improving health metrics like weight and cardiometabolic risk factors in pediatric patients dealing with obesity.

Participation in culinary medicine workshops has increased healthcare employees' confidence and knowledge in preparing whole plant-based meals, suggesting that such programs can enhance healthy lifestyle behaviors both in patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. Fals, AM., Brennan, AM.[2023]

Community-based fruit and vegetable prescription programs, primarily targeting low-income, non-white females, have shown significant improvements in diet quality (94% of studies), health outcomes (83%), and food security (82%), indicating their effectiveness in promoting healthier eating habits.

Despite the positive outcomes, the considerable variation in study design and measurement techniques makes it difficult to compare the effectiveness of different program methodologies, highlighting the need for more standardized and well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. Greatorex Brooks, E., McInerney, M.[2023]

The patient-centered counseling model improves long-term dietary adherence by personalizing interventions based on individual patient needs and stages of change.

This model includes a 4-step counseling process that helps nutrition professionals effectively support patients in following nutrition care plans and dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. Rosal, MC., Ebbeling, CB., Lofgren, I., et al.[2022]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

The Fruit and Vegetable Prescription (FVRx) Program, which includes produce prescriptions and nutrition education, significantly enhances participants' motivation and access to farm direct settings compared to those receiving only nutrition education or standard healthcare.

Participants in the FVRx Program reported improved experiences in accessing fresh produce, indicating that the program effectively reduces barriers related to cost and food access for individuals with low income.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Produce Prescriptions and Nutrition Education Improve Experiences and Perceptions of Farm Direct Settings in Adults With Low Income. Slagel, N., Thompson, JJ., Lee, JS.[2022]

In a study of 514 participants invited to a web-based intervention for increasing fruit and vegetable consumption, only 6.1% of probable Hispanics enrolled compared to 11.8% of probable non-Hispanics, indicating that Hispanics were 48% less likely to participate.

Factors influencing enrollment included gender and income level, with females being significantly more likely to enroll than males, and individuals from higher-income areas showing increased likelihood of participation, highlighting the need for targeted strategies to engage Hispanic populations in nutritional interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying and oversampling Hispanics by the Passel-Word surname list for enrollment in a web-based nutritional intervention. Carroll, NM., Ritzwoller, DP., Stopponi, MA., et al.[2021]

The Farm Fresh Foods for Healthy Kids (F3HK) trial, involving 305 caregiver-child pairs, found that a cost-offset community supported agriculture (CSA) program combined with nutrition education significantly improved caregivers' fruit and vegetable intake and household food security after one growing season.

Despite these positive outcomes for caregivers, the intervention did not lead to significant changes in children's dietary intake, BMI, or physical activity, highlighting the need for ongoing support beyond the CSA season to maintain improvements in dietary behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community supported agriculture plus nutrition education improves skills, self-efficacy, and eating behaviors among low-income caregivers but not their children: a randomized controlled trial. Seguin-Fowler, RA., Hanson, KL., Jilcott Pitts, SB., et al.[2021]

The Farm Fresh Foods for Healthy Kids (F3HK) program successfully reached 305 enrolled caregivers, primarily older females, and provided a 21-week community-supported agriculture (CO-CSA) intervention that included nutrition education, demonstrating its feasibility in improving diet quality among low-income families.

Most participants engaged with the program, with 88% median CSA pickup and 77% of adults attending at least one nutrition class, indicating a positive reception and potential for enhancing dietary habits in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making community-supported agriculture accessible to low-income families: findings from the Farm Fresh Foods for Healthy Kids process evaluation. Garner, JA., Jilcott Pitts, SB., Hanson, KL., et al.[2021]

Participants in the Full Plate Living (FPL) program, which promotes a whole food plant-predominant diet, showed significant improvements in eating behaviors and health measures over 16 weeks, including increased fruit and vegetable intake and an average weight loss of 3.5 pounds.

The program positively affected self-perceived health, energy levels, and confidence in making healthy food choices, with benefits observed across different generational cohorts, suggesting its effectiveness as a corporate wellness initiative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Benefits of a 16-Week Whole Food, High Fiber, Plant Predominant Diet among U.S. Employees. Kelly, R., Hanus, A., Payne-Foster, P., et al.[2023]

Community-supported agriculture (CO-CSA) programs, like the Farm Fresh Foods for Healthy Kids initiative, can significantly improve fruit and vegetable intake among low-income households, with participation levels varying widely across different communities (33% to 89%).

Factors such as the availability of multiple share sizes and community pick-up locations influence participation rates, suggesting that CO-CSA programs should adapt their offerings to better meet the needs of diverse communities, especially in rural areas with lower education and higher poverty levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in Cost-offset Community Supported Agriculture by Low-income Households in the U.S. is Associated with Community Characteristics and Operational Practices. Hanson, KL., Xu, L., Marshall, GA., et al.[2023]

The Expanded Food and Nutrition Education Program (EFNEP) curriculum, Eating Smart-Being Active (ESBA), significantly improved nutrition-related behaviors in adults, including food resource management, food safety, nutrition knowledge, and physical activity levels, with positive changes observed across multiple states.

ESBA outperformed previous curricula in promoting better outcomes for fruit and vegetable intake and overall nutrition, demonstrating its effectiveness and suitability for community nutrition programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome effectiveness of the widely adopted EFNEP curriculum Eating Smart-Being Active. Auld, G., Baker, S., Conway, L., et al.[2014]

The Wisconsin Farm to School programs significantly increased students' willingness to try fruits and vegetables (FV) and improved their knowledge of nutrition and agriculture, with notable increases in FV availability in school lunches.

While overall dietary patterns did not change significantly, students with the lowest initial FV intake saw a remarkable 135% increase in fruit consumption, indicating that the program effectively targeted and improved FV behaviors among those who needed it most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Farm to elementary school programming increases access to fruits and vegetables and increases their consumption among those with low intake. Bontrager Yoder, AB., Liebhart, JL., McCarty, DJ., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Interventions designed to increase adult fruit and vegetable intake can be effective: a systematic review of the literature. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Teaching Kitchens and Culinary Gardens as Integral Components of Healthcare Facilities Providing Whole Person Care: A Commentary. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Community-based fruit and vegetable prescription programs: a scoping review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Facilitating dietary change: the patient-centered counseling model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Produce Prescriptions and Nutrition Education Improve Experiences and Perceptions of Farm Direct Settings in Adults With Low Income. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Identifying and oversampling Hispanics by the Passel-Word surname list for enrollment in a web-based nutritional intervention. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Community supported agriculture plus nutrition education improves skills, self-efficacy, and eating behaviors among low-income caregivers but not their children: a randomized controlled trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Making community-supported agriculture accessible to low-income families: findings from the Farm Fresh Foods for Healthy Kids process evaluation. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Health Benefits of a 16-Week Whole Food, High Fiber, Plant Predominant Diet among U.S. Employees. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Participation in Cost-offset Community Supported Agriculture by Low-income Households in the U.S. is Associated with Community Characteristics and Operational Practices. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Outcome effectiveness of the widely adopted EFNEP curriculum Eating Smart-Being Active. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

Farm to elementary school programming increases access to fruits and vegetables and increases their consumption among those with low intake. [2015]