NCT04038385

Brief Summary

Whole grains, non-starchy vegetables, fruit, and beans are a consistent feature of diets associated with a lower risk of cancer and other diet-related diseases. For cancer risk reduction, the American Cancer Society recommendation is to consume at least 2.5 cups of a variety of fruits and vegetables daily. Other than dietary choices, weight control and physical activity levels are important modifiable determinants of cancer risk. This study finalized a novel, theory-driven farm-to-WIC intervention developed in preliminary work to promote vegetable intake among low-income adults served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). In New Jersey (the location of the study), WIC provides participants up to $30 in seasonal Farmers' Market Nutrition Program (FMNP) vouchers and monthly cash value vouchers or CVV (valued at $11 for adults and $8 for children at the time of the study) redeemable at farmers' markets. The program combined behaviorally focused nutrition education with the establishment of a WIC-based farmers' market (implemented in the summer of 2019 during the FMNP voucher issuance period). Content to address other modifiable determinants of cancer risk was added. To create additional opportunities for experiential and hands-on learning, monthly trips to an area farmers' market were held (between September 1, 2019 \[after the WIC-based market was discontinued\] and November 30, 2019 \[the end of the local growing season\]). The research employed an experimental design to initially test the intervention in 3 WIC agency sites (1 intervention and 2 control sites) with 297 urban, primarily Hispanic adults. Program effects on primary outcomes of vegetable intake (measured objectively using dermal carotenoids as a biomarker of intake and via self-report) and FMNP voucher redemption (objectively assessed using data provided by WIC) were examined at mid- and post-intervention (3 and 6 months post-baseline, respectively). Intervention effects on potential hypothesized mediators and the redemption of CVV at farmers' markets, participant satisfaction with the program, and the cost-effectiveness of the intervention also were examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
297

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 23, 2021

Completed
Last Updated

December 23, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

July 14, 2019

Results QC Date

October 20, 2021

Last Update Submit

November 24, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • Vegetable Intake Carotenoid Scores at 3 Months

    Vegetable intake was objectively assessed using a reflection spectroscopy device (the Veggie Meter) to measure the level of carotenoid pigments in participants' skin (scores can range from 0 to 800). Higher scores indicate a better outcomes (higher carotenoid levels).

    3 months

  • Vegetable Intake Carotenoid Scores at 6 Months

    Vegetable intake was objectively assessed using a reflection spectroscopy device (the Veggie Meter) to measure the level of carotenoid pigments in participants' skin (scores can range from 0 to 800). Higher scores indicate a better outcomes (higher carotenoid levels).

    6 months

  • Self-Reported Vegetable Intake at 3 Months

    Assessed with one of two items in a screening instrument developed by the National Cancer Institute. Participants reported the number of cups of vegetables (including 100% vegetable juice) they ate or drank each day (range 0-7). Higher numbers represent a better outcome (higher cups/day of vegetables consumed).

    3 months

  • Self-Reported Vegetable Intake at 6 Months

    Assessed with one of two items in a screening instrument developed by the National Cancer Institute. Participants reported the number of cups of vegetables (including 100% vegetable juice) they ate or drank each day (range 0-7). Higher numbers represent a better outcome (higher cups/day of vegetables consumed).

    6 months

  • Number of Participants Who Redeemed Any Farmers' Market Nutrition Program (FMNP) Vouchers at 6 Months

    Objectively assessed using data provided by the collaborating WIC agency. WIC reported whether participants redeemed any FMNP vouchers (yes or no) from baseline to 6 months.

    6 months

Secondary Outcomes (20)

  • Knowledge of Vegetable Intake Recommendations at 3 Months

    3 months

  • Knowledge of Vegetable Intake Recommendations at 6 Months

    6 months

  • Home Vegetable Availability (Quantity) at 3 Months

    3 months

  • Home Vegetable Availability (Quantity) at 6 Months

    6 months

  • Home Vegetable Availability (Variety) at 3 Months

    3 months

  • +15 more secondary outcomes

Other Outcomes (3)

  • Number of Participants Who Redeemed Any Cash Value Vouchers or CVV at Farmers' Markets at 6 Months

    6 months

  • Overall Satisfaction With Intervention

    6 months

  • Satisfaction With Intervention

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive routine services provided by WIC and an intervention that will combine behaviorally-focused nutrition education with 1) the establishment of a WIC-based farmers' market (implemented in 2019 during the WIC Farmers' Market Nutrition Program voucher issuance period \[June 19 to August 19\]), and 2) monthly trips to an area farmers' market (between September 1, 2019 and November 30, 2019 \[the end of the local growing season\]).

Behavioral: Multilevel Behavioral Intervention

Control

NO INTERVENTION

This group will receive routine services provided by WIC only.

Interventions

Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers at farmers' markets.

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English- or Spanish-speaking
  • Farmers' Market Nutrition Program (FMNP) voucher recipient or caregiver of a child FMNP voucher recipient
  • Not less than 3 months from expected delivery date (pregnant women)
  • Eligible to receive WIC benefits for 6 months after study entry

You may not qualify if:

  • ● Restrictions of food intake (has food allergies or foods that cannot be eaten)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph's WIC Program

Paterson, New Jersey, 07524, United States

Location

Related Publications (4)

  • Di Noia J, Gellermann W. Use of the Spectroscopy-Based Veggie Meter(R) to Objectively Assess Fruit and Vegetable Intake in Low-Income Adults. Nutrients. 2021 Jun 30;13(7):2270. doi: 10.3390/nu13072270.

    PMID: 34209048BACKGROUND
  • Di Noia J, Monica D, Jensen HH, Sikorskii A. Economic evaluation of a farm-to-Special Supplemental Nutrition Programme for Women, Infants and Children intervention promoting vegetable consumption. Public Health Nutr. 2021 Aug;24(12):3922-3928. doi: 10.1017/S1368980021001981. Epub 2021 May 11.

  • Di Noia J, Monica D, Sikorskii A, Nelson J. Pilot Study of a Farm-to-Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Intervention Promoting Vegetable Consumption. J Acad Nutr Diet. 2021 Oct;121(10):2035-2045. doi: 10.1016/j.jand.2020.12.020. Epub 2021 Jan 22.

  • Di Noia J, Monica D, Sikorskii A. Process Evaluation of a Farm-to-WIC Intervention. J Acad Nutr Diet. 2021 Oct;121(10):2021-2034. doi: 10.1016/j.jand.2021.05.014. Epub 2021 Jun 16.

Results Point of Contact

Title
Jennifer Di Noia, PhD, Principal Investigator
Organization
William Paterson University, Sociology Department

Study Officials

  • Jennifer Di Noia, PhD

    William Paterson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Sociology

Study Record Dates

First Submitted

July 14, 2019

First Posted

July 30, 2019

Study Start

June 3, 2019

Primary Completion

January 31, 2020

Study Completion

August 31, 2021

Last Updated

December 23, 2021

Results First Posted

December 23, 2021

Record last verified: 2021-11

Locations