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Cancer PreventionNCT04038385

WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers

A study testing Multilevel Behavioral Intervention in people with Cancer Prevention and Diet Modification, run by William Paterson University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
What is being tested?
Multilevel Behavioral Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
297 participants
Where
1 siteUnited States
Study dates
3 Jun 2019to 31 Aug 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Saint Joseph's WIC Program

    Paterson, New Jersey, 07524

Other trials in United States

About this study

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.

Being tested
Multilevel Behavioral Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multilevel Behavioral InterventionBehavioural

    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.

Study groups in NCT04038385
Study groupRoleWhat they receive
InterventionExperimentalThis 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]).
Receives: Behavioral: Multilevel Behavioral Intervention
ControlNo interventionThis group will receive routine services provided by WIC only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 months

  2. 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).

    Measured: 6 months

  3. 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).

    Measured: 3 months

  4. 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).

    Measured: 6 months

  5. 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.

    Measured: 6 months

Secondary outcomes (20)
  1. Knowledge of Vegetable Intake Recommendations at 3 Months

    Assessed via self-report with an item from the National Cancer Institute's Food, Attitudes, and Behaviors (FAB) survey. Based on their responses, participants were classified as knowledgeable of the recommended cups per day (yes or no).

    Measured: 3 months

  2. Knowledge of Vegetable Intake Recommendations at 6 Months

    Assessed via self-report with an item from the National Cancer Institute's Food, Attitudes, and Behaviors (FAB) survey. Based on their responses, participants were classified as knowledgeable of the recommended cups per day (yes or no).

    Measured: 6 months

  3. Home Vegetable Availability (Quantity) at 3 Months

    Assessed with items from the Healthy Home Survey. Participants reported the number of fresh, frozen, and canned vegetables they had at home. Responses were summed across items to derive a total score (range 0-23). Higher scores indicate a better outcome (a higher number of vegetables at home).

    Measured: 3 months

  4. Home Vegetable Availability (Quantity) at 6 Months

    Assessed with items from the Healthy Home Survey. Participants reported the number of fresh, frozen, and canned vegetables they had at home. Responses were summed across items to derive a total score (range 0-23). Higher scores indicate a better outcome (a higher number of vegetables at home).

    Measured: 6 months

  5. Home Vegetable Availability (Variety) at 3 Months

    Assessed with items from the Healthy Home Survey. Participants reported the number of fresh, frozen, and canned vegetables they had at home. The number of different (unique) vegetables reported was summed across items to derive a total score (range 0-21). Higher scores indicate a better outcome (a greater variety of vegetables at home).

    Measured: 3 months

  6. Home Vegetable Availability (Variety) at 6 Months

    Assessed with items from the Healthy Home Survey. Participants reported the number of fresh, frozen, and canned vegetables they had at home. The number of different (unique) vegetables reported was summed to derive a total score (range 0-21). Higher scores indicate a better outcome (a greater variety of vegetables at home).

    Measured: 6 months

  7. Vegetable Taste Preferences at 3 Months

    Assessed with a single item (the Preference Rating Measure) querying overall, how much the participant likes the taste of vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (stronger vegetable taste preferences).

    Measured: 3 months

  8. Vegetable Taste Preferences at 6 Months

    Assessed with a single item (the Preference Rating Measure) querying overall, how much the participant likes the taste of vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (stronger vegetable taste preferences).

    Measured: 6 months

  9. Vegetable Preparation Practices at 3 Months

    Assessed via items from the Eating Among Teens and Young Adults Study (EAT)-II Survey (Laska et al., 2011). Participants reported how often, in the past month, they 1) bought fresh vegetables, 2) prepared a vegetable salad, and 3) prepared a dinner with vegetables. Responses were on a 5-point scale ranging from never to more than once a week. Ratings were summed across items to derive a total score. Scores can range from 1 to 15. Higher scores represent a better outcome (frequent use of the practices).

    Measured: 3 months

  10. Vegetable Preparation Practices at 6 Months

    Assessed via items from the Eating Among Teens and Young Adults Study (EAT)-II Survey (Laska et al., 2011). Participants reported how often, in the past month, they 1) bought fresh vegetables, 2) prepared a vegetable salad, and 3) prepared a dinner with vegetables. Responses were on a 5-point scale ranging from never to more than once a week. Ratings were summed across items to derive a total score. Scores can range from 1 to 15. Higher scores represent a better outcome (frequent use of the practices).

    Measured: 6 months

  11. Vegetable Preparation Skills at 3 Months

    Assessed via a single item (the Preparation Skills Rating Measure) querying how the participant would rate his or her overall skill in preparing vegetables (on a 7-point scale ranging from poor to excellent). Scores can range from 1 to 7. Higher scores represent a better outcome (greater vegetable preparation skills).

    Measured: 3 months

  12. Vegetable Preparation Skills at 6 Months

    Assessed via a single item (the Preparation Skills Rating Measure) querying how the participant would rate his or her overall skill in preparing vegetables (on a 7-point scale ranging from poor to excellent). Scores can range from 1 to 7. Higher scores represent a better outcome (greater vegetable preparation skills).

    Measured: 6 months

  13. Social Support for Vegetable Consumption at 3 Months

    Assessed via a single item (the Social Support Rating Measure) querying how much others support the participant to consume vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (greater social support for vegetable consumption).

    Measured: 3 months

  14. Social Support for Vegetable Consumption at 6 Months

    Assessed via a single item (the Social Support Rating Measure) querying how much others support the participant to consume vegetables (on a 7-point scale ranging from not at all to a lot). Scores can range from 1 to 7. Higher scores represent a better outcome (greater social support for vegetable consumption).

    Measured: 6 months

  15. Self-efficacy for Vegetable Consumption at 3 Months

    Assessed with a validated measure used to evaluate the Stellar Farmers' Market program (Dannefer et al., 2015). Participants rated how much they agreed or disagreed with statements designed to measure confidence in the ability to prepare and consume fresh produce. Item ratings are on a 4-point scale ranging from strongly disagree (1) to strongly agree (4). Ratings were summed across items to derive a total score. Scores can range from 5 to 20. Higher scores represent a better outcome (greater self-efficacy for vegetable consumption).

    Measured: 3 months

  16. Self-efficacy for Vegetable Consumption at 6 Months

    Assessed with a validated measure used to evaluate the Stellar Farmers' Market program (Dannefer et al., 2015). Participants rated how much they agreed or disagreed with statements designed to measure confidence in the ability to prepare and consume fresh produce. Item ratings are on a 4-point scale ranging from strongly disagree (1) to strongly agree (4). Ratings were summed across items to derive a total score. Scores can range from 5 to 20. Higher scores represent a better outcome (greater self-efficacy for vegetable consumption).

    Measured: 6 months

  17. Body Mass Index at 3 Months

    Height and weight were measured by trained research staff with participants wearing light clothing without shoes. Body mass index was calculated as weight in kilograms divided by height in square meters.

    Measured: 3 months

  18. Body Mass Index at 6 Months

    Height and weight were measured by trained research staff with participants wearing light clothing without shoes. Body mass index was calculated as weight in kilograms divided by height in square meters.

    Measured: 6 months

  19. Number of Participants Who Met Physical Activity Guidelines at 3 Months

    Assessed with a validated 2-item measure (the Brief Physical Activity Assessment Tool or BPAAT [Marshall et al., 2005]). The instrument consists of two questions, one that assesses the frequency and duration of vigorous intensity physical activity and one that assesses the frequency and duration of moderate intensity physical activity undertaken in a usual week. A scoring algorithm is used to derive a total score (scores can range from 0 to 8). Participants are classified as meeting current physical activity guidelines (yes or no) based on the scores (a score greater than or equal to 4 indicates that the participant is meeting current physical activity guidelines, whereas a score between 0 and 3 indicates that the participant is not).

    Measured: 3 months

  20. Number of Participants Who Met Physical Activity Guidelines at 6 Months

    Assessed with a validated 2-item measure (the Brief Physical Activity Assessment Tool or BPAAT [Marshall et al., 2005]). The instrument consists of two questions, one that assesses the frequency and duration of vigorous intensity physical activity and one that assesses the frequency and duration of moderate intensity physical activity undertaken in a usual week. A scoring algorithm is used to derive a total score (scores can range from 0 to 8). Participants are classified as meeting current physical activity guidelines (yes/no) based on the scores (a score greater than or equal to 4 indicates that the participant is meeting current physical activity guidelines, whereas a score between 0 and 3 indicates that the participant is not).

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start3 Jun 2019
  3. Primary completion31 Jan 2020
  4. Study completion31 Aug 2021

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04038385
Sponsor's protocol ID
1R21CA230476-01
Status last verified
Aug 2026
First submitted
14 Jul 2019
Last updated
10 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34209048
  • 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.

    PubMed 33972002
  • 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.

    PubMed 33487590
  • 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.

    PubMed 34144918

Questions about this trial

What is this clinical trial studying?

A study testing Multilevel Behavioral Intervention in people with Cancer Prevention and Diet Modification, run by William Paterson University of New Jersey 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 10 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?

Yes. Results are posted in the registry (first posted 23 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vegetable Intake Carotenoid Scores at 3 Months (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04038385, which also lists 4 linked publications.

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 10 Sep 2026.

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