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

November 24, 2021 updated by: Jennifer Di Noia, William Paterson University of New Jersey
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Paterson, New Jersey, United States, 07524
        • Saint Joseph's WIC Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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
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.
No Intervention: Control
This group will receive routine services provided by WIC only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vegetable Intake Carotenoid Scores at 3 Months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knowledge of Vegetable Intake Recommendations at 3 Months
Time Frame: 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).
3 months
Knowledge of Vegetable Intake Recommendations at 6 Months
Time Frame: 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).
6 months
Home Vegetable Availability (Quantity) at 3 Months
Time Frame: 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).
3 months
Home Vegetable Availability (Quantity) at 6 Months
Time Frame: 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).
6 months
Home Vegetable Availability (Variety) at 3 Months
Time Frame: 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).
3 months
Home Vegetable Availability (Variety) at 6 Months
Time Frame: 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).
6 months
Vegetable Taste Preferences at 3 Months
Time Frame: 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).
3 months
Vegetable Taste Preferences at 6 Months
Time Frame: 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).
6 months
Vegetable Preparation Practices at 3 Months
Time Frame: 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).
3 months
Vegetable Preparation Practices at 6 Months
Time Frame: 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).
6 months
Vegetable Preparation Skills at 3 Months
Time Frame: 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).
3 months
Vegetable Preparation Skills at 6 Months
Time Frame: 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).
6 months
Social Support for Vegetable Consumption at 3 Months
Time Frame: 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).
3 months
Social Support for Vegetable Consumption at 6 Months
Time Frame: 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).
6 months
Self-efficacy for Vegetable Consumption at 3 Months
Time Frame: 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).
3 months
Self-efficacy for Vegetable Consumption at 6 Months
Time Frame: 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).
6 months
Body Mass Index at 3 Months
Time Frame: 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.
3 months
Body Mass Index at 6 Months
Time Frame: 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.
6 months
Number of Participants Who Met Physical Activity Guidelines at 3 Months
Time Frame: 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).
3 months
Number of Participants Who Met Physical Activity Guidelines at 6 Months
Time Frame: 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).
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Redeemed Any Cash Value Vouchers or CVV at Farmers' Markets at 6 Months
Time Frame: 6 months
Objectively assessed using data provided by the collaborating WIC agency. WIC reported whether participants redeemed any cash value vouchers at farmers' markets (yes or no) between baseline and 6 months.
6 months
Overall Satisfaction With Intervention
Time Frame: 6 months
Assessed via a single item (the Overall Satisfaction Rating Measure) querying how satisfied intervention recipients were with the intervention (on a 7-point scale ranging from very dissatisfied to very satisfied). Scores can range from 1 to 7. Higher scores represent a better outcome (greater overall satisfaction).
6 months
Satisfaction With Intervention
Time Frame: 6 months
Assessed with a 5-item measure developed by the investigators querying how satisfied intervention recipients were with the intervention. Item responses were on a 7-point scale ranging from strongly disagree to strongly agree. Scores were averaged across items to derive a total score. Scores can range from 1 to7. Higher scores represent a better outcome (greater satisfaction with the intervention).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
William Paterson University of New Jersey

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Di Noia, PhD, William Paterson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R21CA230476-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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