Skip to main content
OpenTrials
Completed

NCT Number: NCT04038385

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph's WIC Program

Paterson, New Jersey, 07524, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multilevel Behavioral Intervention

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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).

  16. 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).

  17. 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.

  18. 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.

  19. 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).

  20. 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).

Other outcomes

  1. 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.

  2. 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).

  3. 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).

Sponsors and collaborators

Lead sponsor

William Paterson University of New Jersey

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jul 30, 2019
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.