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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer Prevention, Diet Modification, Vegetable Intake

Intervention / Treatment
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* Behavioral: Multilevel Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>This group will receive routine services provided by WIC only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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). | 3 months | 
| 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). | 6 months | 
| 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. | 3 months | 
| 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. | 6 months | 
| 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). | 3 months | 
| 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). | 6 months |