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

Diet Modification Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04038385
• Other study ID #: 1R21CA230476-01
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2021
• Source: William Paterson University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: August 31, 2021
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Prevention
• Diet Modification
• Vegetable Intake

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Joseph's WIC Program	Paterson	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
William Paterson University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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: 10.101 — View Citation

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.j — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Who Redeemed Any Cash Value Vouchers or CVV at Farmers' Markets at 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
Other	Overall Satisfaction With Intervention	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
Other	Satisfaction With Intervention	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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