Clinical trial NCT04038385: WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers
Official title: WIC-Based Intervention to Promote Healthy Eating Among Low-Income Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Prevention
Diet Modification
Vegetable Intake
Lead sponsor: William Paterson University of New Jersey
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Vegetable Intake Carotenoid Scores at 3 Months
timeFrame: 3 months
measure: Vegetable Intake Carotenoid Scores at 6 Months
timeFrame: 6 months
measure: Self-Reported Vegetable Intake at 3 Months
timeFrame: 3 months
measure: Self-Reported Vegetable Intake at 6 Months
timeFrame: 6 months
measure: Number of Participants Who Redeemed Any Farmers' Market Nutrition Program (FMNP) Vouchers at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Knowledge of Vegetable Intake Recommendations at 3 Months
timeFrame: 3 months
measure: Knowledge of Vegetable Intake Recommendations at 6 Months
timeFrame: 6 months
measure: Home Vegetable Availability (Quantity) at 3 Months
timeFrame: 3 months
measure: Home Vegetable Availability (Quantity) at 6 Months
timeFrame: 6 months
measure: Home Vegetable Availability (Variety) at 3 Months
timeFrame: 3 months
measure: Home Vegetable Availability (Variety) at 6 Months
timeFrame: 6 months
measure: Vegetable Taste Preferences at 3 Months
timeFrame: 3 months
measure: Vegetable Taste Preferences at 6 Months
timeFrame: 6 months
measure: Vegetable Preparation Practices at 3 Months
timeFrame: 3 months
measure: Vegetable Preparation Practices at 6 Months
timeFrame: 6 months
measure: Vegetable Preparation Skills at 3 Months
timeFrame: 3 months
measure: Vegetable Preparation Skills at 6 Months
timeFrame: 6 months
measure: Social Support for Vegetable Consumption at 3 Months
timeFrame: 3 months
measure: Social Support for Vegetable Consumption at 6 Months
timeFrame: 6 months
measure: Self-efficacy for Vegetable Consumption at 3 Months
timeFrame: 3 months
measure: Self-efficacy for Vegetable Consumption at 6 Months
timeFrame: 6 months
measure: Body Mass Index at 3 Months
timeFrame: 3 months
measure: Body Mass Index at 6 Months
timeFrame: 6 months
measure: Number of Participants Who Met Physical Activity Guidelines at 3 Months
timeFrame: 3 months
measure: Number of Participants Who Met Physical Activity Guidelines at 6 Months
timeFrame: 6 months
Other outcomes:
measure: Number of Participants Who Redeemed Any Cash Value Vouchers or CVV at Farmers' Markets at 6 Months
timeFrame: 6 months
measure: Overall Satisfaction With Intervention
timeFrame: 6 months
measure: Satisfaction With Intervention
timeFrame: 6 months
Locations:
city: Paterson
country: United States
facility: Saint Joseph's WIC Program
state: New Jersey
Study officials:
affiliation: William Paterson University
name: Jennifer Di Noia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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: 10.1017/S1368980021001981. Epub 2021 May 11.
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.jand.2020.12.020. Epub 2021 Jan 22.
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.