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临床试验/NCT04038385
NCT04038385已完成不适用

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

William Paterson University of New Jersey2 个研究点 分布在 1 个国家目标入组 297 人开始时间: 2019年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
297
试验地点
2
主要终点
Number of Participants Who Redeemed Any Farmers' Market Nutrition Program (FMNP) Vouchers at 6 Months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Intervention

Experimental

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]).

干预措施: Multilevel Behavioral Intervention (Behavioral)

Control

No Intervention

This group will receive routine services provided by WIC only.

结局指标

主要结局

Number of Participants Who Redeemed Any Farmers' Market Nutrition Program (FMNP) Vouchers at 6 Months

时间窗: 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.

Vegetable Intake Carotenoid Scores at 3 Months

时间窗: 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).

Vegetable Intake Carotenoid Scores at 6 Months

时间窗: 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).

Self-Reported Vegetable Intake at 3 Months

时间窗: 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).

Self-Reported Vegetable Intake at 6 Months

时间窗: 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).

次要结局

  • Knowledge of Vegetable Intake Recommendations at 3 Months(3 months)
  • Knowledge of Vegetable Intake Recommendations at 6 Months(6 months)
  • Home Vegetable Availability (Quantity) at 3 Months(3 months)
  • Home Vegetable Availability (Quantity) at 6 Months(6 months)
  • Home Vegetable Availability (Variety) at 3 Months(3 months)
  • Home Vegetable Availability (Variety) at 6 Months(6 months)
  • Vegetable Taste Preferences at 3 Months(3 months)
  • Vegetable Taste Preferences at 6 Months(6 months)
  • Vegetable Preparation Practices at 3 Months(3 months)
  • Vegetable Preparation Practices at 6 Months(6 months)
  • Vegetable Preparation Skills at 3 Months(3 months)
  • Vegetable Preparation Skills at 6 Months(6 months)
  • Social Support for Vegetable Consumption at 3 Months(3 months)
  • Social Support for Vegetable Consumption at 6 Months(6 months)
  • Self-efficacy for Vegetable Consumption at 3 Months(3 months)
  • Self-efficacy for Vegetable Consumption at 6 Months(6 months)
  • Body Mass Index at 3 Months(3 months)
  • Body Mass Index at 6 Months(6 months)
  • Number of Participants Who Met Physical Activity Guidelines at 3 Months(3 months)
  • Number of Participants Who Met Physical Activity Guidelines at 6 Months(6 months)

研究者

发起方
William Paterson University of New Jersey
申办方类型
Other
责任方
Sponsor
主要研究者

Jennifer Di Noia

Professor, Department of Sociology

William Paterson University of New Jersey

研究点 (2)

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