Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption

Obesity Clinical Trial

Official title:

Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565706
• Other study ID #: WIC NEI-12-TX
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2019
• Source: William Paterson University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).

Description:

This study is evaluating the WIC Fresh Start program, a theory-driven, web-based nutrition education lesson to promote fruit and vegetable (FV) consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Designed to leverage vouchers provided to WIC participants for FV purchases through the Farmers' Market Nutrition Program (FMNP) and monthly cash value vouchers (CVVs) redeemable at farmers' markets, the lesson is conceptually grounded in formative research on knowledge, attitudes and skills influencing farmers' market FV purchases and consumption and theoretical understanding of approaches for modifying them. Lesson content delivery is primarily through short video segments and audio output to increase accessibility for low-literate learners. Informed by a community-based participatory research approach, WIC participants are engaged as full partners in the development of the lesson and the delivery of content (videos feature WIC participants). The setting is a large WIC agency serving three New Jersey counties. Separate samples of women were recruited to participate in 1) focus groups for guiding lesson content development (N = 56 participants) and pretesting the resulting content (N = 52 participants), 2) cognitive testing to assess the clarity and interpretability of items and response formats in measures of knowledge, attitudes and skills developed for the study (N = 15), 3) one-on-one sessions to assess reactions to initial versions of video segments developed for the lesson (N = 20), and 4) the outcome evaluation (N = 744). Stratified based on FMNP voucher receipt, participants are randomized to receive the lesson or existing online health education. Outcome measures (administered orally to reduce literacy demands of the response task) are completed at pretest (immediately before the lesson), posttest (two weeks after the lesson), and 3 and 6 months after posttesting. Short- and long-term lesson effects on FV intake, FMNP voucher redemption and the redemption of CVVs at farmers' markets will be evaluated. Evidence for mediation by knowledge, attitudes, and skills of lesson effects on FV intake and voucher redemption, dose-response relationships, and user satisfaction with the lesson also will be examined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant or postpartum WIC participant

• Female caregiver of infant/child WIC participant

Exclusion Criteria:

• Restrictions on food intake

• Classified by WIC as high risk/requiring an individualized nutrition care plan

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Diseases
• Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• WIC Fresh Start Program
The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills.
• Existing Online Health Education
Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
William Paterson University of New Jersey	USDA Food and Nutrition Service

Country where clinical trial is conducted

United States, 

References & Publications (6)

Di Noia J, Cullen KW, Monica D. Social Desirability Trait Is Associated with Self-Reported Vegetable Intake among Women Enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children. J Acad Nutr Diet. 2016 Dec;116(12):1942-1950. doi: 10.1016/j.jand.2016.07.008. Epub 2016 Sep 21. — View Citation

Di Noia J, Monica D, Cullen KW, Pérez-Escamilla R, Gray HL, Sikorskii A. Differences in Fruit and Vegetable Intake by Race/Ethnicity and by Hispanic Origin and Nativity Among Women in the Special Supplemental Nutrition Program for Women, Infants, and Children, 2015. Prev Chronic Dis. 2016 Aug 25;13:E115. doi: 10.5888/pcd13.160130. — View Citation

Di Noia J, Monica D, Cullen KW, Thompson D. Perceived Influences on Farmers' Market Use among Urban, WIC-enrolled Women. Am J Health Behav. 2017 Sep 1;41(5):618-629. doi: 10.5993/AJHB.41.5.11. — View Citation

Di Noia J, Monica D, Gray HL, Cullen KW. The Special Supplemental Nutrition Program for Women, Infants, and Children Fresh Start Randomized Controlled Trial: Baseline Participant Characteristics and Reliability of Measures. J Acad Nutr Diet. 2016 Dec;116( — View Citation

Di Noia, J., Monica, D., Cullen, K. W., & Sikorskii, A. (2015). A randomized controlled trial of nutrition education to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC): Rationale and design of the WIC Fresh Start program. BMC Nutrition, 1, 33. doi:10.1186/s40795-015-0032-8

Di Noia, J., Monica, D., Sikorskii, A., & Cullen, K. W. (2017). Outcomes of a randomized controlled trial of nutrition education to promote farmers' market fruit and vegetable purchases and consumption among women enrolled in the Special Supplemental Nutr

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Redeemed FMNP Vouchers	The state WIC agency is providing data on FMNP voucher redemption.	6 months (2015 farmers' market season [June to November 2015])
Primary	Frequency of Fruit and Vegetable Intake	Times per day fruits and vegetable are consumed as assessed by a validated food frequency questionnaire.	Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
Primary	Quantity of Fruit and Vegetable Intake	Cups per day consumed of fruits and vegetables as assessed by a validated fruit and vegetable screener.	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets	The state WIC agency is providing data on cash value voucher redemption.	6 months (2015 farmers' market season [June to November 2015])
Secondary	Response to Survey Items Assessing Knowledge of the WIC Farmers' Market Nutrition Program Using a True/False Format.	Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to an Item Assessing Knowledge of WIC-authorized Farmers' Markets Using a Yes/no Format.	Knowledge of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers Scores: No (0) and yes (1). Higher scores (yes responses) indicate that the respondent knows of a farmers' market with farmers approved by WIC to accept WIC farmers' Market Nutrition Program and Cash Value vouchers. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (knowledge of such markets) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Attitudes Towards Farmers' Market Fruits and Vegetables Using 7-point Likert Rating Scales.	Attitudes towards Farmers' Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format.	Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales.	Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.	Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format.	Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers' Market Using a Yes/no Format.	Lifetime Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate indicate that the respondent has ever purchased fruits and vegetables at a farmers' market. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having ever purchased fruits and vegetables at a farmers' market) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Farmers' Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales.	Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills	2 weeks
Secondary	Response to an Item Assessing Whether the Participant Purchased Fruits and Vegetables at a Farmers' Market in the Past Two Weeks Using a Yes/no Format.	Recent Farmers' Market Fruit and Vegetable Purchases Scores: No (0), Yes (1). Higher scores (yes responses) indicate that the respondent purchased fruits and vegetables at a farmers' market in the past two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (having purchased fruits and vegetables at a farmers' market in the past two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to an Item Assessing Behavioral Intentions to Purchase Fruits and Vegetables at a Farmers' Market in the Next Two Weeks Using a Yes/no Format.	Intentions to Purchase Fruits and Vegetables at a Farmers' Market Scores: no (0), Yes (1). Higher scores (yes responses) indicate that the respondent intends to purchase fruits and vegetables at a farmers' market in the next two weeks. Odds ratios and 95% confidence intervals indicate the likelihood of the outcome (intending to purchase fruits and vegetables at a farmers' market in the next two weeks) among those in the WIC Fresh Start (FMNP) arm relative to the comparator arm.	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers' Markets in July Using a Yes/no Format.	Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers' Markets in July Score range:0-9 Higher scores indicate greater knowledge	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format	Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge	Pretest, posttest, and 3- and 6-month follow-up
Secondary	Response to Survey Items Assessing Knowledge of Area Farmers' Markets	Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge	Pretest, posttest, and 3- and 6-month follow-up