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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
25 de octubre de 2019 actualizado por: Jennifer Di Noia, William Paterson University of New Jersey
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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
744
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Jersey
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Paterson, New Jersey, Estados Unidos, 07524
- Saint Joseph's WIC Program
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: WIC Fresh Start Program
Participants in this arm receive the Fresh Start program.
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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.
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Comparador activo: Existing Online Health Education
Participants in this arm receive existing online WIC health education.
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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.
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Experimental: WIC Fresh Start Program (FMNP)
Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.
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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.
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Comparador activo: Existing Online Health Education (FMNP)
Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Redeemed FMNP Vouchers
Periodo de tiempo: 6 months (2015 farmers' market season [June to November 2015])
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The state WIC agency is providing data on FMNP voucher redemption.
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6 months (2015 farmers' market season [June to November 2015])
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Frequency of Fruit and Vegetable Intake
Periodo de tiempo: Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
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Times per day fruits and vegetable are consumed as assessed by a validated food frequency questionnaire.
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Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
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Quantity of Fruit and Vegetable Intake
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Cups per day consumed of fruits and vegetables as assessed by a validated fruit and vegetable screener.
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Pretest, posttest, and 3- and 6-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Periodo de tiempo: 6 months (2015 farmers' market season [June to November 2015])
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The state WIC agency is providing data on cash value voucher redemption.
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6 months (2015 farmers' market season [June to November 2015])
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Response to Survey Items Assessing Knowledge of the WIC Farmers' Market Nutrition Program Using a True/False Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to an Item Assessing Knowledge of WIC-authorized Farmers' Markets Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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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.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Attitudes Towards Farmers' Market Fruits and Vegetables Using 7-point Likert Rating Scales.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Attitudes towards Farmers' Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings
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Pretest, posttest, and 3- and 6-month follow-up
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Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers' Market Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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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.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Farmers' Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales.
Periodo de tiempo: 2 weeks
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Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills
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2 weeks
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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.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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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.
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Pretest, posttest, and 3- and 6-month follow-up
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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.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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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.
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers' Markets in July Using a Yes/no Format.
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers' Markets in July Score range:0-9 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Response to Survey Items Assessing Knowledge of Area Farmers' Markets
Periodo de tiempo: Pretest, posttest, and 3- and 6-month follow-up
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Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge
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Pretest, posttest, and 3- and 6-month follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Di Noia, PhD, Professor, Department of Sociology, William Paterson University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Di Noia J, Monica D, Sikorskii A, Cullen KW. 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 Nutrition Program for Women, Infants, and Children (WIC). BMC Nutr. 2017 Jun 21;3:48. doi: 10.1186/s40795-017-0172-0. eCollection 2017.
- Di Noia J, Monica D, Cullen KW, Perez-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.
- 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.
- 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.
- 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(12):1899-1913. doi: 10.1016/j.jand.2016.07.020. Epub 2016 Sep 20.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2014
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
29 de septiembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2015
Publicado por primera vez (Estimar)
1 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de octubre de 2019
Última verificación
1 de octubre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WIC NEI-12-TX (Otro identificador: UC Davis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
Descripción del plan IPD
The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Marco de tiempo para compartir IPD
Data are available for sharing.
Criterios de acceso compartido de IPD
Contact the PI with requests (dinoiaj@wpunj.edu).
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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