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- Ensaio Clínico NCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
25 de outubro de 2019 atualizado 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).
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
744
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: 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 Ativo: 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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants Who Redeemed FMNP Vouchers
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer Di Noia, PhD, Professor, Department of Sociology, William Paterson University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2014
Conclusão Primária (Real)
1 de junho de 2016
Conclusão do estudo (Real)
1 de junho de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
29 de setembro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de setembro de 2015
Primeira postagem (Estimativa)
1 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de outubro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de outubro de 2019
Última verificação
1 de outubro de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- WIC NEI-12-TX (Outro identificador: UC Davis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Sim
Descrição do plano IPD
The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Prazo de Compartilhamento de IPD
Data are available for sharing.
Critérios de acesso de compartilhamento IPD
Contact the PI with requests (dinoiaj@wpunj.edu).
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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