- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
25 ottobre 2019 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
744
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New Jersey
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Paterson, New Jersey, Stati Uniti, 07524
- Saint Joseph's WIC Program
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: 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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Comparatore attivo: 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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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants Who Redeemed FMNP Vouchers
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Jennifer Di Noia, PhD, Professor, Department of Sociology, William Paterson University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 luglio 2014
Completamento primario (Effettivo)
1 giugno 2016
Completamento dello studio (Effettivo)
1 giugno 2016
Date di iscrizione allo studio
Primo inviato
29 settembre 2015
Primo inviato che soddisfa i criteri di controllo qualità
30 settembre 2015
Primo Inserito (Stima)
1 ottobre 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 ottobre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 ottobre 2019
Ultimo verificato
1 ottobre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- WIC NEI-12-TX (Altro identificatore: UC Davis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Sì
Descrizione del piano IPD
The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Periodo di condivisione IPD
Data are available for sharing.
Criteri di accesso alla condivisione IPD
Contact the PI with requests (dinoiaj@wpunj.edu).
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .