- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
25. oktober 2019 oppdatert av: 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).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
744
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New Jersey
-
Paterson, New Jersey, Forente stater, 07524
- Saint Joseph's WIC Program
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: WIC Fresh Start Program
Participants in this arm receive the 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.
|
|
Aktiv komparator: Existing Online Health Education
Participants in this arm receive existing online WIC 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.
|
|
Eksperimentell: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Redeemed FMNP Vouchers
Tidsramme: 6 months (2015 farmers' market season [June to November 2015])
|
The state WIC agency is providing data on FMNP voucher redemption.
|
6 months (2015 farmers' market season [June to November 2015])
|
|
Frequency of Fruit and Vegetable Intake
Tidsramme: Pretest, posttest (2 weeks after pretest), and 3- and 6-month follow-up
|
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
|
|
Quantity of Fruit and Vegetable Intake
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Tidsramme: 6 months (2015 farmers' market season [June to November 2015])
|
The state WIC agency is providing data on cash value voucher redemption.
|
6 months (2015 farmers' market season [June to November 2015])
|
|
Response to Survey Items Assessing Knowledge of the WIC Farmers' Market Nutrition Program Using a True/False Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge
|
Pretest, posttest, and 3- and 6-month follow-up
|
|
Response to an Item Assessing Knowledge of WIC-authorized Farmers' Markets Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to Survey Items Assessing Attitudes Towards Farmers' Market Fruits and Vegetables Using 7-point Likert Rating Scales.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to Survey Items Assessing Awareness of Locally Grown, Seasonal Fruits and Vegetables Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity
|
Pretest, posttest, and 3- and 6-month follow-up
|
|
Response to Survey Items Assessing Fruit and Vegetable Food Safety Skills Using 7-point Likert Rating Scales.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills
|
Pretest, posttest, and 3- and 6-month follow-up
|
|
Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills
|
Pretest, posttest, and 3- and 6-month follow-up
|
|
Response to Survey Items Assessing Positive Outcome Expectations for Consuming Locally Grown Fruits and Vegetables Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to an Item Assessing Whether the Participant Ever Purchased Fruits and Vegetables at a Farmers' Market Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to Survey Items Assessing Farmers' Market Fruit and Vegetable Preparation Skills Using 7-point Likert Rating Scales.
Tidsramme: 2 weeks
|
Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills
|
2 weeks
|
|
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.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
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.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to Survey Items Assessing Knowledge of Locally Grown Seasonal Fruits and Vegetables Found at Farmers' Markets in July Using a Yes/no Format.
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
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
|
|
Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge
|
Pretest, posttest, and 3- and 6-month follow-up
|
|
Response to Survey Items Assessing Knowledge of Area Farmers' Markets
Tidsramme: Pretest, posttest, and 3- and 6-month follow-up
|
Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge
|
Pretest, posttest, and 3- and 6-month follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jennifer Di Noia, PhD, Professor, Department of Sociology, William Paterson University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2014
Primær fullføring (Faktiske)
1. juni 2016
Studiet fullført (Faktiske)
1. juni 2016
Datoer for studieregistrering
Først innsendt
29. september 2015
Først innsendt som oppfylte QC-kriteriene
30. september 2015
Først lagt ut (Anslag)
1. oktober 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. oktober 2019
Sist bekreftet
1. oktober 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WIC NEI-12-TX (Annen identifikator: UC Davis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
IPD-delingstidsramme
Data are available for sharing.
Tilgangskriterier for IPD-deling
Contact the PI with requests (dinoiaj@wpunj.edu).
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .