NCT02565706

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
744

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

September 29, 2015

Results QC Date

May 15, 2018

Last Update Submit

October 25, 2019

Conditions

Keywords

Fruit, vegetables, income, WIC program, farmers' market

Outcome Measures

Primary Outcomes (3)

  • 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])

  • 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

  • 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 Outcomes (15)

  • Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets

    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.

    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.

    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.

    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.

    Pretest, posttest, and 3- and 6-month follow-up

  • +10 more secondary outcomes

Study Arms (4)

WIC Fresh Start Program

ACTIVE COMPARATOR

Participants in this arm receive the Fresh Start program.

Behavioral: WIC Fresh Start Program

Existing Online Health Education

ACTIVE COMPARATOR

Participants in this arm receive existing online WIC health education.

Behavioral: Existing Online Health Education

WIC Fresh Start Program (FMNP)

EXPERIMENTAL

Participants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.

Behavioral: WIC Fresh Start Program

Existing Online Health Education (FMNP)

ACTIVE COMPARATOR

Participants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets.

Behavioral: Existing Online Health Education

Interventions

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.

WIC Fresh Start ProgramWIC Fresh Start Program (FMNP)

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.

Existing Online Health EducationExisting Online Health Education (FMNP)

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant or postpartum WIC participant
  • Female caregiver of infant/child WIC participant

You may not qualify if:

  • Restrictions on food intake
  • Classified by WIC as high risk/requiring an individualized nutrition care plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Joseph's WIC Program

Paterson, New Jersey, 07524, United States

Location

Related Publications (5)

  • 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.

    PMID: 32153828BACKGROUND
  • 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.

    PMID: 27560723BACKGROUND
  • 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.

    PMID: 27665255BACKGROUND
  • 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.

    PMID: 28760184BACKGROUND
  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasmsDiabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jennifer Di Noia
Organization
William Paterson University

Study Officials

  • Jennifer Di Noia, PhD

    Professor, Department of Sociology, William Paterson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2015

First Posted

October 1, 2015

Study Start

July 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

October 30, 2019

Results First Posted

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.

Time Frame
Data are available for sharing.
Access Criteria
Contact the PI with requests (dinoiaj@wpunj.edu).

Locations