Cardiovascular DiseasesNCT02565706
Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
A study testing WIC Fresh Start Program and Existing Online Health Education in people with Cardiovascular Diseases and Cancer, run by William Paterson University of New Jersey at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cancer, Type 2 Diabetes
- What is being tested?
- WIC Fresh Start Program and Existing Online Health Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant or postpartum WIC participant
- Female caregiver of infant/child WIC participant
Who cannot join
- Restrictions on food intake
- Classified by WIC as high risk/requiring an individualized nutrition care plan
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Joseph's WIC Program
Paterson, New Jersey, 07524
About this study
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).
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, Cancer, Type 2 Diabetes, Obesity
- Being tested
- WIC Fresh Start Program, Existing Online Health Education
- Keywords
- Fruit, vegetables, income, WIC program, farmers' market
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIC Fresh Start ProgramBehavioural
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.
Existing Online Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WIC Fresh Start Program | Active comparator | Participants in this arm receive the Fresh Start program. Receives: Behavioral: WIC Fresh Start Program |
| Existing Online Health Education | Active comparator | Participants in this arm receive existing online WIC health education. Receives: 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. Receives: 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. Receives: Behavioral: Existing Online Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Redeemed FMNP Vouchers
The state WIC agency is providing data on FMNP voucher redemption.
Measured: 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.
Measured: 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.
Measured: Pretest, posttest, and 3- and 6-month follow-up
Secondary outcomes (15)
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
The state WIC agency is providing data on cash value voucher redemption.
Measured: 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.
Index of Knowledge of the FMNP Score range: 0-6 Higher scores indicates greater knowledge
Measured: 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.
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.
Measured: 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.
Attitudes towards Farmers' Market Fruits and Vegetables Score range: 6-42 Higher scores indicate more favorable attitudes
Measured: 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.
Familiarity with Locally Grown Seasonal Items Score range: 0-3 Higher scores indicate greater familiarity
Measured: 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.
Fruit and Vegetable Food Safety Skills Score range: 19-85 Higher scores indicate greater skills
Measured: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.
Farmers' Market Asking Skills Score range: 0-3 Higher scores indicate greater skills
Measured: 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.
Positive Outcome Expectations for Consuming Locally Grown Fruit and Vegetables Score range:0-3 Higher scores indicate more favorable ratings
Measured: 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.
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.
Measured: 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.
Farmers' Market Fruit and Vegetable Preparation Skills Score range:12-84 Higher scores indicate greater skills
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Knowledge of Locally Grown Seasonal Fruits and Vegetables found at Farmers' Markets in July Score range:0-9 Higher scores indicate greater knowledge
Measured: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format
Food-specific Knowledge Score range: 2-13 Higher scores indicate greater knowledge
Measured: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Knowledge of Area Farmers' Markets
Farmers' Market-specific Knowledge Score range:0-2 Higher scores indicate greater knowledge
Measured: Pretest, posttest, and 3- and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startJul 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- William Paterson University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Food and Nutrition Service
- Responsible party
- Principal investigator, Jennifer Di Noia, William Paterson University of New Jersey
- Investigators
- Jennifer Di Noia, PhD, Principal investigator, Professor, Department of Sociology, William Paterson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565706
- Sponsor's protocol ID
- WIC NEI-12-TX
- Status last verified
- Oct 2019
- First submitted
- 29 Sep 2015
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 32153828Di 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.
PubMed 27560723Di 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.
PubMed 27665255Di 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.
PubMed 28760184Di 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.
PubMed 27663256
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online WIC Nutrition Education to Promote Farmers' Market Fruit and Vegetable Purchases and Consumption
- ClinicalTrials.gov ID
- NCT02565706
- Acronym / sponsor ID
- WIC NEI-12-TX
- Conditions
- Cardiovascular Diseases, Cancer, Type 2 Diabetes, Obesity
- Keywords
- Fruit, vegetables, income, WIC program, farmers' market
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- William Paterson University of New JerseyUniversity, hospital or other
- Collaborators
- USDA Food and Nutrition Service
- Study start
- Jul 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Posted 30 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| WIC Fresh Start Program | Active comparator | Behavioral: WIC Fresh Start ProgramParticipants in this arm receive the Fresh Start program. |
| Existing Online Health Education | Active comparator | Behavioral: Existing Online Health EducationParticipants in this arm receive existing online WIC health education. |
| WIC Fresh Start Program (FMNP) | Experimental | Behavioral: WIC Fresh Start ProgramParticipants in this arm receive the Fresh Start program and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets. |
| Existing Online Health Education (FMNP) | Active comparator | Behavioral: Existing Online Health EducationParticipants in this arm receive existing online WIC health education and WIC Farmers' Market Nutrition Program (FMNP) vouchers redeemable at farmers' markets. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant or postpartum WIC participant
- Female caregiver of infant/child WIC participant
Key exclusion criteria (2 listed)
- Restrictions on food intake
- Classified by WIC as high risk/requiring an individualized nutrition care plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WIC Fresh Start ProgramThe 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. | Behavioural | WIC Fresh Start Program, WIC Fresh Start Program (FMNP) |
| Existing Online Health EducationAny 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. | Behavioural | Existing Online Health Education, Existing Online Health Education (FMNP) |
Primary outcome
Number of Participants Who Redeemed FMNP Vouchers
Time frame: 6 months (2015 farmers' market season [June to November 2015])
The state WIC agency is providing data on FMNP voucher redemption.
Frequency of Fruit and Vegetable Intake
Time frame: 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.
Quantity of Fruit and Vegetable Intake
Time frame: 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.
15 secondary outcomes
Number of Participants Who Redeemed Cash Value Vouchers at Farmers' Markets
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Farmers' Market Asking Skills Using a Yes/no Format.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Food-specific Knowledge Using a True/False Format
Time frame: Pretest, posttest, and 3- and 6-month follow-up
Response to Survey Items Assessing Knowledge of Area Farmers' Markets
Time frame: Pretest, posttest, and 3- and 6-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32153828Di 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.
- Background: PubMed 27560723Di 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.
- Background: PubMed 27665255Di 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.
- Background: PubMed 28760184Di 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.
- Results publication: PubMed 27663256Di 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.
- Individual participant dataSharing planned: Yes. The data sets used and/or analyzed during this study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Di Noia, PhD principal investigator
Professor, Department of Sociology, William Paterson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIC Fresh Start Program and Existing Online Health Education in people with Cardiovascular Diseases and Cancer, run by William Paterson University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Redeemed FMNP Vouchers (time frame: 6 months (2015 farmers' market season [June to November 2015])). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565706, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.