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Food InsecurityNCT05153577

Fresh Start: Increasing Early Produce Intake

A study testing Group A: $5 produce box and Group B: $10 produce box in people with Food Insecurity, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nearly 22% of children in Philadelphia live in food-insecure (FI) households, often leading to reliance on inexpensive, nutrient-poor foods and associated poor health outcomes. Despite this, utilization of food benefit programs is often low, including the Special Supplemental Nutrition Program Women, Infants, and… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Food Insecurity
What is being tested?
Group A: $5 produce box and Group B: $10 produce box
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
9 Jun 2021to 10 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects must:
  • Be over 18 years of age
  • Be the parent or guardian for children ages 0 to 5 years of age who receive or are eligible to receive WIC benefits
  • Be the parent or guardian for children ages 0 to 5 years of age who receive pediatric care at CHOP Primary Care - Cobbs Creek
  • Live or have access to an address where packages can be delivered
  • Have access to an electronic device and internet in order to access the online produce box ordering portal
  • Be willing to complete three 10-15 minute surveys throughout the intervention either online or via telephone
  • Consent to have their contact information shared with Farm to Families and Food Connect

Who cannot join

  • Subjects must not:
  • Be participating in another intervention which provides produce just prior to or simultaneous with participation in this study (e.g. Farm Food Box Program, etc.)
  • Be subjects who, in the opinion of the Investigator(s), may be non-compliant with study schedules or procedures Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19146

Other trials in United States

About this study

Official title: Fresh Start: Increasing Produce Access and Intake Among WIC-eligible Children in West Philadelphia

Nearly 22% of children in Philadelphia live in food-insecure (FI) households, often leading to reliance on inexpensive, nutrient-poor foods and associated poor health outcomes. Despite this, utilization of food benefit programs is often low, including the Special Supplemental Nutrition Program Women, Infants, and Children (WIC) Farmer's Market Nutrition Program (FMNP). In the prior qualitative study, Investigators found that parents desire to increase their children's intake of produce but face many barriers to produce access; caregivers described a preference for delivery-based, low-or-no cost food programs to increase produce access and intake among children. This pilot trial seeks to assess the effectiveness of a short-term, tiered-fee produce delivery program in retaining participants and increasing produce access and intake among families with WIC-eligible children

Read the detailed description

Investigators are piloting a produce box delivery program to approximately 50 WIC-eligible, low-income families in West Philadelphia in partnership with the Farm to Families Initiative (St. Christopher's Foundation for Children) and Food Connect, a local food delivery program. Both partnerships have been previously established and are maintained through the Office of Community Relations. The program will be 8 weeks in duration; in the first 4 weeks, all families will receive a free, weekly produce box from Farm to Families. In the second two weeks, the 50 families will be randomized into two groups, each with 25 participants. One group will be asked to pay $5 for the produce box and the other group will pay $10, using food benefits or their own income. Recipes that include foods in the produce box will be included with the delivery along with children's activities (books, coloring pages, card games, etc.) related to fruits and vegetables. Participating parents will complete three online surveys throughout the program. These pre-, mid-, and post-intervention surveys will assess the effect of the program and participant satisfaction.

The expected goals are to:

  1. Evaluate the effect of different pricing models on participation of low-income, WIC-eligible families in a produce delivery program
  2. Evaluate the efficacy of a low-cost produce delivery program to increase perceived intake of produce among low-income young children.
  3. Evaluate efficacy of a low-cost produce delivery program to increase perceived access to produce among low-income families in West Philadelphia.
Conditions
Food Insecurity
Being tested
Group A: $5 produce box, Group B: $10 produce box
Keywords
WIC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A: $5 produce boxOther

    Participants receive free weekly produce boxes delivered to their home for the first 4 weeks of the study and are then randomized to pay $5 per box (with continued free weekly delivery) for the remaining 4 weeks of the study. Participants also complete survey at the beginning, middle, and end of the produce delivery program.

  • Group B: $10 produce boxOther

    Participants receive free weekly produce boxes delivered to their home for the first 4 weeks of the study and are then randomized to pay $10 per box (with continued free weekly delivery) for the remaining 4 weeks of the study. Participants also complete survey at the beginning, middle, and end of the produce delivery program.

Study groups in NCT05153577
Study groupRoleWhat they receive
Group A: Free produce boxActive comparatorParticipants receive free weekly produce boxes for the first 4 weeks of the study and are then randomized to pay $5 per box (with continued free weekly delivery) for the remaining 4 weeks of the study.
Receives: Other: Group A: $5 produce box
Group B: Free produce boxActive comparatorParticipants receive free weekly produce boxes for the first 4 weeks of the study and are then randomized to pay $10 per box (with continued free weekly delivery) for the remaining 4 weeks of the study.
Receives: Other: Group B: $10 produce box

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants in both groups who continue to participate in the program weekly in different pricing models

    Participant ordering in each group will be tracked weekly in RedCap for week 1, 2, 3, 4, 5, 6, 7, and 8.

    Measured: 8 weeks

Secondary outcomes (7)

  1. Evaluate the impact of the produce delivery program on perceived intake and enjoyment of fruits and vegetables

    The impact of the produce delivery program on perceived intake and enjoyment of fruits and vegetables will be measured using open-ended questions and 5-point Likert scale pre-enrollment, at midpoint during weeks 4-6, and at the end of the intervention after week 8. The measures of the scale include (1)Never, (2)Rarely, (3)Sometimes, (4)Often, and (5) Always.

    Measured: Up to 6 months

  2. Assess the efficacy of the produce delivery program in improving perceived diet

    The efficacy of the produce delivery program in improving perceived diet of participants and their children will be measured using open-ended questions and 5-point Likert scale pre-enrollment, at midpoint during weeks 4-6, and at the end of the intervention after week 8. The measures of the scale include (1) Strongly Disagree, (2) Disagree, (3) Neither Agree or Disagree, (4) Agree, and (5) Strongly Agree.

    Measured: Up to 6 months

  3. Evaluate the efficacy of the produce delivery program in improving perceived produce access, including attainability and cost, among the study population

    The efficacy of the produce delivery program in improving perceived produce access will be measured using open-ended questions and 5-point Likert scale pre-enrollment, at midpoint during weeks 4-6, and at the end of the intervention after week 8. The measures of the scale include (1) Strongly Disagree, (2) Disagree, (3) Neither Agree or Disagree, (4) Agree, and (5) Strongly Agree.

    Measured: Up to 6 months

  4. Assess self-efficacy among the study population in regards to preparing home-cooked meals, particularly with fruits and vegetables.

    Self-efficacy among the study population in regards to preparing home-cooked meals, particularly with fruits and vegetables will be measured using open-ended questions and 5-point Likert scale pre-enrollment, at midpoint during weeks 4-6, and at the end of the intervention after week 8. The measures of the scale include (1) Strongly Disagree, (2) Disagree, (3) Neither Agree or Disagree, (4) Agree, and (5) Strongly Agree.

    Measured: Up to 6 months

  5. Evaluate for changes in reported food insecurity among the stated study population.

    Investigators will evaluate for food insecurity using a validated food insecurity screening tool pre-enrollment, at midpoint during weeks 4-6, and at the end of the intervention after week 8. Questions in the tool include (1)In the past 30 days, we worried that our food would run out before we got money to buy more; (2) In the past 30 days, the food we bought ran out and we didn't have money to get more; and (3) In the past 30 days, we couldn't afford to eat balanced meals. Response options include (1) Often True, (2) Sometimes True, and (3) Never True.

    Measured: Up to 6 months

  6. Determine if the Fresh Start produce delivery program leads to changes in food purchasing patterns among the study population.

    Impact of the produce delivery program leading to changes in food purchasing patterns will be measured using open-ended questions and 4-point Likert scale at midpoint during weeks 4-6 and at the end of the intervention after week 8. The measures of the scale include (1) I Buy Less, (2) I Buy The Same Amount, (3) I Buy More, and (4) Does Not Apply/I Have Never Bought This.

    Measured: Up to 6 months

  7. Assess participant satisfaction with the Fresh Start produce delivery program

    Investigators will assess participant satisfaction with the Fresh Start produce delivery program will be measured using open-ended questions and 5-point Likert scale at midpoint during weeks 4-6 and at the end of the intervention after week 8. The measures of the scale include (1)Very Unhappy, (2) Unhappy, (3)Neutral, (4)Happy, and (5) Very Happy.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2021
  2. Study start9 Jun 2021
  3. Primary completion23 Sep 2021
  4. Study completion10 Nov 2021

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Potential subjects will initially be recruited from a list of 30 parents who participated in the previous IRB-exempt, qualitative study (IRB 20-017497 - Fresh Start) and consented to be re-contacted for future studies. The remaining subjects will be recruited from a list of families who received a WIC prescription for their child(ren) from a provider at the Children's Hospital of Philadelphia (CHOP) Cobbs Creek between 2019-2020; this list was obtained via IT query of Epic for our prior study. No medical records will be accessed for screening for this study. Potential subjects will be screened using the protocol inclusion and exclusion criteria during the initial recruitment call.
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05153577
Sponsor's protocol ID
21-018757
Status last verified
Nov 2021
First submitted
30 Nov 2021
Last updated
10 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: N/A - The IPD will only be utilized by the researchers currently on the project.

Publications

  • Kim SA, Moore LV, Galuska D, Wright AP, Harris D, Grummer-Strawn LM, Merlo CL, Nihiser AJ, Rhodes DG; Division of Nutrition, Physical Activity, and Obesity, National Center for Chronic Disease Prevention and Health Promotion, CDC. Vital signs: fruit and vegetable intake among children - United States, 2003-2010. MMWR Morb Mortal Wkly Rep. 2014 Aug 8;63(31):671-6.

    PubMed 25102415

  • Di Noia J, Byrd-Bredbenner C. Determinants of fruit and vegetable intake in low-income children and adolescents. Nutr Rev. 2014 Sep;72(9):575-90. doi: 10.1111/nure.12126. Epub 2014 Aug 4.

    PubMed 25091630

  • Krolner R, Rasmussen M, Brug J, Klepp KI, Wind M, Due P. Determinants of fruit and vegetable consumption among children and adolescents: a review of the literature. Part II: qualitative studies. Int J Behav Nutr Phys Act. 2011 Oct 14;8:112. doi: 10.1186/1479-5868-8-112.

    PubMed 21999291

  • COUNCIL ON COMMUNITY PEDIATRICS; COMMITTEE ON NUTRITION. Promoting Food Security for All Children. Pediatrics. 2015 Nov;136(5):e1431-8. doi: 10.1542/peds.2015-3301.

    PubMed 26498462

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Food and Nutrition Board; Committee to Review WIC Food Packages. Review of WIC Food Packages: Improving Balance and Choice: Final Report. Washington (DC): National Academies Press (US); 2017 May 1. Available from http://www.ncbi.nlm.nih.gov/books/NBK435902/

    PubMed 28605175

  • Anderson JV, Bybee DI, Brown RM, McLean DF, Garcia EM, Breer ML, Schillo BA. 5 a day fruit and vegetable intervention improves consumption in a low income population. J Am Diet Assoc. 2001 Feb;101(2):195-202. doi: 10.1016/S0002-8223(01)00052-9.

    PubMed 11271692

  • Kropf ML, Holben DH, Holcomb JP Jr, Anderson H. Food security status and produce intake and behaviors of Special Supplemental Nutrition Program for Women, Infants, and Children and Farmers' Market Nutrition Program participants. J Am Diet Assoc. 2007 Nov;107(11):1903-8. doi: 10.1016/j.jada.2007.08.014.

    PubMed 17964309

  • Di Noia J, Monica D, Sikorskii A, Nelson J. Pilot Study of a Farm-to-Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Intervention Promoting Vegetable Consumption. J Acad Nutr Diet. 2021 Oct;121(10):2035-2045. doi: 10.1016/j.jand.2020.12.020. Epub 2021 Jan 22.

    PubMed 33487590

  • Lagisetty P, Flamm L, Rak S, Landgraf J, Heisler M, Forman J. A multi-stakeholder evaluation of the Baltimore City virtual supermarket program. BMC Public Health. 2017 Oct 23;17(1):837. doi: 10.1186/s12889-017-4864-9.

    PubMed 29061141

  • Townsend MS, Kaiser LL, Allen LH, Joy AB, Murphy SP. Selecting items for a food behavior checklist for a limited-resource audience. J Nutr Educ Behav. 2003 Mar-Apr;35(2):69-77. doi: 10.1016/s1499-4046(06)60043-2.

    PubMed 12725713

  • Couch SC, Glanz K, Zhou C, Sallis JF, Saelens BE. Home food environment in relation to children's diet quality and weight status. J Acad Nutr Diet. 2014 Oct;114(10):1569-1579.e1. doi: 10.1016/j.jand.2014.05.015. Epub 2014 Jul 23.

    PubMed 25066057

  • Lahne J, Wolfson JA, Trubek A. Development of the Cooking and Food Provisioning Action Scale (CAFPAS): A new measurement tool for individual cooking practice. Food Qual Prefer. 2017;62(July):96-105. doi:10.1016/j.foodqual.2017.06.022

  • Hager ER, Quigg AM, Black MM, Coleman SM, Heeren T, Rose-Jacobs R, Cook JT, Ettinger de Cuba SA, Casey PH, Chilton M, Cutts DB, Meyers AF, Frank DA. Development and validity of a 2-item screen to identify families at risk for food insecurity. Pediatrics. 2010 Jul;126(1):e26-32. doi: 10.1542/peds.2009-3146.

    PubMed 20595453

  • Joshi P, Van Remortel BJ, Rameswaran J, Cullen DL. Effect of Price on Women, Infants, and Children-Eligible Caregiver Participation in a Produce Program: A Randomized Trial. Acad Pediatr. 2025 Nov-Dec;25(8):102884. doi: 10.1016/j.acap.2025.102884. Epub 2025 Jul 9.

    PubMed 40645578

Questions about this trial

What is this clinical trial studying?

A study testing Group A: $5 produce box and Group B: $10 produce box in people with Food Insecurity, run by Children's Hospital of Philadelphia 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 8 inclusion and 3 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 10 Dec 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in both groups who continue to participate in the program weekly in different pricing models (time frame: 8 weeks). 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 NCT05153577, which also lists 14 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 10 Dec 2021.

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