Clinical trial NCT05153577: Fresh Start: Increasing Early Produce Intake
Official title: Fresh Start: Increasing Produce Access and Intake Among WIC-eligible Children in West Philadelphia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Insecurity
Keywords: WIC
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2021-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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

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.

Eligibility criteria: Inclusion Criteria:

Subjects must:

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

Exclusion Criteria:

Subjects must not:

1. 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.)
2. 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.

Primary outcomes:
measure: Number of participants in both groups who continue to participate in the program weekly in different pricing models
timeFrame: 8 weeks
Secondary outcomes:
measure: Evaluate the impact of the produce delivery program on perceived intake and enjoyment of fruits and vegetables
timeFrame: Up to 6 months
measure: Assess the efficacy of the produce delivery program in improving perceived diet
timeFrame: Up to 6 months
measure: Evaluate the efficacy of the produce delivery program in improving perceived produce access, including attainability and cost, among the study population
timeFrame: Up to 6 months
measure: Assess self-efficacy among the study population in regards to preparing home-cooked meals, particularly with fruits and vegetables.
timeFrame: Up to 6 months
measure: Evaluate for changes in reported food insecurity among the stated study population.
timeFrame: Up to 6 months
measure: Determine if the Fresh Start produce delivery program leads to changes in food purchasing patterns among the study population.
timeFrame: Up to 6 months
measure: Assess participant satisfaction with the Fresh Start produce delivery program
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Danielle Cullen, MD, MPH, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
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