EBT Fruit and Vegetable Prescription

BEHAVIORAL

Prevention Plus

Families will receive a behavioral intervention for childhood obesity provided by a BHC. This will consist of three, in-person meetings (months 1, 3, and 5), and three, 20-minute phone calls (months 2,4, and 6). During in-person visits, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. During these sessions, families will receive feedback on child growth and weight status. Prevention Plus materials and child and caregiver energy balance behavior goals will be reviewed. The phone calls will be with the caregiver, where caregivers will be asked to measure the height and weight of their child, calculate BMI, and plot on the BMI-for-age growth chart. The BHC will discuss the family's progress on achieving child and caregiver goals and implementation of behavioral parenting strategies. Families will receive a fruit and vegetable prescription (FVx) in addition to the standard Prevention Plus family-based behavioral weight loss treatment.

Project Reach, the number of participants who participate in the study

Time frame: through study completion, an average of 6 months

Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who participate in the study.

Project Reach, participants who are eligible to participate in this study, but decline to participate in the study

Time frame: through study completion, an average of 6 months

Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the number of participants who are eligible to participate in this study, but decline to participate in the study.

Project Reach, total number of participants/patients who meet eligibility criteria

Time frame: through study completion, an average of 6 months

Measurement in project reach will aid in the evaluation of the implementation process for the study, and will help us determine the feasibility of a larger study. Reach will be determined using the data from the EHR at CHS. Specifically, investigators will use data reports from the EHR to determine the total number of participants/patients who meet the eligibility criteria for the study.

Intervention Session Completion

Time frame: through study completion, an average of 6 months

Completion of the number of each intervention session will be documented in the EHR.

Funds spent on FV deliveries

Time frame: through study completion, an average of 6 months

Looking at total amount spent of FV deliveries will help us to identify if the fruit and vegetable prescription program was implemented as intended.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.