EBT Fruit and Vegetable Prescription
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorThe University of Tennessee, Knoxville
About this trial
Eating Better Together is a 6-month pilot program that teaches families about healthy eating and activity and provides home deliveries of fresh fruits and vegetables from a local retail partner.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients at the Cherokee Health Systems clinic in Cherokee Mills
Child age between 4 to 10 years old
Child BMI > 85th percentile
Child must have an adult caregiver (> 18 years) living in the household and be willing to participate in the program
Disqualifiers
Not patients at the CHS Knox County Pediatric Clinic
A child not within the 4 to 10 years age range
Child BMI at or below the 85 percentile
Child without an adult caregiver (> 18 years) living in the household and not willing to participate in the program
Trial design
Design model
Single group
Treatments tested in this trial
Prevention Plus
BehavioralFamilies 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Prevention PlusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Project Reach, the number of participants who participate in the study
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.
Time frame
through study completion, an average of 6 months2
Project Reach, participants who are eligible to participate in this study, but decline to participate in the study
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.
Time frame
through study completion, an average of 6 months3
Project Reach, total number of participants/patients who meet eligibility criteria
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.
Time frame
through study completion, an average of 6 months4
Intervention Session Completion
Completion of the number of each intervention session will be documented in the EHR.
Time frame
through study completion, an average of 6 monthsSecondary outcomes
1
Demographics
Will be assessed and used to describe the study sample. Demographics collected will include: child and caregiver measures of age, gender, race/ethnicity, and caregiver measures of marital status, caregiver education level, employment status, and income.
Time frame
Baseline only2
Household Information
The number of people living in the household and federal food program participation (e.g., SNAP, WIC, NSLP) will be collected.
Time frame
Change from baseline and through study completion, an average of 6 months3
Food Purchasing and Household Food Availability
This assessment asks participants about food purchasing habits and to report of selected common food and beverage items had been purchased for the household in the last month, as well as, if the food or beverage item is available in the home. This assessment will allow us to explore differences in food purchasing patterns, and differences in the healthfulness of the food/beverages available in the home before and after the provision of the weight management intervention with fruit and vegetable home deliveries.
Time frame
Change from baseline and through study completion, an average of 6 months4
Food Security
Food security will be assessed using the gold-standard, USDA food security modules to test for food insecurity in both adults and children in a household.
Time frame
Change from baseline and through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov