Clinical trial NCT05028205: EBT Fruit and Vegetable Prescription
Official title: Eating Better Together: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Obesity
Obesity
Keywords: Fruit and Vegetable Prescription
Food Security
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Efficacious primary care-based childhood overweight/obesity interventions for children from low-income homes are needed to address health disparities. The University of Tennessee (UT) and Cherokee Health Systems (CHS), a federally qualified health center, has piloted a 6-month childhood overweight/obesity intervention for underserved children (R34DK109504). The intervention was based upon Prevention Plus, the recommended primary care-based treatment for childhood overweight/obesity, which includes targeting fruit and vegetable (FV) and sugar-sweetened beverage intake, physical activity, and screen time; incorporates behavior modification techniques, and uses a family-based approach. The intervention structure was designed to reduce family costs related to time, thus monthly contact alternated between in-person sessions and phone calls, and in-person sessions could occur using "warm hand-offs" between providers (allowed piggybacking of appointments). The pilot demonstrated CHS' ability to implement the intervention using their electronic health record (EHR). The intervention significantly reduced child standardized BMI (ZBMI).

While the intervention reduced ZBMI, the degree of reduction was below what is recommended to achieve cardiometabolic improvements in children (-0.25 ZBMI). Families (58.9% with a household income of \< $20,000/yr, 32.9% with household food insecurity, 50.7% receiving SNAP benefits, and 94.5% receiving free or reduced-price school meals) reported problems with having enough food, particularly FVs, which was a barrier for intervention participation. Thus, increasing the affordability of FVs may enhance the achievement of intervention dietary goals, which should increase diet quality and enhance ZBMI reduction.

One method to increase FV affordability is a prescription incentive program. In these programs, a "prescription," often for FVs, from a health care provider is given to the participant, and the prescription includes delivery of fresh FVs to the family's home. Adult FV prescription studies have reported increases in FV intake and decreases in BMI. In children, three uncontrolled studies reported that an FV prescription program increased FV intake, with the influence on child weight status not reported. Thus, to enhance the efficacy of our 6-month Prevention Plus intervention in addressing health disparities in childhood overweight/obesity, investigators will pilot test Prevention Plus, our tested intervention, with the addition of an FV prescription incentive program (Prevention Plus+FVx). For Prevention Plus+FVx, to assist families in achieving FV goals (FV prescription), they will receive up to $60/month ($1/day for each child and parent) deliveries of fresh FVs to their home from a local retail partner (Food City). Thirty families receiving their primary care from CHS, with an adult caregiver and a child aged 4 to 10 years with a BMI \> 85th percentile, will participate in the program.

Participants

CHS families eligible for the trial will be patients at the CHS Knox County Pediatric Clinic. Additional eligibility criteria include families with a child who is aged 4 to 10 years, with a BMI \> 85 percentile, who have an adult (\> 18 years) caregiver living in the household willing to participate in the program. The adult caregiver needs to be able to read and speak English; and be willing to shop for fresh fruits and vegetables at the Western Ave Food City store (1950 Western Ave., Knoxville, TN, 37921).

Recruitment

For recruitment, the EHR, via the client dashboard, will alert if a family is eligible when the EHR is opened by any primary care provider. This alert will prompt the provider to conduct a "warm hand-off" of the family to the Behavioral Health Consultant (BHC) in the clinic to start the enrollment process. The BHC will discuss the study with the family and will ask interested families to write their name and phone number at the bottom of an eligibility form, which will indicate that the family would like to be contacted by the research team. BHCs will provide families with a flyer about the program. After BHCs discuss the program with families, they will complete a template in the EHR indicating the enrollment status of the family. This will allow the EHR to give an appropriate alert (or not) to physicians in the future about the need (or not) of the "warm hand-off" of the family to the BHC.

Research staff will engage with interested potential participants in two ways. The first option is an in-person greeting at Cherokee Mills, an office campus that houses both the CHS Knox County Pediatric Clinic and a UT office space. When research staff are present at UT's Cherokee Mills office, BHCs will be able to introduce interested families to research staff in-person. If the family is interested and available, research staff can provide a study overview, complete an eligibility screening, and schedule an orientation session at that time. When staff are not present at Cherokee Mills, completed eligibility forms will be sent to the lead BHC at CHS, who will securely send scanned copies of the documents to Dr. Raynor's research team using Vault, UT's secure file transmission service. Once scanned/sent the original copies will be destroyed/shredded by the lead BHC at CHS. Interested potential families will be contacted by the research team and phone screened for eligibility. Eligible families will be invited to an orientation.

Orientations will be at in-person at UT's campus or UT's office space at Cherokee Mills, or online via Zoom, depending on the family's preference. All in-person meetings will follow any health safety procedures that are in place at the time of the meeting. The orientations sessions will occur one-on-one between a family and a research team member. Families will be mailed/emailed the consent forms prior to the orientation. For potential families who are interested, the research team will review the consent form at the end of the orientation and adult caregivers will sign consent forms and children will provide assent (verbal or written). Families that are engaging in the orientation online via Zoom will sign the consent/assent form on Qualtrics.

Baseline Assessment

Following the signing of the consent form, the complete baseline assessment will occur. This will include the completion of all questionnaires and measures of anthropometrics.

For orientations occurring online, following the signing of the consent form, questionnaires will be completed by verbally reviewing the questionnaires with families and collecting responses. An appointment will be set-up to collect height and weight (anthropometrics) measures at the participant's home or at UT's campus or the UT's office space at Cherokee Mills (the location will depend on participant preference). These meetings will follow health safety procedures in place at the time.

Study/Project Procedures

Following baseline assessment, families will begin the intervention. Children will continue to receive standard care at CHS. After attendance to the first intervention session (the 30-minute session in month 1 delivered by the BHC), families will receive a monthly newsletter on general nutrition topics (such as MyPlate or the Dietary Guidelines for Americans). Additionally, each family will receive a scale; a BMI-for-age growth chart; a binder for intervention materials; a self-monitoring diary to record the child's monthly height, weight, BMI, and BMI percentile; and picture-based diaries to monitor daily energy balance behaviors. Additional family materials will be included in the EHR template for each session. Family materials provided at each session will outline a process to measure growth and include information about how children grow, as well as cover behavioral parenting strategies to assist with changing child behavior (self-monitoring, modeling \[caretakers will be asked to make and monitor the same energy balance behavior changes as their child\], stimulus control, and positive reinforcement) for energy balance behaviors. These behavioral parenting strategies are based upon Social Cognitive Theory. Sessions will be written at the fifth-grade reading level.

Families will meet in person or via telehealth appointment (depending on the current standard of care at CHS, and University of Tennessee policy-- meaning that when CHS or UT has a policy place that does not allow in-person contact, investigators will hold these appointments via telehealth, when these policies are not in effect, the family can choose to attend the appointment in-person or via telehealth) with a BHC at the CHS clinic in which they receive care for 30 minutes during months 1, 3, and 5. In these sessions, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. Families will receive feedback about growth and the weight status of their child. Additionally, the session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietaryy and two leisure-time activity (energy balance) behaviors of the child. As is traditional in a family-based approach, the caregiver will also change the same energy balance behaviors as the child, as adult caregivers can then model healthy behaviors for the child, assisting the child in learning the new weight-related behaviors. Thus, both the caregiver and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. Achievement of energy balance behavior goals of both the child and the caregiver will be reviewed (via the picture-based diaries) and BHCs will problem-solve areas to assist families with achieving goals, suggesting the use of the behavioral parenting strategies as needed.

During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caregiver. Caregivers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. During the call, the BHC will provide feedback on the changes in child growth since the previous contact. Additionally, the BHC will discuss the family's progress on achieving child and caregiver energy balance behavior goals and implementation of behavioral parenting strategies.

The child's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverages (e.g., regular carbonated soft drinks, sports drinks, lemonades, ice teas, flavored milk, juice drinks \< 100% juice, and punches) servings /wk, ≥1 1/2 cups/day of whole vegetables and ≥ 1 cup/day of whole fruit, engage in ≥ 60 minutes/day of moderate- to vigorous-intensity physical activity, and reduce TV viewing to \< 2 hours/day. The caregiver's energy balance behavioral goals will be to consume \< 3 sugar-sweetened beverage servings/wk, ≥ 2 1/2 cups/day of whole vegetables and ≥ 1 1/2 cups/day of whole fruit, engage in ≥ 150 minutes of moderate- to vigorous-intensity physical activity per week and reduce TV viewing to \< 10 hours/wk. To increase self-efficacy, the goals will be incrementally increased, with families implementing the full program goals at month four. Additionally, children and caregivers will be asked to achieve at least three of the five goals each day (child) or week (adult caregiver). The cost will be considered in all sessions, with BHC's providing low-cost options for achieving goals (purchasing canned or frozen fruits and vegetables to eat instead of fresh fruits and vegetables).

To help children and families meet their goals-particularly their dietary goals related to fruit and vegetable consumption-- families will receive a fruit and vegetable prescription (FVx) in addition to the standard Prevention Plus family-based behavioral weight loss treatment. The FVx will include home deliveries of fresh FVs from our retail grocery partner (Food City), up to $60/month for each session attended. Families will have access to the $60 for one month and then it will expire. Families will receive weekly texts that include available delivery windows, remaining funds for the month, and reminders of expiration date.

Eligibility criteria: Inclusion Criteria:

* 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
* Adult caregivers need to be able to read and speak English

Exclusion Criteria:

* 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
* Adult caregivers that are not able to read and speak English

Primary outcomes:
measure: Project Reach, the number of participants who participate in the study
timeFrame: through study completion, an average of 6 months
measure: Project Reach, participants who are eligible to participate in this study, but decline to participate in the study
timeFrame: through study completion, an average of 6 months
measure: Project Reach, total number of participants/patients who meet eligibility criteria
timeFrame: through study completion, an average of 6 months
measure: Intervention Session Completion
timeFrame: through study completion, an average of 6 months
measure: Funds spent on FV deliveries
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Demographics
timeFrame: Baseline only
measure: Household Information
timeFrame: Change from baseline and through study completion, an average of 6 months
measure: Food Purchasing and Household Food Availability
timeFrame: Change from baseline and through study completion, an average of 6 months
measure: Food Security
timeFrame: Change from baseline and through study completion, an average of 6 months
measure: Dietary Intake of Fruits and Vegetables
timeFrame: Change from baseline and through study completion, an average of 6 months
measure: Beverage Intake
timeFrame: Change from baseline and through study completion, an average of 6 months
measure: Anthropometrics
timeFrame: Change from baseline and through study completion, an average of 6 months
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Cherokee Health Systems, Dameron Avenue Pedatrics
state: Tennessee
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory
state: Tennessee
Study officials:
affiliation: University of Tennessee, Knoxville
name: Hollie A Raynor, PhD
role: PRINCIPAL_INVESTIGATOR
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