Recruiting

Healthy Eating

Sponsor:

The University of Tennessee, Knoxville

Code:

NCT05028205

Conditions

Childhood Obesity

Obesity

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Accepted

Interventions

Prevention Plus

Study Details

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.

Conditions

Childhood Obesity

Obesity

Study ID

NCT05028205

Start date

Aug 16, 2021

Status verified date

Jun, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Dec 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 10

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prevention Plus

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.

Interventions

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.

Primary outcome measure

  • Project Reach, the number of participants who participate in the study [ Time Frame: through study completion, an average of 6 months ]
  • 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 ]
  • Project Reach, total number of participants/patients who meet eligibility criteria [ Time Frame: through study completion, an average of 6 months ]
  • Intervention Session Completion [ Time Frame: through study completion, an average of 6 months ]
  • Funds spent on FV deliveries [ Time Frame: through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Hollie A Raynor, PhD

865-974-9126hraynor@utk.edu

Locations

Cherokee Health Systems, Dameron Avenue Pedatrics

Recruiting

Knoxville, Tennessee, United States, 37917

Contacts

More Information

Sponsor

The University of Tennessee, Knoxville

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Fruit and Vegetable Prescription
  • Food Security

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Tennessee, Knoxville on 2026-06-09.