Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
Healthy Volunteers
ID05028205

Eating Better Together: A Pilot Study for Childhood Overweight and Obesity Including a Fruit and Vegetable Prescription Intervention

Led by The University of Tennessee, Knoxville · Updated on 2025-04-03

30

Participants Needed

2

Research Sites

3 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a 6-month pilot program called Eating Better Together, aimed at helping families with children aged 4 to 10 years who have overweight or obesity. This program addresses health disparities by focusing on healthy eating and activity habits in underserved families, particularly those with low income. The study builds on a previously tested family-based intervention called Prevention Plus, which targets fruit and vegetable intake, sugar-sweetened beverage consumption, physical activity, and screen time, using behavior change techniques. Families participating in the study will receive the Prevention Plus behavioral intervention delivered by a Behavioral Health Consultant through three in-person sessions at months 1, 3, and 5, and three phone calls at months 2, 4, and 6. During these contacts, children's height and weight are measured, and families receive feedback on growth and weight status. In addition to this, families will be given a fruit and vegetable prescription that provides home delivery of fresh fruits and vegetables up to $60 per month to support dietary goals. The intervention alternates between in-person and phone sessions to reduce family time costs and may be conducted in person or via telehealth based on policies. Participants will be involved in regular assessments including height, weight, and BMI measurements, and will monitor dietary and physical activity behaviors using diaries provided. The study will track participation rates, delivery of fruit and vegetable prescriptions, dietary changes, food security, and anthropometrics over the six-month period. Families will receive materials to support behavior changes and will be contacted regularly to encourage progress. The total participation duration is approximately six months, with ongoing support and feedback throughout.

CONDITIONS

Brief Title

EBT Fruit and Vegetable Prescription

Who Can Participate

Age: 4Years - 10Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 willing to participate in the program
  • Adult caregivers need to be able to read and speak English
Not Eligible

You will not qualify if you...

  • Not patients at the CHS Knox County Pediatric Clinic
  • Child not within the 4 to 10 years age range
  • Child BMI at or below the 85th percentile
  • Child without an adult caregiver (> 18 years) living in the household and not willing to participate
  • Adult caregivers unable to read and speak English

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Baseline Assessment

Duration - 1 to 2 weeks

Participants complete questionnaires and have anthropometric measurements taken to establish baseline health data.

1 visit (in-person or at home) for measurements and questionnaires

Outpatient Treatment

Duration - 6 months

Participants engage in a 6-month family-based behavioral weight loss intervention including in-person sessions and phone calls focusing on energy balance behaviors and fruit and vegetable intake, supplemented by a fruit and vegetable prescription program with home deliveries.

3 in-person visits (months 1, 3, and 5) and 3 phone calls (months 2, 4, and 6)

Trial Site Locations

Total: 2 locations

1

Cherokee Health Systems, Dameron Avenue Pedatrics

Knoxville, Tennessee, United States, 37917

Actively Recruiting

2

Healthy Eating and Activity Laboratory

Knoxville, Tennessee, United States, 37996

Enrolling by Invitation

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Research Team

H

Hollie A Raynor, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Skinner AC, Ravanbakht SN, Skelton JA, Perrin EM, Armstrong SC. Prevalence of Obesity and Severe Obesity in US Children, 1999-2016. Pediatrics. 2018;141(3):e20173459.

https://pubmed.ncbi.nlm.nih.gov/30177517

Prevalence of Obesity Among Youths by Household Income and Education Level of Head of Household - United States 2011-2014.

Cynthia L Ogden, Margaret D Carroll, Tala H Fakhouri...

https://pubmed.ncbi.nlm.nih.gov/29447142

Prevalence of diagnosed and undiagnosed type 2 diabetes mellitus among US adolescents: results from the continuous NHANES, 1999-2010.

Ryan T Demmer, Aleksandra M Zuk, Michael Rosenbaum...

https://pubmed.ncbi.nlm.nih.gov/23887044

Obesity evaluation and treatment: Expert Committee recommendations. The Maternal and Child Health Bureau, Health Resources and Services Administration and the Department of Health and Human Services.

S E Barlow, W H Dietz

https://pubmed.ncbi.nlm.nih.gov/9724677