Evidence update on the treatment of overweight and obesity in children and adolescents.
Myra Altman, Denise E Wilfley
https://pubmed.ncbi.nlm.nih.gov/25496471/Actively Recruiting
Led by The University of Tennessee, Knoxville · Updated on 2026-06-09
30
Participants Needed
2
Research Sites
3 weeks
Total Duration
Researchers are evaluating a 6-month family program called Eating Better Together to address childhood overweight and obesity in underserved children aged 4 to 10 years with a BMI above the 85th percentile. This program combines a behavioral intervention based on Prevention Plus, which focuses on improving fruit and vegetable intake, reducing sugar-sweetened beverages, increasing physical activity, and reducing screen time, with a fruit and vegetable prescription incentive to increase access to fresh produce. The study targets families with low income and food insecurity, aiming to improve child weight status and diet quality through a family-based approach. Families in the study will participate in the Prevention Plus program, which includes three in-person sessions at months 1, 3, and 5, and three phone calls at months 2, 4, and 6 with a Behavioral Health Consultant. During visits, child height, weight, and BMI are measured and feedback is provided. The program uses behavioral parenting strategies and self-monitoring tools for both children and caregivers to encourage healthy energy balance behaviors. In addition, families receive up to 60 per month in home deliveries of fresh fruits and vegetables from a local retail partner to support dietary goals. Participants will complete baseline assessments including questionnaires and anthropometric measurements. Throughout the study, families monitor child and caregiver behaviors using diaries and receive newsletters on nutrition. Progress is tracked through growth measurements and behavioral goals during sessions and calls. Outcome measures include participation rates, intervention completion, funds spent on produce deliveries, and changes in dietary intake, food security, and anthropometrics. The total study duration is approximately 6 months, with ongoing support and monitoring to enhance child health outcomes.
CONDITIONS
EBT Fruit and Vegetable Prescription
H
Hollie A Raynor, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
The University of Tennessee, Knoxville
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Family-Based Behavioral Program with FVx | Multicomponent Behavioral Care (Guideline Standard) |
|---|---|---|
| What it is | A family-based behavioral intervention for childhood obesity that includes three in-person sessions and three phone calls with a behavioral health consultant, plus a fruit and vegetable prescription to support healthy eating. | A family-based, multicomponent behavioral intervention recommended by clinical guidelines for pediatric obesity, typically involving nutrition counseling, physical activity support, behavior modification strategies, and regular follow-up. |
| Role in trial | This is the only intervention tested in the study; all eligible participants receive the family behavioral program and FVx. | Serves as the recommended current-care approach outside the trial for similar children, per national guidelines. |
| Primary use | Designed to help children maintain healthy weight and improve dietary habits, with a focus on family goal-setting and behavior change. | Aims to reduce BMI and prevent obesity complications in children through comprehensive behavioral counseling and lifestyle support. |
| How it is given or performed | Families attend three in-person meetings (months 1, 3, 5) and three 20-minute phone calls (months 2, 4, 6), receive FVx, and work with a consultant to set goals and monitor child's BMI. | Typically delivered as regular in-person or telehealth sessions with a multidisciplinary team, including nutrition, physical activity, and behavioral counseling, plus frequent follow-up visits. |
| Evidence status | This specific combination of FVx plus behavioral family-based intervention is under clinical investigation; published outcome evidence is not yet established. | Multicomponent behavioral treatments are supported by strong evidence and national guidelines for improving BMI and health outcomes in children with obesity. |
| Important limitations | Single-center study, limited sample size of 30 families, and real-world adherence may vary. Outcomes depend on both caregiver engagement and consistent FVx use. | Access to multidisciplinary care and intensive follow-up may be restricted in many communities, and real-world implementation can be challenging. Family engagement remains critical for success. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or phone)
Duration - 1 to 2 weeks
Families complete questionnaires and measurements of child height and weight to establish starting health status.
1 to 2 visits (in-person or home visit)
Duration - 6 months
Families participate in three 30-minute in-person or telehealth sessions and three 20-minute phone calls over 6 months. They receive behavioral guidance, track progress, and get home deliveries of fresh fruits and vegetables.
3 in-person or telehealth visits and 3 phone calls
Duration - 6 months
Researchers track participation, diet, growth, and behavior changes through questionnaires and diaries throughout the intervention period.
Ongoing assessments during visits and calls
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Myra Altman, Denise E Wilfley
https://pubmed.ncbi.nlm.nih.gov/25496471/Gabrielle G Banks, Kristoffer S Berlin, Tiffany M Rybak...
https://pubmed.ncbi.nlm.nih.gov/26117140/Jayne A Fulkerson, Melissa C Nelson, Leslie Lytle...
https://pubmed.ncbi.nlm.nih.gov/18983668/Andy Menke, Sarah Casagrande, Linda Geiss...
https://pubmed.ncbi.nlm.nih.gov/26348752/Cynthia L Ogden, Margaret D Carroll, Tala H Fakhouri...
https://pubmed.ncbi.nlm.nih.gov/29447142/Susan M Krebs-Smith, TusaRebecca E Pannucci, Amy F Subar...
https://pubmed.ncbi.nlm.nih.gov/30146071/Jessica Marcinkevage, Alyssa Auvinen, Susmitha Nambuthiri
https://pubmed.ncbi.nlm.nih.gov/31322108/Shannon M Looney, Hollie A Raynor
https://pubmed.ncbi.nlm.nih.gov/25006118/R C Whitaker, M S Pepe, J A Wright...
https://pubmed.ncbi.nlm.nih.gov/9481024/The University of Tennessee, Knoxville
Lead Sponsor